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Part IV

Environmental

Protection Agency

40 CFR Part 799

Testing of Certain High Production

Volume chemicals; Data Collection and

Development on High Production Volume

(HPV) Chemicals; Proposed Rule and

71 Notice
p. 2

81658 Federal Register/ Vol . 65, No. 248/Tuesday, December 26, 2000/Proposed Rule s

ENVIRONMENTAL PROTECTION Data developed under this proposed proper receipt by EPA, it is imperative

AGENCY rule will provide critical information that you identify docket control number

about the environmental fate and OPPTS-42213A in the subject line on

40 CFR Pa rt 799 potential hazards associated with these the first page of your response .

[OPPTS-42213A ; FRL-6758-4] chemicals which, when combined with FOR FURTHER INFORMATION CONTACT: For

information about exposure and uses, general information contact : Barbara RIN 2070-AD16 will allow the Agency and others to Cunningham, Acting Director,

Testing of Ce rtain High Production evaluate potential health and Environmental Assistance Division

Volume Chemicals environmental risks and take (7408), Office of Pollution Preventio n

appropriate follow up action . Persons and Toxics, Environmental Protection

AGENCY: Environmental Protection who export or intend to export any Agency, 1200 Pennsylvania Ave ., NW.,

Agency (EPA). chemical substance included in the final Washington, DC 20460 ; telephone

ACTION : Proposed rule. rule based on this proposed rule would numbers: (202) 554-1404 ; e-mail

be subject to the export notification address: TSCA-HotlineQepa,gov . SUMMARY: EPA is proposing a test rule requirements in TSCA section 12(b)(1) For technical information contact :

under section 4(a)(1)(B) of the Toxic and at 40 CFR part 707, subpart D . EPA Keith Cronin, Chemical Control

Substances Control Act (TSCA) to has also taken steps, as described in this Division (7405), Office of Pollution

require manufacturers (including document, to consider animal welfare Prevention and Toxics, Environmental

importers) and processors of certain and to provide instructions on ways to Protection Agency, 1200 Pennsylvania

high production volume (HPV) chemical reduce or in some cases eliminate Ave„ NW ., Washington, DC 20460 ;

substances to conduct testing for acute animal testing, while at the same time telephone number : (202) 260-8130 ; fax toxicity; repeat dose toxicity ; ensuring that the public health is number: (202) 260-1096 ; e-mail address:

developmental and reproductive protected, ccd .citb@epa .gov.

toxicity; genetic toxicity (gen e

mutations and chromosomal DATES : Comments, identified by docket SUPPLEMENTARY INFORMATION :

aberrations); ecotoxicity (in fish, control number OPPTS-42213A, must I

. General Information

Daphnia, and algae) and environmental be received by EPA on or before April

fate (including five tests for physical 25, 2001 . If you want to request an A . Does this Action Apply to Me?

chemical and opportunity to present oral comments, proper-ties You may be affected by this action if

biodegradation). EPA has preliminarily refer to Unit I.E. of the SUPPLEMENTARY you manufacture (defined by statute to

determined that each of the 37 chemical INFORMATION . Your request must be in include import) or process any of the

substances included in this proposed writing and must be received by EPA on chemical substances that are listed in

rule is produced in substantial or before January 25, 2001 . Only if such § 799,5085(j) of the proposed regulatory

quantities and that there is substantial a request is received, would EPA text. Any use of the term "manufacture"

human exposure to each of them, schedule a public meeting on this in this document will encompass

Moreover, EPA believes that there are proposed rule, which would be "import," unless otherwise stated . In

insufficient data to reasonably announced in a subsequent document in addition, as described in Unit VI . , once

determine or predict the effects on the Federal Register and held in the Agency issues a final rule, any

health or the environment of the Washington, DC. person who exports, or intends to

manufacture, distribution in commerce, ADDRESSES : Comments may be export, any of the chemical substances

processing, use, or disposal of the submitted by mail, electronically, or in included in the final rule will be subject

chemicals, or any combination of these person . Please follow the detailed to the export notification requirements

activities. EPA has concluded that this instructions for each method as in 40 CFR part 707, subpart D .

proposed testing program is needed and provided in Unit I. of the Potentially affected entities may

appropriate for developing such data . SUPPLEMENTARY INFORMATION, To ensure include, but are not limited to:

TABLE 1 .-ENTITIES POTENTIALLY AFFECTED BY THE PROPOSED TESTING REQUIREMENTS

Type of entity NAICS codes Examples of potentially affected entities

Chemical Manufacturers (including Import- 325, 32411 Persons who manufacture (defined by statute to include import) one

ers) or more of the subject chemical substances .

Processors 325, 32411 Persons who process one or more of the subject chemical substances.

This listing is not intended to be examine the applicability provisions in process any of the chemical substance s

exhaustive, but rather provides a guide Unit V.E. entitled Would I be required that are listed in § 799 .5085(j) of the

for readers regarding entities likely to be to test under this rule? and consult the proposed regulatory text .

affected by this action. Other types of proposed regulatory test . If you have B. How Can I Get Additional

entities not listed in Table 1 of this unit any questions regarding the

Information, Including Copies of this could also be affected. The North applicability of this action to a

American Industrial Classification particular entity, consult the technica Document or Other Related Documents? l

System (NAICS) codes have been person listed under FOR FURTHER 1 . Electronically. You may obtain

provided to assist you and others in INFORMATION CONTACT. electronic copies of this document, and

determining whether this action might If you are an entity identified in Table certain other related documents from

apply to certain entities . To determine 1 of this unit, you would only be subject the EPA Internet Home Page at http ://

whether you or your business is affected to the testing requirements contained in www.epa .gov/. To access this

by this action, you should carefully this proposed rule if you manufacture or document, on the Home Page select
p. 3

Federal Register / Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 8165 9

"Laws and Regulations," "Regulations Agency, 1200 Pennsylvania Ave ., NW., the scheduling of the public meeting in

and Proposed Rules," and then look up Washington, DC 20460 . a subsequent document in the Federal

the entry for this document under 2 . In person or by courier. Deliver Register. If a public meeting is

"Federal Register-Environmental your comments to: OPPT Document announced, and if you are interested in

Documents." You can also go directly to Control Office (DCO), East Tower Rm . attending or presenting oral and/or

the Federal Register listings at http :// C-099, Waterside Mall, 401 M St., SW„ written comments at the public meeting,

www.epa .gov/fedrgstr/. Washington, DC. The DCO is open from you should follow the instructions

You may also access additional 8 a.m. to 4 p.m., Monday through provided in the subsequent document

information about the Chemical Right- Friday, excluding legal holidays . The announcing the public meeting .

to-Know Program at http ://ww.epa .gov/ telephone number for the DCO is (202 )

chemrtk/ or about the TSCA testing 260-7093 . F. What Should I Consider as I Prepare

program at http ://www.epa .gov/ 3 . Electronically. You may submit My Comments for EPA?

opptintr/chemtest/. For your your comments electronically by e-mail EPA invites you to provide your

convenience, EPA may have also to : oppt.ncic@epa .gov or mail your views on the various options proposed,

provided some non-EPA internet computer disk to the address identified new approaches not yet considered, the

addresses. In doing so, the Agency has above . Do not submit any information potential impacts of the various options

verified the accuracy of these addresses electronically that you consider to be (including possible unintende d

at the time of signature . However, since CBI. Electronic comments must be consequences), and any data or

EPA is not responsible for these non- submitted as an ASCII file avoiding the information that you would like the

EPA sites, the Agency does not have any use of special characters and any form Agency to consider during th e

control over these addresses. A paper of encryption . Comments and data will development of the final rule . You may

copy of any document referenced in this also be accepted on standard computer find the following suggestions helpful

way has been included in the public disks in WordPerfect 6/7/8/9 or ASCII for preparing your comments :

version of the official record for this file format . All comments in electronic 1 . Explain your views as clearly as

document as described in Unit I.B.2 . form must be identified by docket possible.

2 . In person.

The Agency has control number OPPTS-42213A, 2 . Describe any assumptions that you

established an official record for this Electronic comments may also be filed used .

action under docket control number online at many Federal Depository 3 . Provide copies of any technical

OPPTS-42213A. The official record Libraries. information and/or data you used that

consists of the documents referenced in D. How Should I Handle CBI That I support your views ,

this action, any public comments Want to Submit to the Agency? 4 . If you estimate potential burden or

received during applicable comment costs, explain how you arrived at the an aPP Do not submit any information estimate

.

period, and other information related to electronically that you consider to be 5, Provide specific examples to

this action, including information CBI. You may claim information that illustrate your concerns

.

claimed as Confidential Business you submit to EPA in response to this 6 . Offer alternative ways to improve Information (CBI). This official record document as CBI by marking any part or the rule or collection activity,

includes the documents that are all of that information as CBI . 7. Make sure to submit your

physically located in the docket, as well Information so marked will not be comments by the deadline listed unde r

as the documents that are referenced in disclosed except in accordance with DATES .

those documents. The public version of procedures set forth in 40 CFR part 2 . 8. To ensure proper receipt by EPA,

the official record does not include any In addition to one complete version of be sure to identify the docket control

information claimed as CBI. The public the comment that includes any number assigned to this action in the

version of the official record, which information claimed as CBI, a copy of subject line on the first page of your

includes printed, paper versions of any the comment that does not contain the response . You may also provide the

electronic comments submitted during information claimed as CBI must be name, date, and Federal Registe r

an applicable comment period, is submitted for inclusion in the public citation .

available for inspection in the TSCA version of the official record

Nonconfidential Information Center, Information not marked confidential t . II. Authori y

Rm, NE B-607, 401 M St., SW., will be included in the public version This document proposes a test rule

Washington, DC. The Center is open of the official record without prior under section 4(a)(1)(B) of TSCA, 15

from noon to 4 p .m„ Monday through notice. If you have any questions about U .S.C. 2603(a)(1)(B), that would require

Friday, excluding legal holidays. The CBI or the procedures for claiming CBI1 certain health and environmental tests

telephone number for the Center is (202) consult the technical person listed for 37 chemical substances that are

260-7099, under FOR FURTHER INFORMATION produced in substantial quantities, and

C. How and to Whom Do I Submit CONTACT . that enter or may reasonably be

Comments? E. Can I Request an Opportunity to anticipated to enter the environment in

substantial quantities and/or to which

You may submit comments through Present Oral Comments to the Agency? there is or may be significant o r

the mail, in person, or electronically. To You may submit a request for an substantial human exposure . The tests

ensure proper receipt by EPA, it is opportunity to present oral comments . pertain to acute toxicity; repeat dose

imperative that you identify docket This request must be made in writing. toxicity; developmental and

control number OPPTS-42213A in the If such a request is received on or before reproductive toxicity ; genetic toxicity

subject line on the first page of your January 25, 2001, EPA will hold a (gene mutations and chromosomal

response . public meeting on this proposed rule in aberrations); ecotoxicity (tests in fish ,

1 . By mail. Submit your comments to : Washington, DC. This written request Daphnia, and algae); and environmental

Document Control Office (7407), Office must be submitted to the address fate (including five tests for physica l

of Pollution Prevention and Toxics provided in Unit I.C.1 and 2 . If such a chemical properties and

(OPPT), Environmental Protection request is received, EPA will announce biodegradation) . Some or all of these
p. 4

81660 Federal Register/ Vol. 65, No. 248/ Tuesday, December 26, 2000 /Proposed Rules

tests would be required for a particular Once the Administrator has made a data . For the remaining chemicals,

chemical substance, depending upon finding under TSCA section 4(a)(1), EPA limited amounts of the data are

what data are already available for that may require any type of health or available . This lack of available hazard

substance . environmental effects testing necessary data compromises EPA's and others'

Section 2(b)(1) of TSCA, 15 U.S.C. to address unanswered questions about ability to determine whether these HP V

2601(b)(1), states that it is the policy of the effects of the chemical substance . chemicals pose potential risks to human

the United States that "adequate data EPA need not limit the scope of testing health or the environment, as well as

should be developed with respect to the required to the factual basis for the the public's right-to-know about the

effect of chemical substances and TSCA section 4(a)(1)(A)(i) or (B)(i) hazards of chemicals that are found in

mixtures on health and the environment findings, as long as EPA finds that there their environment, their homes, their

and that the development of such data are insufficient data and experience workplaces, and the products that they

should be the responsibility of those upon which the effects of the buy. It is EPA's intent to close this

who manufacture [which is defined by manufacture, distribution in commerce, knowledge gap . EPA believes that for

statute to include import] and those processing, use, or disposal of such most of the HPV chemicals, insufficient

who process such chemical substances substance or mixture or of any data are readily available to reasonably

and mixtures [ .]" To implement this combination of such activities on health determine or predict the effects on

policy, TSCA section 4(a) mandates that or the environment can reasonably be health or the environment from the

EPA require by rule that manufacturers determined or predicted, and that manufacture (including importation),

and processors of chemical substances testing is necessary to develop the data, distribution in commerce, processing,

and mixtures conduct testing if the This approach is explained in more use, or disposal of the chemicals, or any

Administrator finds that : detail in EPA's statement of policy for combination of these activities . EPA ha s

(1)(A)(i) the manufacture, distribution in making findings under TSCA section concluded that a program to collect and,

commerce, processing, use, or disposal of a 4(a)(1)(B) (frequently described as the where needed, develop basic screening

chemical substance or mixture, or that any "B" policy) in the Federal Register of level toxicity data is necessary and

combination of such activities, may present May 14, 1993 (58 FR 28736) (Ref . 24 at appropriate to provide information in

an unreasonable risk of injury to health or the 28738_28739) . order to assess the potential hazards/

environment, In this proposed rule, EPA intends to risks that may be posed by exposure to

(ii) there are insufficient data and use its broad TSCA section 4 authority HPV chemicals ,

experience upon which the effects of such to obtain the data necessary to support On April 21, 1998, a national effort, manufacture, distribution in commerce,

processing, use, or disposal of such substance the development of preliminary or known as the "Chemical Right-Toor mixture or of any combination of such "screening level" hazard and risk Know" (ChemRTK) Program, was

activities on health or the environment can characterizations for certain HPV announced in order to empower citizen s

reasonably be determined or predicted, and chemical substances (see § 799 .5085(j) with knowledge about the most

(iii) testing of such substance or mixture of the proposed regulatory text for the widespread chemicals in commercewith respect to such effects is necessary to list of chemicals). EPA has made chemicals that people may be exposed

develop such data ; or preliminary findings for these chemicals to in the places where they live, work,

(B)(i) a chemical substance or mixture is or under TSCA section 4(a)(1)(B) that : study, and play. EPA's ChemRTK

will be produced in substantial quantities, They are produced in substantia

l

anticipated to enter the environment in quantities

; Program is being designed in such a way

and (I) it enters or may reasonably be there is or may be substantial as to make certain basic informatio

n substantial quantities or (II) there is or may human exposure to them ; existing data about HPV chemicals available to the

public . be significant or substantial human exposure are insufficient to determine or predict pu EPA plans to make available to th

e to such substance or mixture, their health and environmental effects

(ii) there are insufficient data and and testing is necessary to develop such; public the summarized data obtained on

pexperience upon which the effects of the data, Testing for additional HPV HPV chemicals . Additional information

manufacture, distribution in commerce, chemical substances (Ref . 1) will be that EPA receives will also be shared

processing, use, or disposal of such substance with the public, other Federal agencies,

or mixture or of any combination of such proposed at a later date as the Agency and any other interested parties . As

activities on health or the environment can learns more about these additional appropriate, this information will be

reasonably be determined or predicted, and substances with respect to human used to ensure a scientifically soun

d

(iii) testing of such substance or mixture exposure, release, and sufficiency of the basis for risk assessment/management

with respect to such effects is necessary to data and experience available on the actions

develop such data 1 . This effort, will serve to further .1 hazards of the substances

. the Agency's goal of identifying and

If EPA makes these findings for a III. Background controlling human and environmental

chemical substance or mixture, the risks as well as providing greater

Administrator must require by rule that A. Why is EPA Pursuing Hazard

protection and knowledge to the public .

testing be conducted on that chemical Information on HPV Chemicals.

In addition, EPA and other parties substance or mixture . The purpose of EPA found that, of those non- agreed to work with other nations and

the testing would be to develop data polymeric organic substances produced international groups to ensur e

about the substance or mixture's health or imported in amounts equal to or commensurate increases in the pace of

and environmental effects where there greater than 1 million pounds per year complementary voluntary international

is an insufficiency of data and based on 1990 reporting for EPA's data collection and development efforts

experience, in order to support a Inventory Update Rule (IUR) (40 CFR on HPV chemicals

.

determination that the manufacture, part 710), only 7% have a full set of This ChemRTK Program is consistent

distribution in commerce, processing, publicly available internationally with the U .S . policy as presented in the

use or disposal of the substance or recognized basic health and TSCA . Section 2(b)(1) of TSCA, 15

mixture, or any combination of such environmental fate/effects screening test U.S.C. 2601(b)(1), states that it is the

activities, does or does not present an data (Ref. 2). Of the over 2,800 U .S. HPV policy of the United States that

unreasonable risk of injury to health or chemicals based on 1990 data, 43% "adequate data should be developed

the environment . have no publicly available basic hazard with respect to the effect of chemical
p. 5

Federal Register / Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 81661

substances and mixtures on health and HPV chemicals . EPA's study found C. Why is EPA Focusing on HPV

the environment and that the major gaps in the basic information on Chemicals ?

development of such data should be the HPV chemicals that is readily available It is generally accepted that chemicals

responsibility of those who manufacture to EPA and to the public, and reinforced having a high level of production have

and those who process such chemical the need for governmental leadership on an increased potential for exposure in

substances and mixtures." this issue. The study analyzed the comparison to low production volume

B. What Do We Currently Know About availability of test data for 2,863 HPV chemicals, The focus on HPV chemicals

the Basic Health and Environmental chemicals (defined as those non

- polymeric organic substances produced is derived from the experience gaine d

Hazards of HPV Chemicals?

in or imported into the United States in over the past 15 years by EPA and the

The information relevant to OECD. The OECD is a n

amounts equal to or greater than 1 intergovernmental organization understanding the basic health and million pounds per year based on 1990 consisting of 29 developed countries,

environmental hazards of HPV reporting for EPA's IUR (40 CFR part includin the United States, with

chemicals is derived from a battery of 710) . EPA searched for publicly g

tests agreed upon by the international available data on these chemicals and advanced worldwide market economies.

community as appropriate for screening The OECD is helping coordinate a

international HPV chemical substances have been tested for any or most of the y learned that most of them may never coo erative, international effort to

p

for toxicity . Six basic testing endpoints SIDS endpoints. The search strategy secure basic toxicity information on

have been adopted by the Organization HPV chemicals in use worldwide .

used a total of 11 publicly accessible The OECD, after considerin a varie for Economic Cooperation and g yt

Development (OECD) as the minimum data bases in its analysis. Details of the of priority setting approaches ,

required to screen international HPV report (Ref, 2) search strategy can be found in the concluded in 1990 that consideration of

chemical substances for toxicit . The major conclusions of HPV status provided a useful and

y endpoints, 4) . EPA's study are described in Unit III.A, effective organizing focus for a

The agreed-upon testing p In June 1998, the American Chemistry voluntar testin and assessment effort

known as the OECD's Screening Council (ACC, formerly the Chemical y g Information Data Set (SIDS) include : y to screen and thereby identify priorities

Acute toxicity; repeat dose toxicity ; Manufacturers Association (CMA)) among international HPV chemicals,

developmental and reproductive issued a report (Ref. 3) regarding public In the late 1980s, OECD initiated a

toxicity; genetic toxicity (gene data availability for HPV chemicals voluntary program to ensure that basic

mutations and chromosomal based on a study conducted with 11 information is available on international

aberrations); ecotoxicity (studies in fish, main data sources, including data HPV chemicals . This program, which is

Daphnia, and algae); and environmental sources other than those searched by a part of the OECD's program o n

fate (including physical/chemical EPA for its study . The ACC report, existing chemicals, produced an

properties [melting point, boiling point, entitled Public Availability of SIDS- internationally agreed upon set of basic

vapor pressure, n-octanol/water Related Testing Data for U.S. High SIDS screening tests and is working to

partition coefficient, and water Production Volume Chemicals (Ref. 3) develop complete SIDS data sets for all

solubility], photolysis, hydrolysis, reached conclusions similar to EPA, that international HPV chemicals . The SIDS

transport/distribution, and is, that only limited toxicity and includes information on the identity of

biodegradation). As conceived by the environmental fate data appear to exist each chemical, uses, sources and extent

OECD, the "SIDS battery" of tests can be in the public domain for many U.S. HPV of exposure ; physical and chemical

used by governments to conduct an substances. Details of the search strategy properties; environmental fate ; and

initial assessment of the hazards and used can be found in the ACC report certain limited toxicity data for humans

risks posed by HPV chemical substances (Ref. 3), and the environment. The SIDS is not

and prioritize HPV chemicals to identify EPA recognizes that additional data intended to describe a chemica l

those in need of additional, more in- may exist beyond those identified thoroughly, but rather is intended to

depth testing and assessment . through either the EPA, ACC, or provide enough information to support

A need for basic screening level data Environmental Defense studies. To the an initial (or screening) assessment an d

on HPV chemicals has been identified extent that additional relevant data are to assign a priority for further work . By

and supported by various data known to exist, EPA is particularly 1990, the United States and 13 other

availability studies conducted by EPA interested in receiving this information OECD member countries established a

and others, Toxic Ignorance, which was as part of the HPV Initiative (see Unit voluntary international testing program

prepared by Environmental Defense III.D .), including a full citation for to develop the basic data set for all

(formerly the Environmental Defense publications and "robust" (i .e ., detailed) international HPV chemicals. To date,

Fund), raised a variety of concerns summaries of pertinent published and the OECD has initiated or completed

about the untested chemicals that are unpublished studies. If relevant work on approximately 500 chemicals.

produced in and/or imported into the scientifically adequate existing data are The OECD threshold for high

United States (Ref, 28). Environmental submitted at any time before testing is production volume chemicals is 2 .2

Defense found that baseline data on initiated, including after the final rule is million pounds (equivalent to 1 million

health effects were not publicly issued, the Agency will consider such kilograms) reported in any member

available for a selected set of 100 HPV data to determine if they satisfy the country . (Note that the OECD HPV

chemicals. testing requirement and will take threshold, like the U.S. HPV threshold ,

In April 1998, EPA completed a study appropriate necessary action to ensure is not applied to polymers . However,

entitled Chemical Hazard Data that unnecessary testing is no longer the OECD threshold, unlike the U .S . Availability Study: What Do We Really required . In addition, exemption HPV threshold, is applied to inorganics

Know About the Safety of High procedures to be used are found at 40 (Ref. 5)). The presence of a chemical on

Production Volume Chemicals? (Ref. 2) CFR 790.80 and 790 .82 . Guidance on the OECD's list of HPV chemicals was

that evaluated the public availability of the preparation of robust summaries is and continues to be accepted (Ref. 5) by

screening level health hazard data and available on EPA's ChemRTK website OECD member countries as providing a

environmental hazard/fate data on U .S. (Ref. 34). sufficient indicator of potential
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81662 Federal Register/ Vol. 65, No. 248/Tuesday, December 26, 2000/ Proposed Rule s

exposure to warrant testing at the SIDS States, EPA considers the OECD HPV Initiative, when combined with

level. SIDS program to be an integral part of information about exposure and uses,

EPA does not believe that a domestic testing activities . EPA, in will allow the Agency and others to

production volume threshold which is developing and implementing the OECD evaluate and prioritize potential health

chosen for an international program on HPV SIDS program, worked jointly with and environmental effects and take

existing chemicals and which is the industry and environmental groups in appropriate follow up action. The HPV

only trigger for entry into that program the United States and with governments Initiative will generally be carried out in

should be determinative of the and industry in other OECD member a manner consistent with the OECD

threshold chosen for "substantial countries to achieve the common goal of HPV SIDS program to ensure that the

production" under TSCA section developing this minimum level of data and information generated can be

4(a)(1)(B)(i). See EPA's "B" policy (Ref. testing for HPV chemicals. EPA contributed to the international effort

24). Among the reasons is that the TSCA continues to work with other parties and, conversely, that international SIDS

section 4(a)(1)(B)(i) finding of (international organizations, testing and assessments can be used to

substantial production is not the sole environmental groups, unions, animal fulfill the data gaps identified as part of

finding EPA must make to require welfare groups, other Federal agencies, the HPV Initiative . Additional detailed

testing based on TSCA section and others) to secure their interest and information is available on the SIDS

4(a)(1)(B), EPA must also find that there continued support for this effort . website (http://www.oecd.org/ehs/

is substantial release, or substantial or Nevertheless, because of the slow sidsman.htm) and EPA's ChemRTK

significant human exposure under pace of the OECD's international efforts website (http ://www.epa .gov/chemrtk).

TSCA sections 4(a)(1)(B)(i)(I) and (II) . In to generate the needed data (which The following is a brief summary of

addition, EPA must find that data are would have potentially required over 30 this HPV Initiative, For additional

insufficient and testing is necessary years to complete), the OECD has background information related to the

under TSCA sections 4(a)(1)(B)(ii) and recognized the need to accelerate its HPV Initiative, please refer to th e

(iii) . efforts in order to ensure the availability document that is published elsewhere

In response to EPA's proposed "B" of the basic data needed to support in this issue of the Federal Register policy (Ref. 23), both ACC and the screening level assessments of (Ref. 27).

Society of the Plastics Industry Inc ., international HPV chemicals. EPA has 1 . Voluntary HPV Challenge Program.

commented that EPA's proposed also recognized the need to accelerate A primary component of this HPV

production volume threshold of 1 its efforts to develop SIDS data on US Initiative is the voluntary HP V

million pounds is a reasonable HPV chemicals to support domestic Challenge Program, which was created

interpretation of "substantial efforts on chemicals . The HPV Initiative, in cooperation with industry,

production" under TSCA (Ref, 6 and 7) . which is described in Unit III.D,, reflects environmental groups, and other

Additionally, they indicated that the EPA's interest in collecting, developing interested parties, and is designed to

OECD 2 .2 million pound threshold and making publicly available these assemble and make publicly available

would be preferable to achieve needed data . basic screening level data on the

consistency between EPA's activities D. Why is EPA Proposing to Take this potential hazards of U .S. HPV chemicals

under TSCA section 4 and the OECD

Action? while avoiding unnecessary o r

HPV SIDS program. duplicative testing. The voluntary HPV

The 1 million pound threshold for A major component of the Agency's Challenge Program is described in detail

production normally used by EPA under ChemRTK activity is the HPV Initiative, the document that is publishe d

the "B" policy generally narrowed the which is a data collection and elsewhere in this issue of the Federal

universe of chemicals potentially development program established by Register (Ref. 27).

subject to TSCA section 4(a)(1)(B) to EPA for existing U.S. HPV chemicals. As of November 9, 2000, EPA has

11% of the TSCA Inventory of chemical Under this Initiative, HPV chemicals are received full or provisional

substances (see TSCA sections 8(a) and defined as non-polymeric organic commitments from 469 companies,

8(b)), using Inventory information chemicals manufactured (including individually or through 187 consortia to

available in 1988 (Ref. 23 at 32296) . imported) at or above 1 million pounds sponsor 2,155 chemicals under in the

However, that small percentage of the per year based on information submitted voluntary HPV Challenge Program .

Inventory accounts for 95% of total under the 1990 TSCA IUR. The strategy Continually updated information

chemical production in the United and overall approach that EPA is using regarding the chemicals bein g

States . EPA believes it reasonable to use to address data collection needs for U .S . sponsored under the voluntary HPV

this information as a basis for making a HPV chemicals are discussed in a Challenge Program and the names of

finding of "substantial production" for separate document entitled Data company sponsors and consortia can be

substances produced at or above that Collection and Development on High found on EPA's ChemRTK website

threshold. Furthermore, EPA equates Production Volume (HPV) Chemicals (http://www.epa .gov/chemrtk/

"substantial production" with that is published elsewhere in this issue sumresp .htm), and on the US HPV

production in "high volumes." of the Federal Register (Ref. 27). Chemical Tracking System (http ://

The United States committed to Through the HPV Initiative, which www,hpvchallenge.com) .

conducting SIDS testing and assessment includes a voluntary component (the Under the voluntary HPV Challenge

on 25% of the international HPV HPV Challenge Program), certain Program, alternatives to the testing

chemicals as its contribution to the international efforts, and rulemaking proposed under this proposed rule are

OECD HPV SIDS effort; other countries' under TSCA such as this proposed rule, available . For example, under the OECD

commitments for conducting SIDS basic screening level hazard data HPV SIDS program, some instances

testing and assessment on international necessary to provide critical information have been identified where, usin g

HPV chemicals vary in proportion to the about the environmental fate and chemical category approaches, less than

size of the country's gross domestic potential hazards associated with HPV a full set of SIDS tests for every

product. Because most of the chemicals will be collected or, where chemical in the category has been

international HPV chemicals are also necessary, developed . Data collected judged sufficient for screening purposes.

commercially available in the United and/or developed under the HPV In addition, the OECD HPV SIDS
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Federal Register/ Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 81663

program allows some use of structure December 1, 1999, you can still facilitate making the information

activity relationships (SAR) analysis for volunteer through a viable commitment publicly available, as well as facilitate

individual chemicals. These strategies (as described in Unit III.D.1 .b) to its review.

have the potential to reduce the time sponsor chemicals under the HPV EPA plans to include in a final TSCA

required to complete the program, the Challenge Program . Sponsors who wish section 4 HPV SIDS rulemaking any

number of tests actually conducted, and to use alternative approaches to those chemical that is listed in a proposed

the number of test animals needed . proposed for a chemical listed in a rule, unless a sponsor, in addition t o

While EPA is encouraging the use of proposed TSCA section 4 HPV SIDS agreeing to making a viable commitment

scientifically appropriate categories of rulemaking should seriously consider under the voluntary HPV Challenge

related chemicals and SAR under the sponsoring that chemical in this under Program, provides the following

voluntary component of the HPV the voluntary HPV Challenge Program additional information:

Initiative, these approaches are not prior to the close of the comment period i . Evidence that work is underway

included in this proposed rule . for that rulemaking. and proceeding in a timely manner ;

However, EPA has not identified any b. How can I participate in the ii. Data required to complete the SIDS

possibilities that will allow inclusion of voluntary HPV Challenge? At this stage, battery are developed within the time

the category and SAR approach for any persons who wish to sponsor a chemical frame set by EPA in the proposed rule ;

chemicals listed in this proposed rule . through a viable commitment under the and

EPA believes that the incorporation of HPV Challenge Program must submit iii . Robust summaries, and full copies

such elements in a test rule would the following : of all final study reports fr om new

require complex, time consuming, and i . Commitment letter ; studies and existing data submitted to

resource intensive procedural steps, ii. Test plan, robust summaries of EPA in a timely manner .

such as multi-phase rulemaking . EPA existing studies with full citations of Viable commitments that involve SAR

specifically solicits comments and published studies and full copies of and categories and that are consistent

suggestions on procedures that would unpublished studies ; and with the guidance available on the

allow inclusion of such approaches in iii . Robust summaries of any newly website (Ref. 30 and 31) regarding SAR

HPV test rules. EPA solicits comments conducted studies, and full copies of and categories under the voluntar y

on simplified procedures which would these studies, component of the HPV Initiative can

allow inclusion of such approaches in Commitments must be consistent with still be submitted to EPA, bu t

TSCA section 4 HPV SIDS rulemaking . the guidance available on the ChemRTK submission as early as possible will best

Although the Agency believes that website . Full commitments must specify avoid unnecessary or duplicativ e

none of the chemicals included in this the names and the Chemical Abstract testing. If a viable commitment is made

proposed rule appear to be candidates Service (CAS) numbers of the chemicals and kept, and the information is deemed

for these approaches, persons who to be sponsored, the year in which adequate, EPA would not include that

believe that a chemical under this sponsors will begin the assessment of chemical in a final TSCA section 4 HPV

proposed rule can be dealt with using a each chemical, and the name and SIDS rulemakin g ,

category or SAR approach are contact information for the technical Additional information on the

encouraged to submit appropriate person within the company who should voluntary HPV Challenge Program is

information, along with their comments be reached for more information . available on the ChemRTK website .

which substantiate this belief. If, based Commitment le tters under the voluntary 2 . Certain international efforts, To fill

on submitted information and other HPV Challenge Program must be any data gaps not addressed as part of

information available to EPA, the submitted to the EPA Administrator the voluntary HPV Challenge Program,

Agency determines that a chemical according to the instructions on the EPA is continuing to participate in the

meets the requirements for ChemRTK website ( Ref. 35). international efforts coordinated by the

consideration under a category or SAR EPA encourages industry and other OECD to secure basic hazard

approach, and that practicable measures interested parties to identify and information on HPV chemicals in use

are available at the time to modify the provide any additional existing data worldwide, including some of those on

testing requirement, EPA will take such which are relevant to the hazard the U .S . HPV chemicals list. This

measures as are necessary to avoid characterization to avoid any includes agreements to sponsor a U .S.

unnecessary testing . Modifications can unnecessary or duplicative testing . HPV chemical under either the OECD

also be applied for after the final rule Furthermore, anyone may provide any HPV SIDS Program, includin g

issues under 40 CFR 790 .55 up to 60 relevant information to the Agency that sponsorship by OECD member countries

days before the specified reporting indicates that certain endpoints need beyond the United States, or the

deadline . Category or SAR approaches not be tested . If EPA judges the available international HPV Initiative that is being

which represent significant alterations data to be adequate, the data gap organized by International Council o f

in the scope of testing, however, would identified in the HPV Initiative will be Chemical Associations (ICCA). The

likely require multi-phase rulemaking considered to be filled . To the extent OECD HPV SIDS Program has already

involving publication of additional that additional data relevant to the HPV been described in Unit III .C . The ICCA

Federal Register document(s) soliciting chemicals are known to exist, EPA is consists of representatives of chemical

comment on the proposed procedures to interested in receiving this information industry trade associations from th e

be used. Comment is specifically under the voluntary HPV Challenge United States, Europe, Japan, Australia,

requested on simplified approaches Program . In addition to submitting the Canada, Mexico, Brazil, New Zealand,

which might allow for the efficient and full citation for published studies and and Argentina . The ICCA HPV Initiative

effective handling of category and SAR full copies of any unpublished studies, calls for the testing and screening-level

approaches via rulemaking . Commenters under the HPV Challenge assessment of 1,000 "high priority "

a . Can I still participate in the Program and/or a proposed TSCA chemicals by the end of the year 2004,

voluntary HPV Challenge Program? section 4 HPV SIDS rule(s) who wish to Most of the chemicals on the ICCA

Certainly . Although the participants in submit any additional relevant studies, working list (Ref. 8) are also U .S. HPV

the voluntary HPV Challenge Program are encouraged to also prepare a robust chemicals. The ICCA testing/assessment

were asked to submit commitments by summary ( Ref. 34) for each study to work will be tied directly to that under
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81664 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rule s

the OECD HPV SIDS Program and to the and chemical properties ; environmental "substantial human exposure" under

U.S. HPV Initiative, fate; and certain limited toxicity data for EPA's "B" Policy (Ref. 24). Any U.S. HPV chemicals that are humans and the environment . The SIDS The data availability study conducted

handled under the OECD HPV SIDS data set is not intended to describe a by EPA, discussed in Unit III .B.,

Program or the ICCA HPV Initiative are chemical thoroughly, but rather is demonstrated that only a limited

considered by EPA to be "sponsored" intended to provide enough information number of HPV chemicals have a full set

and are not intended to be addressed in to support an initial ( or screening level) of publicly available S IDS data . For

either the voluntary HPV Challenge assessment and to assign a priority for chemicals for which some data are

Program or in any TSCA section 4 HPV fu rther work, if necessary . To date, the available on one or more SIDS

SIDS rulemaking unless the OECD has initiated or completed work endpoints, EPA is not requiring testing

international commitments are not met. on approximately 500 HPV chemicals. for those endpoints. However, n o

3 . TSCA rulemaking . In establishing The OECD HPV SIDS Program seeks the definitive determination has been made

the HPV Initiative in 1998, the Agency development of test data, if such data as to the adequacy of those data for an

indicated that data needs which remain are not already available, related to six initial assessment of a chemical's

unmet in the voluntary HPV Challenge health and environmental effects hazards or risks to health or the

Program or through international effo rts endpoints for international HPV environment. The Agency intends to

may be addressed through TSCA chemicals (see Unit III.B .). The SIDS promulgate additional test rules for any

rulemaking. This proposed rule is the data set is regarded as the minimum HPV chemicals for which S IDS testing

first rulemaking associated with the data set required to make an informed is needed and for which a voluntary

HPV Initiative, and addresses the unmet preliminary judgment about the hazards commitment to collect, develop, and

data needs of the 37 chemicals that are of a given HPV chemical . make publically available the needed

included in this proposed rule . EPA is implementing the HPV data has not been received .

E. What Information is being Collected Initiative as part of its domesti c

g industrial chemical screening efforts, in F. What Role do Existing Data Play

on HPV Chemicals? g

e

Under the HPV Initiative ?

a manner that is consistent with OECD

In identifying the data needs for efforts. The information to be gathered The HPV Initiative, including this

chemicals contained in the HPV under EPA's HPV Initiative comes from rulemaking, is designed to make

Initiative, EPA is utilizing information the same battery of tests agreed upon by maximum use of scientifically adequate

and sources in EPA's study, the the OECD member countries as being existing test data and to avoid

Chemical Hazard Data Availability appropriate for screening international unnecessary, duplicative testing ,

Study (Ref. 2), and ACC's report, i .e, HPV chemicals for toxicity and thereby avoiding the excessive use of

Public Availability of SIDS-Related environmental fate (Ref. 4) . As animal testing. If at any time, including Testing Data for U.S. High Production conceived by the OECD, the SIDS data after this rule is finalized, the Agency

Volume Chemicals (Ref. 3), to determine set can be used by governments and receives adequate existing data that

whether screening level data for others worldwide to conduct an initial fulfill a specific data gap, EPA will

characterizing the hazards of these HPV assessment of the hazards and risks ensure that unnecessary testing is not

chemicals are publicly available . If no posed by HPV chemical substances and required .

data are available for a SIDS testing to prioritize chemicals to identify those During the continued development of

endpoint, there cannot be sufficient data which are in need of additional, more the HPV Initiative, EPA was encouraged

to characterize the potential hazards and in-depth testing and assessment, as well to consider the relationship between

risks associated with the chemical. As as those of lesser concern . existing data submitted under the HPV

the Agency found in its study, This proposed test rule is intended to Initiative and reporting requirements

insufficient data are available to obtain needed SIDS testing for 37 of the under TSCA section 8(e). In response to

characterize the hazards and risks of approximately 2,800 chemicals these concerns, and as part of th e

many of the U.S. HPV chemicals with ( excluding polymers and inorganics) Agency's efforts to ensure the fullest use

respect to the internationally accepted that are produced and/or impo rt ed at of existing test data, EPA intends to

SIDS testing endpoints, including acute high volumes in the United States. EPA consider existing data submissions in

toxicity, repeat dose toxicity, has chosen this group of 37 chemicals the manner described in an October 14,

developmental and reproductive for its initial TSCA section 4 HPV S IDS 1999, letter to the voluntary HPV

toxicity, genetic toxicity (gene rulemaking because of their high Challenge Program participants (herein

mutations and chromosomal production and/or importation volumes after "the October 14, 1999, letter") (Ref .

aberrations), ecotoxicity ( tests in fish, and their potential for exposure to a 29) . EPA's guidance document on

Daphnia, and algae), and for substantial number of workers . literature searches, which deals with

environmental fate ( including five tests In developing the list of candidates pa rt of this issue, is available on th e

for physical chemical prope rties for this proposed test rule, EPA Agency's ChemRTK website (Ref. 36).

[melting point, boiling point, vapor included only chemical substances EPA believes that it is in the economic

pressure, n-octanol/water partition which were repo rted on 1994 TSCA best interest of companies to identify

coefficient, and water solubility), and section 8(a) IUR as being manufactured and make publicly available all relevant

biodegradation). As a result, EPA and (including imported) in the United existing data in order to reduce possible

others cannot reasonably determine or States in amounts greater than or equal testing costs.

predict the human health and to one million pounds, In addition, each Studies that have been conducted as

environmental effects resulting from of the candidate chemical substances specified in appropriate OECD test

manufacture, processing, and use of listed in this proposed rule was guidelines ( as noted in the SIDS Manual

these chemical substances. identified in the National Occupational (Ref. 4) or comparable EPA test

The OECD HPV SIDS Program is part Exposure Survey (NOES) as having a guidelines (such as the OPPTS

of the OECD overall program on existing total potential exposure of greater than Harmonized Guidelines available at

chemicals, and includes information on 1,000 or more workers, A potential http ://www.epa .gov/opptsfrs/home/

the identity of each chemical, its uses, exposure of 1,000 or more workers to a guidelin.htm), and appropriate Good

sources and extent of exposure ; physical chemical substance is a threshold for Laboratory Practice Standards (GLPS)
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Federal Register / Vol. 65, No. 248/ Tuesday, December 26, 2000/Proposed Rules 81665

like those for TSCA (40 CFR part 792) G . How Would the Data Developed to cover chemicals with unmet data

consistently generate data adequate to Under this Test Rule be Used? needs or if voluntary HPV Challenge

fulfill the HPV Initiative needs. Data The availability of hazard information Program commitments are not met. U.S.

from studies that did not follow these on individual chemicals is fundamental HPV chemicals that have been or are

procedures, however, may not be to EPA's ability to accomplish its being handled through the OECD HPV

adequate . mission of environmental protection- SIDS Program or under a

As stated in the October 14, 1999, risk assessment, risk management, complementary program being

letter to the voluntary HPV Challenge safeguarding children's health, coordinated by the ICCA (Ref. 8) will

Program participants, in analyzing the expanding the public's right-to-know, not be listed in any of these follow-up

TSCA section 4 HPV SIDS rulemaki n

adequacy of existing data, participants and promoting the pollution prevention unless commitments under those g

shall conduct a thoughtful and ethic . Activities to ensure the international programs are not met (see

qualitative analysis rather than using a availability of basic hazard information Unit. IV.G. of the document that is

rote checklist approach (Ref. 29). The on HPV chemicals are an integral part published elsewhere in this issue of the

same applies to persons of meeting these objectives . principle Federal Register (Ref, 27) for more

evaluating existing data in connection The testing proposed is essentiall y

identical in scope and applicability to information on these programs) . In

with this rulemaking, If EPA judges the that which has been internationally addition, as indicated in Unit IV .B,2 . of

available data to be adequate, the data the document that is publishe d

gap identified in the HPV Initiative will the man iupo

n mum neede d the Eto screen H Ving elsewhere in this issue of the Federa l

be considered to be filled . EPA has chemicals and identify priorities for Register (Ref. 27), chemicals identified

developed a guidance document on additional testing or assessment . While as GRAS for a particular use by FDA are

determining data adequacy which is the SIDS data set does not fully measure only intended to be included in a future

available on EPA's ChemRTK website a chemical's toxicity, it does provide a TSCA section 4 HPV SIDS rulemaking if

(Ref. 37). consistent minimum set of information SIDS data needs remain unmet .

EPA solicits comment concerning the that can be used to determine the As indicated in the October 14, 1999, letter to the participants in the availability of SIDS data on the relative hazards and risks of chemicals voluntary HPV Challenge Program (Ref

.

chemicals included in the HPV and to judge if additional testing or 29), and restated in the document that

Initiative and encourages industry and assessment is necessary . Thus, EPA will is published elsewhere in this issue of

other interested parties to identify and use the data obtained from this the Federal Register (Ref. 27), EPA

provide any additional existing data proposed test rule to support intends for the TSCA section 4 HPV

which are relevant to hazard development of preliminary hazard and SIDS rulemaking to proceed in a manner

risk assessments for these HP V characterization to avoid any that is consistent with the principles

unnecessary or duplicative testing . chemicals. Furthermore, the data obtained under this testing outlined in the letter for the participant s

Anyone may provide any relevant g program will in the voluntary program. As such, EPA

information to the Agency that indicates be used to set priorities for further has incorporated the criteria established

testing that will produce hazard under the voluntary HPV Challeng e

that certain endpoints need not be information on these chemicals which is Pro ram into this rulemakin to the tested. If EPA judges the available data g g

to be adequate, the data gap identified needed by EPA, other Federal agencies, extent possible, and has also considered

the public, industry, and others, to improvements based on experience s in the HPV Initiative will be considered support adequate risk assessments . EPA with implementing that Program. to be filled. To the extent that additional has used data from test rules to support . Potential endpoints for testing under

data relevant to the HPV chemicals are such activities as the development of test rules. As with the voluntary HPV

known to exist, EPA is interested in water quality criteria, Toxic Release Challenge Program, the test data needs

receiving this information, including a Inventory listings, chemical advisories, that are addressed in this proposed rule

full citation for publications and full and reduction of workplace exposures . pertain to physical/chemical properties, copies of unpublished studies. Although H. What is the Role of this Proposed acute toxicity; repeat dose toxicity ;

the Agency encourages anyone with

Rule with Regard to the HPV Initiative? developmental and reproductive

such information to submit it to EPA toxicity; genetic toxicity, ecotoxicity;

during the early stages of this Initiative To fill data gaps not addressed as part and environmental fate . Testing for

in order to avoid any unnecessary of the voluntary HPV Challenge Program some or all of these endpoints would be

testing, such submissions may be made or international efforts, EPA indicated required for a particular chemica l

at any time to allow EPA to take in the document that is published substance where such data are not

appropriate action. Commenters are also elsewhere in this issue of the Federal already available for that substance . The

encouraged to prepare a robust Register (Ref. 27) that it would specific testing, reporting, and

summary (Ref. 34) for each study to supplement the voluntary HPV recordkeeping requirements contained

facilitate EPA's review of the full study Challenge Program and international in this proposed rule are described for

report or publication . It is important to efforts with rulemaking under TSCA. each chemical substance in the

note that EPA does not intend to Specifically, EPA intends to use its proposed regulatory text .

include any chemicals which are authority under section 4 of TSCA to . Potential timetable for testing under

Generally Recognized as Safe (GRAS) propose the testing of those chemicals test rules. EPA stated in the October 14,

listed at http:/www.epa .gov/chemrtk/ 1999, letter to the participants in th e

for a particular use by the Food and hpvchmtl

.htm which have an indicator voluntary HPV Challenge Program (Ref,

Drug Administration (FDA) in this value of "0," which identifies a 29), that testing of closed system

initial TSCA section 4 HPV SIDS chemical as a candidate for sponsorship intermediates shall be deferred until

rulemaking. However, such chemicals under the voluntary HPV Challenge 2003 ; and that testing of individua l

may be included in a future TSCA Program and a sponsorship status value chemicals (i .e ., those HPV chemicals not

section 4 HPV SIDS rulemaking where of "N," i,e ., not sponsored . EPA intends proposed for testing in a category) that

SIDS data needs remain unmet, to issue additional test rules as needed require further testing on animals shall
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81666 Federal Register/ Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules

be deferred until November 2001 . EPA use of animals is minimized, As a thoughtful, qualitative analysis of

will use these time frames in the general matter, EPA does not require existing data before testing. EPA also

effective dates of TSCA section 4 HPV that tests on animals be conducted if an asked that all animal testing o n

SIDS rulemakings as well . alternative scientifically validated individual chemicals (as opposed t o

• Existing data submissions during method is found acceptable and testing of categories of chemicals) under

the rulemaking phase . As indicated in practically available for use. Where the voluntary HPV Challenge Program,

Unit III,B., if relevant scientifically testing must be conducted to develop or under an associated rule(s), not be

adequate existing data are submitted to adequate data, the Agency is committed initiated earlier than November 2001,

EPA during the comment period for this to reducing the number of animals used and that testing of chemicals solely

proposed rule, EPA does not intend to for testing, to replacing test methods manufactured as closed syste m

include that HPV chemical in the final requiring animals with alternative test intermediates not begin earlier than

rule . If relevant scientifically adequate methods when acceptable alternative 2003 . This proposed rule reflects many

existing data are submitted to EPA after methods are available, and to refining of the principles presented in th e

the final rule is issued, or at any other existing test methods to optimize animal referenced voluntary HPV Challenge

time before testing is initiated, the use when there is no substitute for Program letter . Ce rtain components of Agency will consider such data to animal testing . EPA believes that these these principles, however, are not

satisfy the testing requirement and will reduction, replacement, and refinement pertinent to this proposed rule . For take any necessary action to ensure that objectives are all impo rtant elements in example, this proposed rule does not

unnecessary testing is not required. the overall consideration of alternative require any dermal toxicity testing o

r

• Treatment of testing endpoints testing methods, any terrestrial toxicity testing. under HPV SIDS test rules. EPA The governmental and non- Furthermore, a primary focus of the

proposes that testing under this governmental scientific community is HPV Initiative, including the voluntary

proposed rule be consistent with the working to design, validate, and employ HPV Challenge Program and associated

voluntary HPV Challenge Program's new methods of toxicity testing that are TSCA section 4 HPV SIDS rulemaking is

treatment of the following end points: more accurate, less costly, and that to implement these effo rts as

-Acute aquatic toxicity studies reduce the need to use live animals . contributors to a larger international

would not always be needed under the Over the years, significant research has activity with global involvement and in

TSCA section 4 HPV SIDS rulemaking been pursued to develop and validate a manner consistent with meeting the

associated with this Initiative (See Unit non-animal test methods. U.S.

scientists needs of the OECD HPV SIDS program V.A.3 .). in academia, government, and industry and to further the goals under

-Dermal toxicity or terrestrial have pa rticipated in both domestic and Programme Area (c) of Agenda 21, toxicity testing would not be included international efforts to develop Chapter 19 of the United Nations

in TSCA section 4 HPV SIDS alternative, non-animal tests, As pa rt of Conference on Environment and rulemaking associated with this the enterprise, the National Institute of Development (UNCED) concerning

Initiative ( See Unit III.I. and Unit V.A.). Environmental Health Sciences (NIEHS) information exchange on toxi

c -The LD5o test (OECD 401) would established a Federal Interagency chemicals and chemical risks. EPA not be needed for mammalian acute Committee, the Interagency solicits comment on the potential

toxicity testing under the TSCA section Coordinating Committee on Validation approaches that may be used t

o 4 HPV SIDS rulemaking associated with of Alternative Methods (ICCVAM), to incorporate the principles contained in this Initiative (See Unit V .A.4 .), review the status and validation of the October 14, 1999, letter in the

-EPA will encourage persons subject toxicological test methods including context of TSCA section 4 HPV SID

to the TSCA section 4 HPV SIDS those that are performed S in vitro.

rulemaking to use EPA rulemakings (Ref. 29) . in vitro testing unless scientists have contributed significantly

there are chemical properties (including to this body of knowledge and are IV. EPA Findings

chemical class considerations) or other continuing to play a vital role by

aspects which may call its use into developing test methods for A, What is the Basis for EPA's Proposal

question (see Unit V to Test These Chemical Substances? .A.5 .). consideration. Many test methods hav e

-EPA will consider combining some begun the process of validation and As indicated in Unit II., in order to

of the mammalian toxicity protocols several have completed the steps develop a rulemaking under TSCA

under TSCA section 4 HPV SIDS leading to government-wide regulatory section 4(a) requiring the testing of

rulemaking associated with this acceptance . Within the SIDS battery of chemical substances or mixtures, EPA

Initiative (See Unit V .A.6 .). tests, ce rt ain in vitro genotoxicity tests, must make ce rtain findings regarding

If necessary for a particular chemical such as the Ames test for gene either risk (TSCA section 4(a)(1)(A)(i)) ;

and/or endpoint, any variations are mutations in bacteria, have received or production and either chemical

described in detail in this proposed uniform acceptance among regulatory release or human exposure (TSCA

rule . agencies. section 4(a)(1)(B)(i)), with regard t o

I. How are Animal Welfare Issues being In addition, as pa rt of the voluntary those chemicals. EPA is proposing to

Considered in the HPV Initiative? HPV Challenge Program, EPA asked require testing of the chemical

participants in that program to observe substances included in this propose d

EPA recognizes the concerns that ce rtain principles laid out in the test rule based on its preliminary

have been expressed about the use of October 14, 1999, letter, in which the findings under TSCA section

test procedures that require the use of Agency also indicated its intention that 4(a)(1)(B)(i) relating to "substantial"

animals. As discussed in Unit II.E. of related TSCA rulemaking proceed in a production and "substantial human

the document that is published manner consistent with the principles exposure," as well as findings under

elsewhere in this issue of the Federal (Ref. 29). This letter is available in the TSCA sections 4(a)(1)(B)(ii) and (iii) . Register (Ref. 27), EPA is making every public version of the official record for In EPA's "B" policy (see Unit II.), effort to ensure that as the HPV this rulemaking, as well as on EPA's "substantial production" of a chemical

Initiative is implemented, unnecessary ChemRTK website . In the letter, EPA substance or mixture is generall y

or duplicative testing is avoided and the requested that participants conduct a interpreted to be aggregate production
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Federal Register / Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 8166 7

(including import) volume equaling or are "substantial" as that term is used comprehensive source of this kind of

exceeding 1 million pounds per year of with reference to production in TSCA information ,

that chemical substance or mixture, section 4(a)(1)(B)(i). (See also Ref. 24 at Each of the chemicals in this

(Ref. 24 at 28747) . For workers, the "B" 28746). proposed rule was identified in the

policy threshold for "substantial human

C. Are a Substantial Number of Workers NOES as having a total potential worker

exposure" is the exposure of 1,000 Exposed to These Chemicals? exposure of greater than 1,000 workers

workers annually to that chemical (Ref. 10). EPA believes that an exposure

substance or mixture, (Ref. 24) See EPA finds that the manufacture, of over 1,000 workers to a chemical

EPA's "B" policy for further discussion processing, and uses of the chemical substance is "substantial" as that term

on how EPA makes decisions under substances included in this action result is used with reference to "huma n

TSCA section 4(a)(1)(B)(i). For the or may result in exposure to a exposure" in section 4(a)(1)(B)(i) of

reasons set out in the "B" policy, EPA substantial number of workers . These TSCA. EPA believes, based on

believes that the thresholds included in chemical substances are used in a wide experience gained through case-by-case

the "B" policy are appropriate for use in variety of industrial applications, which analysis of existing chemicals, that an

this proposed rule . (Ref. 24) result in potential exposures to workers, exposure of 1,000 workers or more to a

EPA has found preliminarily that, as described in the exposure support chemical substance is a reasonable

under TSCA section 4(a)(1)(B)(i), each of document for this proposed rule (Ref. interpretation of the phrase "substantial

the 37 chemical substances included in 10) . human exposure" in TSCA section

this proposed rule is produced in EPA defines chemical exposure as the 4(a)(1)(B)(i) . See 58 FR 28736, 28746.

"substantial" quantities (see Unit IV .B .) contact of a chemical with a person' s

and that there is or may be "substantial outer boundary (for example, the skin or D. Do Sufficient Data Exist for These

human exposure" to each chemical lungs) (Ref. 11), Worker exposure is the Chemical Substances ?

substance (see Unit IV.C.). In addition, chemical exposure that occurs while a In developing the testing

under TSCA section 4(a)(1)(B)(ii), EPA person is working . Exposure to workers requirements for chemicals contained in

believes that there are insufficient data may have various causes. Chemical this proposed rule, EPA utilized

and experience to reasonably determine releases are a common cause of information and sources in EPA's study,

or predict the effects of the manufacture, exposure . For example, a chemical the Chemical Hazard Data Availability

processing, or use of these chemical manufacturing plant can release a Study (Ref. 2), and in ACC's study, the

substances, or of any combination of chemical from pumps as fugitive Public Availability of SIDS-Related

such activities, on human health or the emissions, from reactor and condenser Testing Data for U .S . High Production

environment (see Unit IV.D .) . In vents as stack emissions, and/or as a Volume Chemicals (Ref . 3), to determine

particular, EPA has preliminarily particulate. Diffusion and air currents whether screening level data for

determined that there are insufficient may carry a chemical through the air in characterizing the risks of these HPV

data on these chemicals. EPA has also the plant. Plant workers breathe air chemicals are available . Sectio n

found preliminarily that testing the 37 containing this chemical, resulting in 799 .5085(j) of the proposed regulatory

chemical substances identified in this exposures. Human activity such as text lists each chemical and the tests for

Federal Register document is necessary manually transferring a chemical from which no data are currently available to

to develop such data (TSCA section one container to another may cause the Agency . If no data are available for

4(a)(1)(B)(iii)) (see Unit IV .E.) . EPA has exposures. a SIDS testing endpoint, there cannot be

not identified any "additional factors" For each of the chemicals in this sufficient data to characterize the ris k

as discussed in the "B" policy (Ref. 24 proposed rule, estimates for the number associated with exposure to th e

at 28746) to cause the Agency to use of exposed workers were identified in chemical. The Agency preliminarily

decisionmaking criteria other than those the National Occupational Exposure finds that for the SIDS testing

described in the policy. Survey (NOES). The NOES was a endpoints, including acute toxicity ,

The chemical substances included in nationwide data gathering project repeat dose toxicity, developmental and

this proposed test rule are listed in conducted by the National Institute for reproductive toxicity, genetic toxicit y

§ 799 .5085(j) of the proposed regulatory Occupational Safety and Health (gene mutations and chromosomal

text along with their CAS numbers. (NIOSH), which was designed to aberrations), ecotoxicity (tests in fish,

B

develop national estimates for the Daphnia, and algae), and for

. Are These Chemical Substances

number of workers potentially exposed environmental fate (including five tests Produced and/or Imported in to various chemical, physical and

Substantial Quantities? biological agents and describe the for physical chemical properties [melting point, boiling point, vapor

Each of the chemical substances distribution of these potential pressure, n-octanol/water partition

included in this proposal is produced exposures. Begun in 1980 and coefficient, and water solubility], and

and/or imported in an amount equal to completed in 1983, the survey involved biodegradation), there are insufficient

or greater than one million pounds per a walk-through investigation by trained data and experience to reasonably

year (Ref. 9), based on information surveyors of 4,490 facilities in 523 determine or predict the human health

gathered pursuant to the 1998 TSCA different types of industries . Surveyors and environmental effects resulting

section 8(a) IUR (40 CFR part 710) recorded potential exposures when a from manufacture, processing, and use

which is the most recently available chemical agent was likely to enter or of the chemical substances included in

compilation of TSCA Inventory data, contact the worker's body for a this proposal

.

and which is contained in the TSCA minimum duration . These potential EPA solicits comment concerning the

Chemical Update System. EPA also exposures could be observed or inferred . availability of SIDS data on these

considered the fact that all of these Information from these representative substances and encourages industry and

chemicals were produced and/or facilities was extrapolated to generate others to identify and provide any

imported above 1 million pounds national estimates of potentially additional existing test data which are

annually based on the 1990 and 1994 exposed workers for more than 10,000 relevant to the proposed testing . If EPA

IUR. EPA believes that these annual different chemicals (Ref. 12). The NOES judges such data to be sufficient,

production and/or importation volumes survey is the most recent and corresponding testing will not be
p. 12

81668 Federal Register/ Vol . 65, No. 248/Tuesday, De cember 26, 2000/Proposed Rule s

included in the final rule . To the extent subject chemicals will provide data For the n-Octanol/Water Partition

that additional data relevant to the relevant to a determination of whether Coefficient and Water Solubilit y

testing proposed in this rulemaking are the manufacture, processing, and use of endpoints, EPA is proposing that certain

known to exist, EPA strongly the chemical substances does or does "Special Conditions" in the form of the

encourages the submission of this not present an unreasonable risk of chemical substance's physical/chemical

information as comments to the injury to human health and the properties or physical state (acute only)

proposed rule, including full citations environment . be considered by test sponsors in

for publications and full copies of V . Proposed Rule determining the appropriate test method unpublished studies. Commenters are that would be used from among those

also encouraged to prepare a robust A . What Testing is being Proposed in included for these endpoints in Table 2

summary (Ref. 34) for each such study this Action? in § 799 .5085(j) of the propose d

to facilitate EPA's review of the full EPA is proposing specific testing and regulatory text .

study report or publication

. EPA has not reporting requirements for the chemical For the "n-Octanol/Water Partition included any chemicals in this proposa

which specified in § 799

l

.5085(j) of Coefficient" endpoint, the test method, hich are GRAS for a particular use b y

the FDA. As indicated proposed regulatory text. if any, would be determined by the test dicated in Unit III

.F„ All of the proposed testing substance's estimated n-octanol/water

such chemicals may be included in a requirements are listed in Table 2 in partition coefficient (log 10 basis future TSCA section 4 HPV SIDS § ; "log

rulemaking where SIDS data needs p p g rY ' p 799.5085(j) of the proposed re ulato Ko, ')EPA proposes three methods for p

remain unmet. text and consist of a series of test measuring the substance's n-Octanol/

methods covering many of the Water Partition Coefficient . The method

E. Is Testing Necessary for These endpoints in the OECD HPV S IDS that would be required would be based

Chemical Substances? testing battery . Most of the proposed on the test substance's estimated lo g

Of the nearly 3,000 chemicals that the testing requirements for a particular Kow . Prior to determining the

U.S. manufactures at more than 1 endpoint are specified in one test appropriate standard to use, if any, to

million pounds per year, EPA's study standard, although in the case of certain measure the n-octanol/water partition

concluded that 43% of them have no endpoints, any of one or more listed coefficient, EPA is recommending that

SIDS data . For the remaining chemicals, methods could be used. The following the log Ko,v be quantitatively estimated,

generally limited amounts of the data endpoints and proposed test standards EPA suggests that the method described

appear to be available (see Unit III.A. would be required under this proposed in Atom/Fragment Contribution Method

and Ref, 2), The lack of available data rule . For several of the proposed test for Estimating Octanol-Water Partition

compromises EPA's and others' ability standards, EPA has identified and is Coefficients (Ref. 13) be used in making

to determine whether these chemicals proposing certain "Special Conditions" such an estimation . EPA is proposing

pose unreasonable risks to human as discussed below in this unit. Because that test sponsors be required to submit

health or the environment, as well as terrestrial toxicity testing will normally with the final study report the

the public's right to know about the be considered to belong at the OECD underlying rationale for the tes t

hazards of chemicals that are found in post-SIDS tier, EPA is not proposing any standard selected for this endpoint. EPA

their environment, their homes, their terrestrial toxicity testing (including is proposing this approach in

workplaces, and the products that they avian toxicity) in this rulemaking . recognition of the fact that depending

buy. It is EPA's intent to close this 1 . Physical/Chemical Properties. on the chemical substance's log Kow, one

knowledge gap . EPA will use the data Melting Point: American Society or more test methods can be expected to

obtained from this proposed rule to for Testing and Materials (ASTM) E 324 provide adequate information for

support development of preliminary (capillary tube) determining the log Kow. In general, EPA

hazard and risk assessments for these Boiling Point : ASTM E 1719 believes that the more hydrophobic a

HPV chemicals and to set priorities for (ebulliometry) subject chemical is, the less well

further testing that will produce more Vapor Pressure: ASTM E 1782 Method A (799 .6755-shake flask) will

definitive hazard information where (thermal analysis) work and Method B (ASTM E 1147) and

needed on such chemicals. Such n-Octanol/Water Partition Method C(799,6756-generator column)

additional information is needed by Coefficient: Method A (40 CFR become more suitable, especiall y

EPA, other Federal agencies, the public, 799.6755-shake flask) Method C. The proposed test

industry, and others to ensure that Method B (ASTM E 1147- methodologies have been developed to

adequate hazard and risk assessments liquid chromatography) meet a wide variety of needs and, as

can be conducted on these chemicals, Method C (40 CFR such, are silent on experimental

EPA has used data from test rules to 799 .6756-generator column) conditions related to pH. Therefore,

support such activities as the Water Solubility : Method A: (ASTM EPA highly recommends that all

development of water quality criteria, E 1148-shake flask) required n-Octanol/Water Partition

Toxic Release Inventory listings, Method B : (40 CFR Coefficient tests be conducted at pH 7

chemical advisories, and input for 799.6784-shake flask) to ensure environmental relevance. The

actions resulting in reduction of Method C: (40 CFR proposed test standards and log Ko,y

workplace exposures. 799.6784-column elution) ranges that would determine which tests

EPA believes that conducting the Method D: (40 CFR must be conducted for this endpoint are

needed SIDS testing identified for the 37 799 .6786-generator column) shown below:
p. 13

Federal Register/Vol . 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 8166 9

Testing category Test requirements and references Special conditions

Physical/Chemical Properties n-Octanol/Water Partition Coefficient : rrOctanol/Water Partition Coefficient :

The appropriate irOctanol/Water Partition Coefficient Which method is required, if any, would be detertest, if any, would be selected from those listed mined by the test substance's estimated rroctanoi/

below-see Special Conditions in the adjacent col- water partition coefficient (log 10 basis) . Test sponumn . sors would be required to submit in the final study Method A: 40 CFR 799 .6755 (shake flask) report the underlying rationale for the method se- Method B: ASTM E 1147 (liquid chromatography) lected . In order to ensure environmental relevance, Method C : 40 CFR 799 .6756 (generator column) EPA is recommending that the selected study be

conducted at pH 7 .

log Kow <0 : no testing required .

log Kow range 0-1 : Method A or B.

log Kow range 1-4 : Method A or B or C.

log Kow range 4-6 : Method B or C .

log Ka,,,>6 : Method C .

For "Water Solubility," the test method, if any among the four proposed, would be determined by the test substance's

estimated water solubility . EPA recommends that water solubility be quantitatively estimated prior to initiating this study. One recommended method for estimating water solubility is described in Improved Method for Estimating Water

Solubility From Octanol/Water Partition Coefficient (Ref . 14) . EPA is also proposing that test sponsors be required

to submit in the final study report the underlying rationale for the test standard selected for this endpoint . The proposed

test methodologies have been developed to meet a wide variety of needs and, as such, are silent on experimental

conditions related to pH. Therefore, EPA highly recommends that all required Water Solubility tests be conducted

at pH 7 to ensure environmental relevance . The estimated water solubility ranges that EPA is proposing for use in

selecting an appropriate proposed test standard are shown below :

Testing category Test requirements and references Special conditions

Physical/Chemical Properties Water solubility : Water Solubility:

The appropriate method to use, if any, to test for Which method is required, if any, would be deterWater Solubility would be selected from those list- mined by the test substance's estimated water soled below-see Special Conditions in the adjacent ubility. Test sponsors would be required to submit column . with the final study report the underlying rational e Method A: ASTM E 1148 (shake flask) for the method selected . In order to ensure envi- Method B : 40 CFR 799 .6784 (shake flask) ronmental relevance, EPA recommends that the Method C : 40 CFR 799 .6784 (column elution) selected study be conducted at pH 7 . Method D : 40 CFR 799 .6786 (generator column) >5,000 milligram/Liter (mg/L) : Method A or B .

<5,000 mg/L but > 10 mg/L : Method A, B, C, or D .

<10 mg/L but > 0 .001 mg/L : Method C or D.

<0 .001 mg/L : No testing required .

2 . Environmental Fate and Pathways. toxicity is unlikely to be observed over text) are proposed : Acute toxicity to fish Inherent Biodegradation: ASTM the duration of acute toxicity studies (ASTM E 729) ; Acute toxicity to

1625-94 (Semicontinuous Activated because of reduced uptake, and the Daphnia (ASTM E 729); and Toxicity to

Sludge Test) or International Standards extended amount of time required for plants (algae) (ASTM E 1218). For test

Organization (ISO) 9888 (Zahn-Wellens such substances to reach toxic substances determined to have a log Ko,,,

Method) concentrations in the test organism 3 . Aquatic Toxicity, . For that is greater than or e ual to 4 q .2, one

Test Group 1: Acute toxicity to such situations, the OECD HPV S IDS or both of the following tests (described

fish (ASTM E 729) battery recommends use of chronic as "Test Group 2" in Table 2 in

Acute toxicity to Daphnia toxicity testing in Daphnia in place of § 799 .5085(j) of the proposed regulatory

(ASTM E 729)Toxicity to plants (algae) acute toxicity testing in fish and text) are proposed : Chronic toxicity to

(ASTM E 1218) Daphnia. EPA is proposing that the Daphnia (ASTM E 1193) and Toxicity to

Test Group 2 : Chronic toxicity to testing requirement be determined plants (algae) (ASTM E 1218) . As

Daphnia (ASTM E 1193) based on the test substance's log K.,v as outlined in Table 2 in § 799.5085(j) of

Toxicity to plants (algae) determined by using the approach the proposed regulatory text, dependin g

(ASTM E 1218) outlined in Unit V.A.I . "n-Octanol/ on the testing proposed in Test Group

For "Aquatic Toxicity," the OECD Water Coefficient" and in Table 2 in 1, the Test Group 2 chronic Daphnia test

HPV SIDS test battery recognizes that § 799 .5085(j) of the proposed regulatory may substitute for either or both th e

for certain chemicals acute toxicity text . For test substances determined to acute fish toxicity test and the acute

studies are of limited value in assessing have a log Kow of less than 4.2, one or Daphnia test.

the substances' aquatic toxicity. This more of the following tests (described as EPA recognizes that in som e

issue arises when considering chemicals "Test Group 1" in Table 2 in circumstances, acute aquatic toxicity

with high log Ko, values. In such cases, § 799 .5085(j) of the proposed regulatory testing (Test Group 1) may be relevant
p. 14

81670 Federal Register/ Vol. 65, No. 248 / Tuesday, December 26, 2000/Proposed Rules

for certain chemical substances having a Acute Oral Toxicity (rat) : Method B properties preclude its use, These could

log K°, equal to or greater than 4 .2 . (ASTM E 1163-98 or 40 CFR include, for example, physical chemical

Using SAR, a log K°w of 4 .2 corresponds 799.9110(d)(1)(i)(A)) properties or chemical class

with a fish bioconcentration factor For the "Mammalian Toxicity- characteristics. A primary focus of both

(BCF) of about 1,000 (Refs . 15, 16, and Acute" endpoint, EPA is proposing that the voluntary HPV Challenge Program

17) . A chemical with a fish BCF value certain "Special Conditions" in the form and this proposed rule is to implement

of 1,000 or more is characterized as of the chemical substance's physical/ this program in a manner consistent

having a tendency to accumulate in chemical properties or physical state be with the OECD HPV SIDS program and

living organisms relative to the considered in determining the as part of a larger international activity

concentration of the chemical in the appropriate test method that would be with global involvement . This proposed

surrounding environment (Ref. 18). For used from among those included for this approach provides the same degree of

the purposes of this proposed endpoint in Table 2 in § 799.5085(j) of flexibility as that which currently exists

rulemaking, EPA's use of a log K°μ, equal the proposed regulatory text. The OECD under the OECD HPV SIDS testing

to or greater than 4 .2 (which HPV SIDS program recognizes that for program (Ref . 4). A subject person who

corresponds with a fish BCF value of most chemical substances, the oral route uses one of the in vivo methods instead

1,000) is consistent with the approach of administration will suffice for this of the in vitro method to address this

taken in the Agency's proposed endpoint. However, consistent with the end-point must submit to EPA a

Persistent, Bioaccumulative and Toxic approach taken under the voluntary rationale for conducting that alternate

(PBT) Policy Statement under section 5 HPV Challenge Program, EPA is test in the final study report . EPA

of TSCA (63 FR 53417, October 5, 1998) proposing that for test substances that solicits comment on whether the

(FRL-5771-6) Policy Statement under are gases at room temperature (25° C), Agency should instead require that a

TSCA section 5 entitled Category for the acute mammalian toxicity study be subject person wishing to use an

Persistent, Bioaccumulative, and Toxic conducted using inhalation as the alternate testing scheme submit to EPA

New Chemical Substances (64 FR exposure route (described as Method A a notice that includes the rationale for

60194, November 4, 1999) (FRL-6097- (40 CFR 799 .9130) in Table 2 in conducting the alternative tests prior to

7)] (Ref. 25) . EPA has also used a § 799.5085(j) of the proposed regulatory planned initiation of those studies .

measured BCF that is "equal to or text) . In the case of a potentially Comments should include suggestions

greater than 1,000x or, in the absence of explosive test substance, care must be for efficient procedures for such a

bioconcentration data, a log P [same as taken to avoid the generation of notification process.

log K°W,] value equal to or greater than explosive concentrations . For all other 6. Mammalian Toxicity-Repeated

4 .3" to help define the potential of a chemicals (i .e ., those that are either pose/Reproduction/Developmental.

new chemical substance to cause liquids or solids at room temperature), Combined Repeated Dose

significant adverse environmental EPA is proposing that the acute toxicity Toxicity Study with the Reproduction/

effects (Significant New Use Rules; testing be conducted via oral Developmental Toxicity Screening Test :

General Provisions For New Chemical administration using an "Up/Down" 40 CFR 799.9365

Follow-Up under sections 5 and 26(c) of test method (described as Method B Reproduction/Developmenta

l TSCA (54 FR 31307, July 27, 1989 ; see (ASTM E 1163-98 or 40 CFR Toxicity Screening Test: 40 CFR

also 40 CFR 721 .3) (Ref. 26). EPA 799.9110(d)(1)(i)(A)) in Table 2 in 799. 935 5

considers the difference between the log § 799.5085(j) of the proposed regulatory Repeated Dose 28-Day Oral

K°w of 4 .3 cited in the 1989 Federal text) . Dermal toxicity testing is not Toxicity Study : 40 CFR 799 .9305

Register document and the log K°w required in this rulemaking, and the Fo "Mammalian Toxicity-Repeate d

r Dose/Reproduction/Developmental, "

value of 4.2 cited in this proposed TSCA Agency does not intend to include an

y section 4 test rule to be negligible, dermal toxicity testing in any TSCA EPA recommends the use of th

e Chemical substances that are section 4 HPV SIDS rulemakings . Combined Repeated Dose Toxicity

5 . Mammalian Toxicity- Study with the Reproduction/ dispersible in water (e .g ., surfactants, Genotoxicity. Developmental Toxicity Screening Test

detergents, aliphatic amines, and Gene , Mutations: (40 CFR799.9365).

dyes) may have log K°w values . EPA recognizes,

greater than 4.2 and may still be acutely Bacterial Reverse Mutation Test however, that there may be reasons to

toxic to aquatic organisms. One (in vitro): 40 CFR 799 .9510 test a particular chemical using both the

for dealing with such Chromosomal Damage : Reproduction/Developmental Toxicityapproach g In Vitro Mammalian Screening Test (40 CFR 799 .9355) and

chemicals would be to allow test Chromosome Aberration Test (40 CFR the Repeated Dose 28-Day Oral Toxicity

sponsors who wish to conduct Test 799,9537), or use either the In Vivo Study (40 CFR 799.9305) instead of the

Group 1 studies on chemicals with a log Mammalian Bone Marrow Chromosomal Combined Repeated Dose Toxicit y

K°w greater than or equal to 4 .2 to Aberration Test (rodents: mouse Study with the Reproduction /

submit to EPA for approval a written (preferred species), rat, or Chinese Developmental Toxicity Screening Test

request to conduct these Test Group 1 hamster): 40 CFR 799 .9538, or the In (40 CFR 799,9365) . With regard to such studies . The written request would have Vivo Mammalian Erythrocyte cases, a subject person who uses th e

to include the rationale for conducting Micronucleus Test (sampled in bone combination of the Reproduction/

these Test Group 1 studies and be marrow) (rodents: mouse (preferred Developmental Toxicity Screening Test approved by the Agency prior to (e .g ., species), rat, or Chinese hamster): 40 and the Repeated Dose 28-Day Ora l

90 days before) initiating these Test CFR 799 .9539. Toxicity Study in place of the Combined Group 1 studies. EPA is soliciting public Persons required to conduct testing Repeated Dose Toxicity Study with

comment on this approach as well as for chromosomal damage are Reproduction/Developmental Toxicity

other alternative approaches in this encouraged to use in vitro genetic Screen must submit to EPA a rationale

area . toxicity testing (Mammalian for conducting these alternate tests i n

4 . Mammalian Toxicity-Acute . Chromosome Aberration Test) to the final study reports . EPA solicits Acute Inhalation Toxicity (rat): generate needed genetic toxicity comment on whether the Agency should

Method A (40 CFR 799 .9130) screening data, unless known chemical instead require that a subject person
p. 15

Federal Register/ Vol. 65, No . 248/Tuesday, December 26, 2000/Proposed Rules 81671

wishing to use an alternate testing submit the required final report by the attained for any of the Class 1

scheme submit to EPA a notice that deadline indicated as the number of substances listed in this proposed rule

.

includes the rationale for conducting months after the effective date that For the Class 2 chemical substances that

the alternative tests prior to planned would be shown in § 799 .5085(j) of the are listed in the proposed rule, EPA is

initiation of those studies. Comments proposed regulatory text . As indicated proposing that the test substance be any

should include suggestions for efficient previously, in establishing the time representative form of the chemical

procedures for such a notification frame for testing under this rulemaking, substance, to be defined by the test

process. the Agency will consider the time sponsor(s).

Certain of the chemicals for which frames used under the voluntary HPV In proposing a different approach for

Mammalian Toxicity-Repeated Dose/ Challenge Program. Specifically, any identifying the substance to be tested

Reproduction/ Developmental testing is testing of closed system intermediates with regard to Class 2 substances, EPA

proposed may be used solely as "closed (as described in Unit III.I.) will be recognizes two characteristics which

system intermediates," as described in deferred until 2003 ; and any testing of further distinguish Class 1 from Class 2

the EPA guidance document developed individual chemicals (i.e ., those HPV chemical substances. First, unlike for

for the voluntary HPV Challenge chemicals not proposed for testing in a Class 1 substances, knowledge of the

Program (Ref. 32). As described in that category) that require further testing on composition of commercial Class 2

guidance, such chemicals may be animals will be deferred until November substances can vary in quality and

eligible for a reduced testing battery 2001, specificity from substance to substance

. which substitutes a developmental

C. How Would the Studies Proposed The composition of the chemical

toxicity study for the SIDS requirement ~ species which comprise a Class 2

to address repeated dose Under this Test Rule be Conducted ? (e .g ., substance may be:

subchronic), reproductive, and Persons required to comply with the • Well-characterized in terms of

developmental toxicity . In other words, final rule would have to conduct the molecular formulae, structural

since only the developmental toxicity necessary testing in accordance with diagrams, and compositiona l

study would be conducted for those those testing and reporting percentages of all species present (for

chemicals that qualify for a reduced requirements, and with the TSCA GLPS example, methyl phenol) ;

testing battery, repeated dose (e .g ., (40 CFR part 792). . Less well-characterized, for

subchronic) and reproductive studies example, characterized only by D

n.d

Wh

e

r Wha

t thi

s Substances

Rule? would not be conducted, At the Would be Testedp

resent U molecular formulae, non-specific

time, EPA does not have sufficient structural diagrams, and/or by

information to know with any degree of EPA is proposing two distinct incomplete or unknown compositional

certainty which if any of the chemicals approaches for identifying the specific percentages of the species present (for

that are listed in the proposed substances that would be tested under example, C1Z-Ci4 tert-akyl amines) ; or

regulatory text are solely closed system this proposed rule, the application of . Poorly characterized because all that

intermediates as defined by OECD/SIDS which would depend on whether the is known is the identity of only some of

guidelines, Persons who believe that a substance is considered to be a "Class the chemical species present and their

chemical fully satisfies the terms 1" or a "Class 2" chemical substance . percentages of composition, or of only

outlined in the guidance document are First introduced when EPA compiled the feedstocks and method of

encouraged to submit appropriate the TSCA Chemical Substance manufacture used to manufacture the

information along with their comments Inventory, the term Class 1 chemical substance (for example, nut shell liquor

which substantiate this belief. If, based substance refers to a chemical substance of cashew) .

on submitted information and other having a chemical composition that Secondly, the composition of some

information available to EPA, the consists of a single chemical species Class 2 substances may vary from one

Agency believes that a chemical is (not including impurities) that can be manufacturer to another, or, for a single

considered likely to meet the represented by a specific, complete manufacturer, from production run to

requirements for use solely as a closed structure diagram . By contrast, the term production run, because of small

system intermediate, EPA will address Class 2 chemical substance refers to a variations in feedstocks, manufacturing

any developmental toxicity testing need chemical substance having a methods, or other production variables.

in a subsequent rulemaking, In those composition that cannot be represented A "Class 2" designation most frequently

cases in which the Agency can by a specific, complete chemical represents a group of substances

determine that chemicals are solely structure diagram, because such a comprising substances that have similar

closed system intermediates, it plans to substance generally contains two or combinations of different chemical

handle them in accordance with the more different chemical species (not species and/or that were prepared from

existing OECD procedures. EPA intends including impurities) . Table 2 in similar feedstocks using similar

that actual initiation of testing of closed § 799 .5085(j) of the proposed regulatory production methods . By contrast, Class

system intermediates be deferred until text identifies the listed substances as 1 substances generally represent a much

2003. either Class 1 or Class 2 substances. narrower group of substances for which

B. When Would any Testing Imposed by EPA is proposing that, for the Class 1 the only variables are their impurities .

this Rulemaking Begin? chemical substances that are listed in EPA believes that, for purposes of thi s

the proposed rule, the test substance proposed rule which would require

The testing requirements contained in have a purity of 99% or greater . EPA has basic screening-level testing, the testing

this proposed rule are not effective until generally applied this standard of purity of any representative form of a subject

and unless the Agency issues a to the testing of Class 1 chemical Class 2 substance would be relevant to

subsequent final rule . Based on the substances in the past under TSCA a determination of whether the chemical

effective date of the final rule, which is section 4(a) testing actions, except for substance would or would not present

typically 30 days after the publication of substances where it has been shown that an unreasonable risk to human health or

a final rule in the Federal Register, the such purity is unattainable . EPA is the environment. However, EPA would

test sponsor may plan the initiation of soliciting comment on whether a purity encourage the selection o f

any required testing as appropriate to level of 99% or greater cannot be representative forms of test substances
p. 16

81672 Federal Register / Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rule s

that meet industry or consensus To facilitate EPA's review of obtain without unreasonable burden),

standards, where they exist . In exemption applications under this you would not be subject to the rule .

accordance with TSCA GLPS at 40 CFR alternative, the Agency would require 2 . When would my manufacture or part 792, the final study report must the submission of certain chemical processing (or my intent to do so) cause include test substance identification substance-identifying data, including me to be subject to this rule? You would information, including name, CAS characteristics and properties of the be subject to this rule if yo

u

number, strength, purity, and exemption applicant's substance, such manufacture or process, or intend to

composition, or other appropriate as boiling point, melting point, chemical manufacture or process, a substance

characteristics. See 40 CFR 792 .185. analysis, additives (if any), and spectral listed in the rule at any time from th

As an alternative to requiring the data information e

. effective date of the final test rule to the testing of a representative form of a EPA solicits comment on the end of the test data reimbursement

Class 2 substance designated by a proposed alternative approaches to the period

. The term "reimbursement person subject to the final rule, EPA is testing of Class 2 substances included in period" is defined at 40 CFR 791

.3(h) considering whether the Agency should this proposed rule, Additionally, EPA and may vary in length for eac

h specify the particular form of each solicits comment on whether the substance to be tested under a final

substance that must be tested, and, if so, proposed approach for testing Class 1 TSCA section 4(a) test rule, depending

what criteria EPA should use to identify substances in the proposed rule, i .e ., on what testing is required and when the particular representative form that that Class 1 test substances have a testing is completed

would be tested . See Unit V.E.4 . , . EPA might specify, for purity of 99% or greater, should be entitled

example, a form of a substance that applied to any Class 2 substances in the How do the reimbursement

meets an industry or consensus proposed rule procedures work?

. Similarly, EPA solicits

specification, if one exists, or the form comment on whether the proposed or 3 . Would I be required to test if I were

with the highest production volume, alternative approaches for the testing of subject to the rule? It depends on the

which could potentially be identified Class 2 substances should be applied to nature of your activities . All persons

via information reported under a TSCA any Class 1 substances, who would be subject to this TSCA

section 8(a) rule, or by other means . E. Would section 4(a) test rule, whic h

Under both of the approaches I Be Required to Test Under incorporates EPA's generic procedures

described in this unit, manufacturers this Rule? applicable to TSCA section 4(a) test

and processors of each chemical Under TSCA section 4(a)(1)(B)(ii), rules (contained within 40 CFR part

substance listed in the rule would be EPA has made preliminary findings that 790), would fall into one of two groups,

jointly responsible for the testing of a there are insufficient data and designated here as Tier 1 and Tier 2 .

representative form of each Class 2 experience to reasonably determine or Persons in Tier 1(those who would

substance, predict health and environmental effects have to initially comply with the final

EPA is also considering whether, for resulting from the manufacture, rule) must either :

some or all Class 2 substances, more processing, or use of the chemical . Submit to EPA letters of intent to than one form of a substance should be substances listed in this rulemaking . As conduct testing, conduct this testing, tested. Regardless of which of the above a result, under TSCA section 4(b)(3)(B), and submit the test data to EPA

; or approaches for testing Class 2 manufacturers and processors of these

substances is ultimately chosen (i .e ., substances would be subject to the rule exemptions from testing . Apply to and obtain from EPA

persons subject to the rule choosing vs .

. with regard to those listed chemical s

EPA choosing the forms(s) of the Class which they manufacture or process . Persons in Tier 2 (those who would

2 substances to be tested), EPA is 1 . Would I be subject to this rule? You not have to initially comply with the

considering requiring that persons would be subject to this rule and may final rule) need not take any action

applying for an exemption provide data be required to test if you manufacture or unless they are notified by EPA tha t

to EPA that would allow the Agency to process, or intend to manufacture or they are required to do so, as described

determine whether: process, one or more chemical in Unit V.E.3,d, entitled What would

1 . The form of the Class 2 substance substances listed in this proposed rule my obligations be if I were in Tier 2 ?

with respect to which an exemption during the time period discussed in Note that persons in Tier 1 who obtain

application is being submitted is Unit V.E.2 , entitled When would my exemptions and persons in Tier 2 would

equivalent to the form of a test manufacture or processing (or my intent nonetheless be subject to providing

substance for which data required under to do so) cause me to be subject to this reimbursement to persons who actually

the rule have been or will be submitted ; rule? However, if you do not know or conduct the testing, as described in Unit

and cannot reasonably ascertain that you V.E .4 . , entitled How do the

2 . The submission of the required test manufacture or process a listed test reimbursement procedures work?

data concerning a particular form of a substance (based on all information in a . Who would be in Tier 1 and Tier 2?

Class 2 substance would be duplicative your possession or control, as well as all All persons subject to this rule would be

of data that have been or will be information that a reasonable person considered to be in Tier 1 unless they

submitted to EPA in accordance with similarly situated might be expected to fall within Tier 2 . The following table the test rule . possess, control, or know, or could describes who is in Tier 1 and Tier 2 .

TABLE 2 .-PERSONS SUBJECT TO THE RULE : PERSONS IN TIER 1 AND TIER 2

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply )

Persons who manufacture (as defined at TSCA section 3(7)), or intend Persons who manufacture (as defined at TSCA section 3(7)) or intend

to manufacture, a test rule substance, and who are not listed under to manufacture a test rule substance solely as one or more of the

Tier 2 following:

-As a byproduct (as defined at 40 CFR 791 .3(c));

-As an impurity (as defined at 40 CFR 790 .3));

-As a naturally occurring substance (as defined at 40 CFR 710.4(b));
p. 17

Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 81673

TABLE 2 .-PERSONS SUBJECT TO THE RULE : PERSONS IN TIER 1 AND TIER 2-Continue d

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply)

-As a non-isolated intermediate (as defined at 40 CFR 704.3);

-As a component of a Class 2 substance (as described at 40 CFR

720 .45(a)(1)(i));

-In amounts of less than 500 kg (1,100 Ibs) annually (as described at

40 CFR 790 .42(a)(4)); or

-In small quantities solely for research and development (as described at 40 CFR 790 .42(a)(5))

Persons who process (as defined at TSCA section 3(10)) or intend to

process a test rule substance (see 40 CFR 790 .42(a)(2))

b. When would it be appropriate for reimbursement to persons in Tier 1, as • Manufacturers of less than 500 kg

a person in Tier 1 to apply for an described in Unit V,E .4 . You are (1,100 lbs) per year ("small-volume

exemption rather than to submit a letter considered to have an automatic manufacturers") (40 CFR 790 .42(a)(4)) ;

of intent to conduct testing? You may conditional exemption. You would not and

apply for an exemption if you believe need to take any action unless you are . Manufacturers of small quantities

that the required testing will be notified by EPA that you are required to for research and development ("R&D

performed by another person (or a do so. manufacturers") (40 CFR 790.42(a)(5)). consortium of persons formed under If a problem occurs with th e

TSCA section 4(b EPA has historically place )(3)(A)) in Tier 1 d

. You initiation, conduct, or completion of the processors in Tier 2 because the Agency

can find procedures relating to required testing, or the submission of "expected that, in most cases, testing

exemptions in 40 CFR 790 .80 through the required data to EPA, the Agency will be performed by the manufacturers

790.99, and § 799,5085(c)(2), (c)(5), and may require you to submit a notice o f

(c)(7) of the proposed regulatory text, In intent to test or an exemption and that part of the cost of testing will

this rule, EPA would not require application . See 40 CFR 790 .93 and be passed on to processors through the

equivalence data (Le ., data § 799.5085(c)(6) of the proposed pricing mechanism, thereby enabling

demonstrating that your substance is regulatory text . them to share in the costs of testing" (50

equivalent to the substance actually In addition, you would need to FR 20652, 20654, May 17, 1985) . In

being tested) as a condition for approval submit a notice of intent to test or an addition, "[t]here are so man y

of your exemption, See § 799 .5085(j) of exemption application if: processors that it would be difficult to

the proposed regulatory text for a . No manufacturer in Tier 1 has include them all in the technical

description of the substances that would notified EPA of its intent to conduct decisions about the tests and in the

be tested under this proposed rule . testing; and financial decisions about how to

c . What would happen if I were in • EPA has published a document in allocate the costs" (48 FR 31786, 31789,

Tier 1 and I submitted an exemption the Federal Register directing all July 11, 1983) .

application? EPA believes that requiring persons in Tier 2 to submit to EPA EPA has historically placed smallthe collection of duplicative data is letters of intent to conduct testing or volume manufacturers and R&D

unnecessarily burdensome . As a result, exemption applications. See 40 CFR manufacturers in Tier 2 because this

if EPA has received a letter of intent to 790 .48(b) and § 799.5085(c)(4) and (c)(5) type of manufacturing "normally

test from another source or has received of the proposed regulatory text . The represents a small percentage of the

(or expects to receive) the test data that Agency would conditionally approve an overall production volume [and] test

would be required under this rule, the exemption application under 40 CFR sponsors are not expected to expend the

Agency would conditionally approve 790 .87 if EPA has received a letter of administrative resources to recover the

your exemption application under 40 intent to test or has received (or expects small proportional amounts of th e

CFR 790 .87. The Agency would to receive) the test data required under testing costs from these manufacturers"

terminate conditional exemptions if a this rule . (55 FR 18881, May 7, 1990).

problem occurs with the initiation, e . How did EPA decide who would be In this proposed test rule, EPA has

conduct, or completion of the required in Tier 1 and Tier 2 and who would be reconfigured these tiers . EPA has added

testing, or the submission of the excluded from the rule? the following persons to Tier 2 :

required data to EPA . EPA may then Under 40 CFR 790 .2, EPA may Byproduct manufacturers; impurity

require you to submit a notice of intent establish procedures applying to manufacturers ; manufacturers o f

to test or an exemption application. See specific test rules that differ from the naturally occurring substances;

40 CFR 790 .93 and § 799.5085(c)(6) of generic procedures governing TSCA manufacturers of non-isolate d

the proposed regulatory text. Note that section 4 test rules in 40 CFR part 790 . intermediates; and manufacturers of

persons in Tier 1 who obtain For the purposes of this proposed rule, components of Class 2 substances. The

exemptions and persons in Tier 2 would EPA is proposing to set forth certain Agency took administrative burden and

nonetheless be subject to providing requirements that differ from those complexity into account in determining

reimbursement to persons who do under 40 CFR part 790, who was to be in Tier 1 in this proposed

actually conduct the testing, as Under 40 CFR part 790, in TSCA rule . EPA believes that those persons in described in Unit V .E.4 ., entitled How section 4(a) test rules EPA traditionally Tier 1 who would conduct testing under

do the reimbursement procedures work? has treated the persons specified below this proposed rule, when finalized ,

d. What would my obligations be if I as being in Tier 2 . (These rules are would generally be large chemica l

were in Tier 2? If you are in Tier 2, you found at 40 CFR part 799, subparts B manufacturers who, in the experience of

would be subject to the rule and you and D .): the Agency, have traditionally

would be responsible for providing • Processors (40 CFR 790 .42(a)(2)); conducted testing or participated in
p. 18

81674 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules

testing consortia under previous TSCA reimbursement from these G. What Would I Need to do If I Cannot

section 4(a) test rules. manufacturers. EPA is particularly Complete the Testing Required by the

TSCA section 4(b)(3)(B) requires all interested in comments on the Final Rule?

manufacturers and processors of a appropriate annual production amount A company who submits a letter of

chemical substance to test that chemical at which test sponsors would not be intent to test under the final rule and

substance if EPA has made findings for expected to seek reimbursement such who subsequently anticipate s

that chemical substance, and therefore that the reason for requiring an difficulties in completing the testing by

issued a TSCA section 4(a) test rule exemption application to be filed by the deadline set forth in the final rule requiring testing . However, practicality these manufacturers would not exist. may submit a modification request to

must be a factor in determining who is please provide a rationale and the Agency, pursuant to 40 CFR 790 .55 . subject to a particular test rule . Thus, supporting information for any EPA will determine whethe r

persons who do not know or cannot alternative threshold(s) suggested, modification of the test schedule is reasonably ascertain that they ar e

manufacturing or processing a substance EPA is also soliciting comment on appropriate, and may first seek public

would not be subject to the proposed who should be included in Tier 1 and comment on the modification .

rule. See Unit V.E.1 . and Tier 2. The Agency may define these H. Would There be Sufficient Test

§ 799 .5085(b)(2) of the proposed categories differently in response to Facilities and Personnel To Undertake

regulatory text. comments received. EPA is also the Testing Proposed Under this Test

Under 40 CFR 790.42(a)(4), certain soliciting comment on who should not Rule ?

small-quantity manufacturers (i.e ., those be subject to the rule. The latter persons Yes. In 1996, EPA conducted a study who manufacture less than 500 kg are described in Unit V.E.1 . and of TSCA testing laboratories to evaluate (1,1001b) of the test rule chemical § 799.5085(b)(2) of the proposed the expected capacity of these annually) do not initially need to submit regulatory text . laboratories to conduct various tests letters of intent to test or exemption 4 . How do the reimbursement through the year 2000 (Ref. 19) . The applications under a test rule unless

procedures work? In the past, persons results suggest that laboratory capacity EPA specifically requires them to do so

. subject to test rules have independently is expected to expand at a rate such that

EPA established this provision because worked out among themselves their the testing that would be required by such small quantity manufacturing this ro osed rule should be readil

y

of the overall production volume, so those persons who have actually accommodated by testing laboratorie

. However, if (Ref s that test sponsors are not expected to conducted the testing . 9).

expend the administrative resources persons are unable to agree privately on I. Might EPA Seek Further Testing of the

necessary to seek reimbursement of the reimbursement, they may take Chemicals in this Proposed Test Rule?

associated small proportional amounts advantage of EPA's reimbursement If EPA determines that it need

s

of the testing costs from these small- procedures at 40 CFR part 791, additional data regarding any of the

quantity manufacturers. As a result, promulgated under the authority of chemical substances included in this

EPA determined that the reason for TSCA section 4(c) . These procedures proposed rule, the Agency might seek requiring an exemption application to include : The opportunity for a hearing further health and/or environmental be filed did not exist for these with the American Arbitration effects testing for these chemical

manufacturers (55 FR 18881, at 18881, Association; publication by EPA of a substances . Should the Agency decide May 7, 1990). document in the Federal Register to seek such additional testing, EPA

During interagency review, it was concerning the request for a hearing; would initiate a separate action for this suggested that EPA consider increasing and the appointment of a hearing officer purpose

,

the small-quantity amount in this to propose an order for fair and

proposed rule in order to eliminate the equitable reimbursement . The hearing VI. Expo rt Notificatio n

need for certain persons subject to the officer may base his or her proposed Any person who exports, or intends to

rule to initially submit a letter of intent order on the production volume formula export, one of the chemical substances

to test or an exemption application. As set out at 40 CFR 791 .48, but is not contained in this proposed rule in any

a result this group of persons would be obligated to do so . Under this proposed form will be subject to the export shifted to Tier 2. As with the existing rule, amounts manufactured as notification requirements in TSCA

tiering system, these persons would still impurities would be included in section 12(b)(1) and at 40 CFR part 707,

be subject to reimbursement production volume (40 CFR 791 .48(b)), subpart D, but only after the final rule

requirements and could potentially be subject to the discretion of the hearing is issued and only if the chemical is required to conduct testing (for officer (40 CFR 791 .40(a)). The hearing contained in the final rule. However,

example, if Tier 1 entities do not submit officer's proposed order may become the export notification would generally not letters of intent to test)

EPA is interested in receiving 40 CFR 707 . Agency's final order, which is be required for articles, as provided by

on whether the 1,1001b (500 reviewable in federal court (40 CFR (b)• .60(b) .

kg) small-quantity threshold in this 791 .60) . VII. Public Comment

proposed rule should be raised (e .g ., to F. What are the Reporting Requirements As discussed in Unit III.D, EPA is 5,000, 10,000, or 25,000 lbs) in order to Proposed Under this Test Rule? interested in comments regarding

shift certain small-quantity specific procedures for incorporating

manufacturers from Tier 1 to Tier 2 . You would be required to submit a the use of categories and SAR into this

These persons would represent a small final report for a specific test by the proposed rule

.

percentage of the overall production deadline indicated as the number of Comments which identify existing

volume of a chemical in the test rule months after the effective date of the data that may meet the requirements of

such that test sponsors would not be final rule, which would be shown in studies under this proposed rule should

expected to expend the administrative § 799,5085(j) of the proposed regulatory include the data with the submission of

resources necessary to seek text. comments to EPA. Data submitted to
P. 19

Federal Register / Vol. 65, No. 248/ Tuesday, December 26, 2000/Proposed Rules 81675

EPA to meet the requirements of testing document is available on the EPA Octanol/Water Partition Coefficient

. under this proposed rule must be in the website at http ://www.epa .gov/opptintr/ Environmental Toxicology an d

form of full copies of unpublished chemtest/hazchem .htm). Chemistry. Vol. 15, No .2, pp. 1006-106 studies or full citations of published 3 . ACC (formerly CMA) . Public (1996),

studies, and may be accompanied by a Availability of SIDS-Related Testing 15 . Veith GD and Kosian P, Estimating robust summary (Ref. 34) . To the extent Data for U.S. High Production Volume bioconcentration potential from octanol/

that studies required under this Chemicals (June 12, 1998). Copies of water partition coefficients, in Physical

proposed rule are currently available, ACC's report can be obtained by writing Behavior of PCB's in the Great Lake

s

and the data are judged sufficient by to ACC at 1300 Wilson Blvd ., Arlington, (MacKay, Paterson, Eisenreich, and

EPA, testing for the endpoint/chemical VA 22209 or by calling ACC at (703) Simmons, eds.), Ann Arbor Science,

combination will not be required in the 741--226. Ann Arbor, MI. (1982) .

final rule based on this proposed rule . 4. OECD Secretariat . SIDS Manual. 16. Bintein S, DeVillers J, and Karcher EPA solicits public comment on the Third Ed . Screening Information Data W. Nonlinear dependence of fish

test methods proposed in this, the Set Manual of the OECD Programme on bioconcentration on n-octanol/water

approach discussed in Unit V.E. entitled the Co-Operative Investigation of High partition coefficient

Would I be required to test under this . SAR and QSAR in

Production Volume Chemicals. Paris, Environmental Research, Vol,1, pp . 29- rule?, and the analysis detailing the France (July 1997). Electronic copies of 39 (1993) .

burdens and costs for the regulatory this Manual can be obtained from OECD 17 . Meylan WM, Howard PH, impacts resulting from this rule . at http://www.oecd.org/ehs/ Boethling RS, Aronson D, Printup H, In addition, EPA solicits comment on sidsman .htm, or by accessing EPA's and Gouchie S . Improved method o f

the proposed and alternative approaches ChemRTK website at http :// estimating bioconcentration/

to the testing of Class 2 substances, www.epa .gov/chemrtk/sidsappb,htm. bioaccumulation factor from octanol/ whether the proposed approach for 5. OECD. Decision-Recommendation water partition coefficient .

testing Class 1 substances (i .e ., that each on the Co-Operative Investigation and Environmental Toxicology an d

Class 1 substance be tested at a purity Risk Reduction of Existing Chemicals- Chemistry, Vol .18, No.4, pp 664-672)

of 99% or more) should be applied to C(90)163/FINAL (January 31, 1991) . (1999), any Class 2 substances, and whether the 6 . ACC, Comments on EPA's TSCA 18 . Smrchek JC and Zeeman MG .

proposed or alternative approaches for section 4(a)(1)(B) Proposed Statement of Assessing Risks to Ecological Systems

the testing of Class 2 substances (i .e . Policy submitted to the TSCA Public from Chemicals, pp. 24-90. In. P.

that a representative sample of each Docket Office, EPA (September 17, Callow (ed

Class 2 substance be tested) should be 1991) .), Handbook of

. Environmental Risk Assessment and applied to any Class 1 substances. 7. Epoxy Resin Systems Task Group of Management, Blackwell Science Ltd .,

VIII. Documents in the Official Record the Society of the Plastics Industry, Inc, Oxford, UK, (1998) .

The official record for this d Comments on EPA's TSCA section 19. EPA. EPA Census of TSCA

rule has been established under docket 4(a)(1)(B) Proposed Statement of Policy Laboratories, Washington, DC (October

control number OPPTS-42213A, and TSCA Public Docket Office , ffice, EPA 10, 1996).

the public version of the official record (September 17, 1991) . 20. EPA. Treatment of 12(b) Export

8 . ICCA. ICCA HPV Working List 22- Notification Unit Costs for Section 4 is available for inspection as specified 040-1999

; Chemicals Common to 2 or Test Rule Analyses, OPPT/EETD/EPAB, in Unit I.B.2 . The following is a listing more of the Regions: Canada, European Washington, DC (April 1, 1999) . of the documents that have already been Union (EU), Japan, and USA (1999) . 21. EPA. Economic Analysis in

placed in the official record for this (Electronic copies of this list can be Support of the TSCA 12(b) Information

proposed rule, including those obtained from the ICCA website at http :/ Collection Request, OPPT/EETD/EPAB, specifically referenced in this /www

document .icca-chem.org/hpv). Washington, DC (October 30, 1998).

. For your convenience, EPA 9. EPA, OPPT. Economic Impact 22. EPA, April 1999 Agenda o f

may have also provided some non-EPA Analysis of a Section 4 Test Rule for Regulatory and Deregulatory Actions ;

internet addresses to allow you to access High Production Volume Chemicals Semiannual regulatory agenda .

the electronic version of the referenced (December 2000). Chemical Right-to-Know, sequence document, In doing so, the Agency has 10. EPA. Comparison of 1990 High #3424 (64 FR 21898, April 26, 1999)

verified the accuracy of these addresses Production Volume (HPV) Chemicals (FRL-6238-9)

. at the time of signature . However, since with National Occupational Exposure 23 . EPA, TSCA section 4(a)(1)(B)

EPA is not responsible for these non- Survey (NOES) Database (November 13, Proposed Statement of Policy (56 FR

EPA sites, the Agency does not have any 1998). 32297, July 15, 1991).

control over these web addresses. A 11. EPA. Guidelines for Exposure 24. EPA. TSCA section 4(a)(1)(B)

paper copy of any document referenced Assessment, Federal Register (57 FR Final Statement of Policy (58 FR 28736,

in this way has been included in the 28888, May 29, 1992) . May 14, 1993).

public version of the official record for 12 . Seta, J.A, et al ., National Exposure 25 . EPA. Document containing EPA's

this document as described in Unit Survey Field Guidelines, Cincinnati Policy Statement under TSCA section 5

I.B .2 . Ohio: National Institute for entitled Category for Persistent, 1 . EPA, OPPT. ChemRTK, HPV Occupational Safety and Health . DHHS Bioaccumulative, and Toxic New Challenge Program Chemical List . (This (NIOSH) Publication No. 88-106 (1988). Chemical Substances (64 FR 60194, list is updated periodically, and is 13 . Meylan WM, and Howard PH. November 4, 1999) (FRL-6097-7). (An available electronically at http

www

:// Atom/Fragment Contribution for electronic copy is available at http :// .epa .gov/chemrtk/hpvchmlt.htm). Estimating Octanol-Water Partition www.epa .gov/opptintr/newchems/ 2 . EPA, OPPT. Chemical Hazard Data Coefficients

Availability Study

. Journal of Pharmaceutical pbtpolcy.htm).

Know About the Safety of High 14

: What Do We Really Sciences. Vol .84, No.1 (January 1995). 26. EPA, Significant New Use Rules;

. Meylan WM, Howard PH, and General Provisions for New Chemical

Production Volume Chemicals? (April Boethling, RS . Improved Method for Followup under sections 5 and 26(c) of

1998) (An electronic copy of this Estimating Water Solubility From TSCA (54 FR 31307, July 27, 1989)

.
p. 20

81676 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rule s

27, Document describing the HPV 36 . EPA, OPPT. Draft Guidance on only require processors to test if no

Initiative, entitled Data Collection/ Searching for Chemical Information and person in Tier 1 has submitted a notice

development on High Production Data (August 1999). (An electronic copy of its intent to conduct testing, or if

Volume (HPV) Chemicals; Notice, of this document is available on the EPA under 40 CFR 790 .93, a problem occurs

which is published elsewhere in this website at http ://www,epa.gov/chemrtk/ with the initiation, conduct, or

issue of the Federal Register (FRL- srchguid .htm). completion of the required testing, or

6754-6). (An electronic copy of this 37 . EPA, OPPT. Determining the the submission of the required data to

document is available on the EPA Adequacy of Existing Data (February 10, EPA. Because EPA has identified at least

website at http://www.epa .gov/fedrgstr/ 1999). (An electronic copy of this one manufacturer in Tier 1 for eac h

) . document is available on the EPA subject chemical, the Agency assumes

28. Environmental Defense (formerly website at http://www,epa.gov/chemrtk/ that, for each chemical in this proposed

EDF). Toxic Ignorance . New York, New datadfin .htm) . rule, at least one such person will

York (Summer 1997). Copies of Toxic 38 . SBA. Office of Advocacy- submit a letter of intent to conduct the

Ignorance can be obtained by accessing Statistics-Major Industry, Firms, required testing and that person will

Environmental Defense's website (http :/ Establishment, Employment, Payroll conduct such testing and will submit

/www.environmentaldefense,org/ and Receipts, 1995 . Information from the test data to EPA. Because processors

Reports/Toxiclgnorance) or by calling the Small Business Administration on would not need to comply with the

1-800-684-3322 . the Internet (http://www.sba,gov/advo/ proposed rule initially, the economic

29. EPA, Office of Prevention, stats/us-ind95.htm1, Downloaded on assessment does not address processors .

Pesticides, and Toxic Substances December 10, 1998). To evaluate the potential for an

(OPPTS). Letter from Susan H. Wayland, IX. Regulatory Assessment adverse economic impact of testing on

Deputy Assistant Administrator, to Requirements manufacturers of the chemical

participants in the voluntary HPV substances in this proposed rule, EPA

Challenge Program (October 14, 1999) A . Executive Order 12866 employed a screening approach that

(An electronic copy of this document is Under E.O. 12866, entitled Regulatory estimated the impact of testing

available on the EPA website at http :// Planning and Review (58 FR 51735, requirements as a percentage of each

www.epa .gov/chemrtk/ceoltr2.htm) . October 4, 1993), the Office of chemical's sale price. This measur e

30. EPA, OPPT. The Use of Structure- Management and Budget (OMB) has compares annual revenues from the sale

Activity Relationships (SAR) in the designated this proposed rule a of a chemical to the annualized testing

High Production Volume Chemicals "significant regulatory action" subject to costs for that chemical to assess the

Challenge Program (August 26, 1999). review by OMB under E.O. 12866, percentage of testing costs that can be

(An electronic copy of this document is because this action may raise novel legal accommodated by the revenu e

available on the EPA website at http :// or policy issues arising out of legal generated by that chemical. Annualized

www,epa .gov/chemrtk/sarfinll.htm). mandates, the President's priorities, or testing costs divide testing expenditures

31 . EPA, OPPT. Development of the principles set forth in section 3(f)(4) into an equivalent, constant yearl y

Chemical Categories in the HPV of the E,O . EPA therefore submitted this expenditure over a longer period of

Challenge Program (Draft) (August 25, proposed rulemaking to OMB for review time, To calculate the percent price

1999). (An electronic copy of this under E.O. 12866, and any comments or impact, testing costs (including

document is available on the EPA changes made during that review have laboratory and administrative

website at http://www.epa .gov/chemrtk/ been documented in the public version expenditures) are annualized over 15

categuid.htm). of the official record for this rulemaking . years using a 7% discount rate .

32. EPA, OPPT. Guidance for Testing In addition, EPA has prepared an Annualized testing costs are then

Closed System Intermediates for the economic assessment entitled Economic divided by the estimated annual

HPV Challenge Program (Draft) (March Impact Analysis for the Proposed revenue of the chemical to derive the

17, 1999). (An electronic copy of this Section 4 Test Rule for High Production cost-to-sales ratio. EPA estimates the

document is available on the EPA Volume Chemicals (Ref. 9), a copy of total annualized compliance cost of

website at http ://www.epa .gov/chemrtk/ which has been placed in the public testing for the 49 chemicals evaluated in

closed9.htm) . version of the official record for this the economic analysis to be $ 1 . 5

33 . EPA, OPPT. Procedures for rulemaking. This economic assessment million under the average cost scenario,

Removing Chemicals that are No longer evaluates the potential for significant In addition, the TSCA section 12(b)

HPV and Not Likely to Become HPV economic impacts as a result of the export notification requirement s

Again from the HPV List (Draft) (March testing that would be required by this (included in the total and annualized

17, 1999) . (An electronic copy of this proposal . The analysis covers 49 cost estimates) that would be triggered

document is available on the EPA chemicals, 12 more than identified in by the final rule are expected to have a

website at http://www.epa.gov/chemrtk/ the proposal, therefore, the costs negligible impact on exporters. The nolohpv8.htm) . presented here are expected to be an estimated cost of the TSCA section 12(b )

34 . EPA, OPPT. Draft Guidance on overestimate. The total social cost of export notification requirements, which,

Developing Robust Summaries (October providing test data on the 49 chemicals under the final rule, would be required

27, 1999). (An electronic copy of this that were evaluated in this economic for the first export to a particular

document is available on the EPA analysis is estimated to be $13 million country of a chemical subject to the

website at http://www.epa .gov/chemrtk/ (Ref. 9). rule, is estimated to be $83.38 for the

robsumgd,htm). While legally subject to this test rule, first time that an exporter must comply

35, EPA, OPPT. ChemRTK HPV processors of a subject chemical would with TSCA section 12(b) export

Challenge Program Making be required to comply with the notification requirements, and $19 .08

Commitments (June 29, 2000) . (An requirements of the rule only if they are for each subsequent export notification

electronic copy of this document is directed to do so by EPA as described submitted by that exporter (Refs . 9, 20,

available on the EPA website at http :// in § 799.5085(c)(5) and (c)(6) of the and 21). The Agency's estimated total

www.epa .gov/chemrtk/makecom .htm) . proposed regulatory text. EPA would costs of testing (including both
p. 21

Federal Register / Vol. 65, No. 248/Tuesday, December 26, 2000/ Proposed Rules 8167 7

laboratory and administrative costs) the costs of compliance to company manufacturing industrial sector (i .e ., SIC

annualized testing cost, price impacts, sales for small businesses . 28 and SIC 29), approximately 98% of

and public reporting burden hours for B. Regulatory Flexibility Act the firms would be classified as small

this proposed rule are presented in the businesses under the default SBA

economic assessment. Pursuant to section 605(b) of the definition, The SBA size standard fo r

Under a least cost scenario, 28 out of Regulatory Flexibility Act (RFA), 5 75% of this industry sector is 500

the 45 chemicals for which price data U,S.C. 601(b) et seq., the Agency hereby employees, and the size standard for

were available (62%) would have a certifies that this rulemaking, if 23% of this industry sector is 750,

price impact at less than the 1% level . promulgated as proposed, will not have 1,000, or 1,500 employees. As a result,

Similarly, 28 out of the 45 chemicals a significant economic impact on a when assessing the potential impacts of

(58%) would be impacted at less than substantial number of small entities. test rules on chemical manufacturers,

the 1% level under an average cost The factual basis for the Agency's EPA believes that a standard based on

scenario. Thus, the potential for adverse determination is presented in the small total annual sales may provide a more

economic impact due to the proposed entity impact analysis prepared as part appropriate means to judge the ability of

test rule is low for at least 58% of the of the economic analysis for this rule a chemical manufacturing firm to

chemicals in this proposed rule, (Ref. 9), and is briefly summarized here . support chemical testing without

Approximately 17 (19) chemicals (38% Two factors are examined in EPA's significant costs or burdens

.

(42%)) of the 45 chemicals for which small entity impact analysis (Ref. 9) in EPA is currently determining what

price data are available would have a order to characterize the potential small level of annual sales would provide the

price impact at a level greater than or entity impacts of this rule : most appropriate size cutoff with regard

equal to 1% under the least (average) 1 . The size of the adverse impact to various segments of the chemical

cost scenario . (measured as the ratio of the cost to industry usually impacted by TSC A

The Agency computed "critical sales or revenue), and section 4(a) test rules, but has not yet

prices" for all 49 chemicals, including 2, The total number of small entities reached a determination . As stated

the 37 chemicals included in this that experience the adverse impact . above, therefore, the factual basis for the

proposed TSCA section 4 HPV SIDS Section 601(3) of the RFA establishes RFA determination for this proposed

rule . Using chemical specific volume as the default definition of "small rule is based on an analysis using the

and test cost data, the critical price per business" the definition used in section default SBA size standards . Although pound that would result in a 1% impact 3 of the Small Business Act, 15 U.S.C. EPA is not currently proposing t o

on the annual revenue of the chemical 632, under which the Small Business establish an alternate definition for use

was estimated . The critical prices are Administration (SBA) establishes small in the analysis conducted for this

particularly proposed rule, the analysis for this informative for the 4 business size standards (13 CF R

chemicals for which price data are 121,201). For this rulemaking, EPA has proposed rule also presents the results

unavailable because they represent the analyzed the potential small business of calculations using a standard based

minimum price that is required to impacts using the size standards on total annual sales (40 CFR 704 .3).

support testing at the 1% level. established under this default EPA is interested in receiving comments Of the 4 chemicals for which price definition. The SBA size standards, on whether the Agency should consider

data were unavailable, an approximate which are primarily intended to establishing an alternate definition for

price range could be inferred for 2 determine whether a business entity is small business to use in the small entity

chemicals based on the knowledge of eligible for government programs and impact analyses for future TSCA section

the nature of these chemicals. Based on preferences reserved for small 4(a) test rules, and what size cutoff may

the critical prices and basic information businesses (13 CFR 121 .101), "seek to be appropriate.

on their nature or use, it is expected that ensure that a concern that meets a The SBA has developed 6 digit NAICS

neither of these chemicals is likely to be specific size standard is not dominant in code-specific size standards based on

impacted at greater than the 1% level . its field of operation." (13 CFR employment thresholds. These siz e

For the remaining 2 chemicals without 121 .102(b)), See section 632(a)(1) of the standards range from 500 to 1,50 0

price information, it is unclear whether Small Business Act, In analyzing employees for the various 6 digit NAICS

they will be impacted at greater than the potential impacts, the RFA recognizes codes that are potentially impacted (Ref

.

1% level. that it may be appropriate at times to 9). For a conservative estimate of the

EPA believes, on the basis of these use an alternate definition of small number of small businesses affected by

calculations, that the proposed testing of business . As such, section 601(3) of the the HPV rule, the Agency chose a n

the chemicals presents a low potential RFA provides that an agency may employment threshold of less than

for adverse economic impact for the establish a different definition of small employees 1,500 for all businesses

majority of chemicals. Because the business after consultation with the regardless of the NAIC-specific

subject chemical substances have SBA Office of Advocacy and after notice threshold to determine small business

relatively large production volumes, the and an opportunity for public comment . status.

annualized costs of testing, expressed as Even though the Agency has used the For each manufacturer of the 4 9

a percentage of annual revenue, are very default SBA definition of small business chemicals in the economic analysis, the

small for most chemicals. There are, to conduct its analysis of potential small parent company (ultimate corporate

however, some chemicals for which the entity impacts for this proposed rule, entity, or UCE) was identified and sales

price impact is expected to exceed 1% EPA does not believe that the SBA size and employment data were obtained for

of the revenue from that chemical . The standards are generally the best size companies where data was available .

potential for adverse economic impact is standards to use in assessing potential The search determined that there were

expected to be higher for these small entity impacts with regard to 103 affected UCEs. Sales and chemicals, In these cases, companies TSCA section 4(a) test rules . employment data could be found for

may choose to use revenue sources The SBA size standard is generally 102 of these UCEs (99%) .

other than the profits from the based on the number of employees an Parent company sales data were

individual chemicals to pay for testing . entity in a particular industrial sector collected to identify companies that

Therefore, the Agency also compared may have . For example, in the chemical qualified for "small business" status .
p. 22

81678 Federal Register/ Vol . 65, No. 248/ Tuesday, December 26, 2000/Proposed Rule s

Based on the SBA size standard applied, the final rule, regardless of the size of estimated burden of approximately 263

35 companies were identified as small . the exporter. hours for each study, the Agency

Employment data were unavailable for 1 Therefore, the Agency certifies that estimated an average burden of 14,444

company. A separate analysis, this proposed rule, if finalized, would hours per test sponsor . When a final

contained in the economic assessment not have a significant economic impact rule based on this proposed rule is

prepared for this proposed rule, was on small entities. Information relating to issued, EPA will verify that the

conducted for these companies to this determination has been included in approved burden hours contained in the

determine the potential economic the public version of the official record ICR are sufficient to cover the estimated

impact of this proposed rule. for this proposed rule. This information burden for the final rule . If not, EPA

The significance of this proposed HPV will also be provided to the SBA Chief will request that the total approved

rule's impact on small businesses was Counsel for Advocacy upon request. burden hour for the ICR be increased

analyzed by examining the number of Any comments regarding the impacts accordingly .

small entities that experienced different that this action may impose on small The standard chemical testing

levels of costs as a percentage of their entities, or regarding whether the program involves the submission of

sales. Small businesses were placed in Agency should consider establishing an letters of intent to test (or exemption

the following categories on the basis of alternate definition of small business to applications), study plans,

cost-to sales ratios: less than 1%, greater be used for analytical purposes for administering the tests, progress reports,

than 1%, greater than 3°/o . This analysis future test rules and what size cutoff and test results . For this proposed rule,

was conducted under both the least and may be appropriate, should be EPA estimates that the informatio n

the average cost scenarios, submitted to the Agency in the manner collection activities related to chemical

Of the 35 companies that qualified for specified under ADDRESSES . testing for all chemicals in this proposal

small business status per the SBA size C. Paperwork Reduction Act (representing the submission of letter

n s standards, only 1 had cost-to-sales ratios of intent or exemtio pursuant to the Paperwork Reduction administering the tests, and applications,

of greater than 1% under least and Act (PRA), 44 U submitting

.S .C. 3501 et seq., an the final reports-the study plan is average cost scenarios . None were agency may not conduct or sponsor, and re resented b this proposed rule an impacted at greater than the 3% level d

. a person is not required to respond to, p y p

p

Given these results, there does not progress reports are not required by this

an information collection request unless proposed rule because testing will be

appear to be a significant impact on a it displays a currently valid OMB completed within 1 year) wuld result substantial number of small entities as control number

. The OMB control in an annual ublic re ortin burden of a result of this proposed rule. P P g

As stated earlier in this unit, numbers for EPA's regulations, after approximately 12,942 hours per

appearing in the preamble of the final sponsor, assuming seven chemicals per

employment data were unavailable for 1 rule, are listed in 40 CFR part 9, and sponsor

. of the identified 103 companies (1%) . included on the related collection The annual public reporting burden

While data on their company level sales instrument . The information collection related to export notification i s

were also unavailable, the volumes of activities related to chemical testing estimated to be 0 .5-1 .5 burden hours for

the chemicals included in this proposed under TSCA section 4(a) have already each chemical/country combination

rule that it produced could be identified been approved under OMB control (Ref. 9). In estimating the total burden from the 1994 IUR database . Combining number 2070-0033 (EPA ICR No .1139), hours approved for the information

secondary data on chemical prices with and the information collection activities collection activities related to export

production volume data, the sales value related to export notification under notification, the Agency has included

of these chemicals could be estimated TSCA section 12(b)(1) are already sufficient burden hours to accommodate

for this company. In addition, the approved under OMB control number any export notifications that may be

minimum critical sales level that would 2070-0030 (EPA ICR No. 0795). This required by the Agency's issuance o f

be needed to avoid an impact at the 1% action does not contain any new final chemical test rules. As such, EPA

and the 3% levels was calculated, These information collection activities does not expect to need to request an

critical sales were then compared to the requiring additional OMB review and increase in the total burden hours

sales estimated using the method approval . approved by OMB for export described in this unit . Using these Although the information collection notifications .

estimates, EPA concluded that this activities contained in this proposed As defined by the PRA and 5 CFR

company is not impacted at greater than rule have already been approved by 1320 .3(b), "burden" means the total

1% of sales in the least or average cost OMB, the total burden hours currently time, effort, or financial resources

scenarios approved for the information collection expended by persons to generate

,

The estimated cost of the TSCA activities related to chemical testing maintain, retain, or disclose or provide

section 12(b)(1) export notification, may not reflect the estimated burden information to or for a Federal agency .

which, as a result of the final rule, hours specifically related to the This includes the time needed to : would be required for the first export to activities contained in this proposed review instructions ; develop, acquire,

a particular country of a chemical rule because the total number of install, and utilize technology and

subject to the rule, is estimated to be chemicals included in this proposed systems for the purposes of collecting,

$83.38 for the first time that an exporter rule exceeds the total number of validating, and verifying information,

must comply with TSCA section chemicals estimated in the ICR . As processing and maintaining

12(b)(1) export notification described in the information collection information, and disclosing and

requirements, and $19 .08 for each instrument for chemical testing (EPA providing information ; adjust the

subsequent export notification ICR No . 1139), the Agency's total existing ways to comply with any

submitted by that exporter (Refs . 9, 20, burden estimate specifically accounts previously applicable instructions and

and 21). EPA has concluded that the for the potential issuance of requirements; train personnel to be able

costs of TSCA section 12(b)(1) export approximately three average test rules to respond to a collection of

notification would have a negligible per year, each assumed to involve five information; search data sources;

impact on exporters of the chemicals in chemicals and three sponsors . With an complete and review the collection of
p. 23

Federal Register / Vol. 65, No . 248/ Tuesday, December 26, 2000/Proposed Rules 8167 9

information; and transmit or otherwise local, or tribal government. EPA is the voluntary testing program is to

disclose the information. requesting comment on whether any obtain toxicity data needed to assess the

Comments are requested on the State, local, or tribal government is potential risks resulting from childhood

Agency's need for this information, the engaged in the manufacture or exposure to certain commercia l

accuracy of the provided burden processing of these HPV chemicals such chemicals.

estimates, and any suggested methods that they might be subject to the G . National Technology Transfer and for minimizing respondent burden, requirements of this proposed rule . On Advancement Ac t

including through the use of automated the basis of these comments, EPA ma y

collection techniques. Send comments determine that it is appropriate to Section 12(d) of the Nationa l

to EPA as part of your overall comments consult with representatives of Technology Transfer and Advancement

on this proposed action in the manner potentially affected State, local, or tribal Act of 1995 (NTTAA), Public Law 104-

specified under ADDRESSES . In the governments prior to promulgating the 113, section 12(d) (15 U .S .C, 272 note),

final rule, the Agency will address any final rule . directs EPA to use voluntary consensus

comments received regarding the E. Executive Order 12898

standards in its regulatory activities

information collection requirements unless to do so would be inconsistent

contained in this proposal. This proposed rule does not involve with applicable law or otherwis e

D. Unfunded Mandates Reform Act and special considerations of impractical. Voluntary consensus

Executive Orders 13084 and 13132 environmental-justice issues pursuant to standards are technical standards (e .g .,

E.O. 12898, entitled Federal Actions to materials specifications, test methods,

Pursuant to Title II of the Unfunded Address Environmental justice in sampling procedures and business

Mandates Reform Act of 1995 (UMRA), Minority Populations and Low-Income practices) that are developed or adopted

Public Law 104-4, EPA has determined Populations (59 FR 7629, February 16, by voluntary consensus standards

that this rulemaking does not contain a 1994). bodies. The NTTAA directs EPA to

Federal mandate that may result in F. Executive Order 13045 provide Congress, through OMB,

expenditures of $100 million or more explanations when the Agency decides

for State, local, and tribal governments, E.O. 13045, entitled Protection of not to use available and applicabl e

in the aggregate, or the private sector in Children from Environmental Health voluntary consensus standards.

any 1 year. It is estimated that the total Risks and Safety Risks (62 FR 19885, If the Agency has made findings

aggregate costs of this proposed rule, April 23, 1997), does not apply to this under TSCA section 4(a), EPA is

which are summarized in Unit XI .A. , proposed rule, because it is not required by TSCA section 4(b) to

would be $13 million . The total designated as an "economically include specific standards for the

annualized costs of this proposed rule significant" regulatory actions as development of data in test rules. For

are estimated to be $1 .5 million. In defined under E.O. 12866, and it does some of the testing that would be

addition, EPA has determined that this not establish an environmental standard required by this rule, EPA is proposing

proposed rule does not significantly or that is intended to mitigate the use of voluntary consensus

uniquely affect small governments. environmental health or safety risks that standards issued by the ASTM and ISO

Accordingly, this proposed rule is not EPA has reason to believe may have a which evaluate the same type of toxicity

subject to the requirements of sections disproportionate effect on children . EPA as the TSCA and OECD test guidelines,

202, 203, 204, and 205 of UMRA . interprets E.O. 13045 as applying only where applicable . Copies of the ASTM

Under E.O. 13084, entitled to those regulatory actions that establish and ISO standards referenced in this

Consultation and Coordination with an environmental standard intended to proposed rule have been placed in the

Indian Tribal Governments (63 FR mitigate health or safety risks, such that public version of the official record for

27655, May 19, 1998), EPA has the analysis required under section 5- this rulemaking . In the final rule, EPA

determined that this proposed rule 501 of the Order has the potential to intends to seek approval from the

would not significantly or uniquely influence the regulation . Director of the Federal Register for the

affect the communities of Indian tribal Although this proposed rule is not incorporation by reference of the ASTM

governments . This determination is subject to this E .O., the information and ISO standards used in the final rule

based on the Agency's experience over obtained by the testing proposed in this in accordance with 5 U .S,C. 552(a) and

the years which indicates that, as a rule will be used to inform the Agency's 1 CFR part 51 .

practical matter, the burden of chemical decision making process regarding EPA is not aware of any potentially

testing under TSCA section 4(a) rules chemicals to which children may be applicable voluntary consensu s

has traditionally fallen on large, private disproportionately disposed . This standards which evaluate partition

sector manufacturers rather than on information will also assist the Agency coefficient (n-octanol/water) generator

tribal governments, Accordingly, the and others in evaluating these chemical column, water solubility (column

requirements of section 3(b) of E.O. substances for potential health or safety elution and generator column), acute

13084 do not apply to this proposed risk concerns, and will serve to further inhalation toxicity, bacterial reverse

rule . Nor will this action have a the Agency's goal of identifying and mutations, in vivo mammalian bone

substantial direct effect on States, on the controlling human and environmental marrow chromosomal aberrations,

relationship between the national risks as well as provide greater combined repeated dose with

government and the States, or on the protection and knowledge to the public . reproductive /developmental toxicity

distribution of power and In addition, in a separate Federal screen, repeated dose 28-day oral

responsibilities among the various Register document (64 FR 46673, toxicity screen, or the reproductive

levels of government, as specified in August 26, 1999), EPA announced the developmental toxicity screen which

E .O. 13132, entitled Federalism (64 FR initiation of a stakeholder involvement could be considered in lieu of the TSCA

43255, August 10, 1999). process to involve stakeholders in the guidelines, 40 CFR 799 .6756, 799.6784 ,

In the history of the TSCA section 4(a) design and development of a voluntary 799 .6786, 799.9130, 799 .9510, 799 .9538,

testing program, the Agency has never program to test commercial chemicals to 799 .9365, 799 .9305, and 799.9355,

received a letter of intent to test or an which children may have a high respectively, upon which the test

exemption application from a State, likelihood of exposure . The purpose of standards in this proposed rule are
p. 24

81680 Federal Register/Vol. 65, No . 248/Tuesday, December 26, 2000/Proposed Rule s

based. The Agency invites comment on Reporting and recordkeeping (b) Am I subject to this section? (1) If

the potential use of voluntary consensus requirements, you manufacture (including import) or

standards in this rulemaking, and, intend to manufacture, or process or

specifically, invites the public to Dated: December 14, 2000 . intend to process, any chemical

identify potentially applicable Susan H. Wayland, substance listed in Table 2 in

consensus standard(s) and to explain Acting Assistant Administratorfor 799,5085(j) at any time from th e

why such standard(s) should be used Prevention, Pesticides and Toxic Substances. effective date of the final rule to the end

here . Therefore, it is proposed that 40 CFR of the test data reimbursement period as

H. Executive Order 12630 chapter I, subchapter R, be amended as defined in 40 CFR 791 .3(h), you are

follows: subject to this section with respect to

EPA has complied with E,O. 12630, that chemical substance.

entitled Governmental Actions and PART 799-[AMENDED] (2) If you do not know or cannot

Interference with Constitutionally reasonably ascertain that you

Protected Property Rights (53 FR 8859, 1 . The authority citation for part 799 manufacture or process a chemical

March 15, 1988), by examining the would continue to read as follows : substance listed in Table 2 in

takings implications of this rule in § 799.5085(j) during the time period

accordance with the Attorney General's Authority: 15 U.S .C. 2603, 2611, 2625

. described in paragraph (b)(1) of this

Supplemental Guidelines for the 2 . By adding § 799 .5085 to subpart D section (based on all information in

Evaluation of Risk and Avoidance of of part 799 that would read as follows: your possession or control, as well as all

Unanticipated Takings issued under the information that a reasonable person

E .O. § 799.5085 Testing of ce rtain High similarly situated might be expected to

I. Executive Order 12988

Production Volume (HPV) chemicals.

P ossess, control, or know, or coul d

In issuing this proposed rule, EPA has

(a) What substances will be tested obtain without unreasonable burden),

g ProP underthis section? Table 2 in you are not subject to this section with

taken the necessary steps to eliminate § 799,5085(j) identifies the chemical respect to that chemical substance .

drafting errors and ambiguity, minimize substances that must be tested unde r

potential litigation, and provide a clear (c) If I am subject to this section, when

p P this section. For the chemical must I comply with it? (1) (i) Persons

legal standard for affected conduct, as substances identified as "Class 1" subject to this section are divided into

required by section 3 of E.O. 12988, substances in Table 2, the purity of each two groups, as set forth in Table 1 : Tier entitled Civil Justice Reform (61 FR substance must be 99% or greater, 1 (persons initially required to comply)

4729, February 7, 1996). unless otherwise specified in this and Tier 2 (persons not initiall y

List of Subjects in 40 CFR Part 799 section. For the chemical substances required to comply). If you are subject

identified as "Class 2" substances, a to this section, you must determine if

Environmental protection, Chemicals, representative form of each substance you fall within Tier 1 or Tier 2, based

Hazardous substances, Laboratories, must be tested . on Table 1.

TABLE 1 .-PERSONS SUBJECT TO THE RULE : PERSONS IN TIER 1 AND TIER 2

Persons initially required to comply with this sectio n

(Tier 1) Persons not initially required to comply with this section (Tier 2 )

Persons not otherwise specified in column 2 of this Persons that manufacture (as defined at TSCA section 3(7)) or intend to manufacture a

table that manufacture (as defined at TSCA section chemical substance included in this section solely as one or more of the following :

3(7)) or intend to manufacture a chemical substance included in this section .

-As a byproduct (as defined at 40 CFR 791 .3(c));

-As an impurity (as defined at 40 CFR 790 .3);

-As a naturally occurring substance (as defined at 40 CFR 710 .4(b));

-As a non-isolated intermediate (as defined at 40 CFR 704 .3);

- As a component of a Class 2 substance (as described at 40 CFR 720 .45(a)(1)(i));

-In amounts of less than 500 kilograms (kg) (1,100 lbs) annually (as described at 40

CFR 790 .42(a)(4)); o r

-For research and development (as described at 40 CFR 790.42(a)(5)).

Persons that process (as defined at TSCA section 3(10)) or intend to process a chemical

substance included in this section (see 40 CFR 790 .42(a)(2)).

(ii) Table 1 expands the list of persons in paragraph (d) of this section, no later to do so by EPA under paragraphs (c)(5)

specified in 40 CFR 790 .42(a)(2), (a)(4) than 30 days after the effective date of or (c)(6) of this section .

and (a)(5), who, while legally subject to the final rule, Sections 790,45(a) and (4) If no person in Tier 1 has notified

this section, must comply with the 790 .80(b)(1) of this chapter do not apply EPA of its intent to conduct one or more requirements of this section only if to this section

directed to do so by EPA under the b . of the tests required b this section on y

circumstances set forth in paragraphs (3) If you are in Tier 2 with respect any chemical substance listed in Table

(c)(4) and (c)(5) of this section, to a chemical substance listed in Table 2 in § 799 .5085(j) within 30 days after

(2) If you are in Tier 1 with respect 2 in § 799.5085(j), you are considered to the effective date of the final rule, EPA

to a chemical substance listed in Table have an automatic conditional will publish a Federal Register

2 in § 799 .5085(j), you will be required exemption and you will be required to document that will specify the test and

to comply with this section with regard comply with this section with regard to the chemical substance for which no

to that chemical substance, as described that chemical substance only if directed letter of intent has been submitted .
p. 25

Federal Register / Vol . 65, No. 248/ Tuesday, December 26, 2000 / Proposed Rules 81681

Section 790,48(b)(2) of this chapter does processing of a chemical substance are unable to agree on the amount or

not apply to this section, listed in Table 2 in § 799 .5085(j) begins method of reimbursement for test data

(5) If you are in Tier 2 with respect after the applicable compliance date development for one or more chemica l

to a chemical substance listed in Table referred to in paragraphs (c)(2), (c)(5) or substances included in this section, any

2 in § 799 .5085(j), and if you (c)(6) of this section, you must comply person may request a hearing as

manufacture or process this chemical as by submitting a letter of intent to test or described in 40 CFR part 791 . In the

of the effective date of the final rule, or an exemption application as of the day determination of fair reimbursement

within 30 days after publication of the you begin manufacture or processing, shares under this section, if the hearing

Federal Register document described in Sections 790 .45(d)(1) and (d)(2), and officer chooses to use a formula based

paragraph (c)(4) of this section, you 790 .80(b)(2) and (b)(3) of this chapter do on production volume, the tota l

must do the following : For each test on not apply to this section. production volume amount will include

that chemical specified in the Federal (d) What must I do to comply with amounts of a chemical substance

Register document described in this section? (1) To comply with this produced as an impurity .

paragraph (c)(4) of this section, either section you must either : (g) Who must comply with the export

notify EPA by letter of your intent to test (i) submit to EPA a letter of intent to notification requirements? Any person

or submit to EPA an exemption who exports, or intends to export, a test, conduct the testing specified in

application. You must comply within 30 Table 2 in § 799 .5085(j), and submit th

e test data to EPA

; or chemical substance listed in Table 2 in

days after the date of publication of the (ii) apply to and obtain from EPA an § 799.5085(j) is subject to part 707,

Federal Register document described in exemption subpart D, of this chapter .

paragraph (c)(4) of this section . Sections (2) ou fmustrom also comply with the (h) What test standards must I follow?

790.48(b)(3), and 790 .80(a)(2) and (b)(1) procedures governing test rule Follow the guidelines and other tes t

of this chapter do not apply to this requirements in part 790 of this chapter, methods described in Table 2 in

section. as modified by this section, including § 799.5085(j).

(6) If a problem occurs with the the submission of letters of intent to test (i) Reporting requirements. A final

initiation, conduct, or completion of the or exemption applications, the conduct report for a specific test must be

required testing or the submission of the of testing, and the submission of data ; submitted by the deadline indicated in

required data with respect to a chemical part 792-Good Laboratory Practice Table 2 in § 799 .5085(j).

substance listed in Table 2 in Standards of this chapter; and this (j) Designation of specific chemical

§ 799.5085(j), under the procedures in section . substances and applicable testing

40 CFR 790.93 and 790.97 EPA will (e) If I do not comply with this section, requirements. The substances identified

terminate all testing exemptions with when will I be considered in violation of by name and the Chemical Abstract

respect to that substance and may notify it? You will be considered in violation Service (CAS) number in Table 2 of this

persons in Tier 1 and Tier 2 that they of this section as of one day after the section must be tested in accordance

are required to submit letters of intent date by which you are required to with the designated testing

to test or exemption applications within comply with this section . Sections requirements, the requirement s

a specified period of time . Notification 790.45(e) and (f) of this chapter do not described in Part 792-Good Laboratory

will be given by certified letter or by apply to this section. Practice Standards of this chapter, and

publication in the Federal Register. ~f) How are EPA's data reimbursement any additional requirements an d

(7) If you are required to comply with procedures affected for purposes of this limitations specified in the following

this section, but your manufacture or section? If persons subject to this section Table 2:

TABLE 2-CHEMICAL SUBSTANCES AND APPLICABLE TESTING REQUIREMENT S

CAS No . Chemical name Chemical Required tests (See Deadline for final report (Months from

class Key) effective date of final rule)

55-63-0 1,2,3-Propanetriol, trinitrate 1 A, C6, E2, F2. 13

62-56-6 Thiourea 1 A. 13

74-95-3 Methane, dibromo- 1 A, C1, E2, F2 . 13

75-36-5 Acetyl chloride 1 A, B, C2, E2, Fl. 13

75-75-2 Methanesulfonic acid 1 A, C1, El, E2, Fl . 13

78-11-5 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, 1 A, B, C6, F2 . 13

dinitrate (ester)

84-65-1 9,10-Anthracenedione 1 A, F2. 13

84-69-5 1,2-Benzenedicarboxylic acid, bis(2- 1 A, E2, F2 13

methylpropyl) este r

88-18-6 Phenol, 2-(1,1-dimethylethyl)- 1 A, C2, D, El, E2, F1 . 13

90-00-6 Phenol, 2-ethyl- 1 A, B, C1, E2, F2. 13

90-1 5-3 1-Naphthalenol 1 A, C5, F2 13

98-11-3 Benzenesulfonic acid 1 A, C3, E2, Fl. 13

105-67-9 Phenol, 2,4-dimethyl- 1 A, C6, E2, F2. 13

107-16-4 Acetonitrile, hydroxy- 1 A, B, C1, E2, F2 . 13

107-18-6 2-Propen-l-ol 1 A, C6, E2 . 13

108-19-0 Imidodicarbonic diamide 1 A, B, C1, D, El, E2, 13

F1 .

110-44-1 2,4-Hexadienoic acid, (E,E)- 1 A, C4, F2 . 13

112-52-7 Dodecane, 1-chloro- 1 A, B, C3, D, E1, E2, 13

F 1

118-82-1 Phenol, 4,4'-methylenebis[2,6-bis(1,1- 1 A, B, D, El, E2, F2 . 13

dimethylethyl)-
p. 26

81682 Federal Register/Vol . 65, No, 248/Tuesday, December 26, 2000/Proposed Rules

TABLE 2-CHEMICAL SUBSTANCES AND APPLICABLE TESTING REQUIREMENTS-Continue d

CAS No . Chemical name Chemical Required tests (See Deadline for final report (Months from

class Key) effective date of final rule)

131-57-7 Methanone, (2-hydroxy-4- 1 A, C1, D, E2, F2 . 13

methoxyphenyl)phenyl149-44-0 Methanesulfinic acid, hydroxy-, monosodium 1 A, B, C1, E2, F1 . 13

sal t

409-02-9 Heptenone, methyl- 2 A, B, C1, D, El, E2, 13

Fl .

594-42-3 Methanesulfenyl chloride, trichloro- 1 A, B, C1, El, E2, F2 . 13

624-83-9 Methane, isocyanato- 1 A, C1. 13

732-26-3 Phenol, 2,4,6-tris(1,1-dimethylethyl)- 1 A, C2, El, E2, F1 . 13

870-72-4 Methanesulfonic acid, hydroxy-, monosodium 1 A, B, C1, El, E2, Fl . 13

sal t

1324-76-1 Benzenesulfonic acid, [[4-[[4- 2 A, B, C1, D, El, E2, 13

(phenylamino)phenyl][4-(phenylimino)-2,5- Fl .

cyclohexadien-lylidene]methyl]phenyl]amino]-

1333-39-7 Benzenesulfonic acid, hydroxy- 2 A, B, C1, El, E2, Fl . 13

2941-64-2 Carbonochloridothioic acid, S-ethyl ester 1 A, B, C1, E2, Fl. 13

3622-84-2 Benzenesulfonamide, N-butyl- 1 A, B, C1, El, E2, F2 . 13

6473-13-8 2-Naphthalenesulfonic acid, 6-[(2,4- 1 A, B, C1, D, El, E2, 1 3

diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4- Fl .

diaminophenyl)azo]-1-hydroxy-3-sulfo-2-

naphthalenyl]azo] phenyl]amino]-3-

sulfophenyl]azo]-4-hydroxy-, trisodium sal t

8005-02-5 C.I . Solvent Black 7 2 A, B, C1, D, E2, Fl. 13

28188-24-1 Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1- 1 A, B, C1, D, El, E2, 13

oxooctadecyl)oxy]methyl]-1,3-propanediyl Fl .

este r

65996-78-3 Light oil, coal, coke-oven 2 A . B, C1, D, El, E2, 13

Fl .

68153-30-0 Quaternary ammonium compounds, 2 A, B, C1, D, El, E2, 1 3

benzylbis(hydrogenated tallow alkyl)methyl, Fl .

salts with bentonit e

68611-64-3 Urea, reaction products with formaldehyde 2 A, B, C1, D . El, E2, 1 3

Fl .

68953-58-2 Quaternary ammonium compounds, 2 A, B, C1, D, El, E2, 13

bis(hydrogenated tallow alkyl)dimethyl, salts Fl .

with bentonit e

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G ., A OR C5 )

Testing category Test Test requirements and references' Special conditions symbo l

Physical/Chemical Properties A 1 . Melting Point: ASTM E 324 (capillary tube) rrOctanol/Water Partition Coefficient :

2 . Boiling Point : ASTM E 1719 (ebulliometry) Which method is required, if any, is determined by the test substance's estimated2

rfoctanol/water partition coefficient (log 10

basis). Test sponsors are required to provide in the final study report the underlying

rationale for the method selected . In order

to ensure environmental relevance, EPA

highly recommends that the selected study

be conducted at pH 7 .

3 . Vapor Pressure : ASTM E 1782 (thermal

analysis )

4 . rrOctanol/Water Partition Coefficient: (See log KoN, <0 : no testing required .

Special Conditions for the rr-Octanol/Water log KoH, range 0-1 : Method A or B .

Partition Coefficient test requirement and log Ko,v range 1-4 : Method A or B or C .

select the appropriate method to use, if log Ko,v range 4-6 : Method B or C .

any, from those listed below .) log Kow >6: Method C.

Method A: 40 CFR 799.6755 (shak e

flask)

Method B: ASTM E 1147 (liquid chromatography )

Method C : 40 CFR 799 .6756 (generator

column)
p. 27

Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 81683

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G ., A OR C5)-Continued

Testing category Test Test requirements and references' Special conditions symbol

5 . Water Solubility : (See Special Conditions Water Solubility.

for the Water Solubility test requirement Which method is required, if any, is deterand select the appropriate method to use, mined by the test substance's estimated3

if any, from those listed below .) water solubility. Test sponsors are required

Method A: ASTM E 1148 (shake flask) to provide in the final study report the unMethod B : 40 CFR 799.6784 (shake derlying rationale for the method selected .

flask) In order to ensure environmental relMethod C : 40 CFR 799.6784 (column evance, EPA highly recommends that the

elution) selectedstudy be conducted at pH 7 .

Method D : 40 CFR 799 .6786 (generator >5,000 mg/L : Method A or B .

column) < 5,000 mg/L but > 10 mg/L: Method A, B, C,

or D .

<10 mg/L but > 0 .001 mg/L : Method C or D .

< 0 .001 mg/L : no testing required.

Environmental Fate and Pathways- B For B, choose either of the following meth- None

Inherent Biodegradation ods:

1 . ASTM 1625 (semicontinuous activated

sludge test) O R

2. ISO 9888 (Zahn-Wellens method )

Aquatic Toxicity C1 For C1, Test Group 1 or Test Group 2 below The following are the Special Conditions for

must be used to fulfill the testing require- C1, C2, C3, C4, C5, and C7 testing ; there

ments-See Special Conditions , are no Special Conditions for C6 .

Test Group 1 for Cl :

log Kow <4 .2 : Test Group 1 is required

1 . Acute Toxicity To Fish : ASTM E 729 log Kow ? 4 .2 : Test Group 2 is required

2 . Acute Toxicity To Daphnia : ASTM E 729 Which test group is required is determined by

3 . Toxicity To Plants (Algae): ASTM E the test substance's log K„„, as obtained

1218 under A.

Test Group 2 for Cl:

1 . Chronic Toxicity To Daphnia : ASTM E

119 3

2 . Toxicity To Plants (Algae) : ASTM E

121 8

C2 For C2, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements-See Special Conditions .

Test Group 1 for C2.

1 . Acute Toxicity To Daphnia : ASTM E 729

2 . Toxicity To Plants (Algae) : ASTM E

121 8

Test Group 2 for C2.

1 . Chronic Toxicity To Daphnia : ASTM E

119 3

2 . Toxicity To Plants (Algae): ASTM E

121 8

C3 For C3, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements-See Special Conditions .

Test Group 1 for C3:

1 . Acute Toxicity To Fish : ASTM E 72 9

2 . Toxicity To Plants (Algae) : ASTM E

121 8

Test Group 2 for C3:

1 . Chronic Toxicity To Daphnia: ASTM E

119 3

2 . Toxicity To Plants (Algae): ASTM E

1218
p. 28

81684 Federal Register/Vol. 65, No . 248/Tuesday, December 26, 2000/Proposed Rule s

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G., A OR C5)-Continued

Testing category Test Test requirements and references ' Special conditions symbo l

C4 For C4, Test Group I or Test Group 2 below

must be used to fulfill the testing requirements-See Special Conditions.

Test Group I for C4 :

1 . Acute Toxicity To Fish : ASTM E 72 9

2 . Acute Toxicity To Daphnia : ASTM E 729

Test Group 2 for C4 :

1 . Chronic Toxicity To Daphnia : ASTM E

1193

C5 For C5, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements-See Special Conditions .

Test Group I for C5.,

1 . Acute Toxicity To Daphnia : ASTM E 729

Test Group 2 for C5:

1 . Chronic Toxicity To Daphnia : ASTM E

119 3

C6 Toxicity To Plants (Algae) : ASTM E 121 8

C7 For C7, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements See Special Conditions .

Test Group 1 for C7:

1 . Acute Toxicity To Fish : ASTM E 729

Test Group 2 for C7:

1 . Chronic Toxicity To Daphnia : ASTM E

119 3

Mammalian Toxicity-Acute D See Special Conditions for this test require- Which testing method is required is determent and select the required method to mined by the test substance's physical

use from those listed below . state at room temperature (25oC). For

Method A: Acute Inhalation Toxicity (rat): 40 those test substances that are gases at

CFR 799 .9130 room temperature, Method A is required;

Method B: EITHER: otherwise, use of either of the two methods

1 . Acute (Up/Down) Oral Toxicity ( rat) : listed under Method B is required .

ASTM E 1163 In Method B, 40 CFR 799.9110(d)(1)(i)(A) reOR fers to the OECD 425 Up/Down test meth2 . Acute (Up/Down) Oral Toxicity (rat): 40 odology.

CFR 799 .9110(d)(1)(i)(A) NOTE: In the case of a potentially explosive

test substance, care must be taken to

avoid the generation of explosive concentrations .

Mammalian Toxicity-Genotoxicity El Bacterial Reverse Mutation Test (in vitro): 40 None

CFR 799 .951 0

E2 Conduct any one of the following three tests Persons required to conduct testing for chrofor chromosomal damage : mosomal damage are encouraged to use

In vitro Mammalian Chromosome Aberration the in vitro Mammalian Chromosome AberTest: (40 CFR 799.9537 ) ration Test to generate the needed data

OR unless known chemical propert ies (e .g .,

In vivo Mammalian Bone Marrow Chromo- physicaUchemical prope rties, chemica l

somal Aberration Test (rodents : Mouse class characteristics) preclude its use . A

(preferred species), rat, or Chinese ham- subject person who uses one of the in vivo

ster): 40 CFR 799 .9538 methods instead of the in vitro method to

OR address this end-point must submit to EPA

In vivo Mammalian Erythrocyte Micronucleus a rationale for conducting that alternate test

Test [sampled in bone marrow] (rodents : in the final study report .

Mouse ( preferred species), rat, or Chinese

hamster): 40 CFR 799 .9539
p. 29

Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Proposed Rules 8168 5

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G ., A OR C5)-Continued

Testing category Test Test requirements and references' Special conditions symbo l

Mammalian Toxicity-Repeated F1 Combined Repeated Dose Toxicity Study EPA recommends use of the Combined ReDose/Reproduction/Developmental with the Reproduction/Developmental Tox- peated Dose Toxicity Study with the Reproicity Screening Test

OR Test

: (40 CFR 799 .9365) duction/Developmental Toxicity Screenin g

. However, EPA does recognize that

Reproduction/Developmental Toxicity Screen- there may be valid reasons to test a paring Test: (40 CFR 799 .9355) (Identified as ticular chemical using both F2 and F3 to fill

F2 below) Mammalian Toxicity Repeated Dose/ReAND production/Developmental data needs . A

Repeated Dose 28-Day Oral Toxicity Study in subject person who uses the combination

rodents : 40 CFR 799.9305) (Identified as of F2 and F3 in place of the Combined ReF3 below) peated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening

Test must submit to EPA a rationale for

conducting these alternate tests in the final

study reports .

F2 Reproduction/Developmental Toxicity Screening Test : (40 CFR 799 .9355 )

F3 Repeated Dose 28-Day Oral Toxicity Study in

rodents : (40 CFR 799 .9305 )

~ Copies of the ASTM and ISO standards referenced in this proposed rule have been placed in the public version of the official record for this

rulemaking . For the final rule, EPA intends to seek approval from the Director of the Federal Register for the incorporation by reference of the

ASTM and ISO standards used in the final rule in accordance with 5 U .S.C . 552(a) and 1 CFR part 51 .

2 EPA recommends, but does not require, that log Ko,v be quantitatively estimated prior to initiating this study . One method, among many similar methods, for estimating log Kow is described in Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients (Ref .

1) .

3 EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating this study . One method, among

many similar methods, for estimating water solubility is described in Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient (Ref. 2).

(k) Effective date . (1) The effective (2) The guidelines and other test date of this section. You can apply for

date of this section is [insert effective methods cited in this section are a modification under 40 CFR 790 .55 .

date of the final rule .] referenced as they exist on the effective [FR Doc . 00-32497 Filed 12-22-00 1

BILLING CODE 6560-50-S