Federal Register: December 26, 2000 (Volume 65, Number 248)
DOCID: FR Doc 00-32497
ENVIRONMENTAL PROTECTION AGENCY
Veterans Affairs Department
CFR Citation: 40 CFR Part 799
RIN ID: RIN 2070-AD16
OPP ID: [OPPTS-42213A; FRL-6758-4]
NOTICE: Part IV
DOCUMENT ACTION: Proposed rule.
SUBJECT CATEGORY:
Testing of Certain High Production Volume Chemicals
DATES: Comments, identified by docket control number OPPTS-42213A, must be received by EPA on or before April 25, 2001. If you want to request an opportunity to present oral comments, refer to Unit I.E. of the SUPPLEMENTARY INFORMATION. Your request must be in writing and must be received by EPA on or before January 25, 2001. Only if such a request is received, would EPA schedule a public meeting on this proposed rule, which would be announced in a subsequent document in the Federal Register and held in Washington, DC.
DOCUMENT SUMMARY:
EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers (including importers) and processors of certain high production volume (HPV) chemical substances to conduct testing for acute toxicity; repeat dose toxicity; developmental and reproductive toxicity; genetic toxicity (gene mutations and chromosomal aberrations); ecotoxicity (in fish, Daphnia, and algae) and environmental fate (including five tests for physical chemical properties and biodegradation). EPA has preliminarily determined that each of the 37 chemical substances included in this proposed rule is produced in substantial quantities and that there is substantial human exposure to each of them. Moreover, EPA believes that there are insufficient data to reasonably determine or predict the effects on health or the environment of the manufacture, distribution in commerce, processing, use, or disposal of the chemicals, or any combination of these activities. EPA has concluded that this proposed testing program is needed and appropriate for developing such data. Data developed under this proposed rule will provide critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and take appropriate follow up action. Persons who export or intend to export any chemical substance included in the final rule based on this proposed rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D. EPA has also taken steps, as described in this document, to consider animal welfare and to provide instructions on ways to reduce or in some cases eliminate animal testing, while at the same time ensuring that the public health is protected.
SUMMARY:
Environmental Protection Agency,
SUPPLEMENTAL INFORMATION
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you manufacture (defined by
statute to include import) or process any of the chemical substances
that are listed in Sec. 799.5085(j) of the proposed regulatory text.
Any use of the term ``manufacture'' in this document will encompass
``import,'' unless otherwise stated. In addition, as described in Unit
VI. , once the Agency issues a final rule, any person who exports, or
intends to export, any of the chemical substances included in the final
rule will be subject to the export notification requirements in 40 CFR
part 707, subpart D. Potentially affected entities may include, but are not limited to:
Table 1.Entities Potentially Affected by the Proposed Testing Requirements
Examples of
Type of entity NAICS codes potentially
affected entities
Chemical Manufacturers 325, 32411 Persons who
(including Importers) manufacture
(defined by
statute to include
import) one 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 exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in Table 1 of this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions in Unit V.E. entitled Would I be required to test under this rule? and consult the proposed regulatory test. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.
If you are an entity identified in Table 1 of this unit, you would only be subject to the testing requirements contained in this proposed rule if you manufacture or process any of the chemical substances that are listed in Sec. 799.5085(j) of the proposed regulatory text. B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents from the EPA Internet
Home Page at http://www.epa.gov/. To access this document, on the Home Page select
[[Page 81659]]
``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then
look up the entry for this document under ``Federal Register
Environmental Documents.'' You can also go directly to the Federal
Register listings at http://www.epa.gov/fedrgstr/.
You may also access additional information about the Chemical RighttoKnow Program at http://ww.epa.gov/chemrtk/ or about the TSCA testing program at http://www.epa.gov/opptintr/chemtest/. For your convenience, EPA may have also provided some nonEPA internet addresses. In doing so, the Agency has verified the accuracy of these addresses at the time of signature. However, since EPA is not responsible for these nonEPA sites, the Agency does not have any control over these addresses. A paper copy of any document referenced in this way has been included in the public version of the official record for this document as described in Unit I.B.2.
2. In person. The Agency has established an official record for this action under docket control number OPPTS42213A. The official record consists of the documents referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, Rm. NE B607, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 2607099.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS42213A in the subject line on the first page of your response.
1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO), East Tower Rm. G099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 2607093.
3. Electronically. You may submit your comments electronically by
email to: oppt.ncic@epa.gov or mail your computer disk to the address
identified above. Do not submit any information electronically that you
consider to be CBI. Electronic comments must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on standard computer disks in
WordPerfect 6/7/8/9 or ASCII file format. All comments in electronic
form must be identified by docket control number OPPTS42213A.
Electronic comments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
consult the technical person listed under FOR FURTHER INFORMATION CONTACT.
E. Can I Request an Opportunity to Present Oral Comments to the Agency?
You may submit a request for an opportunity to present oral
comments. This request must be made in writing. If such a request is
received on or before January 25, 2001, EPA will hold a public meeting
on this proposed rule in Washington, DC. This written request must be
submitted to the address provided in Unit I.C.1 and 2. If such a
request is received, EPA will announce the scheduling of the public
meeting in a subsequent document in the Federal Register. If a public
meeting is announced, and if you are interested in attending or
presenting oral and/or written comments at the public meeting, you
should follow the instructions provided in the subsequent document announcing the public meeting.
F. What Should I Consider as I Prepare My Comments for EPA?
EPA invites you to provide your views on the various options
proposed, new approaches not yet considered, the potential impacts of
the various options (including possible unintended consequences), and
any data or information that you would like the Agency to consider
during the development of the final rule. You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the rule or collection activity.
7. Make sure to submit your comments by the deadline listed under DATES.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.
II. Authority
This document proposes a test rule under section 4(a)(1)(B) of
TSCA, 15 U.S.C. 2603(a)(1)(B), that would require certain health and
environmental tests for 37 chemical substances that are produced in
substantial quantities, and that enter or may reasonably be anticipated
to enter the environment in substantial quantities and/or to which
there is or may be significant or substantial human exposure. The tests
pertain to acute toxicity; repeat dose toxicity; developmental and
reproductive toxicity; genetic toxicity (gene mutations and chromosomal
aberrations); ecotoxicity (tests in fish, Daphnia, and algae); and
environmental fate (including five tests for physical chemical properties and biodegradation). Some or all of these
[[Page 81660]]
tests would be required for a particular chemical substance, depending upon what data are already available for that substance.
Section 2(b)(1) of TSCA, 15 U.S.C. 2601(b)(1), states that it is
the policy of the United States that ``adequate data should be
developed with respect to the effect of chemical substances and
mixtures on health and the environment and that the development of such
data should be the responsibility of those who manufacture [which is
defined by statute to include import] and those who process such
chemical substances and mixtures [.]'' To implement this policy, TSCA
section 4(a) mandates that EPA require by rule that manufacturers and
processors of chemical substances and mixtures conduct testing if the Administrator finds that:
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to such substance or mixture,
(ii) there are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data [.]
If EPA makes these findings for a chemical substance or mixture, the Administrator must require by rule that testing be conducted on that chemical substance or mixture. The purpose of the testing would be to develop data about the substance or mixture's health and environmental effects where there is an insufficiency of data and experience, in order to support a determination that the manufacture, distribution in commerce, processing, use or disposal of the substance or mixture, or any combination of such activities, does or does not present an unreasonable risk of injury to health or the environment.
Once the Administrator has made a finding under TSCA section 4(a)(1), EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA finds that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop the data. This approach is explained in more detail in EPA's statement of policy for making findings under TSCA section 4(a)(1)(B) (frequently described as the ``B'' policy) in the Federal Register of May 14, 1993 (58 FR 28736) (Ref. 24 at 28738 28739).
In this proposed rule, EPA intends to use its broad TSCA section 4
authority to obtain the data necessary to support the development of
preliminary or ``screening level'' hazard and risk characterizations
for certain HPV chemical substances (see Sec. 799.5085(j) of the
proposed regulatory text for the list of chemicals). EPA has made
preliminary findings for these chemicals under TSCA section 4(a)(1)(B)
that: They are produced in substantial quantities; there is or may be
substantial human exposure to them; existing data are insufficient to
determine or predict their health and environmental effects; and
testing is necessary to develop such data. Testing for additional HPV
chemical substances (Ref. 1) will be proposed at a later date as the
Agency learns more about these additional substances with respect to
human exposure, release, and sufficiency of the data and experience available on the hazards of the substances.
III. Background
A. Why is EPA Pursuing Hazard Information on HPV Chemicals?
EPA found that, of those nonpolymeric organic substances produced or imported in amounts equal to or greater than 1 million pounds per year based on 1990 reporting for EPA's Inventory Update Rule (IUR) (40 CFR part 710), only 7% have a full set of publicly available internationally recognized basic health and environmental fate/effects screening test data (Ref. 2). Of the over 2,800 U.S. HPV chemicals based on 1990 data, 43% have no publicly available basic hazard data. For the remaining chemicals, limited amounts of the data are available. This lack of available hazard data compromises EPA's and others' ability to determine whether these HPV chemicals pose potential risks to human health or the environment, as well as the public's rightto know about the hazards of chemicals that are found in their environment, their homes, their workplaces, and the products that they buy. It is EPA's intent to close this knowledge gap. EPA believes that for most of the HPV chemicals, insufficient data are readily available to reasonably determine or predict the effects on health or the environment from the manufacture (including importation), distribution in commerce, processing, use, or disposal of the chemicals, or any combination of these activities. EPA has concluded that a program to collect and, where needed, develop basic screening level toxicity data is necessary and appropriate to provide information in order to assess the potential hazards/risks that may be posed by exposure to HPV chemicals.
On April 21, 1998, a national effort, known as the ``Chemical RightToKnow'' (ChemRTK) Program, was announced in order to empower citizens with knowledge about the most widespread chemicals in commercechemicals that people may be exposed to in the places where they live, work, study, and play. EPA's ChemRTK Program is being designed in such a way as to make certain basic information about HPV chemicals available to the public.
EPA plans to make available to the public the summarized data obtained on HPV chemicals. Additional information that EPA receives will also be shared with the public, other Federal agencies, and any other interested parties. As appropriate, this information will be used to ensure a scientifically sound basis for risk assessment/management actions. This effort, will serve to further the Agency's goal of identifying and controlling human and environmental risks as well as providing greater protection and knowledge to the public. In addition, EPA and other parties agreed to work with other nations and international groups to ensure commensurate increases in the pace of complementary voluntary international data collection and development efforts on HPV chemicals.
This ChemRTK Program is consistent with the U.S. policy as
presented in the TSCA. Section 2(b)(1) of TSCA, 15 U.S.C. 2601(b)(1),
states that it is the policy of the United States that ``adequate data should be developed with respect to the effect of chemical
[[Page 81661]]
substances and mixtures on health and the environment and that the
development of such data should be the responsibility of those who
manufacture and those who process such chemical substances and mixtures.''
B. What Do We Currently Know About the Basic Health and Environmental Hazards of HPV Chemicals?
The information relevant to understanding the basic health and environmental hazards of HPV chemicals is derived from a battery of tests agreed upon by the international community as appropriate for screening international HPV chemical substances for toxicity. Six basic testing endpoints have been adopted by the Organization for Economic Cooperation and Development (OECD) as the minimum required to screen international HPV chemical substances for toxicity (Ref. 4). The agreedupon testing endpoints, known as the OECD's Screening Information Data Set (SIDS) include: Acute toxicity; repeat dose toxicity; developmental and reproductive toxicity; genetic toxicity (gene mutations and chromosomal aberrations); ecotoxicity (studies in fish, Daphnia, and algae); and environmental fate (including physical/ chemical properties [melting point, boiling point, vapor pressure, n octanol/water partition coefficient, and water solubility], photolysis, hydrolysis, transport/distribution, and biodegradation). As conceived by the OECD, the ``SIDS battery'' of tests can be used by governments to conduct an initial assessment of the hazards and risks posed by HPV chemical substances and prioritize HPV chemicals to identify those in need of additional, more indepth testing and assessment.
A need for basic screening level data on HPV chemicals has been identified and supported by various data availability studies conducted by EPA and others. Toxic Ignorance, which was prepared by Environmental Defense (formerly the Environmental Defense Fund), raised a variety of concerns about the untested chemicals that are produced in and/or imported into the United States (Ref. 28). Environmental Defense found that baseline data on health effects were not publicly available for a selected set of 100 HPV chemicals.
In April 1998, EPA completed a study entitled Chemical Hazard Data Availability Study: What Do We Really Know About the Safety of High Production Volume Chemicals? (Ref. 2) that evaluated the public availability of screening level health hazard data and environmental hazard/fate data on U.S. HPV chemicals. EPA's study found major gaps in the basic information on HPV chemicals that is readily available to EPA and to the public, and reinforced the need for governmental leadership on this issue. The study analyzed the availability of test data for 2,863 HPV chemicals (defined as those nonpolymeric organic substances produced in or imported into the United States in amounts equal to or greater than 1 million pounds per year based on 1990 reporting for EPA's IUR (40 CFR part 710). EPA searched for publicly available data on these chemicals and learned that most of them may never have been tested for any or most of the SIDS endpoints. The search strategy used a total of 11 publicly accessible data bases in its analysis. Details of the search strategy can be found in the report (Ref. 2). The major conclusions of EPA's study are described in Unit III.A.
In June 1998, the American Chemistry Council (ACC, formerly the Chemical Manufacturers Association (CMA)) issued a report (Ref. 3) regarding public data availability for HPV chemicals based on a study conducted with 11 main data sources, including data sources other than those searched by EPA for its study. The ACC report, entitled Public Availability of SIDSRelated Testing Data for U.S. High Production Volume Chemicals (Ref. 3) reached conclusions similar to EPA, that is, that only limited toxicity and environmental fate data appear to exist in the public domain for many U.S. HPV substances. Details of the search strategy used can be found in the ACC report (Ref. 3).
EPA recognizes that additional data may exist beyond those identified through either the EPA, ACC, or Environmental Defense studies. To the extent that additional relevant data are known to exist, EPA is particularly interested in receiving this information as part of the HPV Initiative (see Unit III.D.), including a full citation for publications and ``robust'' (i.e., detailed) summaries of pertinent published and unpublished studies. If relevant scientifically adequate existing data are submitted at any time before testing is initiated, including after the final rule is issued, the Agency will consider such data to determine if they satisfy the testing requirement and will take appropriate necessary action to ensure that unnecessary testing is no longer required. In addition, exemption procedures to be used are found at 40 CFR 790.80 and 790.82. Guidance on the preparation of robust summaries is available on EPA's ChemRTK website (Ref. 34).
C. Why is EPA Focusing on HPV Chemicals?
It is generally accepted that chemicals having a high level of production have an increased potential for exposure in comparison to low production volume chemicals. The focus on HPV chemicals is derived from the experience gained over the past 15 years by EPA and the OECD. The OECD is an intergovernmental organization consisting of 29 developed countries, including the United States, with advanced worldwide market economies. The OECD is helping coordinate a cooperative, international effort to secure basic toxicity information on HPV chemicals in use worldwide.
The OECD, after considering a variety of priority setting approaches, concluded in 1990 that consideration of HPV status provided a useful and effective organizing focus for a voluntary testing and assessment effort to screen and thereby identify priorities among international HPV chemicals.
In the late 1980s, OECD initiated a voluntary program to ensure that basic information is available on international HPV chemicals. This program, which is a part of the OECD's program on existing chemicals, produced an internationally agreed upon set of basic SIDS screening tests and is working to develop complete SIDS data sets for all international HPV chemicals. The SIDS includes information on the identity of each chemical, uses, sources and extent of exposure; physical and chemical properties; environmental fate; and certain limited toxicity data for humans and the environment. The SIDS is not intended to describe a chemical thoroughly, but rather is intended to provide enough information to support an initial (or screening) assessment and to assign a priority for further work. By 1990, the United States and 13 other OECD member countries established a voluntary international testing program to develop the basic data set for all international HPV chemicals. To date, the OECD has initiated or completed work on approximately 500 chemicals.
The OECD threshold for high production volume chemicals is 2.2
million pounds (equivalent to 1 million kilograms) reported in any
member country. (Note that the OECD HPV threshold, like the U.S. HPV
threshold, is not applied to polymers. However, the OECD threshold,
unlike the U.S. HPV threshold, is applied to inorganics (Ref. 5)). The
presence of a chemical on the OECD's list of HPV chemicals was and
continues to be accepted (Ref. 5) by OECD member countries as providing a sufficient indicator of potential
[[Page 81662]]
exposure to warrant testing at the SIDS level.
EPA does not believe that a production volume threshold which is chosen for an international program on existing chemicals and which is the only trigger for entry into that program should be determinative of the threshold chosen for ``substantial production'' under TSCA section 4(a)(1)(B)(i). See EPA's ``B'' policy (Ref. 24). Among the reasons is that the TSCA section 4(a)(1)(B)(i) finding of substantial production is not the sole finding EPA must make to require testing based on TSCA section 4(a)(1)(B). EPA must also find that there is substantial release, or substantial or significant human exposure under TSCA sections 4(a)(1)(B)(i)(I) and (II). In addition, EPA must find that data are insufficient and testing is necessary under TSCA sections 4(a)(1)(B)(ii) and (iii).
In response to EPA's proposed ``B'' policy (Ref. 23), both ACC and the Society of the Plastics Industry Inc., commented that EPA's proposed production volume threshold of 1 million pounds is a reasonable interpretation of ``substantial production'' under TSCA (Ref. 6 and 7). Additionally, they indicated that the OECD 2.2 million pound threshold would be preferable to achieve consistency between EPA's activities under TSCA section 4 and the OECD HPV SIDS program.
The 1 million pound threshold for production normally used by EPA under the ``B'' policy generally narrowed the universe of chemicals potentially subject to TSCA section 4(a)(1)(B) to 11% of the TSCA Inventory of chemical substances (see TSCA sections 8(a) and 8(b)), using Inventory information available in 1988 (Ref. 23 at 32296). However, that small percentage of the Inventory accounts for 95% of total chemical production in the United States. EPA believes it reasonable to use this information as a basis for making a finding of ``substantial production'' for substances produced at or above that threshold. Furthermore, EPA equates ``substantial production'' with production in ``high volumes.''
The United States committed to conducting SIDS testing and assessment on 25% of the international HPV chemicals as its contribution to the OECD HPV SIDS effort; other countries' commitments for conducting SIDS testing and assessment on international HPV chemicals vary in proportion to the size of the country's gross domestic product. Because most of the international HPV chemicals are also commercially available in the United States, EPA considers the OECD HPV SIDS program to be an integral part of domestic testing activities. EPA, in developing and implementing the OECD HPV SIDS program, worked jointly with industry and environmental groups in the United States and with governments and industry in other OECD member countries to achieve the common goal of developing this minimum level of testing for HPV chemicals. EPA continues to work with other parties (international organizations, environmental groups, unions, animal welfare groups, other Federal agencies, and others) to secure their interest and continued support for this effort.
Nevertheless, because of the slow pace of the OECD's international efforts to generate the needed data (which would have potentially required over 30 years to complete), the OECD has recognized the need to accelerate its efforts in order to ensure the availability of the basic data needed to support screening level assessments of international HPV chemicals. EPA has also recognized the need to accelerate its efforts to develop SIDS data on US HPV chemicals to support domestic efforts on chemicals. The HPV Initiative, which is described in Unit III.D., reflects EPA's interest in collecting, developing and making publicly available these needed data. D. Why is EPA Proposing to Take this Action?
A major component of the Agency's ChemRTK activity is the HPV
Initiative, which is a data collection and development program
established by EPA for existing U.S. HPV chemicals. Under this
Initiative, HPV chemicals are defined as nonpolymeric organic
chemicals manufactured (including imported) at or above 1 million
pounds per year based on information submitted under the 1990 TSCA IUR.
The strategy and overall approach that EPA is using to address data
collection needs for U.S. HPV chemicals are discussed in a separate
document entitled Data Collection and Development on High Production
Volume (HPV) Chemicals that is published elsewhere in this issue of the Federal Register (Ref. 27).
Through the HPV Initiative, which includes a voluntary component
(the HPV Challenge Program), certain international efforts, and
rulemaking under TSCA such as this proposed rule, basic screening level
hazard data necessary to provide critical information about the
environmental fate and potential hazards associated with HPV chemicals
will be collected or, where necessary, developed. Data collected and/or
developed under the HPV Initiative, when combined with information
about exposure and uses, will allow the Agency and others to evaluate
and prioritize potential health and environmental effects and take
appropriate follow up action. The HPV Initiative will generally be
carried out in a manner consistent with the OECD HPV SIDS program to
ensure that the data and information generated can be contributed to
the international effort and, conversely, that international SIDS
testing and assessments can be used to fulfill the data gaps identified
as part of the HPV Initiative. Additional detailed information is
available on the SIDS website (http://www.oecd.org/ehs/sidsman.htm) and
EPA's ChemRTK website (http://www.epa.gov/chemrtk).
The following is a brief summary of this HPV Initiative. For additional background information related to the HPV Initiative, please refer to the document that is published elsewhere in this issue of the Federal Register (Ref. 27).
1. Voluntary HPV Challenge Program. A primary component of this HPV Initiative is the voluntary HPV Challenge Program, which was created in cooperation with industry, environmental groups, and other interested parties, and is designed to assemble and make publicly available basic screening level data on the potential hazards of U.S. HPV chemicals while avoiding unnecessary or duplicative testing. The voluntary HPV Challenge Program is described in detail the document that is published elsewhere in this issue of the Federal Register (Ref. 27).
As of November 9, 2000, EPA has received full or provisional commitments from 469 companies, individually or through 187 consortia to sponsor 2,155 chemicals under in the voluntary HPV Challenge Program. Continually updated information regarding the chemicals being sponsored under the voluntary HPV Challenge Program and the names of company sponsors and consortia can be found on EPA's ChemRTK website (http://www.epa.gov/chemrtk/sumresp.htm), and on the US HPV Chemical Tracking System (http://www.hpvchallenge.com).
Under the voluntary HPV Challenge Program, alternatives to the
testing proposed under this proposed rule are available. For example,
under the OECD HPV SIDS program, some instances have been identified
where, using chemical category approaches, less than a full set of SIDS
tests for every chemical in the category has been judged sufficient for screening purposes. In addition, the OECD HPV SIDS
[[Page 81663]]
program allows some use of structure activity relationships (SAR)
analysis for individual chemicals. These strategies have the potential
to reduce the time required to complete the program, the number of
tests actually conducted, and the number of test animals needed.
While EPA is encouraging the use of scientifically appropriate categories of related chemicals and SAR under the voluntary component of the HPV Initiative, these approaches are not included in this proposed rule. However, EPA has not identified any possibilities that will allow inclusion of the category and SAR approach for any chemicals listed in this proposed rule. EPA believes that the incorporation of such elements in a test rule would require complex, time consuming, and resource intensive procedural steps, such as multiphase rulemaking. EPA specifically solicits comments and suggestions on procedures that would allow inclusion of such approaches in HPV test rules. EPA solicits comments on simplified procedures which would allow inclusion of such approaches in TSCA section 4 HPV SIDS rulemaking.
Although the Agency believes that none of the chemicals included in this proposed rule appear to be candidates for these approaches, persons who believe that a chemical under this proposed rule can be dealt with using a category or SAR approach are encouraged to submit appropriate information, along with their comments which substantiate this belief. If, based on submitted information and other information available to EPA, the Agency determines that a chemical meets the requirements for consideration under a category or SAR approach, and that practicable measures are available at the time to modify the testing requirement, EPA will take such measures as are necessary to avoid unnecessary testing. Modifications can also be applied for after the final rule issues under 40 CFR 790.55 up to 60 days before the specified reporting deadline. Category or SAR approaches which represent significant alterations in the scope of testing, however, would likely require multiphase rulemaking involving publication of additional Federal Register document(s) soliciting comment on the proposed procedures to be used. Comment is specifically requested on simplified approaches which might allow for the efficient and effective handling of category and SAR approaches via rulemaking.
a. Can I still participate in the voluntary HPV Challenge Program? Certainly. Although the participants in the voluntary HPV Challenge Program were asked to submit commitments by December 1, 1999, you can still volunteer through a viable commitment (as described in Unit III.D.1.b) to sponsor chemicals under the HPV Challenge Program. Sponsors who wish to use alternative approaches to those proposed for a chemical listed in a proposed TSCA section 4 HPV SIDS rulemaking should seriously consider sponsoring that chemical in this under the voluntary HPV Challenge Program prior to the close of the comment period for that rulemaking.
b. How can I participate in the voluntary HPV Challenge? At this stage, persons who wish to sponsor a chemical through a viable commitment under the HPV Challenge Program must submit the following:
i. Commitment letter;
ii. Test plan, robust summaries of existing studies with full citations of published studies and full copies of unpublished studies; and
iii. Robust summaries of any newly conducted studies, and full copies of these studies.
Commitments must be consistent with the guidance available on the ChemRTK website. Full commitments must specify the names and the Chemical Abstract Service (CAS) numbers of the chemicals to be sponsored, the year in which sponsors will begin the assessment of each chemical, and the name and contact information for the technical person within the company who should be reached for more information. Commitment letters under the voluntary HPV Challenge Program must be submitted to the EPA Administrator according to the instructions on the ChemRTK website (Ref. 35).
EPA encourages industry and other interested parties to identify and provide any additional existing data which are relevant to the hazard characterization to avoid any unnecessary or duplicative testing. Furthermore, anyone may provide any relevant information to the Agency that indicates that certain endpoints need not be tested. If EPA judges the available data to be adequate, the data gap identified in the HPV Initiative will be considered to be filled. To the extent that additional data relevant to the HPV chemicals are known to exist, EPA is interested in receiving this information under the voluntary HPV Challenge Program. In addition to submitting the full citation for published studies and full copies of any unpublished studies, Commenters under the HPV Challenge Program and/or a proposed TSCA section 4 HPV SIDS rule(s) who wish to submit any additional relevant studies, are encouraged to also prepare a robust summary (Ref. 34) for each study to facilitate making the information publicly available, as well as facilitate its review.
EPA plans to include in a final TSCA section 4 HPV SIDS rulemaking any chemical that is listed in a proposed rule, unless a sponsor, in addition to agreeing to making a viable commitment under the voluntary HPV Challenge Program, provides the following additional information:
i. Evidence that work is underway and proceeding in a timely manner;
ii. Data required to complete the SIDS battery are developed within the time frame set by EPA in the proposed rule; and
iii. Robust summaries, and full copies of all final study reports from new studies and existing data submitted to EPA in a timely manner.
Viable commitments that involve SAR and categories and that are consistent with the guidance available on the website (Ref. 30 and 31) regarding SAR and categories under the voluntary component of the HPV Initiative can still be submitted to EPA, but submission as early as possible will best avoid unnecessary or duplicative testing. If a viable commitment is made and kept, and the information is deemed adequate, EPA would not include that chemical in a final TSCA section 4 HPV SIDS rulemaking.
Additional information on the voluntary HPV Challenge Program is available on the ChemRTK website.
2. Certain international efforts. To fill any data gaps not addressed as part of the voluntary HPV Challenge Program, EPA is continuing to participate in the international efforts coordinated by the OECD to secure basic hazard information on HPV chemicals in use worldwide, including some of those on the U.S. HPV chemicals list. This includes agreements to sponsor a U.S. HPV chemical under either the OECD HPV SIDS Program, including sponsorship by OECD member countries beyond the United States, or the international HPV Initiative that is being organized by International Council of Chemical Associations (ICCA). The OECD HPV SIDS Program has already been described in Unit III.C. The ICCA consists of representatives of chemical industry trade associations from the United States, Europe, Japan, Australia, Canada, Mexico, Brazil, New Zealand, and Argentina. The ICCA HPV Initiative calls for the testing and screeninglevel assessment of 1,000 ``high priority'' chemicals by the end of the year 2004. Most of the chemicals on the ICCA working list (Ref. 8) are also U.S. HPV chemicals. The ICCA testing/assessment work will be tied directly to that under [[Page 81664]]
the OECD HPV SIDS Program and to the U.S. HPV Initiative.
Any U.S. HPV chemicals that are handled under the OECD HPV SIDS Program or the ICCA HPV Initiative are considered by EPA to be ``sponsored'' and are not intended to be addressed in either the voluntary HPV Challenge Program or in any TSCA section 4 HPV SIDS rulemaking unless the international commitments are not met.
3. TSCA rulemaking. In establishing the HPV Initiative in 1998, the Agency indicated that data needs which remain unmet in the voluntary HPV Challenge Program or through international efforts may be addressed through TSCA rulemaking. This proposed rule is the first rulemaking associated with the HPV Initiative, and addresses the unmet data needs of the 37 chemicals that are included in this proposed rule. E. What Information is being Collected on HPV Chemicals?
In identifying the data needs for chemicals contained in the HPV
Initiative, EPA is utilizing information and sources in EPA's study,
the Chemical Hazard Data Availability Study (Ref. 2), and ACC's report,
i.e, Public Availability of SIDSRelated Testing Data for U.S. High
Production Volume Chemicals (Ref. 3), to determine whether screening
level data for characterizing the hazards of these HPV chemicals are
publicly available. If no data are available for a SIDS testing
endpoint, there cannot be sufficient data to characterize the potential
hazards and risks associated with the chemical. As the Agency found in
its study, insufficient data are available to characterize the hazards
and risks of many of the U.S. HPV chemicals with respect to the
internationally accepted SIDS testing endpoints, including acute
toxicity, repeat dose toxicity, developmental and reproductive
toxicity, genetic toxicity (gene mutations and chromosomal
aberrations), ecotoxicity (tests in fish, Daphnia, and algae), and for
environmental fate (including five tests for physical chemical
properties [melting point, boiling point, vapor pressure, noctanol/ water partition coefficient, and water solubility], and
biodegradation). As a result, EPA and others cannot reasonably
determine or predict the human health and environmental effects
resulting from manufacture, processing, and use of these chemical substances.
The OECD HPV SIDS Program is part of the OECD overall program on
existing chemicals, and includes information on the identity of each
chemical, its uses, sources and extent of exposure; physical and
chemical properties; environmental fate; and certain limited toxicity
data for humans and the environment. The SIDS data set is not intended
to describe a chemical thoroughly, but rather is intended to provide
enough information to support an initial (or screening level)
assessment and to assign a priority for further work, if necessary. To
date, the OECD has initiated or completed work on approximately 500 HPV
chemicals. The OECD HPV SIDS Program seeks the development of test
data, if such data are not already available, related to six health and
environmental effects endpoints for international HPV chemicals (see
Unit III.B.). The SIDS data set is regarded as the minimum data set
required to make an informed preliminary judgment about the hazards of a given HPV chemical.
EPA is implementing the HPV Initiative as part of its domestic
industrial chemical screening efforts, in a manner that is consistent
with OECD efforts. The information to be gathered under EPA's HPV
Initiative comes from the same battery of tests agreed upon by the OECD
member countries as being appropriate for screening international HPV
chemicals for toxicity and environmental fate (Ref. 4). As conceived by
the OECD, the SIDS data set can be used by governments and others
worldwide to conduct an initial assessment of the hazards and risks
posed by HPV chemical substances and to prioritize chemicals to
identify those which are in need of additional, more indepth testing and assessment, as well as those of lesser concern.
This proposed test rule is intended to obtain needed SIDS testing for 37 of the approximately 2,800 chemicals (excluding polymers and inorganics) that are produced and/or imported at high volumes in the United States. EPA has chosen this group of 37 chemicals for its initial TSCA section 4 HPV SIDS rulemaking because of their high production and/or importation volumes and their potential for exposure to a substantial number of workers.
In developing the list of candidates for this proposed test rule, EPA included only chemical substances which were reported on 1994 TSCA section 8(a) IUR as being manufactured (including imported) in the United States in amounts greater than or equal to one million pounds. In addition, each of the candidate chemical substances listed in this proposed rule was identified in the National Occupational Exposure Survey (NOES) as having a total potential exposure of greater than 1,000 or more workers. A potential exposure of 1,000 or more workers to a chemical substance is a threshold for ``substantial human exposure'' under EPA's ``B'' Policy (Ref. 24).
The data availability study conducted by EPA, discussed in Unit
III.B., demonstrated that only a limited number of HPV chemicals have a
full set of publicly available SIDS data. For chemicals for which some
data are available on one or more SIDS endpoints, EPA is not requiring
testing for those endpoints. However, no definitive determination has
been made as to the adequacy of those data for an initial assessment of
a chemical's hazards or risks to health or the environment. The Agency
intends to promulgate additional test rules for any HPV chemicals for
which SIDS testing is needed and for which a voluntary commitment to
collect, develop, and make publically available the needed data has not been received.
F. What Role do Existing Data Play Under the HPV Initiative?
The HPV Initiative, including this rulemaking, is designed to make maximum use of scientifically adequate existing test data and to avoid unnecessary, duplicative testing, thereby avoiding the excessive use of animal testing. If at any time, including after this rule is finalized, the Agency receives adequate existing data that fulfill a specific data gap, EPA will ensure that unnecessary testing is not required.
During the continued development of the HPV Initiative, EPA was encouraged to consider the relationship between existing data submitted under the HPV Initiative and reporting requirements under TSCA section 8(e). In response to these concerns, and as part of the Agency's efforts to ensure the fullest use of existing test data, EPA intends to consider existing data submissions in the manner described in an October 14, 1999, letter to the voluntary HPV Challenge Program participants (herein after ``the October 14, 1999, letter'') (Ref. 29). EPA's guidance document on literature searches, which deals with part of this issue, is available on the Agency's ChemRTK website (Ref. 36). EPA believes that it is in the economic best interest of companies to identify and make publicly available all relevant existing data in order to reduce possible testing costs.
Studies that have been conducted as specified in appropriate OECD
test guidelines (as noted in the SIDS Manual (Ref. 4) or comparable EPA
test guidelines (such as the OPPTS Harmonized Guidelines available at
http://www.epa.gov/opptsfrs/home/guidelin.htm), and appropriate Good Laboratory Practice Standards (GLPS)
[[Page 81665]]
like those for TSCA (40 CFR part 792) consistently generate data
adequate to fulfill the HPV Initiative needs. Data from studies that
did not follow these procedures, however, may not be adequate.
As stated in the October 14, 1999, letter to the voluntary HPV Challenge Program participants, in analyzing the adequacy of existing data, participants shall conduct a thoughtful and qualitative analysis rather than using a rote checklist approach (Ref. 29). The same principle applies to persons evaluating existing data in connection with this rulemaking. If EPA judges the available data to be adequate, the data gap identified in the HPV Initiative will be considered to be filled. EPA has developed a guidance document on determining data adequacy which is available on EPA's ChemRTK website (Ref. 37).
EPA solicits comment concerning the availability of SIDS data on
the chemicals included in the HPV Initiative and encourages industry
and other interested parties to identify and provide any additional
existing data which are relevant to hazard characterization to avoid
any unnecessary or duplicative testing. Anyone may provide any relevant
information to the Agency that indicates that certain endpoints need
not be tested. If EPA judges the available data to be adequate, the
data gap identified in the HPV Initiative will be considered to be
filled. To the extent that additional data relevant to the HPV
chemicals are known to exist, EPA is interested in receiving this
information, including a full citation for publications and full copies
of unpublished studies. Although the Agency encourages anyone with such
information to submit it to EPA during the early stages of this
Initiative in order to avoid any unnecessary testing, such submissions
may be made at any time to allow EPA to take appropriate action.
Commenters are also encouraged to prepare a robust summary (Ref. 34)
for each study to facilitate EPA's review of the full study report or
publication. It is important to note that EPA does not intend to
include any chemicals which are Generally Recognized as Safe (GRAS) for
a particular use by the Food and Drug Administration (FDA) in this
initial TSCA section 4 HPV SIDS rulemaking. However, such chemicals may
be included in a future TSCA section 4 HPV SIDS rulemaking where SIDS data needs remain unmet.
G. How Would the Data Developed Under this Test Rule be Used?
The availability of hazard information on individual chemicals is
fundamental to EPA's ability to accomplish its mission of environmental
protectionrisk assessment, risk management, safeguarding children's
health, expanding the public's righttoknow, and promoting the
pollution prevention ethic. Activities to ensure the availability of
basic hazard information on HPV chemicals are an integral part of meeting these objectives.
The testing proposed is essentially identical in scope and
applicability to that which has been internationally agreed upon by the
OECD as providing the minimum needed to screen HPV chemicals and
identify priorities for additional testing or assessment. While the
SIDS data set does not fully measure a chemical's toxicity, it does
provide a consistent minimum set of information that can be used to
determine the relative hazards and risks of chemicals and to judge if
additional testing or assessment is necessary. Thus, EPA will use the
data obtained from this proposed test rule to support development of
preliminary hazard and risk assessments for these HPV chemicals.
Furthermore, the data obtained under this testing program will be used
to set priorities for further testing that will produce hazard
information on these chemicals which is needed by EPA , other Federal
agencies, the public, industry, and others, to support adequate risk
assessments. EPA has used data from test rules to support such
activities as the development of water quality criteria, Toxic Release
Inventory listings, chemical advisories, and reduction of workplace exposures.
H. What is the Role of this Proposed Rule with Regard to the HPV Initiative?
To fill data gaps not addressed as part of the voluntary HPV Challenge Program or international efforts, EPA indicated in the document that is published elsewhere in this issue of the Federal Register (Ref. 27) that it would supplement the voluntary HPV Challenge Program and international efforts with rulemaking under TSCA. Specifically, EPA intends to use its authority under section 4 of TSCA to propose the testing of those chemicals listed at http:/www.epa.gov/ chemrtk/hpvchmtl.htm which have an indicator value of ``0,'' which identifies a chemical as a candidate for sponsorship under the voluntary HPV Challenge Program and a sponsorship status value of ``N,'' i.e., not sponsored. EPA intends to issue additional test rules as needed to cover chemicals with unmet data needs or if voluntary HPV Challenge Program commitments are not met. U.S. HPV chemicals that have been or are being handled through the OECD HPV SIDS Program or under a complementary program being coordinated by the ICCA (Ref. 8) will not be listed in any of these followup TSCA section 4 HPV SIDS rulemaking, unless commitments under those international programs are not met (see Unit. IV.G. of the document that is published elsewhere in this issue of the Federal Register (Ref. 27) for more information on these programs). In addition, as indicated in Unit IV.B.2. of the document that is published elsewhere in this issue of the Federal Register (Ref. 27), chemicals identified as GRAS for a particular use by FDA are only intended to be included in a future TSCA section 4 HPV SIDS rulemaking if SIDS data needs remain unmet.
As indicated in the October 14, 1999, letter to the participants in
the voluntary HPV Challenge Program (Ref. 29), and restated in the
document that is published elsewhere in this issue of the Federal
Register (Ref. 27), EPA intends for the TSCA section 4 HPV SIDS
rulemaking to proceed in a manner that is consistent with the
principles outlined in the letter for the participants in the voluntary
program. As such, EPA has incorporated the criteria established under
the voluntary HPV Challenge Program into this rulemaking to the extent
possible, and has also considered improvements based on experiences with implementing that Program.
be deferred until November 2001. EPA will use these time frames in the effective dates of TSCA section 4 HPV SIDS rulemakings as well.
Acute aquatic toxicity studies would not always be needed under the TSCA section 4 HPV SIDS rulemaking associated with this Initiative (See Unit V.A.3.).
Dermal toxicity or terrestrial toxicity testing would not be included in TSCA section 4 HPV SIDS rulemaking associated with this Initiative (See Unit III.I. and Unit V.A.).
The LD
EPA will encourage persons subject to the TSCA section 4 HPV SIDS rulemaking to use in vitro testing unless there are chemical properties (including chemical class considerations) or other aspects which may call its use into question (see Unit V.A.5.).
EPA will consider combining some of the mammalian toxicity protocols under TSCA section 4 HPV SIDS rulemaking associated with this Initiative (See Unit V.A.6.).
If necessary for a particular chemical and/or endpoint, any variations are described in detail in this proposed rule.
I. How are Animal Welfare Issues being Considered in the HPV Initiative?
EPA recognizes the concerns that have been expressed about the use of test procedures that require the use of animals. As discussed in Unit II.E. of the document that is published elsewhere in this issue of the Federal Register (Ref. 27), EPA is making every effort to ensure that as the HPV Initiative is implemented, unnecessary or duplicative testing is avoided and the use of animals is minimized. As a general matter, EPA does not require that tests on animals be conducted if an alternative scientifically validated method is found acceptable and practically available for use. Where testing must be conducted to develop adequate data, the Agency is committed to reducing the number of animals used for testing, to replacing test methods requiring animals with alternative test methods when acceptable alternative methods are available, and to refining existing test methods to optimize animal use when there is no substitute for animal testing. EPA believes that these reduction, replacement, and refinement objectives are all important elements in the overall consideration of alternative testing methods.
The governmental and nongovernmental scientific community is working to design, validate, and employ new methods of toxicity testing that are more accurate, less costly, and that reduce the need to use live animals. Over the years, significant research has been pursued to develop and validate nonanimal test methods. U.S. scientists in academia, government, and industry have participated in both domestic and international efforts to develop alternative, nonanimal tests. As part of the enterprise, the National Institute of Environmental Health Sciences (NIEHS) established a Federal Interagency Committee, the Interagency Coordinating Committee on Validation of Alternative Methods (ICCVAM), to review the status and validation of toxicological test methods including those that are performed in vitro. EPA scientists have contributed significantly to this body of knowledge and are continuing to play a vital role by developing test methods for consideration. Many test methods have begun the process of validation and several have completed the steps leading to governmentwide regulatory acceptance. Within the SIDS battery of tests, certain in vitro genotoxicity tests, such as the Ames test for gene mutations in bacteria, have received uniform acceptance among regulatory agencies.
In addition, as part of the voluntary HPV Challenge Program, EPA asked participants in that program to observe certain principles laid out in the October 14, 1999, letter, in which the Agency also indicated its intention that related TSCA rulemaking proceed in a manner consistent with the principles (Ref. 29). This letter is available in the public version of the official record for this rulemaking, as well as on EPA's ChemRTK website. In the letter, EPA requested that participants conduct a thoughtful, qualitative analysis of existing data before testing. EPA also asked that all animal testing on individual chemicals (as opposed to testing of categories of chemicals) under the voluntary HPV Challenge Program, or under an associated rule(s), not be initiated earlier than November 2001, and that testing of chemicals solely manufactured as closed system intermediates not begin earlier than 2003. This proposed rule reflects many of the principles presented in the referenced voluntary HPV Challenge Program letter. Certain components of these principles, however, are not pertinent to this proposed rule. For example, this proposed rule does not require any dermal toxicity testing or any terrestrial toxicity testing.
Furthermore, a primary focus of the HPV Initiative, including the
voluntary HPV Challenge Program and associated TSCA section 4 HPV SIDS
rulemaking is to implement these efforts as contributors to a larger
international activity with global involvement and in a manner
consistent with meeting the needs of the OECD HPV SIDS program and to
further the goals under Programme Area (c) of Agenda 21, Chapter 19 of
the United Nations Conference on Environment and Development (UNCED)
concerning information exchange on toxic chemicals and chemical risks.
EPA solicits comment on the potential approaches that may be used to
incorporate the principles contained in the October 14, 1999, letter in
the context of TSCA section 4 HPV SIDS rulemakings (Ref. 29). IV. EPA Findings
A. What is the Basis for EPA's Proposal to Test These Chemical Substances?
As indicated in Unit II., in order to develop a rulemaking under TSCA section 4(a) requiring the testing of chemical substances or mixtures, EPA must make certain findings regarding either risk (TSCA section 4(a)(1)(A)(i)); or production and either chemical release or human exposure (TSCA section 4(a)(1)(B)(i)), with regard to those chemicals. EPA is proposing to require testing of the chemical substances included in this proposed test rule based on its preliminary findings under TSCA section 4(a)(1)(B)(i) relating to ``substantial'' production and ``substantial human exposure,'' as well as findings under TSCA sections 4(a)(1)(B)(ii) and (iii).
In EPA's ``B'' policy (see Unit II.), ``substantial production'' of
a chemical substance or mixture is generally interpreted to be aggregate production
[[Page 81667]]
(including import) volume equaling or exceeding 1 million pounds per
year of that chemical substance or mixture. (Ref. 24 at 28747). For
workers, the ``B'' policy threshold for ``substantial human exposure''
is the exposure of 1,000 workers annually to that chemical substance or
mixture. (Ref. 24) See EPA's ``B'' policy for further discussion on how
EPA makes decisions under TSCA section 4(a)(1)(B)(i). For the reasons
set out in the ``B'' policy, EPA believes that the thresholds included
in the ``B'' policy are appropriate for use in this proposed rule. (Ref. 24)
EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i), each of the 37 chemical substances included in this proposed rule is prod
FOR FURTHER INFORMATION CONTACT
For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone numbers: (202) 5541404; email address: TSCA Hotline@epa.gov.
For technical information contact: Keith Cronin, Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 2608130; fax number: (202) 2601096; email address: ccd.citb@epa.gov.