[Federal Register Volume 64, Number 144 (Wednesday, July 28, 1999)]
[Notices]
[Pages 40871-40873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19271]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-00597; FRL-6078-6]


Proposed Test Guidelines; Notice of Availability and Request for 
Comments

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability and request for comments.

-----------------------------------------------------------------------

SUMMARY: EPA has established a unified library for test guidelines 
issued by the Office of Prevention, Pesticides and Toxic Substances 
(OPPTS) for use in testing chemical substances to develop data for 
submission to EPA under the Toxic Substances Control Act (TSCA), the 
Federal Food, Drug and Cosmetic Act (FFDCA), or the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). These test 
guidelines represent an Agency effort that began in 1991 to harmonize 
the test guidelines within OPPTS, as well as to harmonize the OPPTS 
test guidelines with those of the Organization for Economic Cooperation 
and Development (OECD). The process for developing and amending these 
test guidelines includes public participation and the extensive 
involvement of the scientific community, including peer review by the 
Scientific Advisory Panel and the Scientific Advisory Board (SAB) and 
other expert scientific organizations. With this notice, EPA is 
announcing the availability of a combined chronic toxicity and 
carcinogenicity test guideline for the Series 870-Health Effects Test 
Guidelines for use in the testing of fibrous particles in the 
development of test data (OPPTS 870.8355). Natural and synthetic fibers 
are one group of substances that have been identified to be of 
potential health concern to humans. An EPA SAB meeting to review the 
proposed test guideline will be scheduled after incorporation of public 
comments. Complete details of this meeting will be announced in a 
subsequent Federal Register notice.

DATES: Comments, identified by docket control number OPP-00597, must be 
received by EPA on or before September 27, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00597 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Christine M. Augustyniak, Associate Director, Environmental Assistance 
Division (7408), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M Street, SW., Washington, DC 
20460; telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e-
mail address: TSCA-H[email protected].
    For technical information contact: David Lai, Risk Assessment 
Division, Office of Pollution Prevention and Toxics (7403), 
Environmental Protection Agency, 401 M Street, SW., Washington, DC 
20460; telephone number: (202) 260-6222; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

     This action is directed to the public in general. Although this 
action may be of particular interest to those persons who are or may be 
required to conduct testing of chemical substances under the Toxic 
Substances Control Act (TSCA), the Federal Food, Drug and Cosmetic Act 
(FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the person listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

II. How Can I Get Additional Information, Including Copies of This 
Document or Other Related Documents?

A. Electronically

    You may obtain copies of this document and certain other available 
documents from the EPA Home Page at http://www.epa.gov/. On the Home 
Page select ``Laws and Regulations'' 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 obtain copies of test guidelines from the EPA Internet 
Home Page by selecting ``Researchers and Scientists/Test Methods and 
Guidelines/OPPTS Harmonized Test Guidelines'' at http://www.epa.gov/
epahome/research.htm.

B. In Person

    The Agency has established an official record for this proposed 
guideline under docket control number OPP-00597. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any 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 
Public Information and Records Integrity Branch, Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Public 
Information and Records Integrity Branch telephone number is (703) 305-
5805.

[[Page 40872]]

III. How Can I Respond to this Action?

A. 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 OPP-00597 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. Submit your comments electronically by e-mail 
to: ``[email protected],'' or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be Confidential Business Information (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 5.1/6.1 or ASCII 
file format. All comments in electronic form must be identified by the 
docket control number OPP-00597. Electronic comments may also be filed 
online at many Federal Depository Libraries.

B. 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, 
please consult the technical person identified in the ``FOR FURTHER 
INFORMATION CONTACT'' section.

IV. What Action is EPA Taking?

    EPA is announcing the availability of and seeking comment on 
proposed test guidelines for developing a combined chronic toxicity and 
carcinogenicity test guideline for use in the testing of respirable 
fibrous substances (OPPTS 870.8355). Natural and synthetic fibers are 
one group of substances that have been identified to be of potential 
health concern to humans. For many of these fibers there are limited, 
inconclusive, or virtually no information about their health effects. 
As a result, EPA has added a ``respirable fibers'' category as priority 
substance for health effects and exposure testing to obtain the 
necessary data to evaluate the extent and magnitude of health risks to 
exposed individuals and populations. However, the Agency's current test 
guidelines for chronic inhalation toxicity and/or carcinogenicity 
studies of chemical substances are not sufficiently specific for the 
testing of fibrous particles, and there is no general agreement upon 
test protocols for chronic inhalation toxicity and carcinogenicity 
testing of fibers for regulatory purposes. On May 8-10, 1995, EPA, in 
collaboration with National Institute of Environmental Health Sciences 
(NIEHS), the National Institute for Occupational Safety and Health 
(NIOSH), and the Occupational Safety and Health Administration (OSHA), 
conducted a workshop to obtain input from the scientific community on a 
number of issues related to fiber testing. The proposed test guideline 
has been developed based largely on the recommendations from the 
workshop expert panel and participants.
    All interested parties are encouraged to submit comments on this 
proposed guideline. Specific comments should reference the specific 
number and paragraph or subparagraph of the related provision in the 
proposed test guidelines. Recommended technical or scientific changes/
modifications should be supported by current scientific/technical 
knowledge and include supporting references. References may be to the 
published literature, studies submitted to OPPTS, or to unpublished 
data. Citations must be sufficiently detailed to allow OPPTS to access 
and evaluate the published information, original documents submitted, 
or unpublished data.

V. Are There Any Applicable Voluntary Consensus Standards That EPA 
Should Consider?

     This notice of availability does not involve a proposed regulatory 
action that would require the Agency to consider voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, section 12(d) (15 
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus 
standards in its regulatory activities unless to do so would be 
inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. The NTTAA requires EPA to provide an explanation to Congress, 
through OMB, when the Agency decides not to use available and 
applicable voluntary consensus standards when the NTTAA directs the 
Agency to do so.
     In the future, these test guidelines could be incorporated into 
regulatory actions taken by EPA under TSCA, i.e., with regard to the 
section 4 testing program. Although the NTTA requirements do not 
specifically apply to the issuance of these particular test guidelines 
today, EPA invites your comment on whether or not there are any 
voluntary consensus standards that should be considered during the 
development of the final test guidelines or any future regulatory 
action that may be taken under TSCA. Future regulatory actions under 
TSCA section 4 may involve notice and comment rulemaking or negotiated 
voluntary testing enforcement consent agreements/orders/decrees. 
Nevertheless, the Agency is interested in whether or not there are any 
voluntary consensus standards that EPA should considered either as part 
of the development of the test guidelines themselves or in leu of these 
test guidelines when the Agency develops any future regulatory action 
that incorporates these test guidelines. Any comments provided will 
assist the Agency in complying with the NTTAA by facilitating the 
Agency's identification of voluntary consensus standards that should be 
addressed in the test guideline or considered during the development of 
a proposed regulatory action that incorporates any standards included 
in the final test guidelines. Please submit your

[[Page 40873]]

comments as directed in Unit III. of this document.

List of subject

    Environmental protection, Chemical testing, Test guideline.

    Dated: July 13, 1999.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 99-19271 Filed 7-27-99; 8:45 am]
BILLING CODE 6560-50-F