[Federal Register Volume 65, Number 109 (Tuesday, June 6, 2000)]
[Notices]
[Pages 35925-35926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14177]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6710-7]


Benchmark Dose Software

AGENCY: Environmental Protection Agency.

ACTION: Notice of availability.

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SUMMARY: This notice announces the availability of the U.S. 
Environmental Protection Agency (EPA) Benchmark Dose Software (BMDS 
Version 1.2). BMDS was developed by EPA's National Center for 
Environmental Assessment (NCEA) as a tool to facilitate the application 
of benchmark dose methods to the assessment of hazardous pollutants. 
The software and supporting documentation are available to Agency

[[Page 35926]]

personnel and to the general public, and can be downloaded from the 
NCEA internet web site or requested directly from NCEA (see addresses 
below).

ADDRESSES: To obtain a copy of the Benchmark Dose Software Version 1.2, 
direct your internet browser to http://epa.gov/ncea/bmds.htm. You will 
be instructed on how to download a self-extracting compressed file 
containing the BMDS program. Windows 95/98/NT and at least sixteen 
megabytes of RAM are required to run this version of the BMDS.
    Accessing a copy of the BMDS program via the internet is highly 
recommended as the BMDS web site will be the official and most current 
source of updates and notifications. However, those for whom internet 
access is impractical may obtain a copy of the program via E-mail or 
CD-ROM by contacting Ms. Diane H. Ray, National Center for 
Environmental Assessment-RTP Office (MD-52), U.S. Environmental 
Protection Agency, Research Triangle Park, NC 27711; telephone: 919-
541-3637; facsimile: 919-541-1818; E-mail: [email protected].
    All comments on the BMDS software, help system and the model source 
code files are welcome. Please email comments, recommendations, 
suggested revisions, or corrections to [email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Jeffrey S. Gift, National Center 
for Environmental Assessment-RTP Office (MD-52), U.S. Environmental 
Protection Agency, Research Triangle Park, NC 27711; telephone: 919-
541-4828; facsimile: 919-541-1818; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: Use of benchmark dose methods involves 
fitting mathematical models to dose-response data, obtained primarily 
from toxicology studies, and using the results to determine the dose of 
a toxicant that is associated with a predetermined benchmark response, 
such as a 10% increase in the incidence of a particular lesion or a 10% 
decrease in body weight gain. BMDS estimates the lower-bound confidence 
limit on the benchmark dose (BMDL), which can serve as a point of 
departure for a non-cancer or cancer chemical risk assessment. BMDS 
facilitates these operations by providing simple data-management tools, 
a comprehensive help manual and online help system, and an easy-to-use 
interface to run multiple models on the same dose-response data set. At 
this time, BMDS (Version 1.2) offers sixteen (16) different models that 
are appropriate for the analysis of dichotomous (quantal) data (Gamma, 
Logistic, Log-Logistic, Multistage, Probit, Log-Probit, Quantal-Linear, 
Quantal-Quadratic, Weibull), continuous data (Linear, Polynomial, 
Power, Hill) and nested developmental toxicology data (NLogistic, NCTR, 
Rai & Van Ryzin). Results from all models include a reiteration of the 
model formula and model run options chosen by the user, goodness-of-fit 
information, the benchmark dose, and the estimate of the lower-bound 
confidence limit on the benchmark dose (BMDL). Model results are 
presented in textual and graphical output files which can be printed or 
saved and incorporated into other documents.
    The software announced here is the result of several years of 
research and development, expert review and quality assurance testing 
conducted by NCEA, with support from EPA's National Health and 
Environmental Effects Research Laboratory and NCEA contractors. 
Extensive peer review input was also received from expert scientists, 
particularly toxicologists and statisticians, from both inside and 
outside the Agency. Following a public review of BMDS Beta Version 
1.1b, which ended on March 31, 1999 (63 FR 71465, Dec. 28, 1998), NCEA 
revised the software based on its experience with the program and in 
response to public comments received. Finally, an extensive and 
independent quality assurance assessment of all facets of the BMDS 
system was conducted, and appropriate modifications were made to create 
BMDS Version 1.2.
    EPA/NCEA will continue to improve the BMDS system in response to 
the needs of Agency and other risk assessors. One example of such a 
project is the ongoing development of the EPA Hybrid model, a 
statistical approach to treating continuous data as dichotomous 
endpoints. A beta version of the Agency's Hybrid model is included in 
BMDS Version 1.2. Another example is the ongoing development of a model 
specifically designed for assessing cancer incidence data, which is 
being developed to support the proposed EPA cancer guidelines currently 
in development. As these and other modifications or additions are 
completed, they will be made available to users of the software via the 
NCEA BMDS web site.
    Currently, the BMDS web site contains the complete BMDS program 
along with its extensive online help system, a separately downloadable 
help manual, and background information concerning the development of 
the software. The executable and source code files for the individual 
models used by BMDS can also be downloaded from the web site.

    Dated: May 25, 2000.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 00-14177 Filed 6-5-00; 8:45 am]
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