PERCHLORATE PEER REVIEW

> Subject: 64FR2492 Technical Workshop on Perchlorate Risk Issues
> From: roboposter@us.govnews.org
> Date: 1999/01/14
> Newsgroups: gov.us.topic.environment.announce
> Archive-Name: gov/us/fed/nara/fed-register/1999/jan/14/64FR2492
> Posting-number: Volume 64, Issue 9, Page 2492
>
> [Federal Register: January 14, 1999 (Volume 64, Number 9)]
> [Notices]
> [Page 2492-2493]
> >From the Federal Register Online via GPO Access [wais.access.gpo.gov]
> [DOCID:fr14ja99-65]
> [[Page 2492]]
>
> ENVIRONMENTAL PROTECTION AGENCY
> [FRL-6219-3]
> Technical Workshop on Perchlorate Risk Issues
> AGENCY: Environmental Protection Agency (EPA).
> ACTION: Notice of meeting.
>
> -----------------------------------------------------------------------
>
> SUMMARY: EPA is announcing a workshop convened by the Research Triangle
> Institute (RTI), an EPA contractor, for external scientific peer review
> of the EPA draft document entitled ``Perchlorate Environmental
> Contamination: Toxicological Review and Risk Characterization Based on
> Emerging Information.'' The workshop will be held in San Bernardino,
> California, and will be open to members of the public as observers. The
> peer review, to be conducted by scientists from outside EPA, is being
> organized to assist in completing the toxicological review and risk
> characterization of perchlorate, and will include the protocols and
> reports of recent studies on perchlorate, as well as EPA's draft
> Toxicological Review document. Stakeholders in the perchlorate issue
> who have additional information which is relevant to the assessment of
> the potential health and ecological effects of perchlorate are invited
> to make a short presentation of this information at the peer review
> workshop.
>
> DATES: The workshop will begin on Wednesday, February 10, 1999 at 8:30
> a.m. and end on Thursday, February 11, 1999 at 12:30 p.m. Members of
> the public may attend as observers.
>
> ADDRESSES: The meeting will be held at the San Bernardino City Council
> Chambers, 300 North D Street, San Bernardino, California 92418. Since
> seating capacity is limited, please contact Ella Darden of RTI, by
> telephone, at 919-541-7026; by facsimile, at 919-541-7155; or by E-
> mail, at ejd@rti.org, by January 31, 1999 to attend the workshop as an
> observer. Observers who wish to make a short presentation of
> information which may be relevant to the assessment of potential health
> and ecological effects of perchlorate should register to do so with RTI
> by January 31, 1999.
>
> FOR FURTHER INFORMATION CONTACT: For technical and logistical inquires,
> contact Ella Darden, Research Triangle Institute, by telephone, at 919-
> 541-7026; by facsimile, at 919-541-7155; or by E-mail, at ejd@rti.org.
> Copies of the draft Toxicological Review document will be available for
> inspection on EPA's National Center for Environmental Assessment web
> site (http://www.epa.gov/ncea/), at EPA's Regional Superfund Records
> Centers, and at the EPA Headquarters Information Resources Center,
> Washington DC. Inquiries concerning additional opportunities for
> document review should be directed to Ella Darden at Research Triangle
> Institute.
>
> SUPPLEMENTARY INFORMATION:
>
> Background
>
> EPA is in the process of conducting a toxicological review for
> perchlorate, including the development of a revised provisional
> reference dose (RfD), a cancer assessment, and an ecological
> assessment. An RfD is an estimate of a daily oral human exposure that
> will result in no deleterious noncancer effects over a lifetime.
> Ideally, an RfD is based on an array of endpoints that address
> potential toxicity during various critical life stages, from developing
> fetus through adult and reproductive stages. The noncancer, cancer and
> ecological assessments may be used to support development of a health
> advisory and/or drinking water regulations and cleanup decisions at
> hazardous waste sites. In accordance with EPA's 1998 Peer Review
> Handbook, a key step in the development of the Toxicological Review
> document for perchlorate is the upcoming external peer review, in the
> form of a workshop, which will cover protocols for and reports of the
> recently completed toxicity studies, the Toxicological Review document,
> and the proposed revised provisional RfD, cancer assessment and
> ecological assessment in that document.
> EPA's Superfund Technical Support Center issued a provisional RfD
> for perchlorate in 1992 and a revised provisional RfD in 1995. The
> provisional RfD values (1992 and 1995) were based on an acute study in
> which single doses of potassium perchlorate caused the release of
> iodide from the thyroids of patients with Graves' Disease. The
> provisional RfD values did not undergo internal Agency, or external,
> peer review. In March of 1997 a peer review panel convened by an
> independent organization, Toxicology Excellence for Risk Assessment
> (TERA), determined that the health effects and toxicity data for
> perchlorate were insufficient to generate a credible RfD for risk
> assessment purposes. The reviewers were concerned that developmental
> toxicity, notably neurological development due to hypothyroidism during
> pregnancy, could be a critical health effect of perchlorate that has
> not been adequately examined in studies to date. They also concluded
> that insufficient data were available on potential effects of
> perchlorate on organs and tissues other than the thyroid.
>
> New Health Effects/Toxicology Studies Underway
>
> As a result of that peer review, a set of toxicological and
> ecological studies was undertaken is underway to address key data gaps
> and provide a comprehensive database related to the toxicity of
> perchlorate. The studies are being funded and overseen by a variety of
> organizations with potential responsibility for perchlorate
> contamination in the environment including the United States Air Force,
> the National Aeronautics and Space Administration and the Perchlorate
> Study Group (PSG).<SUP>1</SUP>
>
---------------------------------------------------------------------------
>
> \1\ The PSG is a consortium of defense contractors and
> manufacturers including: Aerojet, Alliant Techsystems, American
> Pacific/Western Electrochemical Company, Atlantic Research
> Corporation, Kerr-McGee Chemical Corp. Lockheed Martin, Thiokol
> Propulsion Group, and United Technologies Chemical Systems.
>
---------------------------------------------------------------------------
>
> To date, a 90-day subchronic oral study, a neurobehavioral
> developmental toxicity study, genotoxicity studies, a segment II
> developmental toxicity study, and ecotoxicity studies in Daphnia,
> earthworms, lettuce and fathead minnow have been completed. Currently
> ongoing studies include a two-generation reproductive toxicity study,
> absorption, distribution, metabolism, and elimination (ADME) studies,
> perchlorate mechanistic studies, and immunotoxicity studies. The
> results of most of these studies will be discussed in the Toxicological
> Review document and utilized for development of the proposed revised
> RfD, and cancer and ecological assessment for perchlorate.
> Ten independent scientists from the fields of general toxicology,
> thyroid function and toxicology, developmental toxicology,
> neurotoxicology, immunotoxicology, pharmacology, genetic toxicology,
> medical endocrinology with an emphasis on thyroid function,
> biostatistics, assessment of risks due to non-cancer and cancer health
> effects, and assessment of risks due to ecological effects will review
> the scientific data, methods, and analyses, along with the assumptions
> and uncertainties that are associated with the revised provisional RfD,
> cancer assessment, and ecological assessment for perchlorate. These
> scientists were selected by RTI from among the experts nominated by
> stakeholders for possible service as external peer reviewers. Following
> the peer review workshop, RTI will issue a
>
> [[Page 2493]]
>
> report summarizing the workshop. EPA will address the comments of the
> peer reviewers in finalizing the Toxicological Review document for
> perchlorate and adopting the revised perchlorate RfD. The RfD will be
> utilized in performing risk assessments of perchlorate contamination in
> the environment. Although such risk assessments will be one of the
> factors considered in making future decisions regarding perchlorate
> contamination, these decisions and other risk management issues will
> not be a part of the peer review process.
>
> Dated: January 7, 1999.
> Timothy Fields, Jr.,
> Acting Assistant Administrator, Office of Solid Waste and Emergency
> Response.
> [FR Doc. 99-890 Filed 1-13-99; 8:45 am]
> BILLING CODE 6560-50-P
>
> (end of original message)

64FR2492 EPA's Technical Workshop on Perchlorate Risk Issues - You can view this message and the related discussion by following this link:

http://www.dejanews.com/=zzz_maf/dnquery.xp?search=thread&svcclass=dnserver&mailto:recnum=<64FR2492@us.govnews.org>#1/3