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7/14/2021

Dr. Michael Dourson and Dr. Bernard Gadagbui article, The Dilemma of Perfluorooctanoate (PFOA) Human Half-life was accepted for publication in the Regulatory Toxicology and Pharmacology Journal. Click Here to read.

4/15/2021

The Alliance for Risk Assessment (ARA) announces a PFOA project.

The Alliance for Risk Assessment (ARA) at http://allianceforrisk.net is endorsing a collaboration among organizations to explore and possibly resolve the conundrum in human 1/2 life for perfluorooctanote (PFOA), which is reflected in differences in safe doses world-wide of 750-fold (Mikkonen et al., 2020*). This collaboration is anticipated to start in April, 2021 with the selection of an advisory committee who will then conduct a series of virtual and possibly face-to-face meetings, with conclusions later this year. Nominations to this advisory committee are welcome. Toxicology Excellence for Risk Assessment (www.tera.org) has been designated as the nonprofit organization to support this coalition. Because TERA is a 501c3 nonprofit organization, all donations to this effort are tax deductible. 

All interested groups are welcome to contact one of us below for additional details. 

Annette Dietz, Portland State University (acdietz@pdx.edu)
Michael Dourson, Toxicology Excellence for Risk Assessment (dourson@tera.org)
Michael Honeycutt, Texas Commission on Environmental Quality (Michael.honeycutt@tceq.texas.gov)
Matthew McAtee,U.S. Army Public Health Center (Matthew.j.mcatee.civ@mai..mil)
Moiz Mumtaz, Agency for Toxic Substance & Disease Registry (mgm4@cdc.gov)
Ralph Perona, Neptune & Company, Inc. [representing tribal interests] (rperona@neptuneinc.org)

4/12/2021

introducing the Center for Truth in Science to members of the Alliance for Risk Assessment

… In the vein of celebrating partnerships and outreach, last week I had the honor of introducing the Center for Truth in Science to members of the Alliance for Risk Assessment (ARA), a collaboration of organizations that fosters the development of technical chemical risk assessment products and services. I am exceptionally impressed with their commitment to utilizing fact-based scientific evidence to openly, transparently, and accurately assess the risks of exposure to specific chemicals, minerals, compounds, and pharmaceuticals. This cool, calm, and collected approach is often lacking in regulatory agencies’ efforts to quickly enact regulations based on public opinion, political pressure, or partisan ideology rather than sound science and thorough risk analysis.

Raising awareness of the Center with organizations like ARA is one of my most important objectives in 2021, as establishing the integrity of the Center’s research methodologies and the credibility of our research results—especially with members of the scientific community—is absolutely critical to our success…

Thank you,
Joseph Annotti
President & CEO
Center for Truth in Science

News from 2020

Short summary of Perchlorate

Here is a short summary of #perchlorate, a naturally occurring chemical, but also used as rocket fuel and as a drug for thyroid problems. After many years of study, US #EPA has developed an assessment that is similar to that proposed by Toxicology Excellence for Risk Assessment (TERA) in its paper by Strawson et al. (2004),* albeit with a lot more data, support, and additional peer review. EPA’s bottom line is NOT to regulate perchlorate, based on its determination that perchlorate is not found in drinking water with a frequency and at levels of public health concern to support a meaningful opportunity for health risk reduction through a national perchlorate drinking water regulation.

* Strawson, J., Q. Zhao and M. Dourson.  2004.  Reference dose for perchlorate based on thyroid hormone change in pregnant women as the critical effect.  Reg. Tox. and Pharm.  39: 44-65  

Toxicology Excellence for Risk Assessment (TERA) reviews course

Toxicology Education Foundation (TEF) has endorsed a course that integrates the assessment and management in an easy to follow manner, along with games that hone acquired skills and solidify key points.  Toxicology Excellence for Risk Assessment (TERA) is reviewing this course with the idea of working with TEF for future educational opportunities world wide.

News from 2019

11/7/2019

TERA’s recent journal regarding the safety assessment of the chemical chlorpyrifos (dursban).

Journal and appendices
Epidemiology Data and Chlorpyrifos
Clorpyrifos Figures
Appendix A
Appendix B
Appendix C

8/7/2019 UPDATED

“Journal Accepted” Research Case Study with Perfluorooctanoate (PFOA)

Guidelines of the United States Environmental Protection Agency (EPA, 1991) and the International Programme on Chemical Safety (IPCS, 2005) suggest two different default positions for dosimetric extrapolation from experimental animals to humans when the dosimetry of the critical effect is not known. The default position of EPA (1991) for developmental toxicity is to use peak concentration (or Cmax) for this dosimetric extrapolation. In contrast, IPCS (2005, page 39) states its default position for dosimetric choice in the absence of data is to use the area under the curve (or AUC). The choice of the appropriate dosimeter is important in the development of either a Chemical Specific Adjustment Factor (CSAF) of IPCS (2005) or a Data Derived Extrapolation Factor (DDEF) of EPA (2014).

READ THE FULL ARTICLE
Manuscript Appendix Elcombe Data

5/29/2019

Bernard Gadagbui M.S., Ph.D., DABT, ERT chosen as one of the three advisors of SRA-Africa

In 2018, the Society for Risk Analysis (SRA) tasked a group of scientists from the United States, Europe, and Africa to determine the need for forming an African Regional Chapter of SRA. This group was led by Dr. Jo Anne Shatkin (President of Vireo Advisors, LLC).  After several months of conference calls and deliberations, a recommendation for the formation of the African Regional Chapter, to be known as SRA-Africa, was sent to SRA. Based on this recommendation, SRA recently announced the launch of the new regional chapter – SRA Africa. The Chapter held its first meeting and a reception in conjunction with the Fifth World Congress on Risk, which was held jointly with the Society of Environmental Toxicology and Chemistry (SETAC) Africa 9th Biennial Conference, May 6-8, 2019 at the Cape Town International Convention Centre, Cape Town, South Africa.

By popular request, SRA-Africa, SRA and SETAC held a full day training course that featured a lecture series from risk assessors with expertise in human health and ecological risk assessment on May 5, 2019. Leading experts include Gertie Arts, Patricia Fai, Larry Kapustka, Annegaaike Leopold, Lorraine Maltby, Charlie Menzie, Blair Paulik and Thomas-Benjamin Seiler from SETAC and Bernard Gadagbui, Abdel-Razak Kadry and Amy Rosenstein from SRA.

Dr. Gadagbui also presented a talk on “The Role of Nonprofits in Promoting Toxicology and Risk Assessment Training in Africa” at the 5th World Congress.

5/14/2019

Preliminary Research Case Study with Perfluorooctanoate (PFOA)

Guidelines of the United States Environmental Protection Agency (EPA, 1991) and the International Programme on Chemical Safety (IPCS, 2005) suggest two different default positions for dosimetric extrapolation from experimental animals to humans when the dosimetry of the critical effect is not known. The default position of EPA (1991) for developmental toxicity is to use peak concentration (or Cmax) for this dosimetric extrapolation. In contrast, IPCS (2005, page 39) states its default position for dosimetric choice in the absence of data is to use the area under the curve (or AUC). The choice of the appropriate dosimeter is important in the development of either a Chemical Specific Adjustment Factor (CSAF) of IPCS (2005) or a Data Derived Extrapolation Factor (DDEF) of EPA (2014).

1/5/2019

TERA staff published papers in 2018:

Alison M. Pecquet, Jeanelle M. Martinez, Melissa Vincent, Neeraja Erraguntla, Michael Dourson.  2018.  Derivation of a no‐significant‐risk‐level for tetrabromobisphenol A based on a threshold non‐mutagenic cancer mode of action.  Journal of Applied Toxicology.  Pages 1-17.

Michael L. Dourson.  2018.  Let the IRIS Bloom: Regrowing the integrated risk information system (IRIS) of the U.S. Environmental Protection Agency.  Regulatory Toxicology and Pharmacology 97: A4-A5. 

12/30/2018

Michael Dourson presented 3 talks in 2018:

“What do these items have in common? TCE Averaging Time, PFOA Kinetics and the US Senate.”  American Waste Management Association.  Vapor Intrusion, Remediation, and Site Closure Conference. Phoenix, Arizona.  December 6, 2018.

“Remarks on Toxicology, Politics and the Press.” American Council on Safety and Health. Featured talk at the ACSH 40th Anniversary Gala Celebration. Washington, D.C. October 24, 2018.

“Toxicology, Chemicals of Interest and Ways Forward.”  Food Industry Toxicology Roundtable. Columbus, Ohio.  August 15, 2018.

6/5/2018

Dr Michael Dourson’s speaking engagements.

June 14th.  In Cincinnati.  Alliance for Chemical Safety annual Banquet at the Anderson Center, 7850 Five Mile Rd.  Dr. Michael Dourson is giving the keynote talk after dinner.  Meeting is open to all.

June 17th.  Dr Michael Dourson travels to Bangkok, Thailand to attend the AsiaTox meeting on June 17.  Dr. Dourson will be giving a talk entitled “Extrapolating new approaches into a tiered approach to mixture risk assessment.”

June 20th.  Dr. Michael Dourson travels to Stara Lesna, Slovakia to attend the Toxicon, 23rd Interdisciplinary Toxicology Conference.  Dr. Dourson will be giving a talk entitled “Extrapolating new approaches into a tiered approach to mixture risk assessment.”

6 /1 /2018

NEXT Dose-Response Assessment Boot Camp CourseSeptember 24th through the 28th, 2018

Seating is limited, we recommend that you reserve your seat as soon as possible by emailing Valerie at ayers@tera.org. You will receive an email confirmation with more details. We look forward to seeing YOU there! Click here for details.

TERA PRESS RELEASE
2/13/2018
Dr. Michael Dourson Rejoins TERA

Toxicology Excellence for Risk Assessment (TERA) is pleased to welcome Dr. Michael Dourson back to our 501c3 nonprofit organization as the Director of Science.   Under the recent leadership of Dr. Patricia McGinnis, TERA has remained an independent organization. TERA continues its mission to protect public health by conducting hazard identification, dose response assessment, independent peer review, and public education.  TERA’s collaborative work can be viewed by Clicking Here

Click here for Toxicology Excellence for Risk Assessment (TERA) at SOT 2018

2/10/2018

Update: TERA’s History and Mission

Toxicology Excellence for Risk Assessment (TERA) has provided clients with independent, transparent science since 1995.

TERA solves human health risk challenges for diverse government and private sponsors through collaboration that emphasizes partnership building across scientific expertise and multiple perspectives to ensure the use of the best science. These strengths are the basis for TERA’s development of independent and science-driven analyses for risk assessment.

A world leader in independent scientific peer review, TERA provides in-person panel meetings, letter reviews, webcasts and webinars, in-house technical reviews, and workshops.

TERA NEWS UPDATE

12/2017

Example of Collaborative Work in Environmental Risk Assessment by TERA

The following text was prepared as part of EPA’s response to the US Senate hearing on the nomination of Michael Dourson to be Assistant Adminstrator of EPA’s Office of Chemical Safety and Pollution Prevention.  This text, not widely shared at the time, demonstrates the extensive mischaracterization of TERA’ long and successful history of independent, nonprofit science.  Any and all parts of this text can now be cited or quoted as needed. Click Here to Read

Project Highlights

Beyond Science & Decisions: Workshop 9. Workshop 9 will be held in Cincinnati for two days within the period June 9-11.  Key topics for discussion include several case studies on adverse outcome pathways (AOPs), and an alternatives assessment framework for addressing risk from flame retardants.  Information will be posted at https://www.tera.org/Alliance for Risk/ARA_Dose-Response.htm

Be a KidsChemicalSafety.org STAR!! Your organization can become  a STAR by becoming a corporate sponsor for the KidsChemicalSafety.org website. Click here for details on sponsorship.

Independent Workshop on Ozone NAAQS Science and Policy. The workshop was held in April providing an independent evaluation and synthesis of key considerations for approaching the difficult and complex ozone NAAQS decision. Details and a recording of the webcast are available at http://www.tera.org/Peer/ozone/index.html .

OARS Activities with WEELs. Revised WEEL documentation for Butyraldehyde and 2-Chloropropane. Public comment period is closed. Final WEEL will be available soon. New OARS-WEEL for Octamethylcyclotetrasiloxane (D4), 3-Nitro-1,2,4-triazol-5-One (NTO), and cis-1,1,1,4,4,4-Hexafluoro-2-butene (HFO-1336mzz-Z) is now available. D4 has been posted. 

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WEEL OEL

Occupational Exposure Limits (OELs) are designed to safeguard the health of healthy workers during their careers. These limits are based on the assumption of repeated daily exposure throughout a working lifetime, typically averaged over an 8-hour workday. Their purpose is to prevent both immediate (acute) and long-term (chronic) health issues arising from workplace exposures. It’s important to note that OELs are not intended for the general public, which includes vulnerable groups like infants, the elderly, and those with pre-existing health conditions.

Workplace Environmental Exposure Levels (WEELs) are health-based guidelines for chemical hazards in the workplace. These values represent air concentrations believed to protect the majority of workers from negative health effects resulting from occupational chemical exposure.

The WEEL Process
Click Here

The development of new or revision of existing WEELs is typically assigned to voluntarily designated subcommittees. A subcommittee usually comprises 3 – 4 members from the WEEL Committee. New WEELs are developed using the OARS-WEEL administrative standard operating procedure (SOP), while existing WEELs are usually revised every 10 years, unless the availability of significant new data which may impact the existing WEEL value compels the committee to make a revision sooner. The OARS-WEEL SOP contains procedures and guidelines governing conflicts of interest, draft document preparation, literature searches, draft document review, balloting process, post-ballot WEEL documentation quality assurance scientific review, and publication.

Once a subcommittee has prepared a draft WEEL document, a review of the draft is scheduled for the next available Committee meeting. The WEEL Committee members are expected to have reviewed all such drafts prior to the meeting. If no major changes are necessary to a draft, the attending Committee membership may, by a simple majority, approve the WEEL for balloting. Alternatively, the Committee may direct the subcommittee to revise the WEEL and present it for further discussion at a future meeting. If a ballot is not approved by a two-thirds majority of non-abstaining Committee members, it is discussed at the next Committee meeting to determine the appropriate course of action. Once the WEEL is approved by a two-thirds majority of non-abstaining Committee members, copies of ballot comments are forwarded to the designated subcommittee and all substantive comments must be addressed in the final draft. If resolution of a substantive comment results in a change to the WEEL value or a change in the basis for the value, the draft must be re-balloted.

Once all comments have been addressed on a successfully balloted draft, document formatting and editorial review are performed by TERA, before the draft WEEL document is made available for public comment (usually for a period of 30 days but may be extended if the need arises). After the public comment period has elapsed, comments are addressed by the subcommittee responsible for that specific draft, after which the WEEL documentation is submitted to Toxicology and Industrial Health (TIH), a peer-reviewed medical journal that covers research in the fields of occupational health and toxicology, for publication. A thorough review of the galley proof by the scientific content quality coordinator at TERA, and proofreaders and editors at TIH is the penultimate step before eventual publication of the WEEL documentation.

The WEEL Committee

The OARS-WEEL Committee is composed of volunteer experts specializing in the scientific determination of occupational exposure levels. This committee actively seeks a balanced representation of professionals from toxicology and industrial hygiene, drawing upon a diverse range of experience from industry, government, academia, and consulting. Importantly, each member contributes to the Committee based on their individual expertise and not as an official representative of their respective employer, organization, or agency.