Author Archives: ToxStrategies

The Joint Research Centre (JRC) recently published a technical report reviewing recent developments in mixtures assessment methodologies and their applications in the hazard assessments.

The report reviews the use of emerging technologies, including in vitro assays, omics approaches, SAR and QSAR modeling, read-across, and PBTK modeling in evaluating mixtures toxicity. Survey results are also included detailing how experts use these novel methodologies to evaluate chemical mixtures. The report concludes that there is high potential for the application of these new methodologies; however, more guidance and standardization on the use of these tools in hazard assessment of mixtures is still needed.

For a copy of the JRC’s technical report on scientific methodologies for the assessment of combined effects of chemicals – a survey and literature review, please click here.

The National Toxicology Program (NTC) recently released the Handbook for Preparing Report on Carcinogens (RoC) Mongraphs, a science-based public health document.

The Handbook provides instructions for conducting the cancer hazard evaluation and preparing the RoC monographs. It is a living document and may be refined to incorporate new systematic review tools, to harmonize with systematic review methods used by other scientists, and from lessons learned from conducting cancer hazard evaluations on candidate substances with more diverse databases.

For a full copy of NTP’s Handbook for Preparing RoC Monographs, please click here.

On August 31, 2015, the US Food and Drug Administration (FDA) reported that the Food Safety and Modernization Act (FSMA) final preventive control rules for both human and animal food had been submitted to the Federal Register for publication. The final rules were required by the federal district court in Oakland to be submitted by August 30, 2015 based on a 2014 settlement with the Center for Food Safety and the Center for Environmental Health. The documents submitted to the Federal Register can be published several days after submission, with larger files requiring more time to be processed and displayed for public access.

FSMA is the most significant addition to the US food safety laws since the establishment of the Federal Food, Drug, and Cosmetic Act in 1938, over 70 years ago. President Obama signed FSMA into law on January 4, 2011.   At the time of adoption, FDA Commissioner Hamburg stated FSMA was “a call for a new, prevention-oriented safety system”. This new focus on prevention requires food facilities to have written food safety plans encompassing both Good Manufacturing Practices and applicable Hazard Analysis and Preventive Controls. It also allows FDA to focus on foods and food facilities that represent the highest risk to public health.   The final rules will be enforceable beginning in August 2016 for the majority of the human and animal food industries. There will be a delayed implementation timeline for companies meeting the small business definition that will be outlined in the final rules.

Our Foods Practice staff at ToxStrategies has been active in the commenting process for the proposed rules and will closely review the final rules as soon as they become available. Periodic updates will be posted on our website as we learn more about changes included within the final rules. If you have specific questions regarding FSMA, please contact Jodi Miller, Senior Scientist at (937) 681-9476 or Candace Doepker, Ph.D., Food and Consumer Products Practice Leader at (513) 206-9929.

For additional information on FSMA, click here.

The International Agency for Research on Cancer (IARC) recently published its monograph on polychlorinated biphenyls (PCBs) and polybrominated biphenyls (PBBs). Based on their evaluation, the IARC Working Group classified PCBs as Group 1 (carcinogenic to humans). Dioxin-like PCBs were also placed into Group 1 have a peek at this website. PBBs were categorized as Group 2A compounds (probably carcinogenic to humans).

ToxStrategies scientists have extensive experience working with PCBs. Our work has included evaluating the human health and ecological effects of PCBs, conducting risk assessments on sites associated with PCB contamination, as well as evaluating and deriving safe levels of exposures for PCB compounds.

A full copy of the IARC Monograph on PCBs and PBBs can be viewed here.

In accordance with their Endocrine Disruption Screening Program (EDSP), the EPA recently released the Tier 1 screening data for various pesticide chemicals. In these Tier 1 assays, 52 pesticide chemicals were tested to determine their potential to interact with hormone pathways. Of the 52 chemicals evaluated, there was no evidence for potential interaction with any of the endocrine pathways tested for 20 chemicals. Fourteen chemicals showed potential interaction with one or more pathways, but EPA already has enough information to conclude that they do not pose a risk. Of the remaining 18 chemicals, all 18 showed potential interaction with the thyroid pathway, 17 of them with the androgen pathway, and 14 with the estrogen pathway. The EPA will decide which of these pesticides will move on to Tier 2 testing.

ToxStrategies’ own Dr. Susan Borghoff assisted in the EDSP, having implemented more than 40 studies associated with the Tier 1 screening visit this site right here. As an expert in endocrine disruption, Dr. Borghoff is often cited for her organization of a 2013 workshop, Lessons Learned, Challenges, and Opportunities: The U.S. Endocrine Disruptor Screening Program, detailing the information and progress made in the EDSP. Dr. Borghoff organized and chaired a symposium at the 2013 American College of Toxicology Meeting entitled Endocrine Disruption Screening – Status of the U.S. EPA and EU Programs: State of the Science and Slate for the Future in which she presented a talk entitled The U.S. EPA Endocrine Disruptor Screening Program (EDSP) Tier 1 Assays: Retrospective Performance Evaluation.

Dr. Borghoff is well versed in evaluating chemical-specific data from the EPA’s EDSP21 ToxCast database which contains the results of the estrogen and androgen specific in vitro assays. She also has experience in the development and preparation of “Other Scientifically Relevant Information” (OSRI) documents to determine if specific Tier I assays can be waived and or providing an approach to evaluate the weight of evidence for Tier 2 testing.

For more information on the EDSP Tier 1 Assessments, please click here.

On July 23, the US House of Representatives passed bill H.R. 1599, the Safe and Accurate Food Labeling Act of 2015 that would preempt state laws regulating the labeling of genetically modified organisms (GMOs) in foods.  The vote was 275- 150. Representative, Mike Pompeo (R-KS) and G.K. Butterfield (D-NC), introduced the bill with the goal of creating a uniform, national system to govern the premarket review and labeling of genetically engineered foods (foods from or containing GMOs).

Key objectives of the Safe and Accurate Food Labeling Act of 2015 are to:

• Require the Food and Drug Administration (FDA) to conduct a safety review of all new plant varieties used for genetically engineered food before those foods could be introduced into commerce.
• Uphold FDA’s authority to specify special labeling if necessary to protect health and safety.
• Create a legal framework, subject to FDA oversight, regulating the use of label claims regarding the use or absence of genetically engineered food or food ingredients.
• Direct FDA to develop a Federal definition for “natural” claims on product labels
• Allow foods to be labeled as GMO-free, if desired, by participation in a USDA-accredited certification process (Similar to the USDA Organic Standard

ToxStrategies staff will continue monitor the progress of the Safe and Accurate Labeling Act of 2015 as it is of great importance to the food and animal food industries xenical over the counter.

You can learn more about the Safe and Accurate Food Labeling Act of 2015 and track the status of the bill here. You can find out more about the Food and Consumer Products Practice at ToxStrategies by visiting here.

We are pleased to announce that Dr. Kirby H. Tyndall, DABT and Dr. Julia E. Rager have joined ToxStrategies, Inc. and will be based in our Austin, TX office.

Dr. Tyndall is a Senior Scientist and a board certified Toxicologist. She has over 25 years of experience specializing in the areas of toxicology, human health and ecological risk assessment, and development of risk-based cleanup levels. Dr. Tyndall has successfully used these tools to help design overall investigation and remediation strategies that minimize project costs while achieving risk-based objectives under various regulatory programs. In addition to her extensive consulting career, Dr. Tyndall gained regulatory experience while employed at the Texas Natural Resources Conservation Commission (TNRCC; now known as the TCEQ), as well as teaching experience at the College of Santa Fe and the University of Texas at Austin, School of Pharmacology. Dr. Tyndall can be reached by phone at (512) 887-3960 or by email at ktyndall@toxstrategies.com. To learn more about Dr. Tyndall please visit her page on the ToxStrategies website.

Dr. Rager is a Scientist III with postdoctoral and research experience from her time at the University of North Carolina and USEPA. She has experience conducting comprehensive human health evaluations on environmental chemicals, particularly with respect to air toxicants. Dr. Rager has evaluated genomic, epigenomic, and proteomic responses to toxicant exposure while interpreting results at the gene-specific and systems biology/pathway levels. She also has extensive experience assessing statistical trends in high throughput exposure and toxicity data, including the USEPA’s ExpoCast and ToxCast databases and various genome-wide toxicological repositories. Dr. Rager has co-authored over 25 scientific journal articles and book chapters. Dr. Rager can be reached by phone at (512) 813-0242 or by email at jrager@toxstrategies.com. To learn more about Dr. Rager please visit her page on the ToxStrategies website.

The U.S. National Oceanic and Atmospheric Administration’s (NOAA) Office of Response and Restoration recently made its Chemical Aquatic Fate and Effects (CAFE) database software available to the public. This software can be used to estimate the aquatic fate and effects for thousands of different chemicals, oils, and dispersants. The program can be downloaded and run on either Mac or Windows platforms. CAFE has two modules: (1) the Aquatic Fate module, that can be used to predict how a particular chemical will behave in the environment using data such as chemical properties; and (2) the Aquatic Effects (toxicity) module, which estimates the compound’s potential toxicity to various species (e.g., fish, crustaceans, mollusks, coral).

A copy of the free software can be downloaded here.