Author Archives: ricknelson

ToxStrategies’ scientists continue to develop innovative solutions to address some of the most challenging scientific issues that face our clients.  Several recent examples of such projects were presented at the Society of Toxicology 58th Annual Meeting. The SOT 2019 conference was held in Baltimore, MD (March 10–14, 2019). To see a list of our presentations, click here,  and if you would like to receive a copy of one, please contact us.

On February 14, EPA released its first-ever comprehensive nationwide Per- and Polyfluoralkyl Substances (PFAS) Action Plan. The plan is the result of a cross-agency effort and is focused predominantly on protecting the nation’s drinking water. The PFAS Action Plan includes numerous aspects that may have both immediate and long-term effects on regulated parties:

• EPA will work toward establishment of Maximum Contaminant Levels (MCLs) under the Safe Drinking Water Act, potentially complicating the regulatory landscape with additional standards.
• EPA could list two of the most studied PFAS (PFOA and PFOS) as hazardous substances under CERCLA, giving the Agency the ability to impose remediation requirements.
• Additional substances will need to be monitored and controlled through new Effluent Limitation Guidelines (ELGs) under the Clean Water Act.
• EPA plans to develop new analytical methods to detect additional PFAS among the thousands of possible compounds. New toxicity factors and analytical requirements may lead to regulation of PFAS by groups or using toxicity equivalency factors.
• Public awareness of the global presence of PFAS in the environment, people, and animals will require creative approaches to risk communication and could invite public action and litigation.

Priority implications of the Action Plan are discussed in greater detail here. Our scientists and engineers stand ready to help clients as the PFAS regulatory landscape unfolds.

One of the most perplexing issues when distributing animal feeds and feed ingredients in the US is determining how to accurately register and license both the guarantor and products, to be in compliance for national distribution.  A guarantor, the name of the company listed on the feed label or package, is responsible for complying with all applicable food regulations, which include a variety of registrations.  If products are distributed nationally, they must be registered with those state feed regulatory programs that have registration and licensing requirements.

Unfortunately, there is no one-stop shopping for registration, and the first challenge is identifying which states require registration or licensing.  Thankfully, the Association of American Feed Control Officials (AAFCO) has helped demystify this process.  A visit to the website www.aafco.org “Regulatory” tab, will provide guarantors with a document titled, “State Regulatory Requirement Summary.”  This table is updated annually and provides a broad overview of the requirements for each state that requires registration.

This summary is a good start, but the information may be too broad, and additional questions may arise.  In that case, click on the interactive map found under the “Regulatory” tab, and search for the contact information for those within each state who handle registration.  Don’t hesitate to reach out to each state and ask for additional clarification.

Many states are moving from paper document requirements to an electronic data entry system that guarantors can access.  This software is designed to allow each guarantor to enter registration, product, and tonnage information, and to upload labels and pay any required fees online.  These systems also allow for direct delivery of notifications, sample and tonnage reports, and registration renewals.  Not all states will switch to an on-line access system, but many are in the development process to provide better service to guarantors.

The requirements for registration vary from state to state, but ensuring guarantor and product compliance is key to avoiding enforcement actions for failure to comply with state feed program requirements.  Interestingly, although the Food and Drug Administration (FDA) requires registration of facilities that handle food under the Food Safety Modernization Act, the FDA has no requirement for guarantor or product registrations.  ToxStrategies consultants can assist with your state or federal registration needs; please contact Candace Doepker, Ph.D., Food and Consumer Products Practice Leader, at (513) 206-9929.

A new article from ToxStrategies authors describes a framework to systematically and quantitatively integrate mechanistic data in assessments of potential carcinogenicity. The framework builds on the key characteristics organizational approach that is being implemented by authoritative bodies globally, by accounting for the quality and relevance of individual studies when developing weight-of-evidence conclusions regarding the activity of key characteristics. The proposed framework provides a flexible solution to quantitively integrate all available data in a systematic and transparent manner that accords greater weight to data that are best suited to the assessment of potential human carcinogenicity. The paper by Dr. Daniele Wikoff and colleagues has been accepted for publication in Toxicological Sciences and is on ToxStrategies’ website.