Ms. Seneca Fitch, ToxStrategies scientist, has been invited by the Evidence-Based Toxicology Collaboration (EBTC) Board of Trustees at Johns Hopkins Bloomberg School of Public Health to join the Scientific Advisory Council. In this role, she will serve a 3-year term in addition to her ongoing involvement within the organization’s Tox21 working group. The EBTC SAC is an international group of scientists from a variety of organizations, including government agencies, NGOs, industry, and academia. Members provide expertise in evidence-based methods, participating in EBTC projects and advising the EBTC Board and Director on new areas of research and other issues relevant to the toxicology community.
Author Archives: ricknelson
ToxStrategies opens a new office in Asheville, NC
ToxStrategies is pleased to announce the opening of our latest office in Asheville, NC, at 31 College Place, Suite B118, on the east side of the downtown area. Our Asheville office team includes health scientists, engineers, and regulatory specialists who are recognized as leaders in their respective disciplines and bring a high level of technical expertise to every project. Staff in Asheville will serve clients nationwide and are well-suited to assist with a broad range of projects, such as evaluating potential health risks associated with exposures to chemicals in or associated with use of consumer products, foods, pharmaceuticals, biopharmaceuticals, medical devices, occupational settings, and environmental media. As a cornerstone of the ToxStrategies business model, staff in the Asheville office will continue to emphasize flexibility, efficiency, and effectiveness, all of which translate to reduced costs and greater satisfaction for our clients.
ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. We have a reputation for applying sound science and novel approaches tailored to meet the specific needs of our clients, whether that need is for a rapid response or a comprehensive analysis. For more information about ToxStrategies, our staff, or the services we offer, please visit our website at: https://toxstrategies.com.
Analysis: EPA releases next group of high- and low-priority existing chemicals
On March 20, 2019, the EPA released lists of the next 20 high-priority and 20 low-priority existing chemicals that are candidates for TSCA risk evaluations. The Agency released this list to provide the public an opportunity to submit relevant information over the next 90 days, such as the uses, hazards, and exposure for these chemicals. Publication also activates a statutory requirement for EPA to complete the prioritization process in the next 9 to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority by December 2019. According to EPA and TSCA, when prioritization is complete, chemicals designated as high priority will begin a 3-year risk evaluation process to determine whether each chemical, under the conditions of use, presents an unreasonable risk to human health and the environment. The designation of a chemical as a low priority means that further risk evaluation is not warranted at this time.
Based on our review, it appears that all 20 high-priority chemicals are from the 2014 Update of the TSCA Work Plan. TSCA requires that at least 50 percent of all high-priority chemicals be from the Work Plan. For this round, EPA has used 100 percent from the Work Plan list. The low-priority chemicals all are from EPA’s Safer Chemicals Ingredients List (SCIL).
TSCA also requires that EPA give preference to Work Plan chemicals with the following characteristics:
- Persistence and bioaccumulation scores of three
- Known human carcinogens
- High acute or chronic toxicity
ToxStrategies has examined the TSCA Work Plan and has the following observations:
- None of the selected high-priority chemicals have persistence and bioaccumulation scores of three. In fact, eight of the 20 candidates have persistence and bioaccumulation scores of one, particularly the phthalates, which are selected based on aquatic toxicity but have low persistence and low bioaccumulation potential.
- None of the selected high-priority chemicals are from the seven substances that scored 3 on all three criteria (hazard, exposure, persistence/bioaccumulation) and remain in the TSCA Work Plan after eliminating the first 10 already being evaluated. This includes four metals; no metals have been selected to date.
- TSCA Work Plan scores for the 20 high-priority candidates are summarized below.
| HIGH-PRIORITY CANDIDATE | HAZARD Score | EXPOSURE Score | PERSISTENCE BIOACCUMULATION Score |
|---|---|---|---|
| p-dichlorobenzene | 3 possible carcinogen |
3 wide consumer use |
2 moderate P, low B |
| 1,2-dichloroethane | 3 possible carcinogen |
3 wide consumer use |
2 moderate P, low B |
| trans-1,2- dichloroethylene | 2 chronic toxicity | 3 wide consumer use |
2 moderate P, low B |
| o-dichlorobenzene | 2 chronic toxicity | 3 wide consumer use |
2 moderate P, low B |
| 1,1,2-trichloroethane | 3 possible carcinogen |
2 consumer use | 2 high P, low B |
| 1,2-dichloropropane | 2 Acute mammalian toxicity |
3 wide consumer use |
2 high P, low B |
| 1,1-dichloroethane | 2 mutagenetic | 3 wide consumer use |
2 moderate P, low B |
| Dibutyl phthalate | 3 chronic aquatic toxicity |
3 wide consumer use |
1 low P, low B |
| Butyl benzyl phthalate | 3 chronic aquatic toxicity |
3 wide consumer use |
1 low P,low B |
| di-ethylhexyl phthalate | 3 chronic aquatic toxicity |
3 wide consumer use |
1 low P, low B |
| di-isobutyl phthalate | 1 reproductive toxicity | 2 specialty use | 1 low P, low B |
| dicyclohexyl phthalate | 3 chronic aquatic toxicity |
3 plasticizer and heat sealer |
1 low P, low B |
| TBBPA | 2 acute aquatic toxicity |
3 wide use as circuit board flame retardant |
2 high P, low B |
| TCEP | 2 mutagenic | 2 consumer use | 2 moderate P, low B |
| phosphoric acid triphenyl ester | 3 Acute and chronic aquatic toxicity |
3 wide use as circuit board flame retardant |
2 moderate P, moderate B |
| ethylene dibromide | 3 probable carcinogen |
2 commercial/industrial use | 2 moderate P, low B |
| 1,3-butadiene | 3 known carcinogen |
3 major petrochemical commodity |
1 low P, low B |
| HHCB | 2 developmental toxicity | 3 wide consumer use |
2 moderate P, moderate B |
| formaldehyde | 3 known carcinogen |
3 wide consumer use |
1 low P, low B |
| phthalic anhydride | 3 respiratory sensitizer | 3 wide consumer use |
1 low P, low B |
ToxStrategies presents at SOT 2019
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.
Impact of EPA’s PFAS Action Plan
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.
State-level feed regulations summarized by AAFCO
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.
ToxStrategies authors publish systematic framework for mechanistic data
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.