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Lab Error Leads Solvent Makers to Urge EPA Rule Delay

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Solvents manufacturers want an opportunity to redo a toxicity study that could show a machinery degreaser is less harmful than previously thought before the EPA makes a final decision on whether to restrict its use.
The Halogenated Solvents Industry Alliance’s request raises the question of when and whether the Environmental Protection Agency will delay rulemakings to incorporate additional chemical safety data generated by industry or other parties—delays that concern the environmental community.
The alliance asked the EPA to extend by 120 days the comment period on a rule (RIN 2070-AK11) it proposed Jan. 19 that would prohibit commercial use of trichloroethylene (TCE) in vapor degreasing applications of machinery.
Trichloroethylene (CAS No. 79-01-6) is used to clean machine parts across a wide swath of industries including cleaning aircraft parts, defense-related maintenance of vehicles and metal fabrication processes.
The EPA already extended the public comment period for that rule by 30 days following a previous request by the solvents alliance. The comment period now is set to end April 19 unless the EPA extends it again.
Science Provision in Law
The alliance argues it needs more time to rerun a toxicity study specifically designed to replicate a previous study the EPA used to conclude TCE exposure could cause heart problems during development.
The group said its study must be rerun because the laboratory that conducted the test realized late last year that the experimental animals did not receive sufficient trichloroethylene in their drinking water. That invalidated the study’s results.
The EPA should not rely on a “so far unreproducible” study if it wants to comply with the 2016 amendments to the Toxic Substances Control Act, which require it to use the “best available science,” the alliance said.
Opposition
In comments filed April 4 and 5 respectively, a coalition of environmental health organizations led by Safer Chemicals, Healthy Families and the Environmental Defense Fund told the EPA it should not extend the comment period.
“The proposed rule is essential to protect tens of thousands of workers and consumers against serious and widespread risks of adverse health effects,” wrote the Safer Chemicals, Healthy Families coalition.
“Protection of public health demands prompt action by EPA,” the Environmental Defense Fund said. The body of data the EPA evaluated “overwhelmingly support” its determination of that using TCE for vapor degreasing was an unreasonable risk, it said.
The agency’s proposed rule is designed to protect workers in small shops that do vapor degreasing.
The study the alliance seeks to replicate was published more than 13 years ago, giving it ample time to have reproduced or rebutted it before, the Environmental Defense Fund wrote.
The EPA did not reply April 6 to a Bloomberg BNA inquiry as to whether it would extend the comment period. An official with the Halogenated Solvents Industry Alliance could not be reached for comment.

Biotech’s On The Rise Says Leading Expert

Medicilon has successfully established a wide range of in vivo and in vitro study designs to evaluate the safety of your drug candidates. Our toxicology department has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicological studies are conducted in various animal species. Email:[email protected] Web:www.medicilon.com
Toxicity testing of new compounds is critical for the drug development process. If you aren’t a trained expert in biotech, you may not be familiar with his process. A 28-day repeated-dose toxicity study uses the test drug on mammals to observe the effects of the test drug. This testing reveals whether or not there are toxic effects of the investigational product candidate and determines the extent of side effects the drug could produce. The completion of a successful 28-day repeated-dose toxicity study is the next step toward identifying a safe, starting dose to be administered to humans and fight disease.
More good news was released last month concerning PPCH, the Australian-based biotechnology company seeking to develop new long term treatments for cancer. Propanc announced the completion of the low dose group for the GLP-Compliant 28-day repeat-dose toxicity study for its lead product PRP, a solution for once daily intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen.
This is a crucial stage for testing new drugs as this stage tests the drug for both safety and efficacy. «We are very pleased to have successfully completed the first stage of our 28-day study,» said James Nathanielsz, Propanc's Chief Executive Officer. «There were no clinical observations, nor any adverse effects observed from any of the animals and, in fact, all animals gained body weight within the expected range.”
FIRST-IN-MAN STUDIES EXPECTED FOR PPCH
No treatment related effects were observed in the animals in the study and the once-daily dosing by IV injection was successfully accomplished. Results from the study help provide a rationale for a safe starting dose for first-in-man studies targeted late 2017, or early 2018, depending on successful completion of manufacture of the investigational new drug (IND).
»Given we have now identified a dosing group in the 28-day study with no safety concerns, it gives us great confidence that we are close to defining a safe starting dose for our First-In-Man studies," said Professor Klaus Kutz, Propanc's Chief Medical Officer.

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Which IBM backup product should you propose to a customer who wants to meet the disk-based business continuity needs of the enterprise data center?
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