EDF Health

Selected tag(s): Industry tactics

EPA’s New Chemical Regulations: Industry Bias Must Be Fixed

By EDF Blogs / Published: November 9, 2023

By Maria Doa, PhD, Senior Director, Chemicals Policy, and Colin Parts, Legal Fellow

NOTE: This is the fourth in a series about EPA’s regulation of new chemicals. See Time for a New Age for New Chemicals, EPA: Now’s Your Chance to Get Foxes Out of the Henhouse, and New Chemicals Rule: EPA must require more info from industry.

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of these proposed provisions would govern how EPA can change the restricted approvals it issues for new chemicals that may pose unreasonable risks. EPA’s proposed approach would limit the type of stakeholders involved and the potential for stronger chemical regulations.

Posted in Chemical regulation, Conflict of interest, Industry influence, Rules/Regulations, TSCA / Also tagged EPA, New chemicals, Regulatory authority, Rules/Regulations | Authors: admin / Comments are closed

New Chemicals Rule: EPA must require more info from industry

By EDF Blogs / Published: November 3, 2023

By Maria J. Doa, PhD, Senior Director, Chemicals Policy, and Greg Schweer, Consultant

NOTE: This is the third in a series about EPA’s regulation of new chemicals. See Time for a New Age for New Chemicals and EPA: Now’s Your Chance to Get Foxes Out of the Henhouse.

What Happened?

EPA recently proposed regulations to govern how it reviews companies’ pre-manufacture notifications for new chemicals before those chemicals can go on the market.

Why It Matters

Industry often waits until late in the review process to submit information—which means that EPA may spend a significant amount of time and effort to revise its risk assessments to incorporate the new information.

EPA has a major opportunity to improve the New Chemicals Program as it crafts these revised regulations. Requiring industry to provide additional “known or reasonably ascertainable information” as required by the law is an important component of this rule. This should reduce the amount of assessment “rework” the agency currently conducts.

Posted in Chemical regulation, Industry influence, Risk assessment / Also tagged EPA, New chemicals, Risk assessment | Authors: admin / Comments are closed

Industry is Scapegoating EPA for New Chemical Review Delays

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: October 17, 2023

What’s Happening?

The chemical industry has an extensive—and ongoing—history of complaining about how long it takes EPA to do new chemical safety reviews.

The irony is that industry is the very player causing the delays in EPA’s review process. Clear data indicate that chemical manufacturers are primarily responsible for the length of EPA’s reviews and the backlog of cases.

Why It Matters

One of EPA’s vital roles is to assess the safety of new chemicals before they enter the market.

Industry’s outcry about a backlog serves as a smokescreen to pressure EPA into swiftly approving new chemicals even when they may not be safe. This would put us all at risk, particularly those who are more susceptible or maybe more highly exposed, such as children, pregnant people, and people who live and work in fenceline communities.

Posted in Chemical regulation, Industry influence / Also tagged chemical reviews, EPA, New chemicals, Risk assessment | Authors: mdoa / Comments are closed

EPA: Now’s Your Chance to Get Foxes Out of the Henhouse

By Samantha Liskow / Published: October 10, 2023

NOTE: This is the second in a series about EPA’s regulation of new chemicals.

What Happened?

EPA recently proposed new regulations for its safety reviews of new chemicals under our nation’s main chemicals law, the Toxic Substances Control Act (TSCA). With this action, the agency has a big chance to solve major problems that have undermined scientific integrity, transparency, and public confidence in EPA’s ability to ensure the safety of new chemicals. Unfortunately, the proposed regulation that EPA put out for comment this year falls far short of this goal.

EDF has joined with other organizations, including AFL-CIO, the American Federation of Teachers, and the National Resources Defense Council, in a letter urging EPA to make fundamental changes (PDF, 178KB) to these proposed regulations. One of the most important is this: the agency should end its longstanding practice of sharing about the risks of new chemicals with only the companies that make them—and allowing those companies to dispute the results.

Posted in Chemical regulation, Industry influence, TSCA / Also tagged chemical reviews, Conflict of interest, EPA, New chemicals, TSCA reform | Authors: sliskow / Read 1 Response

Broken GRAS: Companies ignore FDA draft guidance; Bias & conflicts of interest prevail in safety determinations

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 6, 2023

By Tom Neltner, Senior Director, Safer Chemicals, Klara Matouskova, PhD, Consultant, and Maricel Maffini, PhD, Consultant

What Happened?

In our new study, we evaluated Generally Recognized As Safe (GRAS) notices—a total of 403 between 2015-2020—that food manufacturers voluntarily submitted to FDA for review. Our goal was to determine whether industry was adhering to FDA’s Guidance on Best Practices for Convening a GRAS Panel.

The guidance was designed to help companies comply with the law and avoid biases and conflicts of interest when determining whether substances added to food are safe and recognized as such by the scientific community. FDA published a draft of the guidance in 2017 and finalized it essentially unchanged in December 2022.

Our study found that no GRAS notices followed the draft guidance. Specifically, we also found there were high risks of bias and conflicts of interest because the companies:

Had a role—either directly or through a hired third party—in
selecting panelists that likely resulted in bias and conflicts of interest.
Depended on a small pool of experts in which seven individuals occupied 46% of panel positions. The seven often served together, further enhancing risk of bias.
Relied on panels that did not realistically reflect the diverse scientific community that evaluates chemical risks to public health—which is needed to comply with the law’s requirement that there be a “general recognition” within that community that a substance is GRAS.

Posted in Broken GRAS, Conflict of interest, FDA, Food, Industry influence / Also tagged FDA, GRAS, Risk assessment | Authors: tneltner / Comments are closed

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 11, 2023

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

Posted in Adverse health effects, Broken GRAS, FDA, Food, Health hazards, Industry influence, Risk assessment, Risk evaluation / Also tagged Consumer products, Exposure and hazard, FDA, GRAS, New chemicals, Risk assessment, Risk evaluation | Authors: drmvma, tneltner / Read 1 Response

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