EDF Health

Scientists push back against a bill that would pervert the whole concept of conflict of interest

By / Published: December 7, 2012

Richard Denison, Ph.D., is a Senior Scientist.

This week, two letters – one signed by 13 prominent public health scientists and the other signed by the heads of 8 major national environmental organizations – were sent to the House Science Committee voicing strong opposition to H.R. 6564, the EPA Science Advisory Board Reform Act of 2012.

The sponsors of this legislation claim that it is needed to “enhance transparency and limit conflicts of interest” on the Environmental Protection Agency’s (EPA) Science Advisory Board (SAB) and its panels.  In fact, it would do the precise opposite.  Here’s how the scientists’ letter summarizes the impacts that would arise from passage of the bill:   

“This proposed legislation would only serve to reverse progress in bringing the best scientific advice and analysis to EPA.  The consequence would be to deprive EPA of needed scientific advice on the most complex and pressing environmental health problems of our day.” 

Among the most perverse provisions of this bill (and there are many) are two that would turn the very notion of conflict of interest on its head.  One would limit scientists that receive competitive grants through EPA’s extramural research program from serving on the SAB or its panels – claiming that such funding constitutes a conflict of interest.  The scientists’ letter goes directly at that provision:

“The underlying idea that scientists who obtain funding from EPA for any project have conflicts about all EPA matters is baseless and reflects a misunderstanding of who we are as scientists and our role in society.”

Another provision is even more perverse:  It would reverse longstanding conflict-of-interest policy and practice followed by virtually every authoritative scientific body in the world – including the National Academy of Sciences, the International Agency for Research on Cancer and the World Health Organization – by allowing unfettered access of industry representatives with direct conflicts of interest to serve on the SAB and its panels, as long as their conflicts are disclosed.

Who’s behind this radical legislation?  Here’s a hint:  The American Chemistry Council (ACC), which represents the chemical manufacturing industry, couldn’t wait to express its unequivocal support, stating it “cannot overstate the importance of this bill to Americans” in a press release titled “House Science Committee Proposes Common Sense Reform To EPA Scientific Advisory Process:  Proposed Legislation Would Improve Expert Panel Selection, Limit Conflicts of Interest and Enhance Systematic Reviews.”  And ACC’s been singing the bill’s praises all over town ever since (see, e.g., slide 6 of this ACC presentation).  Read More »

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ICYMI: Secret GRAS determinations may outnumber those FDA reviews

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: November 22, 2023

Quote from FDA Commissioner Robert Califf, MD. "I want to throw in chemical safety as another really, really important area for the future—for humankind, really—and where science is evolving rapidly."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Posted in Broken GRAS, Chemical regulation, FDA, Food, Health policy, Industry influence, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed

EPA: Now’s your chance to get foxes out of the henhouse

By Samantha Liskow / Published: October 10, 2023

Rooster facing fox on a black background

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.

Read More »

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Broken GRAS: Secret GRAS determinations may outnumber those reviewed by FDA

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2023

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.)

Why It Matters

I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.—Robert Califf, MD, FDA Commissioner

FDA’s review of GRAS safety determinations is critical to ensure food chemicals are safe. When agency scientists receive GRAS notices, they closely review them and ask notifiers tough questions about the safety of the chemical alone—and the potential consequences when that chemical is combined with other chemicals on the market.

But FDA allows companies to withdraw their notices – which they do in about 17% of cases. Sometimes companies fix the problems and resubmit the notice. FDA does not require companies to do this, however. Too many simply continue to market the chemical for food uses as GRAS without seeking further FDA review. That is in addition to the GRAS safety determinations companies choose never to file, which leads to chemicals entering our food system without any FDA notice or review at all.

Our Take

While the GRAS system is clearly broken (something we’ve blogged about at length and the Washington Post covered in-depth back in 2014), FDA does retain the ability and the duty to monitor the marketplace to ensure unsafe chemicals that food companies claim as GRAS are kept off the market. Unfortunately, the agency appears to lack any system to ensure that monitoring takes place. The only examples of agency action to pull industry-certified GRAS products off the market have been caffeinated alcoholic beverages and partially hydrogenated oils (aka artificial trans fat). Both were prompted, in part, by state and media calls for action.

Examples of inaction, however, are numerous and include: tara flour, COZ corn oil, Apocynun ventron, gamma aminobutyric acid (GABA), aquaequorin/Prevagen, and many more.

One of the key breakdowns that contributes to FDA’s failure to monitor is the lack of coordination between the regulatory programs in the Center for Food Safety and Applied Nutrition (CFSAN) and the inspection/enforcement programs in the Office of Regulatory Affairs (ORA).

Next Steps

In January 2023, FDA Commissioner Califf announced a proposal to reorganize the food safety program in response to stakeholder calls for action after the infant formula debacle and to a recent review of the agency by the Reagan-Udall Foundation. This review noted that one key step is to appoint a new Deputy Commissioner for Human Food. This person would have greater responsibility to coordinate efforts between CFSAN and ORA. The Commissioner’s proposal has been strongly criticized since there would be no clear line of authority between the new Deputy Commissioner and ORA.

But Commissioner Califf has stated that chemical safety is a priority, telling a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1]

Fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. Until the broken GRAS system is fixed, FDA will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety. Until the system is fully fixed—which includes ensuring that no chemicals enter our food system without notice to, and review by, the agency—FDA needs to be coordinating with ORA and CFSAN to proactively monitor and enforce GRAS evaluations on chemicals entering the market to ensure they are actually safe.

Go deeper: You can learn more from these resources:

 

NOTES

[1] FoodFix, January 31, 2023, edition.

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Broken GRAS: Undermining the safety of dietary supplements and food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 27, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administration’s (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDA’s decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

  1. Bypass mandatory new dietary supplement ingredient (NDI) notice requirements; and
  2. Expand their market from dietary supplements into conventional food.

We have long-challenged FDA’s interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agency’s flawed approach to GRAS also undermines the safety of dietary supplements. Read More »

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FDA’s short-sighted approach to building trust in the safety of cell-cultured meat and seafood products

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 17, 2021

Tom Neltner, J.D., is Chemicals Policy Director

Consumer trust that products are safe to eat is essential to acceptance of any innovative food product.

One of the most innovative food products expected to enter U.S. markets in coming years is cell-cultured meat and seafood. Producing these products by culturing cells in tanks and forming them into foods that look and taste like their conventionally produced counterparts is a technological achievement. Proponents enthusiastically tout these products as climate-friendly alternatives that provide real hope to meet the world’s growing demand for animal protein in a sustainable way that also minimizes animal welfare concerns.

Consumer trust that products are safe to eat is essential to acceptance of any innovative food product. That trust is built through a rigorous, transparent, and independent scientific review to ensure safety. Without that, questions linger that undermine widespread consumer adoption.

Unfortunately, we have serious concerns that the process the Food and Drug Administration (FDA) may be planning to use to review the safety of cell-cultured meat and seafood is inadequate and will undermine consumer trust. From our perspective, the manufacturing process for cell-cultured meat and seafood is a significant departure from current practice and warrants careful scrutiny. FDA guidance is clear that, for these types of changes, the appropriate review options are a food additive petitions or the voluntary Generally Recognized as Safe (GRAS) notification process. We strongly recommend FDA rely on these existing options existing options rather than create a new approach.

Read More »

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