Search results: fda new food safety rules

I’m working on a new edition of What to Eat and am spending a lot of time in grocery stores seeing what’s new and different since 2006—vastly more than I thought when I signed up to do this project, which is why it is taking a long time to do.

One change is in the number of products displaying Non-GMO labels.  The Non-GMO Project says it has certified 60,000 products, and I believe it.

On the other hand, don’t expect to see labels on foods that are genetically modified even though they are required.  With much searching, I found a few on shipping boxes but not on grocery shelf labels.

So I’m interested to see what the FDA is saying about genetically modified foods.

It sent out a press release recently.

Today, the U.S. Food and Drug Administration (FDA) released new “Feed Your Mind” educational materials to provide science-based information on genetically modified organisms (GMOs). “Feed Your Mind” is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.

The new materials for consumers include:

• A factsheet about how scientists use genome editing to develop food crops that address the needs of a growing global population and adapt to a changing environment:
  • Genome Editing in Agricultural Biotechnology
• Infographics about how growing GMOs can have environmental benefits and benefit the lives of farmers and consumers:
  • GMOs and the Environment
  • GMOs Outside the U.S.: A Closer Look at Bt Eggplant
• Videos featuring how GMOs are regulated in the U.S. and experts who grow them:
  • Talk About GMOs: Experts Who Know Them and Grow Them
  • GMOs: Government Regulation and Your Safety

…Funding for the “Feed Your Mind” initiative was provided by Congress in the Consolidated Appropriations Act of 2017 to conduct “consumer outreach and education regarding agricultural biotechnology and biotechnology derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed.” More funds were provided through 2018 and 2019 Appropriations bills.

For More Information

• Feed Your Mind – Agricultural Biotechnology Initiative
• Resources for Healthcare Professionals
• FDA Releases New “Feed Your Mind” Education Materials on GMOs for Consumers, Health Educators, and Health Care Providers (August 2022)
• FDA Releases New “Feed Your Mind” Consumer Education Materials (September 2020)

The last time I wrote about the FDA’s GMO initiatives, I titled the post “The FDA’s new pro GMO propaganda.”  I pointed out that the FDA’s materials stick with limited issues, and say nothing about:

• Corporate control of commodity agriculture
• Glyphosate, the herbicide used with GMOs and considered carcinogenic by international health agencies and US courts
• How pesticides used on GMO crops contaminate organic production
• The ways GMO companies harrass independent farmers by enforcing intellectual property rights
• How the Farm Bill subsidizes GMO corn and soybeans, causing them to be overproduced and corn to be used for ethanol
• The lack of labeling of the few GMO foods on the market.

No wonder sales of organic foods are booming and so many people look for Non-GMO labels on food products.

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Last week I posted about Bill Marler’s “Take the F out of the FDA” campaign.

Since then, he additionally posted letters from the FDA that make it clear how poorly the agency is doing its job to protect all of us against foodborne illness.

Let’s start with the the agency’s March 8 letter to companies making infant formula.

The agency is asking—not requiring—infant formula companies to:

• Evaluate their systems for ensuring safety
• Comply with existing regulations
• Follow existing rules, and
• “Voluntarily notify the Agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been  distributed.”

What?

The Food Safety Modernization Act (FSMA) of 2011 gave the FDA the authority to ensure safe food by requiring HACCP-like process controls at every stage of production.

Infant formula is the sole source of food for many babies.

The formula crisis of last year, where Abbott Labs produced formula contaminated with Cronobacter and Salmonella, meant that Abbott was not following the law and should have been required to clean up its act instantly.

Companies are supposed to test to make sure their process controls are working.

If FSMA did not require companies to notify the FDA when they found contamination, the FDA should be going to Congress to get that authority to announce its rulemaking to get that authority.

This is not a time for politeness.  Infants’ lives are at stake.

The FDA may argue that it cannot take action because so few companies make infant formula (illustrating why industry consolidation is not good for society).

But it must.  Marler is clear on what the FDA needs to do.

• Put an inspector in every infant formula plant, 24/7.
• Require product testing and report results to the CDC (to compare with illness).
• Lobby to make Cronobacter a reportable infection (to reveal the extent of the problem).

To demonstrate the ineffectiveness of politeness, Marler also posted this 2005 letter from the FDA to lettuce growers (“we strongly encourage your industry to begin or intensify immediately efforts”)….  This was followed a year later by the Dole spinach recalls of 2006 (199 cases, 102 hospitalizations, 3 deaths) and many others, leading up to congressional action in passing FSMA.

It’s the FDA’s job to enforce FSMA.

If the FDA is too captured by industry to do that, let’s get the F out of it and into some place that is serious about doing something about food safety.

FDA Commissioner Califf ‘s tweeted response to Marler’s campaign—a thread of 14 tweets— is not reassuring.

A couple of years ago, the Center for Food Safety filed a lawsuit challenging the USDA’s GMO labeling law.

I’ve discussed the law in a previous post (and in an even earlier one, Goodbye GMO, Hello Bioengineered: USDA publishes labeling rules).

Basically, the current law is supposed to put this logo on GMO foods.

The Center’s lawsuit called for:

1. On package labeling.  The law allowed QR codes instead.
2. Use of the term genetically modified or GMO rathat than bioengineered.
3. Labeling of foods with GM ingredients.
4. More information about GM food.

The District Judge dismissed #2, #3, and #4, but agreed that QR codes are insufficient.

Consequently, plaintiffs have carried their burden of showing that AMS’s decision to implement a standalone text message disclosure option was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”…Summary judgment is granted to plaintiffs on the APA claim for the text message regulation, and Sections 66.106 and 66.108 of the regulations are remanded to the USDA without vacatur for reconsideration in light of this order. Summary judgment is denied in all other respects.

The Center for Food Safety’s translation:

A U.S. District Court has held that the U.S. Department of Agriculture (USDA)’s decision to allow genetically engineered (GMO) foods to only be labeled with a “QR” code was unlawful, and that USDA must instead add additional disclosure options to those foods under USDA’s National Bioengineered Food Disclosure Standard. The Court sent back to the agency the QR code portions of the 2018 Trump administration rules for GMO labeling that went into effect on January 1, 2022, which hindered consumer access with burdensome electronic or digital disclosures.

If you care at all about whether GMO foods are in supermarkets, good luck.  I’ve seen cartons of Hawaiian papayas labeled with that logo, but not the papayas themselves and not much else.

Once again, if you want to know what GMO fruits and vegetables might—in theory—be in supermarket produce sections, you can check the FDA’s website.

The purple tomato recently approved by USDA is not on that list; the FDA hasn’t gotten to it yet.

Mostly, GMO produce is not in supermarkets.  But wouldn’t it be nice to know for sure?

It will be interesting to see if this ruling makes things more transparent.

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Coming soon!  My memoir, October 4.

For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

On January 1, the USDA’s useless rules for labeling bioengineered (BE) foods, those formerly known as genetically modified (GMOs), went into effect.

Will the new rules help you figure out which items in the produce section or anywhere else in the store have been genetically engineered?

Not a chance.

I am particularly curious about what’s in the produce section.  It’s easy enough to know which genetically modified foods have been approved by the FDA; the FDA has a website for this purpose.

But just because they’ve been approved does not necessarily mean they are in production and in your supermarket.

To know which ones are genetically modified, it would be nice to have labels.

Instead, we have the results of USDA’s obfuscation, as I discussed in a blog post two years ago: Goodbye GMO, Hello Bioengineered: USDA publishes labeling rules.  It’s worth repeating:

NutraIngredients.com had an intriguing (to me, at least) article about the latest complaints about FDA’s lack of action on GRAS ingredients—those Generally Recognized As Safe.

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make changes, the authors found.”

The article referred to a this paper, Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

The starting point for this paper is a study done by the Government Accountability Office (GAO) ten years ago: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS)

The new paper argues that ten years later, the FDA has done little to address the GAO’s concerns.

Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. …most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers…FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

This took me right back to a blog post I did in 2016: The FDA’s unfortunate ruling on GRAS regulations.

Scott Faber, Vice President of Government Affairs for the Environmental Working Group summarizes Trump’s Full-Scale War on Food.  Since taking office, he writes, Trump has:

• Proposed to cut food safety funding for the Food and Drug Administration by $117 million.
• Proposed to cut funding for the Supplemental Nutrition Assistance Program, or SNAP, by $193 billion – a 25 percent cut – and cut international food aid by $2 billion.
• Delayed new labeling rules for menus and packaged foods that would give consumers more information about calories and added sugars, and so far failed to issue a draft rule to implement a new law on disclosing genetically modified ingredients in food.
• Weakened new rules designed to drive junk food out of U.S. schools.
• Proposed to eliminate several Department of Agriculture programs that helped farmers sell directly to local consumers.
• Proposed to eliminate funding for an entire division of the Centers for Disease Control and Prevention that works to reduce obesity.
• Withdrawn new rules to protect drinking water supplies from polluters and proposed cutting the Environmental Protection Agency’s budget by 31 percent.
• Proposed to suspended two of the largest farmland stewardship programs and mothball others.
• Postponed new rules designed to strengthen animal welfare standards on organic farms and proposed to eliminate funding for programs that help farmers switch to organic farming.
• Reversed a ban on a pesticide linked to brain damage in kids and proposed cutting EPA funding for pesticide review programs by 20 percent.
• Punted on new rules to protect farmworkers from pesticides, and proposed to eliminate a program to train migrant and seasonal farmworkers.
• Mothballed new voluntary sodium guidelines that would drive reformulation of foods.
• Called for so-called regulatory “reforms” that would block agencies like the FDA and USDA from adopting new rules designed to keep food safe, update food labels or provide students healthier meal options in schools.

This is an impressive list, calling for serious resistance.

How?  That’s the question….

Several food safety advocacy groups are suing the FDA to take responsibility for ensuring the safety of food additives.

Doesn’t the FDA already do this?  No, it does not.

As the press release puts it [with my emphasis in bold],

Federal law requires FDA to ensure that substances used in food are safe, taking into account consumers’ entire diet and all exposure to the chemical and similar chemicals. But any substance designated as “generally recognized as safe” (GRAS) by FDA or by a food or chemical company can bypass the rigorous pre-market review and approval process applied to food additives. The GRAS exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil, but has been applied in recent practice to novel chemicals and is now a loophole that has swallowed the law.

Under pressure from industry, in 1997 and again in 2016, FDA adopted a practice that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe .

I commented on the FDA’s 2016 ruling at the time.  Former FDA Commissioner David Kessler referred to this GRAS policy as a “joke,” noting that it allows the industry to decide whether its own products are safe.

I am particularly interested in this suit because I wrote a commentary on an article about conflicts of interest in GRAS determinations in 2013.   As I said about the article’s findings,

At present, manufacturers of all food additives are permitted to decide on their own whether a substance is GRAS for human consumption, unless the additive affects food color. Companies also can choose whether to even notify the agency about a new additive. In practice, many manufacturers do inform the FDA. But…about a thousand additives are believed to be in the food supply without the FDA’s knowledge…the lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, particularly the additives that the FDA does not even know about.

Let’s hope the lawsuit gets this situation fixed.