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    Breaking News

    Sen. Markey Introduces Bill Calling for Stricter GRAS Framework

    The new bill would direct the U.S. Food and Drug Administration with creating an office that would reassess whether current GRAS substances are safe.

    Sen. Markey Introduces Bill Calling for Stricter GRAS Framework
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    06.06.22
    Senator Edward J. Markey (D-MA) recently introduced a bill titled the Ensuring Safe and Toxic-Free Foods Act, which, among other measures, directs the U.S. Food and Drug Administration (FDA) to revise its Generally Recognized As Safe (GRAS) rule.
     
    Currently, the self-determination GRAS process for substances intended to be added to food does not require FDA’s review or approval of scientific evidence gathered to demonstrate a substance is safe under the conditions of intended use. However, companies can voluntarily file a GRAS notice with FDA.
     
    “The only mystery families should encounter at mealtime is what’s for dinner, not what’s in dinner. Americans deserve to know that the food at their kitchen table is safe for themselves and their families to eat,” said Markey. “The FDA too often falls short on their responsibility to promote food safety, highlighted recently by the baby formula crisis where FDA’s deputy commissioner for food policy did not learn about the whistleblower complaint for four months. It is long past time we revise existing food safety measures and close the loophole allowing manufacturers to self-regulate what new substances can enter our food supply.”
     
    Additional co-sponsors of the Ensuring Safe and Toxic-Free Foods Act include Sen. Richard Blumenthal (D-CT) and Sen. Elizabeth Warren (D-MA). “This legislation will strengthen important food safety measures, protecting Americans and their families from harmful chemicals and substances,” said Blumenthal. “I’m proud to join Senator Markey in this bill to guarantee healthy, toxic-free food for all households.”
     
    “Americans deserve to know what they are eating, and we know that we cannot count on large corporations to put people and safety before profits,” said Warren. “This bill is a step forward to help the FDA ensure the food families eat is safe.”
     
    Provisions
     
    One notable provision of the legislation is that FDA would be tasked with creating an Office of Food Chemical Safety Reassessment, which would be charged with reassessing whether existing substances with GRAS designation are safe for humans to consume.
     
    The bill would prohibit manufacturers from designating substances as safe without supplying notice and supporting information to the Secretary of Health and Human Services. It would be required that safety information on an ingredient is made publicly available on FDA’s website, and that each GRAS ingredient is subject to a 90-day public review period. The legislation would prohibit carcinogenic substances, as well as substances found to induce reproductive or developmental toxicity. Further, the legislation expressly prohibits people with conflicts of interest from serving as experts in GRAS designations.
     
    According to the bill, the first substances subject to reassessment would be Perfluoroalkyl substances and polyfluoroalkyl substances, ortho-phthalates, bisphenols, titanium dioxide, potassium bromate, perchlorate, BHA, BHT, BVO, and propyl paraben, with subsequent substances to be determined.  
     
    The legislation has received endorsement from a number of NGOs, including the Environmental Working Group, the Center for Science in the Public Interest, the Environmental Defense Fund, Breast Cancer Prevention Partners, and Earthjustice.
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