From the FDA announcing it is seeking comments on foods derived from genome edited plants, to the agency removing thousands of expired food facility registrations, below are this week’s interesting reads:
Request for Comments on Genome Editing in New Plant Varieties Used for Foods
Late last month the FDA announced the request for comments on the use of genome editing techniques to produce new plant varieties that are used for human or animal food. What is genome editing? According to the FDA, “Genome editing” is a term used to describe a relatively new set of technologies that enable one to make precise changes in the DNA of a plant, animal or other living organism.”
Why is the FDA requesting information from the public? After the White House Office of Science and Technology Policy (OSTP) issued its National Strategy for Modernizing the Regulatory System for Biotechnology Products document in 2016, the FDA noted its intent to clarify its policy for the regulation of products derived from genome editing techniques. As an initial step, the FDA is requesting information for specific questions to help form its thinking around this topic.
FDA will be accepting comments until April 19, 2017, but it remains to be seen how the information it receives will impact this new administration’s approach.
FDA Removes Expired Food Facility Registrations from Database
Remember when we talked about the deadline to register/renew your food facility registration with the FDA? Yeah…that passed in December. Under the Food Safety Modernization Act (FSMA), the owners, operators, or agents in charge must register with the FDA before the facility begins to manufacture, process, pack, or hold food for consumption in the United States.
The registration period will take place (and took place) between October 1 and December 31 of each even-numbered year, in which the abovementioned would be required to submit a registration renewal to FDA containing the information required under § 1.232.
According to Registrar Corp, on February 1, 2017, the FDA removed all food facility registrations that were not properly renewed for 2017 from its registration database. What does that mean? Facilities with expired registrations will need to re-register with FDA and obtain a new registration number before they can continue business.
If you’re not sure if you were renewed appropriately, Registrar Corp is offering to verify facility registration for free!
FDA Offers Help During Regulatory Freeze
Just a few days after Trump signed an executive order effectively freezing certain regulation and guidance documents, the FDA offered to help food industry associations draft their own guidance documents.
Of course we all know the agency drafts its own documents, but according to the constituent update posted January 31, “Food industry associations also draft guidance documents to capture the best practices to produce food, feed and other regulated products in a way that meets federal safety standards.”
Additionally, the FDA states, “FDA can be involved in a number of ways, including providing technical advice, looking out for potential conflicts with federal regulations, and sharing its experience and insights.”
The FDA also published an article (5 Steps Toward Working with FDA on Human and Animal Food Guidance Documents) aimed at helping industries better understand how to work with the FDA.
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