November 6, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update: FDA Issues Guidance on Fortification of Foods; EPA Issues Proposed Rule to Revoke Tolerances for Chlorpyrifos; Nineteen European Union Member States to Ban GM Crop Cultivation

FDA Issues Guidance on Fortification of Foods

Today, the Food and Drug Administration (FDA) issued a Constituent Update, available here, announcing publication of a new guidance, “Questions and Answers on FDA’s Fortification Policy” available here. According to the Agency, the guidance addresses questions about the current fortification policy (21 Code of Federal Regulations Part 104.20), originally published in 1980, and compiles information in one document on the fortification of various foods. FDA also notes the guidance “is not binding by law except where specific regulations are cited, but is intended to help manufacturers that elect to add nutrients to food for human consumption.” The fortification of fruit juice is mentioned in the guidance.

EPA Issues Proposed Rule to Revoke Tolerances for Chlorpyrifos (Input Requested by November 27, 2015)

On November 3, 2015, JPA members were notified that the Environmental Protection Agency (EPA) had announced the Agency is proposing to revoke all tolerances for the insecticide chlorpyrifos. It was noted that the EPA had been ordered by a court to respond by October 31, 2015 to a petition filed by the National Resources Defense Council (NRDC) and the Pesticide Action Network North America (PANNA). The petition requested that the Agency revoke all chlorpyrifos tolerances and cancel all registrations of products containing the insecticide due to possible risk to human health.

A copy of the prepublication version of the proposed rule was shared with members. Today, the EPA published the proposed rule in the Federal Register (80 FR 69080), available here. The Agency is requesting comment on "whether there is an interest in retaining any individual tolerances, or group of tolerances, and whether information exists to demonstrate that such tolerance(s) meet(s) the FFDCA [Federal Food, Drug and Cosmetic Act] section 408(b) safety standard."

Chlorpyrifos tolerances are codified in 40 Code of Federal Regulations (CFR) Part 180.342. Tolerances have been established for residues on a number of fruits including apple, citrus, banana, cranberry, cherry, pear, peach and strawberry.

The deadline to submit comments to the EPA is January 5, 2016. If you believe JPA should submit comments to the Agency, please provide your input to me by the close of business on November 27, 2015.

Nineteen European Union Member States to Ban GM Crop Cultivation

JPA previously notified members that the European Parliament had voted in favor of allowing member states of the European Union to ban the farming of genetically modified (GM) food crops, even if such crops have been authorized at the EU level. According to an article recently published online by Deutsche Welle, available here, the European Commission announced the following 19 member states are able to ban the cultivation of GM crops on their territory: Austria, Belgium, Britain, Bulgaria, Croatia, Cyprus, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland and Slovenia.

As always, please contact me with questions or comments.

Patricia Faison

(404) 252 - 3663

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