Vermont GE Food Labeling- Hogan Lovells Memorandum

JPA has been providing updates regarding Vermont’s mandatory genetically engineered (GE) food labeling law. JPA’s legal counsel, Hogan Lovells, recently issued a memorandum, available here, summarizing new developments in Vermont’s interpretation of the law. According to Hogan Lovells, “Of interest to every company trying to label products prior to July 1st, is clarification from the Vermont AG [Attorney General] that they will now interpret ‘distributed’ similarly to ‘introduced into commerce.’ Companies that label product with the Vermont GE statements and introduce those products into commerce prior to July 1st should be deemed in compliance regardless if unlabeled products in the distribution channels get shipped into Vermont after July 1, 2016.”

Hogan Lovells also notes that Vermont’s legislature recently passed legislation that stipulates consumers may not bring a private right of action (lawsuit for products in violation of the GE food labeling law) prior to July 1, 2017. Please refer to the memorandum for complete details.

JPA will continue to monitor and provide updates, as information becomes available.

California’s Proposition 65 – Notice of Proposed Rulemaking on the Clear and Reasonable Warning Language

JPA has provided updates regarding California’s Proposition 65 regulation, which is administered by the California Environmental Protection Agency's (EPA) Office of Environmental Health Hazard Assessment (OEHHA). The Proposition 65 regulations are codified in Title 27 of the California Code of Regulations (CCR) and can be accessed here. In part, businesses must provide a “clear and reasonable” warning before exposing the public to a chemical on the Proposition 65 list of chemicals known to cause cancer, birth defects or other reproductive harm. Members were previously notified that OEHHA had issued a notice of proposed rulemaking to revise and adopt a new Article 6 in Title 27 (“Clear and Reasonable Warnings”) to provide more detailed information on the warning language requirements. The Agency had been asked by product manufacturers, retail groups and other interested parties to adopt regulatory amendments that provide more guidance related to acceptable methods for providing warnings to consumers and acceptable warning content.

OEHHA has provided opportunities for stakeholders to comment on the proposed regulatory text for Article 6 in addition to hosting public meetings to obtain input. OEHHA recently issued a notice to inform the public that based on input received from stakeholders, the text for Article 6 has been revised again. As previously noted OEHHA provides guidance regarding the warning requirements for a variety of areas (e.g., environmental, occupational, drugs) including foods. This communication focuses solely on the requirements related to foods.

The revised copy of Article 6 is available here, and the document with all revisions accepted is available here. Of particular note, the warning requirements for foods are highlighted in Section 25607.1, “Food Exposure Warnings Methods of Transmission” and Section 25607.2, “Food Exposure Warnings – Content.” In these sections, OEHHA has specified the proposed warning language for exposures from foods that may cause cancer, reproductive toxicity or both. OEHHA also provides the warning requirements for foods and beverages sold or served in restaurants (Section 25607.5 “Food and Non-Alcoholic Beverage Exposure Warnings for Restaurants – Method of Transmission” and Section 25607.6, “Food and Non-Alcoholic Beverage Exposure Warnings for Restaurants – Content”). Please review the proposed regulatory text for details.

The deadline to submit comments to OEHHA on the proposed Article 6 is June 6, 2016. JPA will continue to monitor and provide updates, as information becomes available.

FDA Draft Guidance for Qualified Facilities

JPA previously notified members that the Food and Drug Administration (FDA) had issued a Constituent Update, announcing the Agency has published a draft guidance, “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food),” to assist qualified facilities (e.g., very small businesses) in complying with the FDA Food Safety Modernization Act’s (FSMA) final rules – Preventive Controls for Human Food and Preventive Controls for Animal Rule. The draft guidance explains how a business can determine whether it meets the definition of a “qualified facility” and how to submit the FDA form attesting to its status as a qualified facility.

JPA members were notified that the FDA had published the pre-publication version of the Federal Register notice announcing the availability of the draft guidance. The FDA recently issued the Federal Register notice (81 FR 30219; May 16, 2016). The deadline to submit comments to the FDA for consideration prior to finalization of the guidance is November 14, 2016. Comments regarding the information collection provisions must be submitted to the Agency by July 15, 2016. The information collection provisions are outlined in Section III. “Paperwork Reduction Act of 1995” in the Federal Register notice.

If you believe JPA should submit comments to the FDA regarding the draft guidance, please provide your detailed input to Headquarters by the close of business on June 10, 2016.

National Academies of Science Report on Genetic Engineering

According to an article posted online on USA Today, available here, the National Academies of Sciences (NAS) recently issued a report that notes genetically engineered (GE) crops are safe for humans and animals to eat and have not caused increases in cancer, obesity, gastrointestinal illnesses, kidney disease, autism or allergies. The article notes the NAS reviewed more than 900 studies covering the last two decades since GE crops were introduced. The NAS press release is available here, and the report, “Genetically Engineered Crops: Experiences & Prospects” is available for free via the National Academies Press website.

In part, the report states the following:

“There have been claims that GE crops have had adverse effects on human health. Many reviews have indicated that foods from GE crops are as safe as foods from non-GE crops, but the committee reexamined the original studies of this subject. The design and analysis of many animal-feeding studies were not optimal, but the large number of experimental studies provided reasonable evidence that animals were not harmed by eating food derived from GE crops. Additionally, long-term data on livestock health before and after the introduction of GE crops showed no adverse effects associated with GE crops. The committee also examined epidemiological data on incidence of cancers and other human-health problems over time and found no substantiated evidence that foods from GE crops were less safe than foods from non-GE crops.”

“… the research that has been conducted in studies with animals and on chemical composition of GE food reveals no differences that would implicate a higher risk to human health from eating GE foods than from eating their non-GE counterparts. Long-term epidemiological studies have not directly addressed GE food consumption, but available time-series epidemiological data do not show any disease or chronic conditions in populations that correlate with consumption of GE foods. The committee could not find persuasive evidence of adverse health effects directly attributable to consumption of GE foods.”

“There have been strong claims made about the purported benefits and adverse effects of GE crops. The committee found little evidence to connect GE crops and their associated technologies with adverse agronomic or environmental problems.”

The study has received significant coverage in the media. Articles may be accessed via the Associated Press, Washington Post, and the Huffington Post. The TODAY Show interviewed Dr. Mehmet Oz, host of the Dr. Oz Show, regarding the report. He advocated for product labeling in the interview, which can be accessed here.

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