Feed Industry and Food Contact Companies Ask FDA for 60 More Days on GRAS Rule

FDA’s proposal to make notices mandatory for ingredients generally recognized as safe, or GRAS, is about five weeks from its comment deadline. Parts of the industry want more time. Critics, meanwhile, are looking at a second change in the same rule.

TLDR

• DLA Piper reported that the American Feed Industry Association and a group of food contact material companies each asked for a 60-day extension.
• Comments on the proposed rule are due Dec. 9, and DLA Piper’s report mentions no FDA decision on extensions.
• The rule would also extend an exemption called the threshold of regulation to substances added directly to food.
• Consumer Reports says the expansion is scientifically unsupported. FDA says it would maintain an equivalent level of safety.

The Extension Requests

FDA’s Aug. 11 proposal would require companies to notify the agency when they conclude an ingredient is GRAS. DLA Piper, citing Politico, reported on Oct. 30 that the requests say businesses need more time to address cost burdens and possible regulatory alternatives.

The Second Provision

The threshold of regulation exempts certain substances that migrate from food packaging or equipment into food at very low levels. FDA created it for uses where it says migration is so trivial there are no safety concerns. Submissions require only minimal data, such as identity and dietary exposure, and no full safety narrative.

The proposed rule would extend the exemption to any substance used in food, whether added directly or indirectly. A substance that qualifies would not need a food additive review or a GRAS notice. FDA also proposes removing the current criterion that the substance have no technical effect in the food.

FDA would also replace the current limit of 0.5 parts per billion. The new limit would be an estimated daily intake of 0.025 micrograms per kilogram of body weight. FDA says that keeps an equivalent level of safety across populations. A substance shown to be a carcinogen would not qualify, and carcinogenic impurities would have to stay under a one-in-a-million lifetime cancer risk. FDA keeps the right to refuse an exemption when information shows a possible public health risk.

The Concerns

Food Safety Magazine reported on Oct. 14 that FDA did not publicize the change, and that The Guardian was first to analyze it. Brian Ronholm of Consumer Reports said the expansion assumes substances below 0.5 parts per billion pose no health risk, which he called scientifically unsupported. He also said it ignores cumulative exposure and has no labeling provision.

Experts who spoke to The Guardian said harms such as endocrine disruption can occur below that level even for substances that are not carcinogens, the magazine reported. Maricel Maffini, an expert on the exemption, said the idea that small amounts pose no problem is not supported by science.

Why It Matters

Companies building a new ingredient case need to know which path applies: a GRAS notice, a food additive petition or a threshold request. FDA recommends that industry use the threshold process for a substance that meets its criteria and is purported to be GRAS. Unless FDA moves the date, comments on all of it close Dec. 9.

---

Sources: Federal Register, DLA Piper, Food Safety Magazine.