In the regulatory world, the big news for 2016 will be the implementation of the hazard analysis and risk-based preventive control (HARPC) provisions under Section 103 of the FDA Food Safety Modernization Act (FSMA). FSMA was signed into law in January 2011 and after almost five years the regulations implementing HARPC have finally been issued.
As background, FSMA represents a significant amendment to the longstanding Good Manufacturing Practices framework. With FSMA, FDA moves from a food safety approach that reacted to potential harm to a preventative framework that puts great responsibility on the food industry to identify potential risks to the safety of the food supply and to counter the risks before harm occurs.
The core obligations of HARPC require covered food facilities to conduct hazard analyses and, when necessary, implement risk-based preventive controls. This requires a covered facility to:
- Identify known or reasonably foreseeable hazards that may be present in the food handled at that facility (including biological, chemical, and physical hazards)
- Implement preventive controls for hazards that require such a control to significantly minimize or prevent them
- Develop effective monitoring procedures for the controls
- Establish written corrective action plans if preventive controls are found to be ineffective
- Validate preventive controls, monitoring and corrective action plans
- Re-analyze the food safety plan at least once every three years and sooner if made necessary by production changes.
Most companies, except for businesses defined in the HARPC rule as “small” or “very small,” must comply with the final rule by Sept. 19. Given the complexities of the rule, companies should immediately begin work on their food safety plans in order to meet the compliance deadline.
Vermont’s mandatory GMO labeling law also figures to impact food companies in 2016. As background, the Vermont law requires foods that are produced entirely or partially with genetic engineering to disclose that fact on the label or, in the case of unpackaged food, on a bin, shelf or container in which the food is displayed. The labeling requirement has numerous exceptions, including food for immediate consumption, food with “minimal” genetically engineered content, and processing aids, among others. The labeling requirement will go into effect on July 1, 2016.
The Vermont GMO labeling law faces several obstacles, however. The Grocery Manufacturers Assn. and other national food trade associations have challenged the law in court; the case is still pending. In addition, bills have been introduced in Congress that would preempt state GMO labeling laws, including Vermont’s. But given the current political climate, it is unlikely those bills will be enacted into law. In the meantime, food manufacturers are faced with the prospect of labeling the GMO content of their foods that are to be sold in Vermont or implementing a potentially complicated distribution structure to avoid distribution of foods in the state.
The regulatory outlook does not always entail additional regulation of industry, and a case in point is California and its law regarding “Made in the U.S.A.” claims. For decades, the California law prohibited such claims for products “if any article, unit, or part thereof, has been entirely or substantially made, manufactured, or produced outside of the United States.” This in effect created a zero tolerance for foreign content in products, including foods, bearing a “Made in the U.S.A.” claim or similar claims in California. The law was recently discovered by plaintiffs’ attorneys and it had become a burgeoning and lucrative area of litigation for them. As an example, just last month, a well-known retailer settled a claim for $4 million regarding jeans with some foreign content labeled as “made in the U.S.A.” and sold in California.
Just as plaintiffs’ attorneys began to turn their full attention to this California law, the California Legislature – surprisingly – softened the impact of the law on businesses. Although the statutory language quoted above remains, the legislature added an exception for products with “articles, units, or parts from outside the United States” if (1) they do not constitute more than 5 percent of the final wholesale value of the product or (2) the manufacturer shows that it can neither produce or source the foreign content in the U.S. and that the foreign content is not more than 10 percent of the final wholesale value of the product. The amended law became effective Jan. 1.