FDA Issues Proposed Rule on Sanitary Transportation of Food


On January 31, 2014, FDA issued a proposed rule on sanitary transportation of human and animal foods — the seventh of seven regulations mandated by the FDA Food Safety Modernization Act. So we now have all the proposed rules that would implement key elements of FSMA.

The other six rules deal with preventive controls for human food, preventive controls for animal food, produce safety, a Foreign Supplier Verification Program, accreditation of third-party auditors, and the prevention of intentional adulteration.

I view this transportation proposal as a valuable and necessary component of the collection of new rules that will introduce a more preventive approach to food safety in the United States. But there is a possible downside to introducing so many regulations at one time – especially for companies that find themselves suddenly required to understand and comply with several new sets of requirements under separate regulations. Animal feed companies, for example, may be unclear about their status relative to all of the FSMA rules. For example, if farmers have their own mills, does the exemption for feeding your own animals also apply to farmers who may feed their own animals that are housed in facilities owned by contract growers?

The sanitary transportation rule deals with requirements for proper refrigeration of food, the cleaning of vehicles between shipments, and the protection of food during transportation. As mandated by the lawmakers who crafted FSMA, the proposed rule would establish requirements for vehicles and transportation equipment and operations, as well as for training, records and procedures for waivers.

With certain exceptions, the proposed rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food enters interstate commerce. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container if it will be consumed or distributed in the United States.

I was interested to see what is not covered by the new requirements. For example, transportation of raw agricultural commodities performed by a farm is exempt. Also exempted are shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. Food that is transshipped and not meant for consumption in the United States is also exempt. In addition, shelf-stable foods, compressed food gases and live food animals are exempt.

According to FDA’s estimates the proposed sanitary transportation rule will impact 83,609 businesses and the average cost is estimated at $1,784 per business in the first year, for a total of $149.1 million. The ongoing annual cost to the regulated companies is estimated at over $30 million.

The agency has scheduled three public meetings on the proposed rule, Feb. 27 in Chicago, IL, March 13 in Anaheim, Calif., and March 20 in College Park, MD.

The deadline for public comments is May 31, 2014.

USDA Expands Generic Labeling Regulations

By EAS Senior Consultant Susan Glenn

For years USDA has required labels be submitted for approval in order for product to be shipped out of a plant. In July of 1996 the first set of generic regulations went into effect allowing companies to approved some labels “in house” or generically. This rule included net weight changes, changing the signature line and changing the vignette. The rule also changed how many times the label had to be submitted to USDA for approval and took the inspector in charge out of the equation. Previously, labels were required to receive a sketch approval and a final approval of the actual label. In 1996, the generic regulations did away with final label approvals.

A new generic labeling rule went into effect on January 6, 2014, 18 years after the first set of generic regulations. The new rule states only certain types of labeling – i.e., 1) labels for temporary approval, 2) labels for products produced under religious exemption, 3) labels for products for export with labeling deviations, and 4) labels with claims and special statements — will have to actually be submitted to USDA for evaluation and approval. Some of the labels that will be allowed for generic approvals are labels with allergen statements, defined nutrition claims, and geographic claims. Labels for temporary approval, whole grain statements, nutrition front of package statements, natural claims and animal production claims are some of the types of labels that will still need to be submitted to USDA for approval. The Labeling and Program Delivery Division, which is responsible for all USDA label approvals, will accept labels for review that can be approved generically, but they will be given secondary status. Labels with claims, temporaries, religious exemptions and labels for export that bear labeling deviations will take precedence.

Many see this as another step toward an all-generic labeling system. Establishments will have more responsibility for label approvals. And Inspectors in Charge are expected to know the new rule. Standardized training will be implemented, but there may still be a big difference between how individual inspectors view labels at the plant. Some may still want to see the USDA stamp on the label even though it can be generically approved. That’s where USDA’s Labeling Submission Approval System may prove useful. It includes a section with a series of question to determine if a label can be generically approved. LPDD is hoping this will cut the turnaround time for label approvals. The process can take anywhere from 3-8 weeks.