From Farm to Fork: The New Food Safety Bill

FOOD SAFETY MODERNIZATION ACT

48 million people (1 in 6 Americans) get sick from food-borne illnesses every year – out of those people, 128,000  go to the hospital and 3,000 of them die.[i] Food dangers have increased because of the consolidation of food production and sale and increased imports and the law has not kept up to keep people safe.  On January 4, 2011, President Obama signed the Food Safety Modernization Act, a giant step in making our food safer. Essentially, the new law asks all players in the food supply chain to protect the food while it is in their custody.  Everyone in the supply chain, from harvest to sale, has a role now. Below  are highlights of the people and their obligations under the new law.

1.  Farms and produce companies

Farms and produce companies have a role in protecting the food, particularly through (a) complying with new harvesting standards; (b) watching the most wanted list of food hazards; and (c) ensuring that produce can be tracked and traced.

Harvesting Standards. Farms and produce companies will need to follow new national standards issued by FDA for producing and harvesting produce, including safety guidelines for specific fruits, veggies and agricultural commodities. As the rules are developed, FDA will be holding public hearings around the country and the public, particularly from the farming communities, should attend. Before that, however, the FDA will release the regulations in draft on its website and, once again, people who understand the burdens and benefits should comment.

Watch the Most Wanted List of Food Hazards. Every two years, FDA will also issue a most wanted list of the biggest dangers around foods and new regulations to avoid them.

Track and Trace Produce. FDA, working with produce companies, will create a way to track and trace fruits and veggies to pull contaminated food out of the market.

2.  Trucking and transport

FDA will issue new rules on the sanitary transportation of food. Those rules are currently being developed.

3.  Food production facility

Food production facilities bear the greatest burdens under the new food law.[ii] To begin with, food production facilities now have to register every two years (as opposed to the near continuous registration under prior law).

Find Hazards and Plan to Avoid Them. Food production facilities will have to evaluate their processes to find hazards, note the hazards and create controls to avoid those hazards. There will also be new recordkeeping requirements. Food production facilities will then have to make reports to the FDA on all identified hazardous practices and plans to fix them. The plans are due for implementation in 18 months.Food producers need to update the plan every 2 years or sooner whenever you change suppliers, ingredients or processes. Companies that fail to do a hazard analysis and implement a prevention plan will have products deemed adulterated (and thus unlawful), subject to fines and penalties.

Avoid Illegal Additives. Food production facilities will also have to follow the lists of illegal additives or chemicals that get issued by FDA, Homeland Security and Dept of Agriculture.

Create a Terrorism Defense Plan. Food production facilities also have to implement processes to prevent intentional contamination. Some of the measures will probably include limiting access to production, background checks on employees, adopting tamper-resistant packaging and using sealed delivery trucks.

The Stakes for Failure

The Poor Guy Who Signs the Report. An individual in charge of the food facility has to sign the plan and report verifying that (a) the prevention program is in place; (b) the plan is adequate and effectively and significantly minimizes hazards; and (c) the plan is reviewed periodically to ensure its effectiveness. This verification puts the signor at risk of liability. Farsighted food producers will want to make sure their insurance covers liability under the Food Safety Modernization Act.

FDA Can Shut You Down.  The FDA can now order a food product recall, suspend or shut down a food production facility if there is a probability of adverse health consequences or death. This is a big change, since before the FDA would have to negotiate with a food producer to get them to pull a bad product. The FDA will also be inspecting plants more frequently (no less than every 3 years for high risk facilities and every 7 years for lower risk facilities). If the FDA wants to see documents about a plant or hazard prevention plans, the plant has to produce them. The FDA can also detain food if it thinks it is adulterated or misbranded.

4.  Supplement Makers

The FDA is going to issue new guidance on when an ingredient in a supplement is a “new dietary ingredient (“NDI”)” requiring NDI notice to the FDA and what proof of safety is required.

5.   Grocery Stores

Grocery stores will now be obligated and deputized to alert customers about food product recalls. Store managers should stay abreast of requirements and sources of product recall information.

6.  Food Importers

Reacting to the contamination of candy by a Chinese producer’s milk products, the Food Safety Act shines a flashlight on imported foods to make them safer. If you are an importer[iii] of foods, you will be required to put in place a Foreign Supplier Verification Program by January 5, 2013,[iv] ensuring that production facilities are certified in compliance with Good Manufacturing Practices and meet other FDA food-safety standards under the Food, Drug, and Cosmetic Act. That means that food importers will probably need to collect safety certificates from 3^rd party testers, just like manufacturers of kids’ products currently do.  There will also be a list on the FDA website listing importers in compliance with these requirements.

The FDA will also be setting up offices in at least 5 foreign countries to work with government officials and food producers to improve the safety of their products.

Entry of imported food products into the U.S. may be expedited based, in part, on the facilities’ compliance history, the exporting country’s food-safety standards and regulatory capacity, and third-party certifications, among other things. This could ease the burden on importers and food manufacturers.

EXEMPTIONS

• Small businesses that make food just for themselves, or who market most of their food directly to consumers, such as through farmers’ markets, bake sales, public events and fundraising events.
• Small food processors that sell less than $500,000 per year and sell most products directly to consumers in producer’s state or within a 275 mile radius of where it was processed or harvested are exempt from the preventive controls/HACCP provisions in Section 103 of the bill, as long as they tell the consumer where the food came from.
• Small farms that sell less than $500,000 per year and sell mostly products directly to consumers in the producer’s state or within a 275 mile radius of where it was processed or harvested are exempt from produce safety standards under Section 105 of the bill, as long as they tell the consumer where the food came from.
• In addition, some small businesses will have more time to comply with some of the food safety rules. The FDA also has the power to tailor or exempt small businesses from the hazard analysis and preventive control requirements based on size and risk.

OPPORTUNITIES

Like all legislation, there are burdens and there are opportunities buried in the text. The new obligations discussed above present opportunities for business.  Below are a few other potential opportunities.

For Insurance Brokers. Insurance brokers may want to ask food production clients if they want to review or purchase coverage for the signor of reports to the FDA.

For Trainers. A critical component of the Food Safety Modernization Act is an emphasis on training people around the country on food safety. The law provides for grants for training. These grant programs could become an area of opportunity for a government contract to provide training. Health and Human Services will develop a planned response to food borne illness outbreak, which could also open up opportunities.

For Consultants. The Food Safety Modernization Act will also require food production facilities and other players in the food supply chain to ramp up their work with consultants to provide the hazards analysis and prevention plan.

Miscellaneous. The law requires Health and Human Services and the department of Education to create food allergy management guidelines. Grants are available to implement these management guidelines in schools. Leading companies test high-risk ingredients and require a combination of internal audits and well-executed third-party audits to check on safety procedures used by suppliers. The produce track and trace program will be an enormous public/private collaboration, requiring all kinds of things, such as tags, databases, technology and documentation.

[i] Centers for Disease Control and Prevention

[ii] There will be no change in who is regulated by the FDA. Section 403 of the Food and Drug Act still divides food and agricultural products between FDA and USDA. Further, who is a “food production facility” is still defined under Section 510 of the Bioterrorism Act of 2002. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

[iii] Food “importer” is (a) the U.S. owner or consignee of the article of food at the time of entry into the United States; or (b) if there is no U.S. owner or consignee, the U.S. agent or representative of a foreign owner or consignee at the time of entry into the United States. 21 U.S.C. § 385(a)(2).

[iv] Foreign Supplier Verification Program includes compliance with Section 418 (hazard analysis and preventive controls) and Section 419 (produce standards); and (b) is not adulterated under Section 402; (c) is not misbranded under Section 403(w) (allergen labeling).