“The way to look at this right now is a tiger is out of the cage, but he has no teeth or claws because Congress hasn’t funded the Act yet,” says P. Terrence Gaffney, an attorney with Eckert Seamans Cherin and Mello LLC, Washington, who advises on matters related to the jurisdiction of the FDA. “We have the legislation, but the FDA doesn’t have the money to implement it. And with a Republican Congress, the appropriations are going to become much more difficult than they otherwise would have.”
Rolling Out A Timeline
Funding aside, food distributors have about 18 months to develop a food safety, in they don’t already have one in place.
“Everybody in the industry knows that the law has been passed, but few have an understanding of what the law says and more importantly, what it really means for them,” says Ryan D. Shadrick Wilson, an attorney with Hogan Lovells, a law firm based in Washington.
Speaking at the 2011 Supply Chain Conference, held in Orlando, FL earlier this month by the FMI-GMA Trading Partner Alliance, Wilson said that her firm, which has been working with food industry trade associations as well as the FDA to help define the new legislation, has been flooded with calls from concerned food distributors.
“Many are unsure if the Act applies to them,” says Wilson. “There is limited exemption for very small businesses with sales less than $500,000, where the majority of food is distributed directly to consumers or restaurants, and distribution is limited to interstate or within a 275 mile radius. But if your facility is registered under Bioterrorism Act of 2002, your company has to comply. If you’re using HACCP (Hazard Analysis of Critical Control Points), you’re already meeting many of the requirements that are falling under the new Act.”
For food distributors, Wilson says the steps companies should take for daily operations include:
- Conduct hazard analysis of hazards reasonably likely to occur;
- Put into place controls designed to significantly reduce or prevent those hazards;
- Implement preventive controls through monitoring, corrective actions and verification activities;
- Verification activities include environmental and finished product testing;
- Reanalysis required every three years;
- Food safety plan and all related records available to FDA during inspection.
Wilson says that food distributors will need to put more controls in place within their operations—including sanitation for food contact surfaces and utensils, as well as food contact surfaces of equipment. “Supervisor, manager and employee training are very important,” she says. “You must also have a recall plan in place.”
Impact On Imported Goods
For food distributors handle imported goods, Geffney says there’s four things that they have to pay attention to:
- The bill requires importers to provide certification activities to ensure the imported food is safe, so the importers have to perform supplier verification activities.
- The FDA is authorized to refuse admission of imported food if the foreign facility or country refuses to allow an FDA inspector.
- The FDA is authorized to require certification based on risk criteria that the imported food is in compliance with food safety requirements.
- The bill provides an incentive to employers to take additional safety measures by the FDA to establish a voluntary program through which imports can receive if the importers have taken certain measures to ensure the food’s safety of the food.
The FDA has to create some guidelines to give those regulated by this some guidance and they haven’t finished creating all of those guidelines yet. The worst case scenario is if you get a non-compliant distributor and the FDA comes in and inspects it, the worse they would do would be to issue a 483 warning letter and it outlines where your deficiencies are and it gives you adequate time to correct those deficiencies. So no one goes to jail or gets fined.
“You can drive down one major cost—and that’s the cost of your insurance because if you can show your insurance carrier that you’ve done certain things to prevent food-born illnesses, your product liability coverage premium would likely drop.”
In addition, retailers selling private label food products governed by the Act will be required to perform risk-based foreign supplier verification indicating that the imported food is in compliance with new FDA requirements and is not adulterated or misbranded, says Janice Lai, a partner with LeClairRyans, a law firm in Hartford, CT.