FDA has started to roll out components of the Food Safety Modernization Act with industry input
It's been eight months since Congress approved the Food Safety Modernization Act, updating regulations for preventing and addressing food safety problems. The new law has given the U.S. Food and Drug Administration the authority to shut down facilities and make mandatory recalls for dangerous products, among other powers, and has created new guidelines for imported and domestic food.
While developing the requirements and rules mandated in FSMA, many industry leaders have been pleased with how FDA has continued communicating with the industry.
“We think FDA's been doing a good job of keeping the industry informed with the FSMA rollout,” said Erik Lieberman, regulatory counsel at the Food Marketing Institute. “They're proceeding in an open and transparent manner. We're confident it will result in effective rules coming out from the agency.”
The agency has also collaborated directly with groups like FMI on projects related to FSMA. For example, FMI worked with the FDA in developing an improved food recall website for consumers, giving the agency input on the website design.
In April, FDA launched the site, which features recall information in an easy-to-read chart with a search engine for recalled products. Now, shoppers can search for recalled products, see scanned photos of product labels and quickly find reasons for each recall.
“We think that the final product reflects the best ideas of everybody involved, so we're happy with that,” said Lieberman. “The website's pretty easy to use. It has good information on it, including pictures of labels of the recalled product, which we think helps consumers quite a bit.”
For retailers with manufacturing facilities and distribution centers that will need to have hazard and preventative control plans filed with FDA by June 2012, FMI will be providing model food safety plans as a guide. As of 2012, facilities will need to be registered with the FDA every two years.
Lieberman said that FMI is also working closely with the FDA on the recall notification provision of FSMA, by meeting with FDA officials and filing public comments.
“The provision of the law is one that's going to affect us directly, so we had a really good meeting with them a month or two ago where we discussed what the industry is currently doing. And, honestly, most operators are exceeding the requirements of the law,” Lieberman told SN last week, adding that FMI educated the FDA on current industry practices.
Lieberman said FDA has been receptive to industry concerns, including the concern that retailers whose safety procedures currently exceed the new law's requirements will have to slow down their process or issue redundant notices to customers.
For example, while the new law requires a 24-hour response to mandated recalls, many retailers already respond to supplier recalls much more quickly.
During class one recalls — recalls on products that can cause health problems — Tops Friendly Markets doesn't shuffle its feet, according to Jim DiMartino, senior manager of food safety at the Williamsville, N.Y.-based chain.
“The stores have a two-hour timeframe to get back to us that everything was pulled off [shelves]. And then … we put a retail block on that to make sure that, in case something got missed, it won't be able to go through the registers,” DiMartino said.
In fact, some retailers don't anticipate a big change from their current food safety practices or those of their suppliers.
DiMartino explained how Tops already seeks out suppliers that follow high food safety standards such as Good Agricultural Practices, and Hazard Analysis and Critical Control Point protocols. Tops also makes visits to new supplier facilities.
And, DiMartino said Topco, their cooperative wholesaler, assures Tops that vendors follow these procedures. On a store level, Tops goes beyond the New York state requirement of having one person on-site food safety certified; Tops' management team members, department heads and leads all receive certification.
Craig Wilson, vice president, quality assurance and food safety at Costco Wholesale Corp., Issaquah, Wash., said he hasn't seen FSMA have a big impact on the industry. “It's a good base guideline, and we use that as a base and move up from there,” he said.
Well-known for its food safety, Costco has started requiring that its produce suppliers test for a range of E. coli, and plans to start similar testing on its ground beef, according to a report by The New York Times.
Thus far, the main impact of FSMA for retailers may be symbolic.
“Well, I think the biggest impact has been one of awareness right now. Retailers already have food safety policies in place, and they have recall notification plans and they've one step back supplier traceability,” said Lieberman. “FSMA serves as a reminder of the need to review the plans that they have in place and update them and also ensure that employees know and implement those plans accordingly.”
DiMartino sees FSMA increasing the safety of imported food, citing the large number of recalls.
In its first step towards improving the safety of imported food, the FDA issued an interim rule in May that requires importers to disclose when food has been refused entry to other countries.
In an anti-smuggling strategy announced by the FDA last month, the agency revealed plans to work with the Department of Homeland Security to share information and conduct joint examinations of imported food. The FDA can now also hold suspect food from the marketplace for 30 days, whether it is imported or domestic.
FSMA is also charged with developing a Foreign Supplier Verification Program by January 2012 to make sure imported food follows FDA requirements and is not adulterated. In addition, FDA is required to ramp up its foreign inspections to 600 by the beginning of the year, and increase the inspections twofold for the five years following.
These laws address concerns of some of the critics of imported food policies, including other government agencies. In the Government Accountability Office report titled “FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” the GAO noted problems with a lack of on-site seafood facility inspections. GAO noted that only 0.1% of imported seafood undergoes drug residue testing, despite the fact that half of imported fish is farmed, and many foreign fish farms use drugs not legal in the U.S. to prevent infections.
However, expensive portions of FSMA, such as the foreign inspections, might be difficult for the FDA to implement if the agency doesn't receive additional funding.
“Our ability to complete the transformation envisioned by Congress with FSMA will be constrained by the resources we are given,” FDA Commissioner Margaret Hamburg said in an earlier interview with SN.
Although the FDA is seeking additional funding to implement FSMA, the House voted in June to cut the agency's funding by $87 million. The Senate has yet to vote on the budget.
With many of the requirements of the new law still being developed, FDA will have to prioritize its funding to the most needed areas if it doesn't gain additional resources.
“What you do is you try to do a risk assessment and say that this is where our risk is; there is where I'm going to put my eggs in that basket because it's going to affect the most number of people or we've [previously] had problems [in those areas],” said Mel Kramer, EHA Consulting Group, a public health, epidemiology and food safety consulting group based in Baltimore. “It seems that those are the ways the government appropriately looks at a small amount of shrinking resources.”
Kramer gave the examples of produce, seafood and canning as possible areas of focus for the FDA.
The new food safety law includes components on developing both production standards for harvesting fruits and vegetables, and a tracking system for tracing produce and other food. Proposed rules for produce safety are due on January 2012, and the FDA is required to conduct pilot programs and report on their findings by June 2012.
The Produce Traceability Initiative, which works with the produce supply chain to develop electronic record keeping, announced in May that the FDA has shown interest in working with them.
FDA Deputy Commissioner for Foods Michael Taylor recently told the PTI leadership council, “We are keenly aware that industry has been at the forefront of understanding traceability, and in order to make progress we know we are going to need to build on and embrace the work that industry has done,” according to a release.
The FDA's cooperation with the industry has not gone unnoticed.
“I really think that there is a definite change in tone. I've not seen anything like this in the almost 30 years I've been involved with the produce industry and with FDA,” said Bryan Silbermann, president and chief executive officer of the Produce Marketing Association, during a June 28 conference call.
“These are real exchanges of information and ideas aimed at finding solutions to achieve the government's public health goals.”— Additional reporting by Roseanne Harper and Matthew Enis