The FDA is seeking additional public comment on upcoming sweeping changes to how food is handled and inspected during production.
The Food Safety Modernization Act updates laws from 1938 and seeks to prevent food-borne illnesses by enacting preventive controls, establishing inspections of food producers and issuing mandatory recalls when necessary. The U.S. Food and Drug Administration has extended the public input period for some proposed rules under the law, which was signed Jan. 4, 2011.
The period was extended "so that the rules could be reviewed all together and stakeholders could comment on how the rules could best work in concert," said Shelly Burgess, FDA spokeswoman.
David Gombas from the United Fresh Produce Association thinks that extension to Nov. 15 was the right move, since the proposed rules are described as an interlocking suite of regulations. He sees myriad ways his organization's member produce companies are affected beyond the "growing, harvesting, packing and holding of produce."
"When you look at these regulations being designed for processed foods, they are painted with a broad brush to include the fresh produce industry," said Gombas, senior vice president of food safety and technology for United Fresh.
While widely publicized for its impact on produce-growers, the FSMA really affects all food manufacturers and importers. It even includes provisions for food given to livestock.
The preventive controls are similar to what is already in place for juice and seafood through Hazard Analysis Critical and Control Points systems. Proposals include frequently testing water sources and restricting when manure can be applied to fields.
The new law gives the FDA mandatory recall authority for the first time, Burgess said in an email.
FSMA "enables FDA to focus more on preventing food safety problems, rather than relying primarily on reacting to problems after they occur," she said.
The goal of FSMA is to reduce food-borne illnesses by seeking to eliminate pathogens such as salmonella, E. coli and Listeria from the food supply. However, some say there remain inconsistencies and questions about how the law will be implemented.
About one in six Americans gets sick from food-borne diseases each year, and 3,000 of those people die, according to statistics from the Centers for Disease Control and Prevention.
Human foods will be undergoing process controls, food allergen controls and sanitation controls, and facilities must each prepare a recall plan. The proposed rule for preventive controls for human foods is one that remains open for public comment.
Pennsylvania Department of Agriculture Deputy Secretary Jay Howes described FSMA as a "huge, huge change to the federal government's approach to food safety."
In early September, Howes attended the National Association of State Departments of Agriculture annual meeting, where he said FSMA was a major topic.
Pennsylvania's agriculture department is submitting comments to the FDA with questions about the state's role and concerns from produce growers and processors. Many question which businesses will be eligible for a possible provision that would exempt small producers, Howes said.
Gombas said he has concerns about small operations with packhouses, such as those on family farms, saying they could possibly be required to meet the same requirements as businesses such as General Mills and Kraft.
"Many of those are going to go out of business if it ends up in the final rule," he said. "They're not unsafe about what they're doing. It just doesn't meet the rule."
People within the state agriculture department are looking through thousands of pages in the first rules released, Howes said.
Burgess said submitted comments have led the FDA to develop fact sheets, diagrams, question-and-answer features and PowerPoint presentations to provide clarification on proposals.
The FSMA focuses not only on domestically produced food, but also food imported from other nations.
The FDA says U.S. residents consume food from more than 150 countries. The FSMA requires importers to verify their suppliers have adequate preventive controls in place, and the law gives the FDA authority to refuse entry of food that has not been inspected.
Some fees for international inspection are higher than domestic ones.
There is no fee for a facility's initial FDA inspection, but FSMA authorizes fee collection for reinspection-related costs after an initial inspection identified food safety problems, according to the FDA's website. The website states those fees could be $237 an hour for reinspection within the United States.
Howes said the state Department of Agriculture currently does other types of inspections for the FDA and questions whether it will be asked to assist with these. It also questions what resources will be made available for that.
"It'd be our preference to be the point of contact for our Pennsylvania growers and processors," Howes said. "We have a good relationship now to build on."
Burgess said that, to implement FSMA, the FDA will look for efficiencies with current funding, redeploy existing funding toward inspections, and partner with state and foreign governments to leverage resources.
"We have found that many people are confused about the rule-making process (in) thinking that the proposed rules currently out for comment are the final rules, that they need to comply now," Burgess said.
Instead, the comments from everyone from industry professionals to consumers will be analyzed and used to shape the final rule, she said.
The public comment period for aspects of the Food Safety Modernization Act has been extended to Nov. 15. Comments can be submitted at www.fda.gov/fsma. The U.S. Food and Drug Administration is required to publish all final regulations by June 30, 2015.