PLUS: Keller & Heckman reaction to food-contact substances subject to FSVP rule

FSMA produce rule is ‘damaging’ - FARFA

By Joseph James Whitworth contact

- Last updated on GMT

Picture: FDA/Flickr
Picture: FDA/Flickr
The Food Safety and Modernization Act (FSMA) final rule relating to produce has been described as ‘damaging’, by a national organization.

Farm and Ranch Freedom Alliance (FARFA) said it is going to be ‘very damaging’ for the growing local food movement and American consumers who want more access to healthy local foods.

The final rule comes after two rounds of proposed rulemaking and has many positive changes from the second round but the Food and Drug Administration (FDA) made only a few additional modifications, said Judith McGeary, founder and executive director of FARFA.

“On the positive side, the final rule retains the changes relating to the use of compost and manure, as well as adding some clarification on grazing and the frequency required for water testing​,” she said.

"Unfortunately, the agency chose to ignore the comments it received about the unrealistic standard for irrigation water, as well as the scope of the qualified exemption."

Concerns on standards for irrigation water

FARFA said the final rule includes standards for irrigation water based on those that apply to recreational waters, such as streams that people swim in and not agricultural uses.

Congress included a "qualified exemption" in FSMA exempting small-scale direct-marketing farmers from the produce rule and setting a gross sales limit of half a million dollars a year, it said.

Although meat and grain products are not regulated under FSMA, under the final rule sales of such products will be counted toward the gross sales limit.

"In practical terms, this rule pressures grain and livestock farmers to avoid diversification, harming farmers financially and discouraging environmentally responsible land use,” ​said McGeary.

“From a food safety standpoint, it does not make sense to treat the small-scale production of produce the same as large-scale production, simply because the same person is producing other types of food as well.

FDA's final rule would allow officials to revoke a farmer's exemption if they claimed there were conditions at the farm or facility that posed a risk of foodborne illness, giving the agency extensive discretion, according to FARFA.

“What sane person would start a small farm, knowing that he or she might have to comply with thousands of dollars of extra expense based on a bureaucrat's say-so and very little due process? This rule creates significant disincentives to farming, at a time when we need more farmers, not fewer,” ​added McGeary.

NASDA responds to final rules

FDA also finalised the Foreign Supplier Verification Programs​ (FSVP) and the Accredited Third-Party Certification rule.

Dr Barbara P. Glenn, CEO of the National Association of State Departments of Agriculture (NASDA), said the FDA and members must have the resources they need to implement the rules.

“To do this, Congress must fully fund this piece of legislation. This is needed to succeed in implementing a preventive approach to food safety while keeping growers and food producers in business to provide safe and nutritious fruits and vegetables and other food products for American consumers.”

Five of the seven major rules have been finalised but Glenn said much of the work will begin now.

“With the massive changes made to food safety authorities, we also envision changes in the rules will be needed. We will continue to work with FDA to get the rules right and fair and equitable programs implemented to assure food safety and security.”

Impact on food-contact material suppliers

Meanwhile, law firm Keller & Heckman said it was ‘surprised’ by FDA’s conclusion that it does not consider it appropriate to exclude food-contact substances from the definition of "food" in one of the final rules and it disagreed with the findings.

“Despite previous assurances from the agency, the FSVP rule does not exempt food-contact substances from the substantive requirements of the new regulation,”​ said Keller and Heckman.

FDA noted comments on the proposed FSVP rule requested it exclude food-contact substances from the definition of food.

“Specifically, the commenters pointed out that facilities that manufacture, process, pack, or hold food-contact substances are not required to register with FDA and therefore are not subject to the proposed regulations on preventive controls; thus, the FSVP should also exclude food-contact substances so that both foreign and domestic food-contact material manufacturers are held to the same requirements,” ​said Keller and Heckman. 

FDA cited a lack of evidence that Congress intended to exclude food-contact substances from the FSVP rule requirements in its decision to not exclude them. 

Keller and Heckman said it is evaluating the FSVP rule to determine the impacts on food-contact material suppliers.

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