Mid-Atlantic

The Food and Drug Administration has issued its semiannual regulatory agenda and had a few details and insights about the pending proposed rules for the "produce safety regulation" and the "hazard analysis and risk-based preventive controls." FDA is still burning the midnight oil, apparently, working on the rules.

For the produce safety rule, the FDA said they intend to the notice of proposed rulemaking this month.

From the abstract of the regulatory agenda:

FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce.

The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the Agency issued general good agricultural practice guidelines entitled "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" (GAPs Guide). The proposed rule also will reflect comments received on the Agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons.

Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory.

FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation.

Regulatory Plan: Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to address the food safety challenges associated with fresh produce and thereby protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Incorporating prevention-oriented public heath principles and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the growing, harvesting, packing, and storing of produce and reducing the foodborne illness attributed to fresh produce.

Costs and Benefits: FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. Monetized estimates of costs and benefits are not available at this time.

Risks: This regulation would directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce consumed in the U.S.

Timetable: Action: NPRM 01/00/2012

Regulatory Flexibility Analysis Required: Business
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

 

TK:The FDA did not even attempt to frame the cost/benefits in real terms.  Not yet, anyway. Interesting numbers on the total number of foreign and domestic growers and packers of fresh produce that will be impacted. What will the FDA actually require of growers with the produce safety rule? Not exactly clear here, but it will bring government directly into the fields of fresh produce growers. Why? "Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation."

Meanwhile, the same semi regulatory agenda document provided info on "hazard analysis and risk-based preventive controls." Again, the document can be found here.

 

 

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