The Food and Drug Administration on Jan. 4 proposed two rules aimed at preventing foodborne illness. The long-awaited proposals are essential components of a regulatory framework being erected to implement the F.D.A. Food Safety Modernization Act that was passed by Congress in 2010 and signed into law by President Barack Obama on Jan. 4, 2011.

The first proposed rule would require each domestic and foreign manufacturer of food to be sold in the United States to develop and implement a written plan for preventing their food products from causing foodborne illness. The rule also would require manufacturers to have written plans for correcting any problems that arise. The second rule proposed enforceable safety standards for the production and harvesting of produce on farms (see sidebar on Page 19).

The F.D.A. indicated its proposed rule on “Current good manufacturing practice and hazard analysis and risk-based preventive controls for human food” would require each food plant to have and implement a written food safety plan that would include a hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures and a recall plan.

Each facility’s written hazard analysis must identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, packed or held at the facility to determine whether there are hazards that are reasonably likely to occur, including biological, chemical, physical and radiological hazards. The analysis would include an evaluation of each identified hazard, including an assessment of the severity of illness or injury to humans if it were to occur.

The owner, operator, or agent in charge of a facility also would be required to identify and implement preventive controls (including at critical control points, if any) to provide assurance that hazards that are reasonably likely to occur will be significantly minimized or prevented. The preventive controls would include, as appropriate, parameters associated with the control of the hazard and the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur; process controls; food allergen controls; sanitation controls; a recall plan; and any other necessary controls.

Additionally, each facility would be required to have a written recall plan developed for food with hazards that are reasonably likely to occur.

Plants would be required to monitor the preventive controls to ensure they are consistently performed. This would include establishing and implementing written monitoring procedures and establishing and maintaining records documenting the implementation of the monitoring procedures.

Each food plant would be required to establish and implement written corrective action procedures that would be employed if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem.

The F.D.A. rule further proposed to require facilities conduct verification activities, including validation of a subset of the preventive controls, verification that monitoring is being conducted, verification that appropriate decisions about corrective actions are being made, and verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur.

The F.D.A. said each facility would have to reanalyze its written food safety plan at least once every three years and more often should circumstances warrant.

Of particular note was the F.D.A. proposal to establish qualification requirements for a designated “qualified individual” who would prepare and implement all aspects of a plant’s food safety plan.

“A ‘qualified individual’ would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system,” the F.D.A. said. “Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.”

The F.D.A.’s proposed rule also contained description of recordkeeping requirements.

The F.D.A. will accept comments on its proposed rule for 120 days following its posting in the Federal Register at After considering the comments, the F.D.A. will prepare and publish a final rule that will go into effect 60 days after it is published in the Federal Register.

The agency proposed staggered compliance dates for businesses of different sizes. A small business that employs fewer than 500 people and does not qualify for an exemption (criteria for which are described in the proposed rule) would have to comply two years after the publication of the final rule. A business that is not small and does not qualify for an exemption would have to comply no later than one year after the final rule is published. Very small businesses (the F.D.A. sought comments on which of three proposed definitions of such entities should be adopted) would have to comply three years after the final rule takes effect.

The agency indicated it will publish a guidance document that will explain “in plain language” how businesses, particularly small businesses, will be able to comply with the proposed rule’s hazard and preventive controls requirements. The F.D.A. also said it was working with stakeholders to develop a core training curriculum as well as to disseminate information on hazards and controls.

In a statement issued Jan. 4, the Grocery Manufacturers Association applauded the F.D.A. for issuing the first two sets of proposed regulations under the F.S.M.A. for public comment.

“Consumers expect industry and government to work together to provide Americans and consumers around the world with the safest possible products,” said Pamela G. Bailey, president and chief executive officer of the G.M.A. “F.S.M.A. and its implementation effort can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal.

“We are pleased that implementation of F.S.M.A. is moving forward and look forward to working with the F.D.A. by continuing to share our food safety expertise and best practices and by evaluating and commenting on the proposed rules.”

The F.D.A. said additional proposed rules related to implementing the F.S.M.A. to be published soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food, and accreditation standards to strengthen the quality of third-party food safety audits overseas.

F.D.A. extends preventive approach to food safety to the farm

WASHINGTON — The Food and Drug Administration on Jan. 4 proposed a new rule, “Standards for the growing, harvesting, packing, and holding of produce for human consumption,” that sets science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious adverse health consequences or death.

The F.D.A. proposed to set standards associated with identified routes of microbial contamination of produce, including agricultural water; biological soil amendments of animal origin; health and hygiene; animals in the growing area, and equipment, tools and buildings.

The rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state. It would not apply to raw agricultural commodities that are rarely consumed raw, those produced for personal or on-farm consumption and (with certain documentation) those destined for commercial processing, such as canning, which would adequately reduce microorganisms of public health concern.

Some farms would not be covered by the rule or would be eligible for a partial exemption from it based on factors such as the monetary value of their food sales and to whom they sell. The partial exemption would still apply certain modified requirements to eligible farms, and the partial exemption could be withdrawn in certain circumstances.

Specifically, the rule proposed that all agricultural water be safe and of adequate sanitary quality for its intended use. The proposed rule would require that, at the beginning of the growing season, the agricultural water system components under a farm’s control be inspected to identify conditions that are reasonably likely to introduce pathogens to produce or food-contact surfaces.

Biological soil amendments of animal origin, such as composted manure, may contain pathogens of public health concern. To address this issue, the rule proposed reasonable time intervals between the application of a biological soil amendment of animal original and crop harvest. The proposed rule also has provisions pertaining to the handling and storage of biological soil amendments of animal origin.

The rule proposed basic worker hygienic practices to prevent bacteria, viruses, and parasites that frequently are transmitted from person to person and from persons to food.

Where there is a reasonable probability animals may contaminate produce, the rule proposed farms be required to take measures to prevent pathogens from being introduced onto the produce and not harvest produce that is visibly contaminated with animal excreta.

The rule also proposed standards for sanitation used for produce operations on farms and for certain equipment, tools and buildings.

The U.S.D.A. invited comment on the proposed rule during the 120 days following the rule’s publication in the Federal Register. After the comment period, the F.D.A. will issue a final rule that will come into effect 60 days after its publication in the Federal Register.

The F.D.A. said it intends to publish guidance documents to help businesses, particularly small and very small businesses, comply with the produce safety requirements.

Bryan Silbermann, president and chief executive officer of the Produce Marketing Association, said, “We’re pleased to see the proposed rules released and are eager to review and assess them … In the coming days, we’ll provide an on-line summary of the proposed rules and will be scheduling a free webinar for members with F.D.A. and P.M.A. experts. And, over the next few months, we’ll read and analyze the proposed rules and work with P.M.A.’s volunteer leaders to submit commentary to the F.D.A.”