WASHINGTON, D.C., U.S. — The National Grain and Feed Association (NGFA) on Nov. 26  urged the U.S. Food and Drug Administration (FDA) to clarify and improve a proposed exemption for grain elevators and other facilities that store, handle and ship raw grains and oilseeds from the agency's new preventive control and current good manufacturing practice (CGMPs) regulations that will apply to human food.

The recommendation was among several significant changes to FDA's proposed rules implementing the Food Safety Modernization Act (FSMA) contained in an extensive statement submitted by the NGFA recently. FDA's proposed rules would revise CGMPs and implement new requirements that facilities establish hazard analysis and risk-based preventive control programs for human food products. The agency's proposed rules for human food are among a suite of several major sets of regulations being issued by FDA to implement the 2011 law.

The proposed rules are significant to NGFA-member companies involved in the production and distribution of human foods and food ingredients, as well as those involved in the storage of raw agricultural commodities, such as grains and oilseeds, since such products may be distributed for use in human foods. A major portion of NGFA's 25-page statement addressed how the requirements within the proposed rule should be applied to facilities, such as grain elevators, involved in storage of raw agricultural commodities other than fruits and vegetables.

FDA proposed to exempt from the rule's requirements those facilities that are "solely engaged in the storage" of raw agricultural commodities, other than fruits and vegetables, intended for further distribution and processing. However, the NGFA stated that the exemption language was drafted in such a way that virtually no grain elevators would qualify because the exemption would be removed if such facilities also performed other common activities associated with the safe and effective storage of raw agricultural commodities, such as screening, cleaning, conditioning and fumigating. The NGFA strongly urged FDA to revise its proposed definition for storage so that it also encompasses these and other storage-related activities. 
The NGFA commended FDA for its intent to exempt grain elevators from the rule's hazard analysis, preventive control and CGMP requirements, since such an exemption would represent an appropriate risk-based approach that accurately reflects the level of food safety risk associated with the operations at such facilities. Grain elevators heretofore have not been subject to FDA's existing set of CGMPs.

The NGFA also provided substantive comments to FDA that addressed numerous other issues within the agency's proposed rule, including:
• Packing of Raw Agricultural Commodities Other than Fruits or Vegetables: Based upon the minimal level of public health risk and the authority provided to the agency under FSMA, the NGFA strongly recommended that FDA modify its proposed regulations and exclude packing activities associated with raw agricultural commodities, other than fruits and vegetables, intended for further distribution or processing from the proposed rule's CGMPs and preventive control requirements.    
• Reconditioning of Food: The NGFA requested that FDA clarify that its proposed requirements that would require food to be reconditioned before re-examination do not apply to grains subject to the review provisions established under the U.S. Grain Standards Act.    
• Employee Training: The NGFA recommended that FDA's proposed requirements allow facilities to conduct employee training in a flexible manner, with the facility determining the training content and frequency appropriate for a given employee's duties that pertain to the safe production and distribution of food.    
• Scope of Preventive Controls: The NGFA urged FDA to allow for the use of appropriate preventive controls that are commensurate with the nature of the associated food safety hazard, instead of mandating that each hazard be addressed in a prescriptive manner that requires extensive and burdensome management activities. 
• Submission of Facility Profile Information: The NGFA strongly opposed the FDA-suggested concept that facilities be required to electronically submit information to the agency concerning its operations and food safety plans. In doing so, the NGFA stated that such information would be of little, if any, value to FDA when received outside the context of an on-site evaluation of the facility's actual operation.     
• Product Testing Requirements: The NGFA recommended that FDA's regulations should provide facilities with the flexibility to determine if there are circumstances or conditions under which product and/or environmental testing is necessary to ensure food safety, to explain the basis for making such determinations, and to incorporate such testing, if any, within the facility's written food safety plan. The NGFA said that such regulatory flexibility would allow facilities to use product testing in a manner that is commensurate with the particular circumstances associated with the facility and its food products.    
• Customer Complaints: The NGFA urged FDA not to include within its final rule a requirement that facilities review customer complaint files as part of the verification activities to be performed to demonstrate that the firm's food safety plan is working effectively. The NGFA said that such a review requirement potentially could pit food companies and FDA in time-consuming and unproductive debates over the complexities associated with such complaints. In addition, the NGFA noted that FDA already has access to records associated with foods that it has a "reasonable belief may cause serious adverse health consequences or death to humans or animals."

Given the significant changes being recommended to the proposed rule by the NGFA and other organizations, the association also urged FDA to issue a second draft of proposed regulations or an interim final rule for human food - both of which should be available for additional public comment.  

"Given the very significant nature of this regulation, we believe that a second opportunity for stakeholder comment is essential to ensure that the requirements in the final rule are practical, achievable and enhance food safety," the NGFA said.

FDA is under a court-mandated deadline to issue its final CGMPs and preventive controls rule for human food by June 30, 2015. The NGFA believes it is unlikely that the agency will publish its final rule much in advance of the prescribed deadline.