Grainnet

NGFA Encourages FDA to Implement Medicated Feed Self-Inspection Plan

Washington, DC–-The National Grain and Feed Association (NGFA) is commending the Food and Drug Administration (FDA) for developing a plan to implement a new model self-inspection program for medicated feed manufacturing facilities.

“The NGFA believes that a voluntary self-inspection program (VSIP) should be a cornerstone of FDA’s initiative to develop a more comprehensive and risk-based approach to feed safety under its Animal Feed Safety System (AFSS) initiative,” the NGFA said in a statement submitted to the agency.

Under the AFSS, FDA has announced its intention to develop a science- and risk-based approach that is inclusive of all sectors of the animal feed, feed ingredient and animal feeding sectors.

“An integrally important component of the AFSS approach is to enable FDA to better prioritize and allocate inspection and enforcement resources to minimize risks to human and animal health,” the NGFA said.

“VSIP offers just such an opportunity, and we encourage the agency to implement it as soon as possible!”

The NGFA, established in 1896, consists of 900 member companies from all sectors of the grain, feed, processing and exporting business that operate about 6,000 facilities nationwide and handle more than 70 percent of all U.S. grains and oilseeds.

With more than 350-member companies operating commercial feed mills and integrated livestock and poultry feeding operations, the NGFA is North America’s largest organization representing feed manufacturing interests. Under VSIP, medicated feed establishments subject to FDA’s current good manufacturing practice regulations would have the opportunity to voluntarily agree to conduct their own annual CGMP compliance inspections, with summary results of those self inspections reported to FDA.

FDA would implement appropriate safeguards, including random spot-check audits to verify that VSIP-participating firms are performing CGMP self inspections properly.

In return, FDA would utilize its enforcement discretion when determining the inspection frequency for VSIP-participating establishments after considering their CGMP compliance history and other factors.

FDA has developed a draft compliance policy guide to implement VSIP, and is considering conducting a one-year pilot program involving up to 100 medicated feed mills before initiating the program on a nationwide basis.

The NGFA said it will alert member companies about the opportunity to participate in the pilot program once FDA evaluates the comments received and finalizes its draft compliance policy guide.

The NGFA took a leadership role in developing the VSIP concept as part of its extensive involvement in the Association of American Feed Control Officials, which endorsed it as an essential component of a National Model Medicated Feed Program submitted to FDA in 1999.

“The risk-based principle underlying VSIP will enable FDA to better allocate scarce inspection resources at medicated feed facilities or other program function areas where additional regulatory focus may be warranted,” the NGFA told FDA.

“VSIP also can provide a regulatory incentive for even further enhancements in feed safety by encouraging the expanded adoption of quality-assurance and internal self-inspection programs by the medicated feed industry.

Further, the NGFA believes VSIP can serve as a useful model for FDA in developing future risk-based regulatory and inspection approaches for other sectors of the feed, feed ingredient and pet food manufacturing industries in the years to come. Simply put, VSIP is right for the times!”

The NGFA suggested that FDA make several revisions and improvements to the agency’s draft VSIP compliance policy guide by:

• Clarifying that companies may utilize corporate-based officials, rather than just individual facility managers, to review and approve the written self-inspection summary reports submitted to the agency;

• Adding a provision describing how medicated feed establishments will be informed about whether their applications to enroll in VSIP have been accepted, as well as that their annual self-inspection summary reports have been received and found to be acceptable; and

• Inserting a statement concerning how FDA plans to prioritize inspection resources to recognize VSIP-participating establishments.

When implementing VSIP, the NGFA also encouraged FDA to:

• Ensure that FDA field offices have sufficient resources to ensure the success of a “robust” VSIP pilot program.

• Provide a mechanism whereby state feed regulatory agencies could have appropriate access to information on VSIP-participating facilities and summary results of self inspections when devising their own risk-based inspection programs.

• Provide web-based tools, personnel and materials for training on the CGMP self-inspection form that is to be used by VSIP-participating facilities to report self-inspection results to FDA.

“The NGFA urges FDA to expedite implementation of this much-needed VSIP initiative, and looks forward to working closely with the agency to ensure its success,” the NGFA concluded in its statement to FDA.

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