Three major national organizations representing the grain, feed and feed ingredient, grain processing and pet food industries have joined in urging the Food and Drug Administration (FDA) to phase in implementation of its new electronic portal, through which facilities will be required to report food- or feed-product safety incidents.
In a 13-page statement submitted recently to FDA, the National Grain and Feed Association (NGFA), National Oilseed Processors Association (NOPA) and Pet Food Institute (PFI) objected to FDA’s announced plan to require firms to begin reporting through the electronic portal – known as the Reportable Food Registry – on Sept. 8. That is the same date FDA intends to first make the portal available for use.
Instead, the three organizations urged FDA to either further extend by an additional 45 to 60 days the effective date for reporting food- or feed-safety incidents through the electronic portal, or to exercise enforcement discretion for a comparable period to provide an appropriate and necessary phase-in period.
“We appreciate FDA’s efforts to establish the Reportable Food Registry and the public outreach and guidance it is undertaking to inform diverse industry sectors of their responsibilities under the law,” the NGFA, NOPA and PFI said. “However, we believe a simultaneous effective date for unveiling the electronic portal, issuing final guidance to industry, and requiring industry to report through the portal is fraught with danger, both for the agency and the regulated industry.”
FDA was required by Congress under the FDA Amendments Act of 2007 to establish the Reportable Food Registry, which requires all domestic and international facilities registered with FDA under the Bioterrorism Act of 2002 to report food- or feed- safety incidents within 24 hours after determining that that they pose a “reasonable probability” of causing “serious adverse health consequences or death to humans or animals.” Failure to report is classified as a felony violation of the federal Food, Drug and Cosmetic Act.
The NGFA, NOPA and PFI noted that FDA already has twice used administrative discretion to delay the statutorily mandated implementation date of the electronic portal until the agency could update its computer system, and said a phase-in period is “absolutely necessary and justified.” The groups cited the fact that FDA indicates that neither the electronic portal nor FDA’s final guidance for industry will be available until on or shortly before the Sept. 8 activation date. Further, they noted the agency has said information being presented during three FDA-conducted public workshops – the last of which does not occur until Aug. 25 – “are not final and are subject to change” prior to Sept. 8. A phase-in period also would provide the agency and industry time to conduct necessary training on the use of the electronic portal, the groups said, and would give FDA additional time to improve the functionality and usability of the portal itself.
The three organizations noted that during a phase-in period, FDA could continue its current policy of strongly encouraging facilities to report food/feed safety incidents through existing mechanisms, such as by notifying the appropriate FDA district office.
Established in 1896, the NGFA consists of more than 1,000 grain, feed and feed ingredient, grain processing, exporting, integrated livestock and poultry, biofuels and other grain-related companies that operate about 6,000 facilities that handle more than 70 percent of all U.S. grains and oilseeds. NOPA is comprised of 16 companies that process more than 1.6 billion bushels of oilseeds annually. NOPA’s members operate 66 plants located throughout the United States, including 61 plants that process soybeans. PFI represents the companies that manufacture more than 98 percent of the dog and cat food sold in the United States, a $17 billion domestic industry, with an additional $1.3 billion in export sales. PFI also consists of affiliated ingredient, packaging and other companies that serve the pet food industry.
The NGFA, NOPA and PFI also recommended that FDA make several significant changes to draft guidance it issued for public comment in mid-June concerning the Reportable Food Registry. The recommended changes submitted by the groups included the following:
➢ FDA should not leave the mistaken impression in the guidance document that the detection of any type or level of pathogen in food or feed would trigger the statutory threshold of posing a “reasonable probability” of causing death or serious adverse health consequences to humans or animals. Further, FDA should clarify in the guidance that its policy is to rely upon confirmed positive test results, not presumptive positive, preliminary or screening test results.
➢ FDA, not the industry, should assume the responsibility for notifying FDA district offices and public health officials about food- or feed-safety incidents reported to the registry. “This would help avoid duplicative or erroneous notifications…and provide a single, direct line of reporting,” the groups said.
➢ FDA’s electronic portal should automatically include on each report the congressionally mandated disclaimer language that states such notifications are product-safety reports, and are not an admission by the reporting party that the product is adulterated or may have caused or contributed to a death, serious injury or serious illness of humans or animals.
In addition, the NGFA, NOPA and PFI recommended that FDA add to the guidance document several questions-and-answers that would:
➢ State more clearly that the legal threshold established under the law for reporting a food- or feed-safety incident is very similar to the language used for current Class I recalls, which is a “serious emergency situation involving recall of a product that may have an immediate or long-range adverse effect on the life or health of animals or humans.”
➢ Clarify that the law’s provisions that exempt from reporting those incidents where the product remains under the control of the facility includes intra-company transfers and products in-transit on conveyances, such as trucks or railcars, that are recalled successfully and returned to the facility from which they were shipped before reaching another party.
➢ Clarify whether farms are required to submit reports of food- or feed-safety incidents that originate on-farm.
➢ Specify that the law does not authorize consumers to submit reports through the Reportable Food Registry, which the groups said was a conscious decision by Congress to avoid submission of unfounded and unsubstantiated reports. Instead, the groups said, FDA should remind consumers of existing avenues they have to report to FDA alleged or suspected food- or feed-safety incidents that may, or may not, prove to be legitimate.
➢ Commit FDA to share promptly with affected industry firms those incidents reported to the agency by public health officials so as to facilitate investigation and timely action by affected companies.
➢ Spell out the specific confidentiality protections that apply to reports of incidents submitted to FDA’s Reportable Food Registry.
➢ Indicate that FDA would expunge from the Reportable Food Registry those reported incidents that, based upon further information or investigation, are determined not to meet the required danger threshold, or are found to be unsubstantiated or fraudulent. This would help prevent such unfounded reports from being disclosed via subsequent Freedom of Information Act (FOIA) requests, the organizations said.
➢ Allow non-electronic reporting by foreign and domestic facilities that may not have access to the Internet.
The NGFA, NOPA and PFI also suggested several changes to the language used on the actual computer screens of the Reportable Food Registry to make it more understandable and to better conform to the terminology used in the FDAAA law.
For Further Information, Contact:
Randy Gordon, Vice President, Communications and Government Relations
National Grain and Feed Association
1250 I St., N.W., Suite 1003, Washington, DC 20005
Phone: 202-289-0873; Email: firstname.lastname@example.org
David Ailor, Vice President, Regulatory Affairs
National Oilseed Processors Association
1300 L St., N.W., Suite 1020, Washington, DC 20005
Phone: 202-842-0463; Email: email@example.com
Nancy K. Cook, Vice President
Pet Food Institute
2025 M St., N.W., Suite 800, Washington, DC 20036
Phone: 202-367-1120; Email: firstname.lastname@example.org