Another Step Forward For The Food Safety Enhancement Act of 2009

Following recent increases in public and media attention focused on food-borne illness, outbreaks and recalls, the House Energy and Commerce Committee has approved the Food Safety Enhancement Act of 2009. The proposed legislation is designed to enhance FDA food safety-related authority. 

The bill, H.R. 2749, passed the committee unanimously with an amendment that would exempt food production facilities and products regulated exclusively by the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act.  The bipartisan bill, spearheaded by Chairman Henry Waxman (D-CA) and Chairman Emeritus John Dingell (D-MI), has received support from a broad coalition of consumer and public health organizations.

According to reports, the full House is expected to vote on the bill prior to the July 4 recess. Click on the following link to view a copy of the proposed legislation, as amended. If enacted, the bill would give the FDA new authority to create robust food safety standards, to establish rules for enhancing traceability, to increase inspections at high-risk facilities, to mandate food product recalls, and to enforce new penalties for violations of federal food safety requirements.

The legislation would also increase FDA funding to facilitate these efforts by requiring food companies to pay new annual registration fees of $500.

Although proposed food safety initiatives are also planned for debate in the U.S. Senate, these efforts, reportedly, may be stalled as a result of ongoing legislative efforts associated with proposed health care reform.

In any event, we’ll continue to report as the debate continues.

Food Safety Enhancement Act Seeks To Impose New Inspection Fees On Food Companies

The House Energy and Commerce Committee has released a discussion draft of the Food Safety Enhancement Act of 2009 which, if passed, would require food manufacturers to pay an annual fee of $1,000 to fund increased inspections by the FDA.

Under the draft bill, high-risk food production facilities would be inspected by the FDA every 6 to 18 months, while low-risk facilities would be inspected every 18 months to three years. In addition to the annual inspection fee, the legislation would also require food manufacturers to pay for costs associated with any additional inspections triggered by food product recalls.  Click on the following link to view a Summary of the Food Safety Enhancement Act of 2009.

The chairman of the House committee, Rep. Henry Waxman (D-Cal.), stated that the proposed legislation is aimed at protecting the nation's food supply. According to Waxman, the new bill “recognizes that the hallmark of strong food safety legislation must be a shared responsibility for food safety oversight between FDA and industry.”

Although food manufacturers are not currently required to pay FDA inspection fees, current budget requests for the FDA include $260 million in new food safety initiatives, with about 35% of that anticipated to come from fees paid for directly by the food industry. While food industry groups strongly support the broad goals of the new proposed food safety measures, questions have been raised about the timing of new fees. According to industry representatives, new inspection fees are being proposed at a particularly bad time, given the slowing economy, for both food companies and consumers alike.

Among other things, the proposed legislation would also require food manufacturers to better trace the food they manufacture abd sell, and would give the FDA authority to issue mandatory recalls. The bill, if passed, would also strengthen criminal and civil penalties for any food companies that fail to comply with federal regulations.

Questions Raised About The Quality Of Third-Party Food Safety Audits

As industry continues to announce recalls of peanut butter products affected by the ongoing Salmonella Typhimurium outbreak, Congressman Waxman held hearings focused on shortcomings in the third-party food safety audits perfomed on behalf of the Peanut Corporation of America (“PCA”). The hearings were triggered after the American Institute of Baking (“AIB”), a private auditing company hired by PCA, was accused of failing to identify various sanitary problems during food safety audits of PCA's facility. Click on the link to view a copy of Congressman Waxman's Opening Remarks.

On March 5, 2009, Michael Moss and Andrew Martin of the New York Times were the first to critique the AIB audits in their article, “Food Safety Problems Slip Past Private Inspectors.” We similarly reported about various inconsistencies found in AIB's reports involving PCA’s plants. On March 27, 2008, for instance, an AIB Food Safety Audit gave PCA credit for developing and implementing a HACCP program “for all processes and product lines.” On April 29, 2008, however, a NSF Cook & Thurber Audit found “[no] documented . . . Hazard Analysis for each of the process steps.”

During the hearings, held by the House Energy and Commerce Subcommittee on Oversight and Investigations, it was also revealed that at least one food company, Nestle USA, used its own inspectors to audit PCA’s facilities. Following a 2002 Nestle Audit, the company concluded that PCA failed to meet its minimum requirements for suppliers. In turn, Nestle elected not to purchase peanut butter products from PCA. In a separate 2006 Nestle Audit of PCA’s Plainview, Texas facility, the company once again concluded that PCA failed to satisfy its food safety standards. While Nestle’s own audits identified numerous key food safety and sanitary issues in this facility, AIB in 2008 awarded PCA a certificate for "superior quality” following its own audit of the plant:

 

           

As we reported previously, PCA voluntarily closed its Plainview facility in February 2009 (only months after this certificate was issued), after governmental investigators discovered numerous sanitary issues existing in the plant. As a result of its own, continuing investigation, Texas health officials eventually ordered a recall of all products ever produced at the facility since it opened in March 2005.  Click on the link to view photos of the insanitary conditions of PCA's facilities.

Many companies that purchased peanut butter from PCA, of course, relied upon the inspections and conclusions of auditors like AIB. Kellogg, one of the companies which relied upon such third-party reports, lost $70 million after having to recall millions of packages of peanut butter crackers manufactured using PCA raw materials. In turn, David Mackay, Kellogg’s chief executive officer, recently joined the growing ranks of responsible food companies seeking tighter food safety laws.  Click on the link to view a copy of Mackay's Statement.  Also providing statements were Martin Kanan (President and CEO of Kanan Enterprises, Inc. d/b/a King Nut), and Heather Isely (Vice President of Vitamin Cottage Natural Foods).  On January 6, 2009, Salmonella was isolated from King Nut peanut butter manufactured using raw materials from PCA's Blakely, Georgia facility.  As recalls of King Nut peanut butter were announced, the source of the pathogen was quickly traced to PCA.  In turn, Vitamin Cottage peanut butter products, made from raw materials from PCA's Plainview, Texas facility, were also found to contain Salmonella.

During testimony today, the committee also released numerous emails exchange before and during the ongoing recalls. In one email, written before the source of the outbreak was identified, Pete Hatfield (an AIB Auditor) tells Sammy Lightsey (a PCA plant manager) that he’s “lucky” Hatfield is performing his annual food safety audit. Click on the link to view the Lightsey email.

In a second email, written as the source of the emerging outbreak was discovered, Stewart Parnell (the President of PCA) tells Joe Valenza (the Vice President of King Nut) that he “[was] sure it's something we did." Recognizing that recalls could not be avoided, Parnell concludes: "now my heart is really in my throat.  I think I'm going to church tonight." Click on the link to view the Parnell email.

In the third email, written as hundreds of recalls had already been announced, NSF representatives discuss the concerns raised by the AIB audits, the lack of micro data made available by PCA to auditors, and the potential implications for third-party auditing firms. Click on the link to view the NSF / Slawinski email.

Debate has begun and will surely continue regarding the quality of third-party food safety audits. Although most audits are valuable, and play an important role in our food safety system, we trust that, moving forward, all auditors, and the companies that rely upon their conclusions, will not repeat the mistakes of a select few.