The U.S. Department of Justice recently announced the convictions of former officials and a broker of the Peanut Corporation of America (“PCA”) – the company at the heart an outbreak of salmonellosis five years ago that was traced to the company’s peanut products. In particular, PCA owner Stewart Parnell was convicted of conspiracy, mail and wire fraud, obstruction of justice, and introduction of adulterated and misbranded food into interstate commerce. The court has not set a date for sentencing.
According to DOJ’s press release, the trial ran for seven weeks and featured the testimony of 45 witnesses for the prosecution – including former operations managers who had already pled guilty to crimes arising from their roles in the sale of the products. Among the schemes to defraud customers for which evidence was presented at trial was the falsification of certificates of analysis. As we noted in a prior posting, the PCA case raised difficult questions about the adequacy of certain approaches to supplier verification – an element left out of the text of FDA’s proposed rule to implement FSMA’s preventive controls requirements.
Although the timing is almost certainly coincidental, it is not surprising that FDA has now proposed changes to the preventive controls rule for human food to require a receiving facility to “establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient” – with certain exceptions that we won’t belabor here. There is some flexibility in the selection of appropriate verification activities, but the receiving facility must consider the following:
- The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients;
- Where the preventive controls for those hazards are applied for the raw material and ingredients – such as at the supplier or the supplier’s supplier;
- The supplier’s procedures, processes, and practices related to the safety of the raw material and ingredients;
- Applicable FDA food safety regulations and information relevant to the supplier’s compliance with those regulations, including an FDA warning letter or import alert relating to the safety of the food;
- The supplier’s food safety performance history relevant to the raw materials or ingredients that the receiving facility receives from the supplier, including available information about results from testing raw materials or ingredients for hazards, audit results relating to the safety of the food, and responsiveness of the supplier in correcting problems; and
- Any other factors as appropriate and necessary. Examples of factors that a receiving facility may determine are appropriate and necessary are storage and transportation practices.
For raw materials and ingredients, the receiving facility must conduct and document at least one of following activities initially and periodically:
- Onsite audits;
- Sampling and testing of the raw material or ingredient, which may be conducted by either the supplier or receiving facility.
- Review by the receiving facility of the supplier’s relevant food safety records; or
- Other appropriate supplier verification activities based on the risk associated with the ingredient and the supplier.
However, “when a hazard in a raw material or ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans,” the receiving facility must conduct an onsite audit initially and at least annually thereafter – unless the receiving facility can show that such auditing is unnecessary to control the hazard.
Additional information on FDA’s proposed changes to the preventive controls rule and to several other rules (preventive controls for animal food, produce safety, and foreign supplier verification) is available here.