Baking&Snack - February 2012 - 84

Q &A

REGULATORY

According to information published by FDA, rates for FY 2012 are as follows: $224 an hour if no foreign travel is required and $325 an hour if foreign travel is required. These fees are effective Oct. 1, 2011, through Sept. 30, 2012. Payment must be made within 30 days of the invoice date, and any fee not paid within 30 days after it is due shall be treated as a claim of the US government. The fee schedule does not contain reduced fees for small businesses. However, during FY 2012, FDA will consider waiving, in limited cases, some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation and other relevant factors. FDA intends to publish a guidance document covering this Economic Hardship Fee Reduction approach.

What documentation and/or monitoring will bakers and snack companies need to do in 2012 vs. what they presently do?
All facilities will have to go through the registration process with a biennial renewal. This requirement will contain an assurance that the Secretary of Health and Human Services will be permitted to inspect the facility. In addition, FSMA establishes that the company must evaluate hazards that could affect food manufactured, processed, packed or held to identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and ensure the food is not adulterated. For many companies that already implement a risk-based approach such as a hazard analysis critical control points (HACCP) system for managing food safety issues throughout their production system, the impact will not be great.

However, US bakers were not required to apply HACCP, and; thus, this will present a new challenge. The biggest challenge will be not only to comply with the paperwork but also to truly address the hazards with proper risk-management procedures. This requires experience and knowledge. Developing a plan may not be as complicated as actually implementing it properly while developing a new risk-management culture within the facility. Facilities are required to maintain for not less than two years all records documenting the monitoring of the preventive controls, control of nonconformances, corrective actions and review of the efficacy of preventive controls and corrective actions as well as the written plan and documentation. Proper document control and record-keeping will be essential because the law expands FDA’s authority to gain access to records about potentially hazardous foods. In addition to examining records tied to a particular food that could pose a health hazard, the agency can now inspect records related to any other food it believes is likely to be affected in a similar manner. The biggest challenge in managing food safety for many bakers will be to address contaminants that are not within their control. Cereal-based products will always be challenged by mycotoxin contamination because in most cases, once a product is contaminated, processing will not reduce contamination. Working closely with suppliers and making sure that the risk is managed throughout the production chain will remain a challenge for many bakers.

calls, I believe in the past, the agency has done a good job of convincing companies to remove adulterated products from the market. At the international level, it is commonly believed that FDA has always had this authority. Thus, at the perception level, the new act has not changed reality. If FDA has more resources for inspection, it may be able to detect more issues than before, and the new recall power will help it stop products from entering the market. Companies should always be prepared for a crisis. If they strive to comply with the new risk-management approach to preventing food safety incidents, they will be better prepared to avoid a crisis. But if a crisis strikes, companies should be prepared, follow their procedures, communicate and, most importantly, work hand-in-hand with the authorities to ensure consumer protection. This approach will also protect their products, their brand and their reputation. Ideally, a company should come back from a crisis stronger and better positioned to supply safe wholesome foods.

How has the science of food safety changed over the years? How much more effectively can agencies pinpoint the sources of a recall vs. several years ago and why?
The major change I see is that now there is a lot more awareness regarding the importance of taking a riskbased approach to the management of food safety. It is true that today’s better analytical techniques enable agencies to pinpoint the sources of contamination, but this is useless if there is no evolution in the way we manage food safety. The shift from reactive to preventive programs is definitely happening throughout the world, but it will take time to really create a better food safety culture.

How likely is it that FDA will use its new mandatory recall power, and how can companies avoid it?
Although FDA now has more power and jurisdiction over mandating re-

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Baking&Snack - February 2012

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