New FDA Food Law Light on Funding?

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Michael Causey, Editor & Publisher,

The new FDA Food Safety Modernization Act sounds like a huge change for the food industry because it gives new enforcement powers to the agency and may put more burden of proof on food manufacturers.

“The bill will usher in a new era of food-safety regulation, with increased enforcement, stiffer penalties and broader record-keeping requirements for high risk food,” says a new mini-report, PricewaterhouseCoopers.

That said, some nagging questions remain such as to whether there will be enough funding behind this law to give it any enforcement teeth.

“There is some feeling in the food safety industry, that this bill may have difficulty being funded,” Cindy Rice, RS, MSPH, CPFS, Food Safety Specialist told us this week. Rice is President of Eastern Food Safety, a food safety educator and consultant to the foodservice and regulatory industry and also the food safety expert for ECOLAB, an international food safety and sanitation company.

“Though commonly described in terms of the new powers it gives FDA, it’s the new obligations that fall directly on food businesses that will make the biggest difference to most companies,” food industry attorney Eric Greenberg told us.

For food companies, the new requirement for implementing hazard analysis and critical control point programs – to be implemented in 18 months – represents the most complex new obligation, he added. “It will require companies to evaluate their processes, identify hazards, put in place controls against those hazards, and maintain records of their actions, otherwise the food they make will be adulterated and unlawful,” Greenberg says. It’s worth noting that small businesses are exempt from these requirements.

However, while the ink is still drying on the actual law, there’s still time for food companies and other to weigh in and perhaps influence some changes.

Greenberg, notes, “Many of the law’s provisions require FDA to make regulations to implement them, so companies should be alert to the process in coming months, because they will have opportunities to offer their views on proposed regulations and thus shape their final form.”

So, is this a big deal or not? Depends a little on who you ask.

Despite the funding concerns, Rice says the bill remains important for these reasons:

  1. FDA would have the authority to “Recall” a defective, or adulterated product from stores, distributors, supermarkets, etc. Currently, FDA has no power to recall a product, and can only suggest to a manufacturer that their product be recalled from public consumption and distribution. It is up to the manufacturer to “voluntarily” recall a product that has been implicated in an outbreak, or has some harmful risks associated with it.
  2. All manufacturers and processors would be required to undergo regular food safety and sanitation inspections (yearly), and maintain records that show that they are following an effective food safety plan, that minimizes risks at every step of production of that food. This plan would ensure that production procedures are safe in terms of water quality, processing and sanitation, pest control, animal control and contamination, transport, distribution channels. Also manufacturers would be required to keep records of their safe procedures, and can be used for traceback purposes. In short this food safety plan (referred to also as HACCP plan) minimizes the risks to food at every step of production.
  3. Farmers and growers would be required to also follow a written food safety plan for its produce and livestock, and maintain such records, unless the farm has less than $500,000 in sales annually. This plan would ensure that production procedures are safe in terms of water quality, processing and sanitation, pest control, animal control and contamination, transport, distribution channels. In short this food safety plan , which also includes record-keeping and labeling of product in distribution, minimizes the risks to food at every step from farm to table and also helps traceback food to its source in case of an outbreak.

Greenberg points to another potentially important aspect of the new law. “FDA is ordered to prioritize food inspections according to risk, and to increase the rate of inspections.” The agency must study what foods are at high risk of intentional contamination (such as by terrorists) and set rules to protect them. Imported foods are now going to come from suppliers who can verify they are made in compliance with good manufacturing practices, and will set up a system of third-party auditors to check them out.

It all sounds good, but will the funding materialize or will this remain a group of tough words? Watch this space.

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