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Food Manufacturing's Market Update for April 2008 – Regulatory Issues


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Regulatory compliance, while often a source of frustration, is an accepted part of daily life in the food industry. FDA and USDA guidelines, policies and inspections are devised to insure the safety of our nation's food supply. Even with such preventative measures in place, a flood of recent recalls has planted doubt in the minds of consumers, as well as launched criticism of federal regulatory agencies. Despite these recent woes, 92 percent of surveyed food manufacturers - arguably those getting the closest look at the safety of the food supply, as well as being consumers with families of their own to feed - still feel that the U.S. has one of the safest food supplies in the world.

Criticism of FDA and USDA effectiveness regarding food safety typically surrounds a lack of funding, lack of enforce capabilities, and a lack of manpower. In our survey, 50 percent of respondents felt that insufficient manpower is hindering the FDA and USDA the most. 28 percent felt lack of funding is the biggest obstacle, while 17 percent felt that the lack of power to enforce is the problem. 5 percent cited the FDA/USDA's limited access to specific plant information was the most prominent hindrance. Several suggestions have been proposed to improve the FDA/USDA's oversight of the food industry, with the most popular suggestions calling for a more global reach: Requiring mandatory FDA inspections on foreign plants that export to the U.S (40%).

Placing U.S. safety inspectors around the world to insure the safety of imports (21%) .

Sharing information among federal agencies worldwide (20 percent).

In response to recent food safety challenges, as well as on - going global changes, the FDA presented a new Food Protection Plan in November of 2007. The plan offers a three-pronged initiative:

Prevention: Promoting increased corporate responsibility so that food problems do not occur in the first place.

Intervention: Risk-based inspections, sampling and surveillance at high risk points.

Response: Communicate clearly with consumers during and after emergencies.

Of these three initiatives:

57 percent of survey respondents felt that the FDA's biggest weakness lies in prevention.

35 percent felt that the biggest weakness is in invention.

9 percent felt that the FDA's response is its biggest weakness.

The food plan comes with several proposed legislative changes, such as empowering the FDA to issue a mandatory recall, authorizing the FDA to accredit highly-qualified third parties for voluntary food inspections, and authorizing the FDA to refuse admission of imported food if FDA inspection access is delayed, limited or denied. 60 percent of respondents reported not being familiar with the new plan. Of the 40 percent who were familiar, just over half think it will be effective in improving the safety of our food supply.

Plant managers, knowing that they cannot rely on regulatory agencies alone, understand their plant's vital role in food safety. While it is important to mention that many survey respondents pointed out that plants should always be ready for FDA/USDA inspection, respondents indicated several key action steps for ensuring plants are inspection-ready:

Review past audits and make sure that problems were corrected (68%).

Utilize an onsite team to handle inspections (65%).

Consult written SOPs for audits (58%).

Train all employees on how to handle FDA inspectors (39 %).

Hire an outside auditor (27%).

Plants square off against numerous obstacles when it comes to regulatory compliance.

According to 40 percent of respondents, the biggest obstacle plants face is interpretation of rulings and policies of the FDA, USDA, EPA and other agencies as they relate to products or practices.

25 percent cite costs associated with compliance as the biggest obstacle.

20 percent indicate the challenge of keeping up-to-date on new regulations.

Registering foreign food facilities with the FDA and preparing and understanding food additive petitions, GRAS reviews and food contact substance notifications generated the least amount of confusion, as indicated by only 2% and 1%, respectively.

When it comes to specific compliance issues, however:

Labeling takes the number one spot as the most challenging to adhere to (26%).

Sanitation and HACCP issues both follow (15%, 14%).

Controlling pathogens (11.5%) and imports (11%) are close behind.

Perhaps the hottest labeling question in the industry right now is whether or not the FDA should mandate special labeling to denote meat and milk products from cloned animals. 62 percent of survey respondents felt that labeling should be mandatory, and numerous comments indicated that it is important to let consumers know what they are eating, despite added labeling challenges for processors and packagers.

Food Manufacturing, Advantage Business Media,

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