At Wixon, Food Safety Is Our Top Priority
For over 30 years, Wixon, Inc. has utilized FDA-approved microbial reduction processes (MRP) for treating not only every lot of implicated black and red pepper products, but every lot of every spice and herb that we import and/or purchase due to the potential presence of Salmonella and other pathogens that may be found on these types of raw agricultural products.
Wixon is very active in the American Spice Trade Association (ASTA), whose membership has worked closely with the FDA to validate that the approved MRP's are extremely effective in eradicating Salmonella and other pathogens that potentially could be found on black pepper, red pepper, and other herbs and spices. As an additional verification step, all lots of all spices and herbs treated with an MRP are sampled and confirmed as meeting our stringent microbiological specifications before being released for use in either our products or for direct shipment to our customers.
Regulatory Agency Updates
On January 26, 2010, Wixon was present at a series of meetings that were held in the Washington, D.C., area between members of the National Seasoning Manufacturer's Association and staff members of both the U.S. Food Regulatory Agencies - FDA-CFSAN and the USDA-FSIS. The purpose of these meetings was to discuss the status of pending regulations in both agencies that could either directly or indirectly impact the spice and seasoning industry as well as to get clarification from the agencies on the specific criteria they use or have used in determining how specific products or types of products should be labeled. These meetings also allow for the industry to help educate the regulators on issues that we see as potentially being troublesome to not only the industry, but also to consumers. Following are two of the proposed regulations that were discussed and what their current status is per the agencies:
"Natural" Labeling Guidelines: FDA has made it clear in both this meeting and in 2009 that neither making a regulatory definition for the term "natural" nor creating further guidance for what constitutes a "natural" labeled product are high priorities for them at this time. However, the USDA-FSIS staff reiterated to the group that they intend to continue the rule-making process after they complete the review of the 7,534 comments they received to date during the most recent comment period. While there was no promise of a target date for the final rule, they did reiterate that products containing spices and herbs that have been treated with an FDA-approved microbial reduction process can be used in meat and poultry products that are labeled "natural," since the process does not materially change the product and the process does not have a lasting effect on the product.
Irradiation Labeling: In April 2007, the FDA issued a proposed rule in 21 CFR Part 179 (Docket #2005N-0272) to revise its labeling regulations applicable to foods for which irradiation has been approved. In essence, the proposed rule removes the requirement for the radura symbol when labeling products that are not materially changed (i.e. change in its organoleptic, nutritional, or functional properties) when irradiated. Also, it would allow for the use of alternate terms in place of “irradiation,” in addition to allowing for the use of the term "pasteurized" if the agency has been notified that the irradiation process used meets the criteria specified for use of this term in the F, D & C Act. The comment period for this proposed rule ended in July 2007. This topic was again discussed, and the FDA stated that they had received over 32,000 comments on this proposed rule, mostly from consumer groups wanting full disclosure and no change. On the other side were industry, academia, and foreign government comments in favor of the change. They mentioned that a focus group was done and it was clear that consumers do not understand irradiation and its benefits to the consumer. The FDA said they are currently doing an audit of irradiation reporting and then will consider making a final rule.
FDA Calls on Food Companies to Correct Labeling Violations
The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act. The action follows an October 2009 statement by Commissioner of Food and Drugs Margaret Hamburg, M.D., encouraging companies to review their labeling to ensure that they were in compliance with FDA regulations and were truthful and not misleading.
In an open letter to Industry dated March 3, 2010, Dr. Hamburg underscored the importance of providing nutrition information that consumers could rely on. "Today, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States," Dr. Hamburg said in the letter. She also expressed her hope that the warning letters would clarify the FDA's expectations for food manufacturers as they review their current labeling.
The violations cited in the warning letters include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as "healthy," and others that have strict, regulatory definitions. Dr. Hamburg has made nutrition labeling a priority for the FDA. The warning letters are the agency's most recent action to help improve consumers’ ability to make nutritious choices. The FDA soon will propose guidance regarding calorie and nutrient labeling on the front of food packages and plans to work collaboratively with the food industry to design and implement innovative approaches to front-of-package labeling that can help consumers choose healthy diets.
Food Safety Legislation Update
Following are the two primary Food Safety bills that are currently in Congress. As of March 15, Senate Bill 510 has passed committee and is currently awaiting activity on the Senate floor, which is likely in the first quarter of 2010. House Bill 759 was already passed in July 2009. Once the Senate Bill is passed, it will go to a Joint Congressional Committee (overseen by the OMB) to formulate a single compromise bill that will be sent to the President for his signature.
Senate Bill S. 510, FDA Food Safety Modernization Act. S. 510 requires food companies to implement food safety plans. Food companies would be required to register every two years. Food companies would be required to conduct a hazard analysis and implement preventive measures on their production lines to ensure the food they produce is safe and meets performance standards set by FDA for controlling hazards. FDA would be required to inspect high risk food processors at least annually and all other food processors at least once every four years. Food importers would be required to ensure their foreign suppliers comply with U.S. food safety laws. FDA may require high risk foods to be certified as complying with U.S. requirements for safety. Certifications would be performed under a program for accrediting third-party certifiers to audit foreign food companies for compliance. FDA would set standards for the safe production of fresh fruits and produce. The bill strengthens enforcement authority by allowing FDA to: 1.) Order recalls; 2.) Detain unsafe food when inspectors find it; and 3.) Set traceability requirements.
House Bill H.R. 759, FDA Globalization Act. H.R. 759 is a comprehensive FDA reform measure. It has provisions for strengthening regulation of drugs, devices and cosmetics, as well as for reforming regulation of food. Under the bill, food companies would have to register annually. A registration fee is charged to pay for increased inspections of foreign and U.S. food plants, as well as more inspections of imported food at the border. Food companies would be required to conduct a hazard analysis and implement preventive measures on their production lines to ensure the food they produce is safe and meets performance standards set by FDA for controlling hazards. FDA would be required to implement a risk-based inspection system that ensures all food facilities (foreign and domestic) are inspected no less than once every four years. Imported food would have to be certified as meeting U.S. safety standards by FDA accredited certifying agents. Imported foods meeting FDA guidelines for safety would have access to an expedited entry program. The bill provides for research, a public health assessment and educational outreach to consumers. FDA would set standards for the safe production of fresh fruits and produce. The bill strengthens enforcement authority by allowing FDA to: 1.) Order recalls; 2.) Require all products to be traceable through electronic records; 3.) Detain unsafe food when inspectors find it; 4.) Impose new civil fines on food companies that violate the law; and 5.) Detect unlawful conduct by protecting whistleblowers from retaliation.
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