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Between food poisoning outbreaks around the world and the enactment of the Food Safety Modernization Act (FSMA) in the US, 2011 brought food safety into global focus — often unwelcome focus. Principal of Logre International Food Science Consulting, Mexico City, Mexico, and a frequent contributor to Baking & Snack, Rebeca López-García, PhD, put the changes into context for Operations Update readers.

Baking & Snack: How has the international regulatory landscape changed for the baking and snack industries in the past year?

Rebeca López-García: In addition to changes in the US, 2011 was also an important year in the EU. Scientists on the European Food Safety Authority (EFSA)’s Panel on Dietetic Products, Nutrition and Allergies (NDA) reached in July a major milestone in its work on health claims by publishing evaluations of the last group of “general function” claims, excluding those related to botanical substances. According to the July 28, 2011, EFSA press release, publication of the final series of 35 evaluations represents more than three years work by EFSA’s experts. The agency’s independent evaluation concluded that a considerable number of claims made on foods are backed by sound science, including those related to a wide range of health benefits. This opens a whole new world of opportunities in the European market.

Some of the favorable opinions related to the baking and snack industries include vitamins and minerals; specific dietary fibers related to blood glucose control, blood cholesterol or weight management; antioxidant effects of polyphenols in olive oil, walnuts and improved function of blood vessels; and fatty acids and function of the heart. The approval of steviol glycosides published in the Official Journal of the EU Nov. 12, 2011, will also bring about several opportunities in the European market.

What differences do US bakers have to navigate for domestic distribution vs. international?

Domestic distributors have to adapt to the new dispositions of FSMA. If they import products from international markets, they will have to comply with the requirement of ensuring that the sources are properly inspected and follow adequate risk-management practices.

International distributors now face new opportunities in the European market. In addition, bakers who export to Mexico had to adapt to that country’s new labeling requirements published in 2010 for which enforcement began in 2011.

In addition, the Global Food Safety Initiative (GFSI) and other certification standards such as British Retail Consortium (BRC) keep gaining momentum in the international market.

How does FSMA affect companies that import products to US markets from Canada, Mexico or elsewhere?

For many companies that now successfully import from Canada and Mexico, it will only be a matter of adapting their paperwork and complying with the inspection requirements since many of these companies have already established risk-based food safety management systems. The new requirements may be more difficult for smaller businesses that are trying to enter the market because they will have to upgrade their systems to comply and prepare themselves for inspection. David Elder, director of FDA’s Office of Regulatory Operations, said, “For imported foods, the primary difference under the new law is that, for the first time, importers will be specifically required to have a program to verify that the food products they are bringing into the country are safe.”

Another hurdle will be to identify qualified third-party auditors who participate in the FDA accreditation program and obtain the correct information verifying this. In many developing countries, it will be important to provide the most accurate information to exporting companies and avoid less-than-scrupulous companies that may try to take advantage of the lack of information and misguide companies into paying fees that are not required or obtaining certification that is not acknowledged by FDA.

My recommendation to companies in other countries is to try to get firsthand information from FDA. According to information from FDA, the international program has logged nearly 75,000 hits to its Web pages on the new food safety law as foreign companies that export food to the US scramble to learn how the law affects them. Many of the outreach materials have been translated into multiple languages to help communicate the new requirements. FDA has also defined the need for International Capacity Building to help exporters in different countries comply with the new provisions.

How does it affect companies that import ingredients? What sort of documentation or certificates of third-party certification do they need from their suppliers? What effects do the traceability measures specified by FSMA have on the international marketplace?

Importers may apply for the voluntary qualified importer program. An importer who intends to participate in the program will have to submit an application. The eligibility will be limited to importers offering food for importation from facilities that have been properly certified, and the Secretary of Health and Human Services will consider the risk of the food based on factors such as:

  • The known safety risks of the food to be imported
  • The compliance history of foreign suppliers used by the importer, as appropriate
  • The capability of the regulatory system of the country of export to ensure compliance with US food safety standards for a designated food
  • The compliance of the importer with the requirements of Section 805 of FSMA
  • The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls and sourcing practices of the importer
  • The potential risk for intentional adulteration of the food
  • Any other factor that the secretary determines appropriate.

Proper traceability and crisis management are still challenging for both domestic and international producers. This challenge must continue to be addressed to properly build capacity. Most successful exporting companies have implemented traceability based on the requirements of many high-value markets and, in many cases, contractual obligations with their major customers. Traceability should not be considered a burden; it is a tool to accurately determine the food linked to an outbreak and control the damage as effectively as possible. Proper crisis preparation and management are  good business practices that protect the brand and the company’s future, now they will also be a regulatory requirement.

According to the text of the law, nothing in the act (or an amendment made to the act) shall be construed in a manner inconsistent with the agreement established with the World Trade Organization or any other treaty or international agreement to which the US is a party.

This story is sponsored by POWER Engineers, which has one of the most comprehensive teams of engineers and specialists serving the baking and snack industry. As an extension of its clients' engineering teams, the company provides program management, integrated solutions and full facility design for the baking and snack industry. Learn more at www.powereng.com/food.