By Phyllis J. Marquitz, M.Sc., J.D.
Food is something that we all have in common. It brings people together across cultures, borders and tables. Today, about 49 percent of fresh fruits, 21 percent of fresh vegetables and 85 percent of seafood eaten in the United States are imported. Many of these products originate from Mexico, and the volume of imported goods is increasing.
Indeed, Mexico ranks second only to Canada as the largest agricultural trading partner with the United States with bilateral trade of over $20 billion, according to the U.S. Department of Agriculture. The ever-increasing imports of food are reshaping the way FDA does business, and the task of ensuring that food is safe and of high quality for American consumers no longer begins or ends at the border.
One important step FDA has taken to ensure the quality of food is to move some of our operations beyond our borders, opening 13 offices in other parts of the world since 2009. The office in Mexico opened in 2010 and is located in the capital, Mexico City, the largest city and most important cultural, educational and financial center. Our five-person office, which includes one other FDA staffer plus three local employees, is part of the agency’s regional Latin American Office, with posts in Costa Rica and Chile.
Part of what we do is educate industry groups and academia about FDA’s public health regulations so that firms will have the tools they need to implement preventive measures that will help ensure that products are safe throughout the supply chain. In this year alone, our Mexico City office organized 20 outreach events that drew over 1,000 representatives from industry, universities and local governments.
A key part of our job is to help implement existing international arrangements between the United States and Mexico and other foreign governments. These arrangements facilitate and help ensure high quality standards we expect and insist on before any food, drug, or other health care product can be imported into the United States.
To help maintain preventive controls and science-based standards and enable swift regulatory action, we conduct outreach activities, translate documents and exchange strategic, scientific, and regulatory information routinely with our Mexican counterparts. They include the Mexican Federal Commission for Protection for Sanitary Risks, known as COFEPRIS. A recent example was the case of a non-compliant dietary supplement that contained active pharmaceutical ingredients. COFEPRIS acted on FDA’s information by conducting its own product analysis and stopped manufacturing of a product that might otherwise have entered the United States.
We’ve also sponsored pilot projects with Mexican counterparts to increase our knowledge base around the inspection systems in both countries. We need to know specifically how preventative systems work in day-to-day production and how Mexico enforces its regulations to ensure product safety and quality.
Partnerships with regulatory counterparts are also part of FDA’s efforts to protect public health. An example is an FDA Statement of Cooperation with COFEPRIS, signed in June 2012. This arrangement demonstrates a strong commitment at all levels of the U.S. and Mexican Governments to work together on food safety under a recent Food Safety Cooperative Arrangement, signed by the U.S. Secretaries of USDA and the Department of Health and Human Services (FDA’s parent department) and their Mexican counterparts in May 2012 in Geneva, Switzerland.
With the FDA-COFEPRIS arrangement, FDA recognizes that COFEPRIS, through the Mexican Shellfish Sanitation Program (MSSP), has an effective molluscan shellfish sanitary control system in place. FDA and COFEPRIS will oversee continued compliance with the U.S. National Shellfish Sanitation Program requirements through jointly conducted audits of the MSSP. These audits include checking water quality and production standards at the source.
FDA continues to work with its international counterparts and partners to help ensure that safe, nutritious food is produced world-wide – before it is made available to U.S. consumers.
Phyllis Marquitz, is Assistant Regional Director for Latin America (Mexico City) within FDA’s Office of International Programs, Office of Global Regulatory Operations and Policy