New System Speeds FDA Import Decisions

By: Douglas Stearn

The data is in. A new automated system for determining whether FDA-regulated products can enter the United States is allowing us to make decisions faster and more efficiently.

Douglas StearnQuick admissibility decisions are critical to commerce, especially when perishable products are involved. The new system brings better response times while still protecting consumers.

FDA has used an automated system to assist in making decisions about the admissibility of FDA-regulated products since the early 1990s. In 2015, FDA began piloting a new system, the Automated Commercial Environment (ACE). It features modernized infrastructure that can more quickly process larger amounts of data.

Part of the pilot involved the collection of additional shipment information, such as intended use codes, that could assist in automatically making informed admissibility decisions. Results were promising. So in July 2016, the use of ACE and the provision of additional data were required for everyone seeking to import FDA-regulated goods into the U.S.

Products offered for import into the U.S. must comply with the same standards as domestic products. ACE is one of many tools FDA uses to determine the admissibility of imports – tools that also include inspections of manufacturing plants abroad, physical inspection of goods arriving at our ports, and import alerts which flag manufacturers or products which have had previous violations. By better automating the admissibility process with respect to lower-risk products, FDA can focus more resources on higher-risk products.

Improvements under ACE

ACE, coupled with other enhancements to FDA systems, has brought benefits to both government and the import community. Among the benefits:

  • Due to a number of changes in FDA systems, including ACE, automated messages that an import “may proceed” into U.S. commerce without manual review by an FDA employee have increased dramatically since ACE was piloted, from 26 percent of lines to 62 percent. (A line is a single type of product in a shipment. A shipment might include one or more types of products).
  • FDA employees have less need to request additional information from the importers of record for additional documents or information. That means fewer delays in FDA admissibility decisions about shipments. Under ACE, 28,374 fewer lines needed additional documents and information than prior to ACE.
  • Although we don’t have an exact count of the average processing time before ACE went into effect, we know that times have improved. Indeed, today, automated “may proceeds” are being processed on average within 1 minute and 36 seconds. 
  • We’re also seeing improvements for products that require manual processing. Products are receiving “may proceed” within a median of one hour if no additional documentation is required. When additional information or documents are needed, decisions are processed within 72 hours, compared to 96 hours under the previous system. 

The import community, which has cooperated in submitting the data needed to optimize ACE, shares the credit for these improvements. Further cooperation, particularly by addressing common errors, will bring even greater benefits.

More Improvements through Compliance – Errors to Avoid

A study of FDA rejections between November 2016 and March 2017 found that the most common problems involved the submission of invalid or canceled food facility registration numbers and invalid FDA product codes, which identify the items in a shipment. When offering an FDA-regulated product for import, those filing the paperwork need to remember to:

  • Submit for all FDA-regulated products the correct company name and address of the importer, the manufacturer, delivered-to party, and shipper. Providing the unique number assigned to the company by Dun & Bradstreet (DUNS) or the FDA Establishment Identifier (FEI) provides additional firm-specific information, which assists in finding the companies in FDA’s database.
  • Submit “Intended use” information for FDA-regulated products.

U.S. Customs and Border Protection (CBP), which makes initial decisions before referring shipments to FDA, cites the three most common errors that lead to rejection of entries prior to their being transmitted to FDA:

  • Missing or invalid entity information, which identifies companies involved in the manufacture and importation of the product; and,
  • Missing or invalid units of measure.

The FDA ACE Error Guide details the messages FDA sends when the agency receives entries with problems that prevent further processing of entries.

FDA is standing by to help. An ACE support center is staffed from 6 a.m. to 10 p.m. EST. Contact the center by e-mail at ACE_Support@fda.hhs.gov or toll free from the U.S. at 877-345-1101. Local and international callers should dial 571-620-7320.

Upon request, FDA will assist those filing an import entry of a particular commodity for the first time. Make the request by emailing the support center.

The Division of Import Operations (DIO) also can be contacted for general import operations and policy questions, including questions surrounding the appropriate FDA product code or for more information about an entry declaration requirement. Email FDAImportsInquiry@fda.hhs.gov or call 301-796-0356.

Thank you for helping us make import operations efficient and effective as we continue to focus on our mission of protecting public health.

Douglas Stearn is FDA’s Program Director, Office of Enforcement and Import Operations, in the Office of Regulatory Affairs

FSMA: The Future Is Now – Stakeholder Perspectives

On April 23-24, 2015, FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives.

Participants: Sandra Eskin, J.D., Director, Food Safety, The Pew Charitable Trust; Leon Bruner, D.V.M., Ph.D., Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer, Grocery Manufacturers Association; Marsha Echols, J.D., Legal Advisor, Specialty Food Association; Richard Sellers, Senior Vice President of Legislative and Regulatory Affairs, American Feed Industry Association; David Gombas, Ph.D., Senior Vice President of Food Safety and Technology, United Fresh Produce Association; Sophia Kruszewski, J.D., Policy Specialist, National Sustainable Agriculture Coalition; Stephanie Barnes, J.D., Regulatory Counsel, Food Marketing Institute. Moderator: Roberta Wagner, Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA.

FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Quick Look at FDA’s Mexico Post and Our Global Work

By Phyllis J. Marquitz, M.Sc., J.D.

En Español

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.

Plate of musselsIndeed, 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