Changes in U.S. food and beverage regulations are happening now. Anyone who is considering exporting food or beverages to the United States needs to be aware of these regulatory changes. The U.S. Food Safety Modernization Act (FSMA), recently passed by U.S. Congress, affects many existing regulations and adds a series of new requirements for food shippers. One of these regulations is that the Food and Drug Administration (FDA) will require the renewal of food facility registrations during the period from October 1, 2012 to December 31, 2012. Food shippers need to be aware of these changes in order to avoid the potential suspension of their registrations and possible detention of their shipments.
The U.S. Food and Drug Administration regulates most food and beverage products sold in the United States. Companies selling these products must meet very specific requirements set-forth by the U.S. Federal Food, Drug and Cosmetic Act, which was originally passed by the U.S. Congress in 1938 and has subsequently been amended by Acts such as the Bioterrorism Act in 2002 and more recently by the Food Safety Modernization Act (FSMA) in 2011.
One of these requirements is that food facilities must register with the U.S. FDA. A “facility” is defined as any establishment, warehouse, or factory that manufactures, processes, packs, or holds food that may be consumed by humans or animals in the United States.
The registration of food facilities helps FDA determine the location of the source of a potential or actual bioterrorism incident or an outbreak of food-borne illness, and permits the agency to quickly notify facilities that may be affected. Examples of foods that may be produced in a facility required to have an FDA food facility registration include, but are not limited to:
– Dietary supplements and ingredients,
– Beverages (including alcoholic beverages and bottled water)
– Infant formula,
– Fruits and vegetables,
– Seafood ,
– Dairy products and eggs,
– Bakery goods, snack food, and candy,
– Live food animals,
– Animal feeds, and pet food
Some facilities may be exempt from registration such as:
– Private residences of individuals,
– Retail food establishments,
– Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture (USDA)
Food facilities located outside the United States must provide contact details for a “U.S. Agent” for FDA communications as part of a facility’s registration. This is different from a commercial agent such your importer or broker. A U.S. Agent facilitates communication between the FDA and the foreign food facility and must be available for FDA to contact 24 hours a day, 7 days a week. FDA will contact the U.S. Agent to schedule inspections of the foreign facility, or to ask questions about a specific shipment of food to the U.S. In responding to FDA, the U.S. Agent is speaking on behalf of the registered foreign facility.
Further, with the passage of the FSMA in 2011, the responsibilities of the U.S. Agent have significantly increased. Under FSMA, FDA will send the invoice for a foreign facility’s reinspection to the U.S. Agent listed for that facility in Section 7of the firm’s food facility registration. FDA will bill for the hours required for the reinspection, without limit, at the rates of $325 per hour and $225 per hour, outside and inside the U.S., respectively. FDA has recently estimated that the average cost for a foreign facility inspection is approximately $52,000 USD per facility, so it is reasonable to assume that a reinspection maybe equally costly.
The direct consequence of these new fees is an increased liability for companies that export to the United States. Although FSMA makes the U.S. Agent responsible for payment of reinspection fees, in most cases, the U.S. Agent will have an understanding that the foreign facility will pay the fee directly to FDA or reimburse the U.S. Agent in the event that that U.S. Agent pays the fee.
Less obvious are the likely indirect effects of the new reinspection fees. Commencing October 2012, each food facility must renew its U.S. FDA registration every two yearsduring the 4th quarter of even-numbered years (i.e., 2012, 2014, 2016, etc.). The renewal will require that facilities located outside the United States update their U.S. Agent information. Most foreign facilities will likely discover that their previous U.S. Agents will no longer serve as their U.S. Agent due to the increased responsibilities. This could mean that approximately 200,000 foreign facilities will be looking to replace their previous U.S. Agent with a professional U.S. Agent during the limited timeframe of October 1, 2012 to December 31, 2012.
If you are one of the 200,000 foreign facilities that will likely be looking for a new U.S. Agent during the required FDA Registration renewal period in October 2012, you would be wise to designate a new U.S. Agent now (to avoid the stress of a lastminute crisis). The largest of the professional U.S. Agents is Registrar Corp with an expert team of Regulatory Specialists in the United States and nineteen international offices. As a firm’s U.S. Agent, Registrar Corp will provide a free pre-inspection audit for companies that receive an FDA Notice of Inspection after October 1, 2012. Registrar Corp will only ask for reimbursement of travel-related expenses.
If a company is notified on October 2, 2012, or a following date, that FDA would like to inspectthe firm’s food facility, Registrar Corp will send a food safety expert to the facility to help the company prepare for the scheduled FDA inspection. Registrar Corp will not charge for its staff’s time – thecompany only pays for the direct cost of Registrar Corp’s travel (airfare and hotel). Although there can be no guarantee, Registrar Corp’s pre-inspection audit may help reduce the risk of future FDA fees.
Registrar Corp is available to help you prepare for the changes in U.S. FDA regulations. Whether it is food facility registration assistance, label reviews, U.S. Agent services, or preparation for an inspection, Registrar Corp can help you comply. Our 24 hour, 7 days a week live help is available to provide immediate answers to your regulatory questions. Prepare for the changes in FDA regulations by contacting Registrar Corp now.
Registrar Corp provides registration, U.S. Agent and compliance assistance for U.S. and non-U.S. companies in the food and beverage, medical device, drug and cosmetics industries.