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FSMA: Import Rules May Foster Global Food Safety

Editor’s note:  This is the third in a series of articles from CSPI Food Safety Director Caroline Smith DeWaal on the implementation of the FDA Food Safety Modernization Act.  In this installment, DeWaal examines some important new food safety tools in FDA’s toolbox for imported foods.

There is no doubt that managing imports is FDA’s most vexing problem in the new millennia.  At a meeting of the Council on Foreign Relations recently, Commissioner Hamburg said, “In recent years in this country, we have experienced events– some clearly deliberate and some unintended–with serious implications for health and safety, as well as for trade, commerce, and the economy: ranging from contaminated heparin (a blood thinning drug), counterfeit glucose monitor strips and surgical mesh, to melamine-tainted vegetable protein and dairy products, salmonella in peppers, to name just a few.  And, the world is poised for even further globalization.”  

Members of Congress were also concerned about imports as they considered the FDA Food Safety Modernization Act.  After melamine-tainted protein from China caused deaths and illnesses in dogs and cats all over the country, both the House and the Senate held hearings on the issues surrounding imports.  The same year, contaminated drugs and toothpaste caused numerous deaths and illnesses, both in the United States and other countries, and there have been recurrent outbreaks linked to fruits and vegetables imported into the United States.

Congress found that FDA’s oversight of imports was inadequate, relying heavily on a border inspection program that checked less than two percent of incoming foods at the border.  Unlike the food safety program at the U.S. Department of Agriculture (USDA), FDA lacked the authority or the ability to develop agreements with foreign countries to ensure safety.  Instead, importers could flood the U.S. with sometimes substandard products, because FDA lacked effective programs to prevent this from occurring.

Giving FDA new tools to manage imports was a driving force behind the enactment of the FSMA.  Several new tools, like inspection and certification, originate in the country of origin. Others, like the Foreign Supplier Verification Program, will hold U.S. importers accountable.  This article will review several of the import provisions, including inspections and certification.  Other components of the new import program will be reviewed in a later article.

The Mandate to Inspect Foreign Facilities Is Not Achievable Without Dramatically Increasing FDA Funding

While compromises were made in the frequency of domestic inspection to achieve passage of the food safety legislation, the mandates for inspection of foreign facilities only grew stronger, reflecting the strong desire among members of Congress to improve FDA’s oversight of imports.  The final bill contains a foreign facility inspection requirement that requires FDA to “inspect not fewer than 600 foreign facilities,” in the year following passage of the Act.  In 2009 (the last year with complete data), FDA conducted 210 foreign facility inspections, so while it is ambitious, the goal of 600 inspections by next January is not out of reach.

The “out-of-reach” clause follows, however.  The law goes on to require FDA to “at least” double foreign facility inspections in each of the next five years. For the mathematically inclined (or budget minded) here is mandate: FDA would conduct 1,200 foreign facility inspections in 2012; 2,400 in 2013; 4,800 in 2014; 9,600 in 2015; and 19,200 in 2016.  This is indeed an extraordinary – if not impossible – goal.  And with the current costs for foreign facility inspections estimated at just under $25,000 per inspection, this provision is unlikely to be achieved in the current budget climate. 

Unless Congress fully funds the new legislation, FDA will be hard pressed to meet the letter of this mandate.  But given the other tools in the bill, it can still meet the spirit of the requirement, perhaps with a more sustainable outcome, using other provisions in the Act. 

Increasing the Role of Foreign Governments

Under our laws, USDA is charged with the safety of all meat and poultry products sold in the U.S.   When it comes to imported products, USDA doesn’t inspect every foreign meat or poultry plant that imports to the U.S.  Instead that agency relies on foreign governments to conduct inspections and certify that the products coming from approved plants meet our safety standards.  USDA regularly audits the foreign inspection programs, and even visits some foreign plants, to provide oversight and assurance that the foreign programs are capable of enforcing our standards.  In addition, USDA checks incoming meat and poultry at the border, including intensive checks on nine percent, as a verification of the foreign program’s effectiveness. Foreign government export certification has long been in use in the meat sector for approving products from other countries.

While it is not possible to exactly replicate the USDA program at FDA, the new law gives FDA some useful tools that can be used to design a more effective system for policing imports.  Prompt implementation of these provisions is vital, especially in the absence of full funding for foreign inspections.  Section 305 of the Food Safety Modernization Act, called Building Capacity of Foreign Governments with Respect to Food Safety, calls on FDA to develop a plan including bilateral and multilateral “arrangements and agreements” that give responsibility to the exporting country to ensure the safety of food. The plan includes provisions for mutual recognition of inspection records, secure electronic data sharing and multilateral acceptance of laboratory methods and testing and detection techniques.  These are the essential elements of a system that would allow FDA to utilize inspections conducted by other countries to ensure the food shipped to the U.S. meets our standards.  

Certification of Imports

The bill also contains authority for FDA to require certification for different foods or all food coming from certain countries as a condition of admission to the U.S.  The legislation provides for a range of options for the certifications or assurances, including shipment-specific certificates, or a listing of approved facilities.  Certification will be dependent on a number of factors, including the known safety risks associated with the food or with the country, territory or region of its origin, or findings that the governmental programs are not adequate to ensure that the food meets U.S. standards.

Certification can be done by either a foreign national government or an entity that is accredited by the Secretary as a third party auditor.  More on third party certification will be discussed in a later article that will cover this topic and the Foreign Supplier Verification Program specifically.

Certification builds on the Prior Notice requirements for imports that were included in the 2002 Bioterrorism Act.  This provision requires all importers to notify FDA when they are shipping foods to the U.S., including what port of entry they will reach.  The new law also allows for the electronic submission of certifications, which could be done along with the prior notices. 

Envisioning a Future of Safer Imports 

Clearly, the safety of imported foods was a major driver both for Congress and for consumers in supporting the Food Safety Modernization Act.  While this portion of the new law is the most complex, it is built upon existing tools and concepts that have been used in other sectors for many years.  While th
e intensive program for inspecting meat and poultry can’t be duplicated for FDA regulated foods, developing a group of trusted foreign governments to provide safety assurances is a new regulatory model that will improve upon FDA’s current practice in reviewing imports.

Last week, Commissioner Hamburg concluded her remarks at the Council on Foreign Relations with the following prescription for change:

“What I envision for the future is a public health safety net for consumers around the world that is created, supported, and maintained by a global alliance of regulators.  Some of the work for this is already underway and has been for several years, as regulators around the world have begun to collaborate.  But these efforts need to be taken to the next level.  We must ask ourselves how we can weave our various efforts into a coherent global system of oversight and safety.”

© Food Safety News
  • Donald Gordon

    The Foreign Inspection mandate will have little effect upon the safety of imported food. There are over 100,000 foreign manufacturers of food shipping to the USA. 600 inspections is hardly a dent into that inventory. Furthermore, the 600 appear to also include other types of inspections such as drug, device, etc. Food inspections probably comprise 200 or less.
    Lastly, FDA wastes tremendous resources reviewing,inspecting and sampling foods from Canada. The number of inspectors along the New York State Border with Canada are equivalent to the numbers of inspectors revewing imports at the Ports of entry in the New York Metro area which receives foods from worldwide sources.

  • David Henze

    Many food processors sell to large customers that inspect plants. Food plants will recieve several inspections and audits each year in order to qualify to supply a specific customer. Maybe the FDA should not double up on inspections but use the data already garnered. I am sure that an AIB, Silliker, or BRC audit is more effective than anything a government agency could do. Also, $25,000 per inspection. I guess that is in line with the $500 hammer and $250 toilet seat.

  • nevs

    As an importer and small business owner, I was subject to the type of inspection discussed in this article on two occasions last year. Ultimately, my products (herbal supplements like Cat’s Claw) were labeled as enemy combatants of the United States by Homeland Security. They were detained for 8 months and the shipment was finally refused. The same package was reshipped, received, opened, inspected, many bottles were opened or damaged, but ultimately the shipment was released. The process costs me thousdands of dollars, countless customers because I could not get my shipment out of release for 8 months!!!! and untold hours upon hours pleading, discussing and haggling over the phone between the FDA and Homeland Security.
    This all happened despite having proper certifications on file by the exporter. In fact, some of the products carry a USDA Certified Organic stamp and GMP certifications plus other certifications beyond what is covered in the article! The exporter has no record of previous contaminants in over 25 years. Also, as an importer for 21 years, I have never had a single citation for contaminants.
    I do not dispute that there are issues with imports. Seriously, there are just as many contamination andfood quality issues within our own borders with the proliferation of GMO and PHUDE items we buy that are making us seriously ill.
    I wish I could say I believe in the safety process.