US FDA Findings on Food Import Refusals
Global food supply chains offer many benefits, but they also present challenges to food safety.
In the US, food imports are inspected and approved, or refused, to ensure that safety is not compromised, poor practice is identified and non-compliant products are removed from the supply chain. Official figures demonstrate the scale of the issue.
In March 2016, the United States Department of Agriculture Economic Research Service (USDA ERS) produced a report on United States Food and Drug Administration (US FDA) import refusals between 2005 and 2013.1 This information was summarized and compared to similar research performed on US FDA import refusals from 1998 to 2004.2 The US import refusal information is publicly available3 and data from 2002 to the present day can be searched by country, product and the refusal criteria. This data can also be downloaded into spreadsheets which list all the information, as well as details of the responsible party.
The US FDA physically inspects roughly 1% of all products imported into the United States, but because they use a targeted risk based approach, they refused 87,552 shipments for 142,679 violations of food during the period between 2005 and 2013. For both periods the top six food categories haven’t changed, but their order has. For the top three categories, nothing has really changed for the period of 2005 to 2013, fishery and seafood products is the most refused category with 20.5% of the refusals, vegetables and vegetable product refusals amount to 16.1% of the refusals, and fruit and fruit products account for 10.5% of overall refusals. For the next three categories there has been a shift because the spices, flavors and salts category has slightly more than doubled, from 3.8% to 7.7% of refusals, so have moved from sixth to fourth on the category refusal list. Non-chocolate candy and chewing gum is fifth with 7.2% of refusals, and bakery products/dough/mix/icing category in sixth. The top six categories contribute roughly 69% of import refusals in the United States between 2005 and 2013.
Adulteration & Misbranding
The US FDA has two primary reasons for a refusal; adulteration and misbranding. For the 2005 to 2013 period, adulteration accounted for 57% of the violations and 41% was a result of misbranding. Some 2% of the refusals are difficult to classify into these two categories. For adulteration, there are three categories of adulteration; microbiological, chemical and physical. The primary microbial adulterant is Salmonella, followed by Listeria while the top chemical adulterants are unsafe color additives and pesticide residues. The primary physical adulterant is filth, which can be any extraneous material ranging from but not limited to decomposition, rodent excreta, insects, metals, glass or parasites.
For some categories adulteration is more common, such as the seafood, vegetable, fruit and spice categories while misbranding is more common in categories such as non-chocolate candy and bakery products. Of course each category has its own unique refusal issues, such as in the seafood category where filth is the top issue, followed by Salmonella and then veterinary drug residues. For the vegetable category, pesticide residues are the top reason for refusal followed by failure to file scheduling process information for low-acid or acidified canned products and then filth. The fruit category is topped by filth, followed by pesticide residues and then unsafe color additives.
Salmonella refusals by category are:
- Nuts and edible seeds
Listeria refusals by category are:
- Cheese and cheese products
- Multi-food dinner/gravy/sauce/specialties
For misbranding, the lack of a nutritional panel is the primary reason for refusal, followed by the lack of one or more of the following, an ingredient list, a net content statement and English text.
Largest Sourcing Countries See Most Refusals
While the three countries seeing most refusals are Mexico, India and China, the data is not a surprise because Mexico ships more vegetables into the US than any other country. Likewise, India ships more spices and China more seafood to the US, than any other country. So the primary refusal categories for these countries are in line with the amount of product shipped. The more important indicator is when a country has a high level of refusal compared to the amount of product shipped into the US. For example, shipments of cheese and cheese products from France account for 14.1% of the overall category, but they have 36.8% of the refusals.
There are also specific trends to be noted. The volume of US FDA refusals for pesticide residues has increased almost four-fold since 2008. The majority of this increase can be seen in the whole-grain/milled grain products/starch category. Listeria refusals are substantially down from the figures noted in 1998 to 2004, with most of this drop coming in the cheese category. This is progress, but not perfection, because refusals for other bacteria categories are mostly in the cheese and cheese product category.
There is one consistent trend. The same violations, for the same product categories, happen year after year, yet total refusals versus the amount of imported product declines because of US FDA budget constraints and shrinking personnel numbers.
Focus on the Importer
With the coming compliance dates of the Food Safety Modernization Act Foreign Supplier Verification Program, importers will be responsible for assuring that products being imported comply with US regulations. These importers will need to utilize this import refusals information and other data to determine the verification procedures necessary to assure compliance. This may include, for example, a label review, or pesticide, color additive, pathogen or veterinary drug testing performed by a competent authority. Final random inspection and loading supervision can help to assure that products are not subjected to temperature abuse or other contaminants. In addition, facility audits assure that processes and procedures are in place to pack, process, hold or manufacture safe food.
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