This post was written by Seattle based attorney Marc Sanchez, who handles food and product safety matters ranging from drafting product recall manuals to assisting US ranchers with import compliance for cattle raised in Mexico. Marc also writes a food law blog called Food Court. I asked Marc to write this post after he told me how recent changes in U.S. food safety laws will likely impact China’s food safety and U.S. companies that import food from China.
In January, the Food Safety Modernization Act (FSMA) was passed and signed into law in the United States. This Act is the first overhaul of the food safety system in 70 years and it will increase the Food and Drug Administration’s authority over food recalls. It allows the FDA to require food producers to have safety plans and it enhances the FDA’s ability to improve the safety of imported foods. However, it does not include any funding provisions to implement the law, even though it is estimated it will cost $1.4 billion over five years.
There are several provisions in the new Act that will directly impact food manufacturers in China and the companies that import Chinese food products into the United States. Imported foods will be inspected and subjected to the same standards as for US foods (see Section 301 and 306). The FDA now has the authority to block foods from facilities or countries that refuse FDA inspections (Id. at 303). The FDA is also required to establish, “a product tracing system to receive information that improves the capacity to effectively and rapidly track and trace food that is in the United States or offered for import into the United States.” (Section 204).
The FDA will also increase its inspection of foreign facilities that produce foods for export to the US. In 2010, before the passage of FSMA, only 2% (roughly 600) of foreign food facilities were inspected. Assuming Congress funds FSMA (a big if in the current budget battle), the FDA will add 2,000 new inspectors to meet the FSMA mandate to inspect 9,600 foreign food facilities by 2015.
China is the fourth largest exporter of food to the US and it sends us a gamut of food products. China is best known for a string of high-profile recalls of tainted food. It began in 2007 with pet food contaminated with melamine and continued into 2008 with infant formula and milk also contaminated with melamine. China’s food production system is broken and in need of real reform.
Foreign inspection of Chinese facilities means increased pressure for China to modernize. China is often described as being in the midst of an industrial revolution similar to what the US experienced in the 19th Century. At that time in the US, there was no food regulation and adulteration ran rampant. There were cases worse than melamine. Lead shavings were added to pepper and textile dyes were used as food coloring. Even after the Pure Food Act passed in 1906, exemptions and a strong industry lobby rendered the new laws nearly meaningless. It was not until a beefed up FDA came into existence in the 1950s that there was marked improvement in the United States’ food production system.
China is in the position where the US was in 1906 but under foreign scrutiny. China has attempted reform legislation, but its vast food production system remains largely unchanged. If FSMA receives its funding, it will act as a new push for rapid modernization of China’s food safety system. It will place FDA inspectors on the ground in China and it will increase border inspection of Chinese food coming into the United States. There is no way the FDA can do what the Chinese bureaucracy has been unable (or unwilling) to do, but it can act on China’s pride. China will not want to make the list of countries blocked from being able to export its foods to the United States.
FSMA also contains a certification program which will depend on a range of factors, including the known safety risks associated with a food product’s country of origin. Though, the certification program is still being formed, my review of its criteria makes me think China is likely to make the list of countries requiring certification. I say this based largely on China’s continuing problems with adulteration of food products sold within China and abroad. If China makes the list, the Chinese government will likely be required to accredit that the food it exports to the United States is safe. Putting this responsibility squarely on the Chinese government is bound to raise the pressure to modernize China’s dirty and broken food production system.
FSMA will also ratchet-up the pressure on US importers of Chinese food products. The enhanced traceability requirements do not hinge on federal funding, merely on an FDA decision on what system to use. Once the FDA decides what system to use, U.S. companies will need to be recall ready. This means they will need to incorporate traceability into their day to day operations. Should a melamine-type scare arise from China, or from any facility, FSMA ought to enable a rapid recall. Traceability will assist in quickly identifying from where the food product originated and where it was sold. Food companies that depend on imports, like all food companies, will want to begin the process to be recall ready and FSMA complaint. If China is identified as a high risk country US companies will be confronted with the additional task of navigating the certification process. FSMA marks a shift in how food products are kept safe in the US with implications that will reach to China.


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