This is one of the key rules that was expected to be released in January 2012 but has been delayed. All members of the food supply chain should pay close attention to these requirements and related guidance documents as soon as they become available.
Sec 105. Standards for Produce Safety
For the first time, FDA is requiring those who produce fruits and vegetables determined to be “high risk” based on their association with outbreaks to enact measures to ensure the safe production and harvesting of the produce. These requirements will apply to both domestic and imported produce and the measures include controls over soil amendments, hygiene, packaging, temperature controls, animals, and water, so as to reduce or eliminate the likelihood of both natural hazards as well as those that may be intentionally introduced from impacting the safety of the product. Like the preventive control rule, stakeholders are anxiously awaiting the release of this rule.
Sec. 301 Foreign Supplier Verification Program
FSMA is moving the burden of imported food safety onto importers. This section of FSMA lays out how importers are going to be held more accountable for the safety of food products and ingredients they import into the U.S. Importers will need to perform riskbased foreign supplier verifications activities to ensure that food entering the US has been produced by firms employing preventive controls (as described in Sec. 103) unless the food is already required to be manufactured using HACCPbased preventative controls (seafood, juice, low acid canned products).
This program, scheduled to be implemented in January 2013 but likely to be delayed, is dependent on the issuance of the preventive control rules that are currently delayed. This section of FSMA is significant for importers of foods and ingredients, as it makes them responsible for ensuring that the products they handle are safe. Thus, supply chain visibility will be crucial for compliance.
Sec. 302 Voluntary Qualified Importer Program (“Green Lane”)
FDA is required to establish a voluntary program that would provide expedited review of food and ingredients from participating importers. The program will be paid for by program participants (as specified in Section 207). Eligibility to participate in the program will depend, in part, on the known safety risk of the food product or ingredient to be imported; the compliance history of foreign suppliers used by an importer; the capability of the regulatory system of the country of export to ensure compliance with U.S. foodsafety standards; recordkeeping, testing, inspection, and audits of facilities; traceability throughout the supply chain; proof of consistent temperature controls; and the potential risk for intentional adulteration of the food. The voluntary program will require the issuance of a facility certification to accompany products brought into the U.S. under this program.
Details emanating from FDA regarding this program have been substantially delayed, and it will likely be years until the program is fully implemented. However, for those exporting to the US, this should be an area of key interest.
In addition to the key provisions described above, there are a number of provisions that impact importers. Additional information can be found at http://leavittpartners.com/globalfoodsolutions/.
Sec. 104 Performance Standards
After periodic review of foodborne contaminant health data, including toxicological and epidemiological studies, FDA may issue guidance documents regarding action levels or regulations based on recommendations of advisory committees, including the Food Advisory Committee.
Sec. 115 Port Shopping
FDA has to provide notification to the Secretary of Homeland Security when refusing to admit food so that other US ports are aware that the food has previously been refused entry.
Sec. 303 Authority to Require Import Certifications for Food
Although unlikely to be required immediately, FDA now has the authority to require certificates issued by independent third parties or governments verifying that the food is in compliance with U.S. laws and regulations. FDA will use a riskbased approach to determine foods and ingredients for which a certificate will be required.