Originally published in the January 2011 Journal of Commerce Magazine
In the waning days of an otherwise stagnant time, the lame-duck session of the 111th Congress produced a number of remarkable pieces of legislation. For international traders, that meant a new food safety law. The FDA Food Safety Modernization Act became Public Law 111-353. Much of it deals with changes internal to the FDA, how it will interact with other government stakeholders and the public, and also how the agency will conduct itself in the future, plus a massive number of reports to be prepared and filed with Congress in the next few years. All of that having said, the new law also contains some significant changes for importers. The one the general press has focused on is FDA will now have mandatory recall authority, including over food in warehouses operated by third party logistics providers which now must be able to determine the precise identity of the food being stored in their warehouses.
Another change with immediate impact is the standard of proof has been lowered when it comes to detentions. The old law required FDA to have “credible evidence or information” before ordering a shipment detained. The new standard will be “reason to believe.” The practical impact of this change remains to be seen since FDA seems to often act on little evidence.
One of the most far-reaching changes has to do with “risk-based preventive controls.” Until now, those who imported seafood, juice and low-acid canned food were the only ones required to have HACCP (Hazard Analysis and Critical Control Points) plans, and their obligations remain unchanged. Now, ALL facilities must have plans which evaluate potential hazards that could “affect manufactured, processed, packed” or food held by the facility. Facilities will now also be required to “implement preventive controls to significantly minimize or prevent” hazards and “provide assurances” their food is not adulterated or misbranded. Facilities will also be expected to monitor the performance of their controls and maintain monitoring records.
In analyzing hazards, a facility is expected to look for biological, chemical, physical and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens and unapproved food and color additives, plus hazards that occur naturally or may be unintentionally introduced. Next comes development of a written analysis of those hazards, followed by preventive controls which must include identification of critical control points so that any hazards identified will be significantly addressed, minimized or prevented.
The next step in the process is the facility must monitor the effectiveness of its preventive controls and provide assurances. If the preventive controls are found not properly implemented or are found to be ineffective, then appropriate action must be taken to reduce the likelihood of recurrence of the implementation failure, all affected food must be evaluated for safety, and no food from that facility may enter U.S. commerce unless the facility can insure that food is not adulterated or misbranded.
Additionally, the facility must verify the preventive measures are adequate to control any identified hazards, monitoring is being conducted as required, and documentation is maintained of these efforts, as well as of the periodic reanalysis of the plan, including documentation related to the relevance of the plan to raw materials, conditions and processes at the facility, and new and emerging threats. This documentation must be maintained for at least two (2) years.
The facility is also required to have a written plan that documents and describes the procedures being used to insure the handling of the various sources of hazard and contamination. This written plan must be made available to FDA representatives upon “oral or written request.” The written plan must include provisions to reanalyze all possible hazards whenever there is a significant change in activities which creates a reasonable potential for a new hazard or significant increase in a previously identified hazard, but not less than every three (3) years. Written plans must be updated accordingly and records kept of all such analyses and reanalyses. At the same time, the Dept. of Health and Human Services (HHS) may require reanalysis to respond to newly identified hazards and developments in scientific understanding, including as a result of Dept. of Homeland Security (DHS) assessments related to biological, chemical, radiological and other terrorism threats.
There will be exemptions provided for small businesses which are tied to the value of the food and also refer to a value of less than $500,000. To invoke the exemption, companies will need to file a request with HHS, most likely directly with the Food and Drug Administration (FDA).
By July 2012, HHS is required to establish “science-based minimum standards for conducting hazard analysis,” but may not prescribe “specific technologies, processes or critical controls” for a given facility. “Critical control points” are defined as points, steps or procedures in a food process where controls can be applied to “prevent or eliminate” a food safety hazard or reduce the hazard to an acceptable level. “Preventive controls” are “risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing or holding of food would employ to significantly minimize or prevent” the identifiable hazards and that are consistent with current scientific understanding of safe food production. These procedures include: sanitation, employee hygiene training, environmental monitoring program, food allergen control program, recall program, employment of Good Manufacturing Practices, and supplier verification procedures re food safety – already a good starting point for any risk-management process.
Another significant change comes from the new burden put on importers to “perform risk-based foreign supplier verification activities” in order to insure their food is not adulterated or misbranded. If the importer is foreign-based, then its U.S. agent will be required to undertake this requirement. How many are going to be willing to do that? The importer’s program must be “adequate to provide assurances that each foreign supplier … produces the imported food” in compliance with the risk-management provisions of the new law. New regulations will be published to implement this requirement (as well as many others), but an adequate program is said to include monitoring records, lot-by-lot certification of compliance, annual on-site inspections, checking hazard analysis and risk-based preventive control plans and periodic testing and sampling of shipments. As accreditation of third party auditors is part of this law. Perhaps many importers will start to rely on these third parties, a possibility to watch out for. Here, too, those who are already required to have HACCP plans in place are exempt, but the law and the later regulations will certainly set out the basics which will apply to any risk-management plan and so may cause changes to existing HACCP plans.
To give teeth to these new requirements, it will be considered a prohibited act to operate a facility that is not in compliance with the new requirements. There will also be new rulemaking within a year for raw agricultural commodities to set minimum standards for those identified to cause risk of serious adverse health consequences or death. These new regulations will incorporate steps to “prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables.” Here, too, new standards may result which will cause changes to programs existing or being developed.
HHS is mandated to conduct a vulnerability assessment of the food system which could result in regulations being published to protect against the intentional adulteration of food which has been identified at high risk of intentional contamination. These regulations are to include mitigation strategies or measures to guard against adulteration, plus a model assessment for parties to use. Perhaps they, too, could lead to more plan changes for importers.
Those who become the subject of reinspections, whether a domestic facility or an importer, now must reimburse the agency for the related fees. On the plus side, a Voluntary Qualified Importer Program will finally be established. This program had previously been described as FDA’s version of C-TPAT. It is intended to allow companies to apply and, in exchange for the information provided to FDA, they are to receive expedited import reviews and releases and allow for the issuance of facility certifications. Eligibility will focus on: known safety risks of the imported product; the foreign supplier’s compliance history; the exporting country’s regulatory system and its capability to ensure compliance with U.S. law; the importer’s compliance record; record keeping, testing, inspections and audits of facilities, traceability of goods, temperature controls and the importer’s sourcing practices; the potential risk for intentional adulteration and other relevant factors. Once a company qualifies, it must be reevaluated at least one every three (3) years.
Even against this backdrop, HHS has the right to demand import certifications which could be shipment specific, a listing of certified facilities that manufacture, process, pack or hold the food, or in some other format as required by HHS.
Another major change will come in the form of inspections. HHS is mandated to identify high-risk facilities and inspect them on a regular basis. For domestic high-risk facilities, the first round of inspections must take place within five (5) years and then once every three (3) years thereafter. For high-risk foreign facilities, 600 are to be inspected in the first year, with that number doubling each succeeding year. Many of these inspections may be accomplished by the foreign government itself via a program laid out by FDA. For non-high-risk domestic facilities, they are to be inspected within seven (7) years and at least once every five (5) years thereafter. More inspections at the Ports of Entry are also mandated. Seafood safety is also mentioned as to be improved through a series of coordinated efforts. For any facility which refuses an inspection, it becomes a prohibited act to deal in food from that facility.
Another plus is that HHS is now to establish a program for accrediting private and other government labs to conduct food testing, including for importers seeking admissibility of their imported goods.
The new law also mandates a pilot program in coordination with the food industry to mitigate outbreaks and to address credible threats or serious adverse health consequences. HHS is to establish within FDA a product tracing system to enhance the ability to track and trace food within the U.S. or food offered for import into the U.S. If food is identified as high-risk, additional record keeping requirements are imposed, again focused on responding to outbreaks and recalls. These record keeping requirements are to be designed to maintain the confidentiality of business proprietary information and trade secrets. Many will extend beyond just high-risk foods and seem designed to allow FDA to identify the immediate previous source and the immediate subsequent recipient of the food. Again to give the new law teeth, it is a prohibited act to fail to meet the record keeping requirements.
HHS is also to conduct a study to enhance the preparedness of the agriculture and food system and is supposed to incorporate development of a business recovery plan to be developed with the private sector. Exactly how this will play out against the “5 Integrated Food Safety Centers of Excellence” also mentioned in the new law remains to be seen.
Another provisions calls for a study to determine whether unique identification numbers should be developed for importers and brokers who import food. Another study is to deal with food transportation, including by air. Port shipping is specifically barred.
If the FDA has reason to believe a food is adulterated, it may demand access to and copies of all records related to the article of food as are needed to determine whether “there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.”
When it comes to the registration of food facilities, there are now provisions which allow that registration to be suspended. In the event of suspension, no person shall import or export food or offer to import or export or otherwise introduce food from such facility into interstate commerce.
Finally, the provision du jour was included, i.e., whistle blower protection. Taken together all these new provisions add to the administrative burden which is being put on companies. In much the same way the ISF (the Importer Security Filing) significantly changed how companies dealt with their suppliers, similar sea changes are going to be needed for importers to be able to meet these food safety requirements. Where will you start? How about with the standard terms and conditions in your purchase order?