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The Food Safety Modernization Act of 2010 ("FSMA"), was passed in the waning days of the 2010 Congress. FSMA amends the Federal Food, Drug and Cosmetic Act in part and is currently impacting industry not only because of issues that are raised by the new provisions in the law, but also, because of the phased implementation of the statute; there are significant requirements that are implemented in general terms before the regulations, that contain the implementing details have been promulgated. In this article we will briefly describe the more significant changes to Food Safety law made by FSMA, the effects on industry, and then outline some basic steps businesses can take to better prepare for the new world of FSMA.

The FSMA statute constitutes a major expansion of the federal food safety requirements that were in effect in 2010 and grants FDA a number of new powers which the agency has sought for some time. The statute is a major undertaking for the agency as at its outset it requires more than 12 separate rule makings and mandates at least 10 additional documents, as well as many other notices, strategies and the like. In this section we identify some of the major changes and how they have already affected the industry.

(1) Registration of Food Facilities (Section 102). All covered facilities under the new statute must now register biennially between October 1 and December 31, each even numbered year. FDA is to provide an abbreviated renewal process for facilities with no changes in information. The definition of covered facility has been clarified to exclude farmer’s markets and roadside stands. Additional new information included in the registration is consent to inspection, email information, and food product categories.

(2) Suspension of Registration (Section 102). FSMA authorizes the FDA to suspend the registration of a facility if the food manufactured, processed, packed, or held, provides a "reasonable probability that the food will cause serious adverse health consequence or death to humans or animals." Suspension may apply to any facility that packed, received or held such food and knew, or had reason to know of, such reasonable probability.

(3) Hazard Analysis and Risk Based Preventive Controls (Section 103). This section requires registered facilities to identify hazards that could affect manufacturing, processing or packing, they are also required to implement preventive controls, monitor performance and establish procedures for corrective actions, and maintain records of those practices. Preventive controls are required to assure that identified hazards are minimized or prevented, intentional hazards are to be minimized or prevented, and in general a facility’s foods are not to be adulterated or misbranded. Among related requirements are a two-year recordkeeping requirement and a review of the process every three years. Certain exemptions apply, including facilities that are already subject to a HAACP program, such as low-acid foods and seafood. Certain on-farm farm operations were also exempt. The requirements in this section are currently in place; however, the regulations implementing details of the plan requirements are not due until July 2012.

(4) Standards for Produce Safety Section (Section 105). The FDA under this section is to provide minimum standards for raw agricultural product practices and is to promulgate updated agricultural best practices and guidance for fresh produce exempting farms of a certain size, and geographic scope. These regulations are due in final by January 2012.

(5) Protection against Intentional Adulteration (Sections 106, 108, 109). The statute requires that covered facilities engage in vulnerability assessments of their food systems and FDA to promulgate further regulations in that respect.

(6) Fee Collection (Section 107). Fees can now be collected by FDA for food facility re-inspections, costs associated with a failure to comply with a recall order, voluntary qualified import program, and importers re-inspection fees. Because of the overwhelming concern raised by this section, the FDA has already issued a policy statement with regard to how re-inspections will be billed.

(7) Increased Inspection of Domestic and Foreign Facilities (Section 201). The FDA is to increase inspection frequency at both domestic and foreign facilities. The frequencies of inspections are to be based on the risk factor of the foods at issue. A food’s risk profile in part is based upon the following: known safety risks, compliance history, the rigor of the hazard and Preventative Plan controls and whether the facility has been certified. Future regulations will articulate how high risk foods will be identified. Increased inspection at import facilities and on-farm operations is also required.

(8) Program for Analytical Testing and Accreditation of Laboratories (Section 202). This section requires the agency to develop a program for testing food by accredited laboratories and includes mandatory testing requirements, as well as requiring private parties to use accredited labs, which would then report directly to the FDA.

(9) Pilot Tracing System (Section 204). Requires that a pilot tracing program be designed to identify efficient tracing methods that would later become regulation. This pilot program was implemented in the summer of 2011 and is intended to be done by July 2012.

(10) Mandatory Recall Authority (Section 206). FDA can now order a responsible party to cease production and provide notice to relevant persons of a recall. Such notice must be given to all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such food. However, they are required to give a responsible party the choice to voluntarily cease distribution to recall an adulterated or misbranded product the use or exposure to which will "cause serious adverse health consequences or death to humans or animals."

(11) Additional Recordkeeping Requirements for High Risk Foods (Section 101/204). New recordkeeping requirements for high risk foods are required; these foods will be identified by regulation.

(12) FDA Records Access Authority (Section 101/204). Current access to records is based upon a "reasonable belief" that food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. Authority under FSMA is now expanded to include access to all records relating to that article of food and any other food that FDA "reasonably believes" is likely to be affected in a similar manner. Further, if there is an active outbreak FDA may request that a farm provide immediate recipients of the product (except consumers). Preventive Control Plans and related records are to be available to FDA upon written or oral request.

(13) Administrative Detention of Food (Section 207). Under current law credible information or evidence that an article of food presents a threat of serious adverse health consequences or death to humans or animals. This section revises the standard for administrative detention to allow such detention without a court order if FDA has "reason to believe" that such article is adulterated or misbranded.

(14) Importation of Food (Section 301). The statute contains a number of new requirements with respect to verification of the safety of imported foods and the inspection of foreign facilities to assure their compliance with applicable requirements related to hazard analysis and standards for produce safety.

(15) Inspection of Foreign Food Facilities (Section 306). In a related section, FDA is required and authorized to enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities, and to direct resources to inspections of foreign facilities.

A. Additional Provisions.
There are a number of other requirements that are not discussed here in detail but may have significant impacts on "Covered Parties" operations:

Section Description Section Description
104 Performance Standards 115 Ports/Notification of all Instances of Failure to Admit
108 National Agriculture and Food Defense Strategy 116 Alcohol-related Facilities
109 Food and Agriculture Coordinating Councils 203 Integrated Labs
110 Building Domestic Capacity/Reports Re: Food Chain Security and Prevention of Food-Borne Illness 204 Surveillance/Enhance Sustainability
111 Sanitary Transportation of Food 208 Decontamination and Disposal Standards
Food Allergy/Anaphylaxis Management/Plans to manage food allergy and anaphylaxis in high risk populations 209 Improve the Training of Governmental Officials
113 New Dietary Ingredient Requirement 210 Enhancing Food Safety in State Agencies
114 Raw Oysters 211 Improving Reportable Food Registry/Responsible Party to Supply Consumer Oriented Information

As noted above, one of the major challenges with the FSMA statute is that it requires the FDA to meet a number of deadlines with respect to a number of regulations and policy documents that they are required to complete. Several sections of the statute are effective, such as increased inspections, produce safety, and increased fees. However, for the most part the regulations have not yet been promulgated. Industry is thus dealing with new stringent statutory requirements without the benefit of regulations to implement them. These issues, along with the requirements themselves, are already affecting the industry.

B. Effects on Industry
(1) Covered Parties have increased their scrutiny of suppliers and vendors including requiring their vendors to engage in inspections and certification, as well as contractual regulatory requirements imposed upon them that may be more stringent than any requirements imposed by FDA.

(2) There are increased industry concerns over FDA inspections, including the new fee provisions. Because of the changes to the recall requirements and administrative detention there are increased concerns over business interruption. This has also triggered a well-placed concern that additional inspections will occur under the new broader requirements and industry is trying to prepare for them.

(3) In a similar manner there is increased concern over recordkeeping and what records are subject to inspection.

(4) Increasing publicity over recalls due to FDA’s new website and other electronic distribution systems for reporting recalls.

(5) Fear that voluntary recalls may result in automatic registration suspension.

Because the statute contains broader requirements, there has been an increased concern over recordkeeping and inspections. Based on the new statute and these identified concerns, we have made the following suggestions to our clients:

(1) We suggest registrants review their current supply and vendor contracts; assure that supply and vendor contracts have sufficient representations or guarantees concerning regulatory compliance, indemnities, duties to defend, and that to the extent possible that there vendors or supplies insurance policies cover our clients as well.

(2) A Detailed Inspection Plan is necessary which includes

(a) Designation of members of an inspection team with specific duties; 
(b) Procedures for the designated members of the inspection team for interacting with an FDA inspector; 
(c) A system for logging the activities of the inspection; 
(d) A plan for FDA’s document access with a limitation on those documents that the FDA is allowed to inspect. The scope of these documents has increased to allow them to inspect documents which may relate to similar products 
(e) Pre-resolution of issues/policies such as photography and document confidentiality; 
(f) Policies to set rules for discretionary policies such as documents and photography; 
(g) Program to deal with exit interview and any agency post-inspection actions.

(3) Detailed recall program is necessary that in summary contains:

(a) A formal procedure for handling compliance; 
(b) Develop a recall team, with members with knowledge of all of the different products.

(4) Review current preventative plans in the context of existing HAACP’s; obtain alternative certifications.

(5) Review insurance policies to ensure they cover recalls as well as, damages due to a similar company’s recall, whether, they cover recalls if there was no risk or actual damages; or recalls that are the vendor’s fault – and what is the extent of coverage, all of which should be reviewed.

The new FSMA statute contains numerous new provisions that should be of concern to industry. The manner in which the statute and underlying regulations have been rolled out have made for increased concern because of the lack of detail. There are however actions that industry can take to resolve some of these issues which we have suggested herein.

Article  written by Lee Smith, Stoel Rives LLP.  Reprinted with the permission of The Food and Drug Law Institute.


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NMI Industrial Holdings
DeHart Construction Services, Inc.
2485 Natomas Park Dr., Suite 550
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