Published on February 21, 2014
FaegreBD Consulting 1050 K Street NW Suite 400 Washington D.C. 20001-4448 Phone +1 202 312 7440 Fax +1 202 312 7460 MEMORANDUM TO: International Foodservice Manufacturers Association FROM: FaegreBD Consulting DATE: February 14, 2014 RE: Overview of FSMA Proposed Rule on Intentional Adulteration On December 20, 2013, FDA released a new proposed rule as part of the implementation of the Food Safety Modernization Act (FSMA). The rule is formally titled “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,” and focuses on preventive measures against acts of terrorism against the food supply, which could cause large-scale public harm. The rule has a similar framework to the proposed rule for preventive controls rule and to HACCP in that it requires a written “Food Defense Plan,” an assessment of the manufacturing process for vulnerabilities, mitigation strategies, accountability measures and recordkeeping requirements. Reasoning Behind the Rule and Context – Why is FDA Doing This? This rule implements three sections of the Federal Food Drug and Cosmetic Act (FFDCA), as amended by FSMA: 1. Section 418, which addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register with FDA 2. Section 419, which addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities; and 3. Section 420, which addresses intentional adulteration in the context of high risk foods and exempts farms except for farms that produce milk. The foundational impetus for this rule is based on intelligence gathered since the attacks on the United States on September 11, 2001, which indicates that terrorist organizations have discussed contamination of the food supply as a means to harm U.S. citizens and disrupt the global economy. FDA
admits in the text of this rule that terrorist attacks on the U.S. food supply have been exceedingly rare, but that the threat is a “potentially exceedingly high consequence event.” The agency states that “intentional adulteration of the food supply can result in catastrophic public health consequences, widespread public fear, loss of public confidence in the safety of food and the ability of government to ensure food safety, and significant adverse economic impacts, including disruption of trade.” It also says “efforts to protect against intentional adulteration require a shift in perspective from that applied to traditional food safety” and that it “tentatively concluded that intentional adulteration, which is not addressed by traditional Hazard Analysis and Critical Controls Point (HACCP) or other food safety systems, likely will require different kinds of controls.” FDA did not address intentional adulteration in its proposed rules on preventive controls for human food, preventive controls for animal food, or produce safety. The scope of this proposed rule covers only acts intended to cause massive public health harm, including acts of terrorism. Acts of disgruntled employees, consumers, or competitors intended to attack the reputation of a company are not included in the scope of this rule. Importantly, the increasingly critical issue of economically-motivated adulteration (EMA) – adulteration for the purposes of obtaining an economic gain – is not covered by this rule. Instead, FDA indicates it is considering addressing the EMA as part of hazard analysis in a preventive controls framework where EMA is “reasonably likely to occur.” We expect FDA will include additional rules and revisions to the preventive controls for human food rules with respect to EMArelated hazards within the next six months to a year. This proposed rule was rushed to publication due to a U.S. District Court ordering a strict timeline for release of proposed and final rules as part of FSMA implementation by June 30, 2015. FDA would have liked more time to develop this rule, but they had no flexibility. Thus, the widely-held belief is that FDA will be flexible with those food facilities which would be regulated under the rule and expects to make changes. Covered Entities and Exemptions – Which Facilities Will Be Covered? Which Will be Exempt? This rule would apply to both domestic and foreign facilities required to register with FDA under Section 415 of the FFDCA. With this rule, however, FDA is targeting four key activity types, the presence of which FDA believes indicates a significant vulnerability and high risk of intentional adulteration. These activity types are: 1. Bulk Liquid Receiving and Loading - a step in which a bulk liquid is received and unloaded from an inbound conveyance or loaded into an outbound conveyance where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed throughout the liquid due to sloshing, movement, or turbulence caused by the receiving and unloading or loading activity -2-
2. Liquid Storage and Handling - a step in which a liquid is contained in bulk storage tanks or in holding, surge, or metering tanks where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food 3. Secondary Ingredient Handling - a staging, preparation, addition, or rework step where a contaminant can be intentionally introduced into a relatively small amount of ingredient or rework and, if it is, it is likely that the contaminant will be distributed into a larger volume of food 4. Mixing and Similar Activities - a step, such as mixing, blending, homogenizing, or grinding where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food Similar to the proposed rule for preventive controls, however, there are a number of categories of exemptions: • • • • • • • • • Receiving and loading of other types of foods (e.g., non-bulk liquids, solid foods, gaseous foods) Holding food, except the holding of food in liquid storage tanks Packing, re-packing, labeling, or re-labeling food where the container that directly contacts the food remains intact Transportation carriers Manufacturing, processing, packing, or holding of animal feed Activities of a food facility that is subject to standards for produce safety (produce farms) Alcoholic beverages at a facility that meets certain conditions Activities that fall within the definition of a “farm” (as defined in 21 CFR § 1.227) Qualified facilities, which are defined as: o A very small business (i.e., a business that has less than $10,000,000 in total annual sales of food, adjusted for inflation)1, or o A facility that meets two requirements: (1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and (2) the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation 1 Note that this definition of “very small business” has a significantly higher total annual sales number than the various numbers proposed with respect to the preventive control for human foods. In other words, certain facilities in may be required to implement preventive controls but not be subject to the intentional adulteration rule. This reflects FDA’s judgment that such facilities are less likely to be targets of terrorism because any act of terrorism with respect to such a facility would have less impact, both from a mortality and economic disruption standpoint. -3-
FDA is specifically asking for comments on these exemptions and whether they are warranted. Requirements of Covered Entities – What Will They Be Required to Do? Much like the preventive controls rules, covered entities will be required to prepare and implement a written food defense plan, which includes actionable process steps, focused mitigation strategies and procedures for monitoring, corrective actions and verification. There are additional requirements for personnel training and recordkeeping as well. The food defense plan is to be based on a vulnerability assessment (analogous to a hazard analysis), for which owners of covered entities will have two options. Facilities can conduct their own vulnerability assessment, for which there are specific requirements such as a “qualified individual” to carry out the assessment; or they may use the vulnerability assessment provided by FDA, which identified the four key activity types list in the section above. The latter would, as FDA states in the rule, “eliminate the need for a full vulnerability assessment.” The law requires that the process of identification of actionable process steps be done “for each type of food manufactured, processed, packed, or held at the facility” because vulnerability to intentional contamination may differ based on the type of food and associated process, practices, and conditions at the facility. Therefore, FDA is requiring that the facility assess whether it has any of the key activity types for each type of food that is manufactured, processed, packed, or held at that facility. The requirements of the food defense plan under the proposed rule are as follows: 1. Identify Actionable Process Steps: The rule defines “actionable process steps” as “a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level” and is analogous to a “critical control point” in the HACCP framework as well as to a “hazard reasonably likely to occur” under the preventive controls framework. The written identification of actionable process steps must include the justification for whatever conclusion the owner, operator, or agent in charge of a facility reaches. A written analysis would still be required even if the conclusion of the analysis is that there are no actionable process steps. One example from the rule, in reference to the key activity type “mixing and similar activities,” is provided here: A facility may identify a mixing tank as involving the key activity type, Mixing and similar activities, in its operation because the mixing tank has an unsecured lid and several sample ports which provide direct access to the food product and because a contaminant can be introduced into the tank through the lid or one of the sampling ports -4-
and, if it is, the contaminant would be distributed into the food. The owner would conclude that the mixing tank is an actionable process step. We would expect that this conclusion would be reached for virtually all steps that involve mixing, blending, homogenizing, or grinding because these kinds of process steps generally: (1) Present an opportunity for access to the product at or just prior to the equipment (e.g., in-feed conveyor); and (2) would cause a contaminant, if intentionally added, to be distributed into the food. We expect this conclusion to be reached regardless of whether the facility may already have mitigation strategies in place to impede access to the mixing tank (e.g., a “buddy system” that ensures that at least two employees were present at the mixing tank at all times or a lock on the mixing tank access ports). 2. Focused Mitigation Strategies: Covered entities must identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. Such strategies are defined as “those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis.” The term “focused mitigation strategies” used in the food defense context is analogous to the term “preventive controls” in a HACCP-type framework. Examples of mitigation strategies may include sealing or locking outbound conveyances of bulk liquid, or requiring that inbound conveyances be sealed or locked as a condition of receipt of the bulk liquid. The rule lists examples of focused mitigation strategies for each of the four activity types. The following is one such example for the key activity type, “bulk liquid receiving and loading”: Controlling access to the receiving or loading area, conveyances, and equipment, including hoses and pumping machinery, to prevent an unauthorized person from gaining access to the food during receiving or loading. Access controls may include: strategies to easily identify authorized persons, such as color-coded uniforms or badges; restricting conveyance drivers to areas away from the receiving or loading area (e.g., restricting them to a lounge or break room); securing hoses with locking caps or in cabinets; and ensuring that conveyance access hatches, vents, and inspection ports are secured. -5-
3. Monitoring: Facilities must also establish and implement monitoring procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies. 4. Corrective Action Procedures: Facilities must establish and implement corrective action procedures that must be taken if focused mitigation strategies are not properly implemented. 5. Verification: Facilities must verify that monitoring is being conducted and appropriate decisions about corrective actions are being made; verify that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing the significant vulnerabilities; and conduct a reanalysis of the food defense plan at least once every three years and more often when circumstances warrant. 6. Training: Facilities must ensure that personnel and supervisors assigned to actionable process steps receive appropriate training in food defense awareness and their respective responsibilities in implementing focused mitigation strategies. 7. Recordkeeping: Facilities must establish and maintain certain records, including the written food defense plan; written identification of actionable process steps and the assessment leading to that identification; written focused mitigation strategies; written procedures for monitoring, corrective actions, and verification; and documentation related to training of personnel. The agency states that the food defense plan can also be used as a resource for facilities to capture additional food defense-related information such as process flow diagrams, an evaluation of broad mitigation strategies, emergency contact information, crisis management plans, action plans for implementation of broad mitigation strategies, results of supplier audits, and other documents, analysis, reviews, or information the facility finds relevant to its food defense program.2 FDA has also developed and publicly released a software tool that can be used to assist a facility to develop its food defense plan. This free tool is available here. Compliance and Effective Dates The proposed effective date is 60 days after a final rule is published, with flexibilities for facilities of certain sizes. Facilities other than small and very small businesses would have one year after the effective date to comply. Small businesses (i.e., those employing fewer than 500 persons) would have two years after the effective date to comply with proposed part 121. Very small businesses (i.e., businesses that have less than $10,000,000 in total annual sales of food, adjusted for inflation) would be considered a qualified facility and would have 3 years after the effective date to comply. Realistically, 2 Note, because a food-defense plan would be subject to FDA review during an inspection, all additional, nonrequired information included with the food defense plan would also potentially be subject to FDA review during inspection. Facilities may wish to consider having separate crisis management and food defense plans which reference each other in order to avoid this concern. -6-
we expect FDA to announce it will exercise enforcement discretion with respect to compliance with this rule for at least six months or a year after the final rule is published. Additional Insights As indicated previously, FDA was ordered by a court to release this rule, even after FDA repeatedly indicated it did not have significant experience and expertise in food defense issues and that it was not ready to release a rule. Not surprisingly, then, FDA has requested comments and sought data on various aspects of this rule. In substance, FDA has admitted that it does not know what it does not know with respect to food defense, how companies have implemented such programs in the past, and what strategies companies have found effective in the past. We expect the final rule may include significant additional changes, including additional exemptions and adjustments to the four key activity types and to the types of focused mitigation strategies. Finally, we note that although the proposed rule uses its own specialized language, it is ultimately remarkably similar to both standard HACCP principles and the preventive controls for human food rules. -7-
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