In the Federal Register of 24 December 2013 (78 FR 78014), we published a proposal for rules to implement the provisions on intentional falsification of sections 103, 105 and 106 of the FSMA (proposed rules). We first asked the public to comment on the proposed rule by March 31, 2014. We extended the comment period on the proposed rule until June 30, 2014, in response to several requests for extensions. Section 106 of the FSMA, Protection against Intentional Falsification, amends the FD&C Act to create a new Section 420 that requires rule-making. Section 420 of the FD&C Act requires the FDA to issue regulations to protect against intentional adulteration of food. Section 420(b)(1) of the FD&C Act requires these regulations to determine how a person is to assess whether to implement mitigation strategies or safeguards against intentional falsification of food. Section 420(b)(2) of the FD&C Act requires the regulation to establish appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerabilities. Section 420(c) of the FD&C Act provides that these regulations apply only to foods where there is a high risk of intentional adulteration and where such intentional adulteration could have serious consequences for the health or death of humans or animals. Section 420(c)(1) provides that these foods include those for which the FDA has identified clear vulnerabilities. Section 420(d) of the FD&C Act limits applicability to farms that produce milk.
In addition, Section 106(d) of the FSMA creates a new Section 301(ww) in the FD&C Act to prohibit “non-compliance with Section 420 [of the FD&C Act].” We enact all provisions of the rule pursuant to Section 420 of the FD&C Act. (Comment 13) One comment indicates that the term “credible threat” is not adequately defined in the proposed rule, and that the relationship between a “credible threat” and a “reasonably foreseeable danger” is not adequately described. The same comment also notes that, since the term “credible threat” is often used to discuss sensitive or classified information, the use of this term may raise an unrealistic expectation for the exchange of sensitive or classified threat information between government agencies and the private sector. The commentary suggests either removing the term “credible threat” from the rule or including a definition with an explanation of the mechanism for exchanging information on credible threats with the food industry. Vulnerability assessment: This is the identification of weaknesses and actionable process steps for each type of food manufactured, processed, packaged or stored in the food facility. For each point, step or procedure in the establishment process, these elements should be assessed: (Response 4) We agree that the management components of the HACCP-type mitigation strategies should be provided where appropriate and necessary. As we have concluded that similar regulatory approaches are appropriate for food safety and protection, we have adopted the flexibility contained in the regulatory text for the administrative components of the FPCHP (§ 117.140(a)) as appropriate for these intentional adulteration requirements. The provisions on deliberate falsification of the management components of mitigation strategies make it clear that the management components of mitigation strategies may be necessary to ensure the proper implementation of mitigation strategies, taking into account the nature of each of these mitigation strategies and its role in the facility`s food protection system, and we have revised the proposed monitoring requirements. Corrective measures and revision to reflect these changes (see §§ 121.138, 121.140, 121.145 and 121.150).
(Answer 16) The FDA understands and accepts feedback that indicates that the training of inspectors conducting food defense inspections is essential to a consistent and appropriate system of inspection, compliance, and enforcement. We agree with the comment that special food safety training is required for inspection and compliance personnel to assess a facility`s compliance with this rule. The FDA has begun assessing its training needs for food defense inspectors. We intend that the training of our inspection and compliance staff be consistent with industry training provided by the Deliberate Adulteration Sub-Committee organized within the Alliance for Preventive Controls of Food Safety (see Comment 105) to facilitate consistent implementation of this rule. This strategy is in line with other FSMA regulations and food safety training strategies. (Answer 23) We disagree. This rule contains the measures that the FDA has deemed necessary to protect foods from intentional adulteration. To the extent that a facility is already taking the steps required by this rule, it needs to make fewer changes to its operations. These security measures should be assessed on a case-by-case basis to determine whether they constitute a mitigation strategy under this rule.
(Answer 8) The final rule requires “basic food defence activities”, as well as the provision of “intensified food defence activities” where justified. To ensure basic food defense, the rule requires a food defense plan (i.e. vulnerability assessment, mitigation strategies and procedures for food prevention, corrective actions, and review) and related measures. Those requirements are the minimum measures necessary to ensure that the risks associated with intentional falsifications intended to cause significant harm to public health are significantly minimised or avoided. Weakening these provisions, for example by eliminating the requirement to implement mitigation strategies to address significant vulnerabilities at each stage of the exploitable process, would result in insufficient food safeguards to counter the threat of a homegrown attacker. As discussed in the response to Comment 1, our interactions with the intelligence community, as well as the conclusions reached in the vulnerability analysis in collaboration with industry, identified an insider as the highest threat. (Comment 11) Some comments indicate that this rule should only come into force when there is a credible threat. One of these comments argues that the oilseed processing industry they represent has never been the target of attacks or threats and is therefore unlikely to be targets for deliberate adulteration and should be exempted from the rule unless there is a credible threat to an asset or industry as a whole. We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food from Intentional Adulteration” (AI Rule). We published the final rule in the Federal Register on May 27, 2016.
(81 FR 34166). (Answer 34) As noted in the proposed rule, based on an analysis of vulnerability assessments conducted by the FDA using the CARVER+Shock methodology, we have identified four main types of activity (bulk liquid consumption and loading; liquid storage and handling; secondary ingredient handling; blending and similar activities) as production processes that require targeted mitigation strategies.
