Comments of the International Liquid Terminals Association
on Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance to Industry, Draft Guidance (Installment 2)
Docket No. FDA-2018-D-1398 (July 2, 2019)
July 2, 2019
The International Liquid Terminals Association (ILTA) appreciates the opportunity to comment on the second installment of Mitigation Strategies To Protect Food Against Intentional Adulteration: Draft Guidance for Industry. ILTA is the leading representative of the bulk liquids terminal industry, with more than eighty-five-member companies. Many of our member companies store food-grade products in their facilities and are therefore subject to FDA’s comprehensive food defense regulations. We are pleased to play an active role in the regulatory process and share the following comments on the latest release of guidelines for Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry.
Maintain the Non-binding and Individual Recommendations
ILTA strongly supports FDA’s commitment to keeping the guidelines as non-binding examples for food defense. A variety of factors such as facility location, already in-place facility and company procedures, and types of products being stored or processed influence a site’s natural level of security. These factors, along with others, heavily influence how companies and regulators think about food defense and the best practices for ensuring food security. Using universal practices at every facility subject to the food defense regulations would be counterproductive. Other practices or risk-based assessments which may not be outlined in the guidelines may work better for the unique features of a food storage facility. ILTA maintains that FDA should continue its policy of employing a facility-by-facility approach to food defense and applying the best tailored approached to food defense at each location. This will maximize food security while minimizing regulatory burden by considering all the individual factors at a facility and determining what is needed to protect the food supply from intentional adulteration.
Understanding Differences in Risk Assessment Criteria
In the scenario described on page 141 risk for a bulk liquid storage is assessed by the Three Fundamental Elements Vulnerability Assessment. Under FDA’s hypothetical scenario liquid storage tanks are assessed at an extreme level of vulnerability. FDA argues that a large volume of food could be contaminated with little in the way of obstacles to stop a potential bad actor. In the real world however, the level of vulnerability is substantially mitigated by facility characteristics. For example, the location of the tanks in the facility, physical barriers like fences, gates, flow controls, pumps, and spill dykes around the tanks, the size of the tanks, security details like cameras, lights, and security officers or other personnel in the facility contribute to lowering the overall risk factor. ILTA suggests FDA more explicitly state in the guidelines that no one step in the food supply chain is inherently more dangerous than any other and that each step could carry a risk. The guidelines and the examples should state that each and every point along the supply chain needs to be evaluated for risk to ensure that food security remains high.
Maintain Food Defense Plans as Sensitive Documents
ILTA recommends that the confidentiality of food defense plans and security measures at facilities be protected. To be truly effective, access to the details of food defense plans must be tightly controlled to prevent potential bad actors from exploiting them. The guidelines should clearly state that facilities have a right to determine which employees have a right or a responsibility to view their site’s food defense plan. In addition, in the guidelines FDA needs to clearly specify under what circumstances it would request access to a site’s plan as well as the procedure it would use for doing so.
ILTA supports FDA’s commitment to seeking industry stakeholders’ input on food defense and its willingness to address comments as it moves forward in preparing its final installment of this guidance. ILTA would be happy to answer any questions that may arise from our comments and we look forward to being involved further as the guideline development process moves forward.
Vice President for Regulatory Affairs, International Liquid Terminals Association