ILTA comments on FDA intentional food adulteration guidance

The International Liquid Terminals Association (ILTA), whose membership includes operators of liquid terminals that store food products in their tanks, recently filed comments regarding the Food and Drug Administration’s Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration guidance document.

The FDA’s Food Safety Modernization Act (FSMA) added sections to the Federal Food, Drug, and Cosmetic Act referencing intentional adulteration, including one that addresses intentional adulteration in terms of facilities that hold food, and another, Section 420, that addresses intentional adulteration with high-risk foods. Those additional provisions were implemented through the Mitigation Strategies to Protect Food Against Intentional Adulteration rule.

The most recent supplemental guidance adds to draft guidance published in March 2019.

ILTA represents more than 85 companies operating liquid terminals in all 50 states and more than 40 countries. Member facilities provide links between all modes of surface transportation for liquid commodities, such as crude oil, petroleum products, chemicals, renewable fuels, fertilizer, vegetable oils and other food-grade materials that are central to the U.S. economy.

The association said members are committed to preventing all forms of purposeful contamination. ILTA provided comments to FDA’s 2019 Mitigation Strategies to Protect Food Against Intentional Adulteration draft guidance, and Peter Lidiak, ILTA’s vice president of regulatory affairs, said in a recent post highlighting the association’s comments, that it approves of most of the provisions in FDA’s new supplemental guidance.

Maintain non-binding and individual recommendations

ILTA agrees with the FDA’s proposed approach to allow food defense plans to be individualized for each facility. ILTA’s July 2019 comments on FDA’s second installment of Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry noted that a universal approach to food defense across all facilities is counterproductive. Where it can, the FDA supplemental guidance in chapters five, six, seven, and nine is right to provide flexibility and direction through examples for a company seeking compliance, such as different approaches to meet verification requirements in chapter six. Type of product, facility location, company procedures, and other facility details should determine best practices for protecting against intentional adulteration. Facility-specific food defense plans will maximize the overall security of the food supply while minimizing regulatory burdens.

FDA should be aware that the supplemental document uses, “guidance,” in its title but that it includes already established requirements (“must” and “shall” statements in International Organization for Standardization rules), meaning the document could be read as mandates rather than guidance. Much of the document provides examples and/or illustrations so when looking solely at “the musts,” the activities to meet the requirements are of similar burden as other standards, e.g., requiring a Corrective Action Log for actions to mitigate inadequately implemented food defense activities, verification of food defense activities, etc.  FDA should avoid repeating regulatory language so as to avoid misinterpretation or confusion over what is guidance and what is regulation.

Maintaining separate food safety and food defense plans

ILTA is concerned that the supplemental guidance establishes requirements for a food defense plan (intentional adulteration) but that a similar approach is already used in 21 CFR Part 117 for a food safety plan (unintentional adulteration). It would be difficult for a company to integrate both plans but the proposed guidance implies that there is no choice but to maintain two while separately validating, verifying, maintaining, and creating corrective actions for both documents. FDA should where possible utilize the already existing regulatory framework around food safety plans and incorporate any new or unique requirements for a food defense plan rather than replicating what is already in the food safety plans. FDA could also allow food defense plans to refer to the already vetted and approved food safety plans at individual facilities so long as they meet all requirements.

Understanding differences in risk assessment criteria

In ILTA’s July 2019 comments, ILTA expressed concern that FDA had suggested in its scenario on pg. 141 that bulk liquid storage tanks were, “significantly vulnerable,” to potential adulteration. FDA maintained that a large volume of food could be contaminated with little to stop a bad actor. ILTA disagrees with that assessment as ILTA members employ numerous layers of security to protect facilities from purposeful contamination. The location of the tanks within the facility, physical barriers such as fences, gates, flow controls, pumps, and spill dykes, the size of the tanks, and security measures such as cameras, lights, and the presence of both operations personnel and security officers at the facility all contribute to lowering the overall risk factors. Mock food recall exercises and sample shipping analyses also serve as additional safety oversight by providing a test of a site’s food defense plan in real time.

While the sample mitigation strategy management components in chapters five and six and the general mitigation strategies discussed in appendix two of the supplemental guidance discuss different types of facilities and their respective challenges, the new document fails to address why liquid terminals could still be considered at an elevated level of vulnerability. If the same measures are in place at other storage facilities and result in a lower risk rating, then bulk liquid storage should also be credited with those efforts and hold the same lower risk rating. ILTA suggests FDA more explicitly state in the guidelines that all portions of the food supply chain carry risks, but that no step is inherently more dangerous than another.

Maintain food defense plans as sensitive documents

ILTA agrees with FDA’s requirement that a facility’s food defense plan be kept secured on-site under 21 CFR 121.315 (C) and its recommendation in the supplemental document that access should be restricted to key personnel. In ILTA’s July 2019 comments, ILTA called on FDA to allow storage facilities to determine which employees should have access to its food defense plan and records, and we are pleased to see that FDA recommends the same on pg. 44 of the new guidance. ILTA also appreciates FDA’s clarification in chapter nine of the supplemental guidance regarding the circumstances under which investigators would request formal documentation of a facility’s food defense plan following a similar request in ILTA’s July 2019 comments. However, FDA’s requirement that a facility present its food defense plan and other food defense materials within 24 hours is unreasonable.  A period of 72 hours would give terminal operators adequate time to ensure that all materials provided are sufficient, accurate and protected.

ILTA supports FDA’s efforts to produce new supplemental food defense guidance and appreciates its openness to industry comments as it prepares to present its final version. ILTA is prepared to answer any questions that FDA may have about these comments.