IWLA Comments on FDA Proposal for Preventive Controls for Human Food

Corn-FlakesIn general, International Warehouse Logistics Association member companies support regulations such as the U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food.  In written comments to the FDA, IWLA said, “The proposed regulations are an important step forward in the continuing efforts of the food industry and the FDA to improve the safety of our nation’s food supply.  The risk-based preventive system, which underlies this proposed rule, is the right approach to address the challenges of today’s diverse and complex food supply chain.”

IWLA supported the exemption in the proposal for warehouses “solely engaged” in the storage of packaged food not exposed to the environment and the modified exemption for packaged food that required time and temperature controls (TCS).  After careful review of proposed regulations, members of IWLA’s Food Council identified several areas where revisions were needed in the proposed rule to accurately reflect the role of warehoused based 3PLs.

Members of the Food Council meet with the FDA rulemaking team in April to educate FDA and to discuss possible revisions The goal was to provide FDA with data and information to support revisions to the proposed rule.  This would clarify areas of the rule and avoid unnecessary compliance requirements once the rule goes into effect.

The following are areas that IWLA address in its written comments to the FDA.  At FDA’s request, the comments included suggested revised regulatory language.

Exemption for warehouses solely engaged in the storage of packaged products that are never exposed to the environment. As proposed, the rule exempts “facilities that are solely engaged in the storage of packaged food that is not exposed to the environment” from the requirements of the proposed rule.

However, for a multiuse warehouse, such as a warehouse that stores canned vegetables or bottled soft drinks, in addition to consumer electronics and toys, the mixed use of the facility potentially would override the exemption although there would be no increased risk to the packaged food with no exposure to the environment.

For warehouses that store packaged food product and at the request of the product owner, are required to sample for quality control and grading purposes. The exposure, though short and direct in scope, but could possibly deny the facility the warehouse exemption.

Regardless of duration, IWLA agrees that the facilities engaged in sampling activities should be in compliance with the proposed preventive control requirements of the rule (Part 117, subpart C) though the facility would not be considered under the full extent of the rule requirements as a result of these minor sampling activities.

For warehouses that handle time- and temperature-controlled foods in the warehouse. The FDA’s requirements on the storage of packaged food kept at refrigerated temperatures necessary for the maintenance of food safety including temperature controls, monitoring, verification and recordkeeping are highly necessary to the security of our food supply. As stated, the proposed rule places responsibility for determining a product’s temperature controls on the warehouse operators, rather than the food product owners.

However, IWLA members reported that they look to their clients to provide the product storage information, and are not legally able to make that determination on their own. Clarification surrounding the most responsible party for dictating time and temperature controls of a product was requested by IWLA as well as a requirement for the most responsible party provide written information to the warehouse facilities added to the rule.

When temperature controls in the warehouse have failed. The proposed rule requires a warehouse facility to “prevent the food from entering commerce,” in the circumstance that the temperature controls were not properly maintained and safety of the food products is in question.

IWLA reminds the FDA of the relationship between the warehouse facility (bailee) and client (bailor). The warehouse is responsible for the care of the product while in custody but at no point does it assume ownership over the product. This distinction makes it impossible for a warehouse operator to decide when or where the product ships from the facility. IWLA recommended that the rule should require a warehouse to notify an owner if he/she is suspicious of the product’s safety and prevent food from entering commerce given direction of the owner.

The IWLA Food Council has taken a proactive approach by raising these issues to the FDA to help modify the rule to fit the needs of a warehouse-based 3PL. The council’s aim is to educate the government agencies on the realities of today’s food supply chain and recommend the most efficient ways to ensure all parties associated with the supply chain can maintain compliance.

See the entire comment document filed with the FDA on Nov. 21, 2013, Final Comments FDA Prev Controls – Human Food.

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