WASHINGTON — Clarification of how an exemption for warehouses/depots would work under the Food Safety Modernization Act is being sought by the baking industry, said Lee Sanders, senior vice-president for government relations and public affairs of the American Bakers Association.

Comments by Ms. Sanders were submitted to the Food and Drug Administration earlier this month in connection with public meetings dealing with preventive controls for human food facilities.

The meetings were/are being held in Washington, Feb. 28; Chicago, March 11; and Portland, Ore., March 27.

The A.B.A. first submitted a petition in July 2011 seeking an exemption for ambient temperature warehouses and depots in connection with preventative control provisions under the F.S.M.A. Ms. Sanders expressed A.B.A.’s appreciation for the administration’s response to the petition and the F.D.A. conclusion “that the hazards associated with stored packaged food can be controlled through compliance with cGMPs and the additional burden of requiring analysis and preventive controls would not result in significant public health benefits.”

In January, the A.B.A. declared a “major victory” when the F.D.A. preventive control provisions were issued with several exemptions, including one for non-refrigerated distribution warehouses such as those utilized by the baking industry.

In seeking further information, Ms. Sanders said the A.B.A. would like clarification about:

  • “A facility that manipulates pallets of food or engages in similar activities remains subject to the exemption provided the units of food remain packaged.
  • facilities that hold ingredients are subject to the exemption provided that the ingredients stay in packaged form while at the facility;
  • and, for facilities that hold food both at ambient temperature and under refrigerated conditions, F.D.A. should confirm that the modified requirements apply only to the refrigerated portion of the facility.”

Explaining its concern, Ms. Sanders pointed to the “risk-based regulatory approach” that weighs costs against benefits.

“For example, in the baking industry, each bakery feeds into upwards of 20-30 storage facilities,” she said. “A.B.A. estimates that the per facility cost of compliance with the full requirements of section 418 would be $10,000-$20,000. A.B.A. applauds F.D.A. for recognizing that these resources would be put to better use in controlling the risks that arise before the product leaves the manufacturing facility.”