WASHINGTON, D.C., U.S. — The U.S. baking industry will need to make the most of a 60-day comment period concerning a Nov. 8 Federal Register notice in which the U.S. Food and Drug Administration (FDA) seeks to remove artificial trans fats from processed foods, said Theresa Cogswell, president of Baker Cogs, Inc., Overland Park, Kansas, U.S., and a consultant to the American Bakers Association, Washington, D.C., U.S.

Questions that may need answering include what is a “zero” level of artificial  trans fat in products, how sustainable is zero trans fat and how will smaller food manufacturers achieve that goal, she said.

The FDA believes partially hydrogenated oils (PHOs) no longer belong on the list of ingredients generally recognized as safe. The agency has published a Federal Register notice to that effect with the goal of removing artificial trans fats from processed foods.

If the FDA’s preliminary determination is finalized, then partially hydrogenated oils would become food additives subject to premarket approval by the agency. Foods containing unapproved food additives are considered adulterated under U.S. law, meaning they cannot be sold legally.

“If FDA determines that PHOs are not GRAS, it could, in effect, mean the end of artificial, industrially-produced trans fat in foods,” said Dennis M. Keefe, Ph.D., director of the FDA’s Office of Food Additive Safety. “FDA is soliciting comments on how such an action would impact small businesses and how to ensure a smooth transition if a final determination is issued.”

The FDA has the authority to act when it believes an ingredient is, in fact, not GRAS, and that’s what the agency said its preliminary determination is doing now with PHOs.

Information on GRAS is found under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act. The information says any substance that intentionally is added to food is a food additive that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

Partial hydrogenation brings about artificial trans fat in food products. According to the FDA, consuming trans fat raises low-density lipoprotein (LDL) or “bad” cholesterol, increasing the risk of coronary heart disease.

The American Bakers Association (ABA) said of the Nov. 8 Federal Register notice, “ABA will work with its members to review the proposal and provide thoughtful comment to FDA.”

The Independent Bakers Association (IBA), Washington, D.C., U.S., said it is reviewing the proposal and investigating the potential impact on the baking industry.

“IBA members are highly encouraged to share thoughts, opinions or questions about the proposal via e-mail, fax or mail,” the IBA said.

Cogswell said the baking industry will need to put comments together “in a very short period of time on an issue that is very important.”

She said the zero level of trans fat possibly may end up meaning less than a certain number of parts per million (ppm) or parts per billion (ppb) For example, in an Aug. 5 Federal Register notice, the FDA ruled gluten-free claims must meet requirements of less than 20 ppm of gluten.

Cogswell said smaller food manufacturers may have more trouble hitting a zero level of trans fat than larger manufacturers. The larger manufacturers already may be at the zero level with their products because larger retailers demanded it.

She said the FDA trans fat announcement “came out of left field.” She said she wondered if possibly the FDA. would have brought up the trans fat issue in a Dietary Guidelines for Americans advisory committee meeting that was cancelled because of the government shutdown.

While the FDA seeks comments on the trans fat issue, the baking industry is dealing with other issues, such as the 2015 Dietary Guidelines for Americans advisory committee and the Food Safety Modernization Act.

“The timing has just been very interesting,” Cogswell said.

Many companies already have eliminated trans fat from many products since the FDA on Jan. 1, 2006, regulated all food products and dietary supplements bearing a nutritional panel must list trans fat content. At the retail level, artificial trans fat still appears in some brands of pies in the frozen food aisle, cookie mixes, ice cream and microwave popcorn.

According to the FDA, since trans fat content information began appearing in the Nutrition Facts label of foods in 2006, trans fat intake among American consumers has declined to 1 gram per day in 2012 from 4.6 grams per day in 2003.

“That’s to be applauded for the entire food industry — and the baking industry as well,” Cogswell said. “It’s important for the industry to remember the success it has had in the last 10 years. That’s dramatic.”