THE Food & Drug Administration threw the food industry a curve ball last fall when it proposed a rule that would phase out partially hydrogenated oils (PHOs) from the "generally recognized as safe" (GRAS) category for human consumption.
Many affected by the rule took the opportunity to provide input during the comment period that closed earlier in March to outline some of their concerns with the rule.
The American Soybean Assn. (ASA) noted that there has been a nearly 70% reduction in the consumption of trans fats over the last decade, and the downward trend continues.
In its comments, the National Oilseed Processors Assn. (NOPA) said it believes FDA should have initiated a rule-making process if the agency wished to revoke the GRAS status of PHOs.
"A rule-making would allow FDA to consider and weigh all of the regulatory approaches at its disposal," NOPA explained.
Revoking the GRAS status of PHOs is only one of several approaches to achieve further reductions in consumption of trans-fatty acids (TFAs), a goal shared by many NOPA members, as well as the Institute of Shortening & Edible Oils (ISEO).
NOPA agreed with ISEO's statement that rather than "banning the substance PHOs as a source of TFAs, FDA should focus its regulatory attention on TFAs themselves. Alternative approaches could include limits on TFAs in food and/or food ingredients and uses of labeling policy to encourage industry to reformulate products to reduce TFAs and consumers to limit their intake of TFAs," the comments said.
If FDA does require removal of PHOs from the food supply, ISEO estimates that the industry will need at least three years to fully commercialize alternative oils capable of replacing PHOs in foods.
While some alternatives can be readied more quickly, "fully commercialized" means that a sufficient quantity of all necessary alternative oils would be available to provide year-round supplies in all regions of the country to replace all current uses of PHOs.
NOPA explained that this estimate addresses only the time needed to provide the supply of alternative oils; it does not take into account the amount of time food manufacturers would need to reformulate their products.
ASA said the soybean industry has worked to develop high-oleic soybean varieties to replace the functionality of soybean oil in certain applications like baking, frying and other food processing without adding trans fats.
Current projections from QUALISOY indicate that approximately 1.3 billion lb. of high-oleic soybean oil will be extracted from the 2016 crop and available for use by the food industry in 2017, with increasing quantities available in subsequent years.
ASA also registered serious concerns that FDA's proposal will have the unintended consequence of raising saturated fat consumption as a result of food manufacturers opting to use palm oil — which has a higher saturated fat content — to substitute for PHOs while waiting for high-oleic soybean production capacity to catch up with demand.
"This would replace our domestically grown and sustainable soybean oil with palm oil," ASA warned. "The saturated fat profile of palm oil is 6.7 g of saturated fat per tablespoon, compared to just 2 g for soybean oil. The result of this trade-off would be a 'lose-lose' for both the government and American consumers."
A further consequence of this substitution, according to ASA, is the loss of more than $1.6 billion in U.S. farmer income.
ASA noted its concern that the FDA proposal addresses the process of hydrogenation rather than the end product of the oil itself.
"We believe that the FDA's proposal is so sweeping in its application that it would stymie technological advances in oil processing that aren't even envisioned today," ASA commented. "As there is no definition of 'partially hydrogenated' and as we know that the term encompasses a whole spectrum of oils, we are concerned that new technologies would be a casualty of the FDA's proposal."
In comments on the FDA rule, the American Feed Industry Assn. (AFIA) asked for a clarification that the PHO phase-out apply only to human food and not animal feed.
"AFIA believes FDA's tentative determination on trans fats is unclear in areas as it does not verify that the language is not valid for food for consumption by animals other than man," said Leah Wilkinson, AFIA director of ingredients, pet food and state affairs. "Based on the information published in the Federal Register notice on Nov. 8, 2013, we believe that is not FDA's intention but are requesting clarification to prevent future confusion between the agency and the feed industry.
"AFIA believes the clarification we are requesting is warranted because the statutory definition of 'food additive' in the Food, Drug & Cosmetic Act applies with equal force to food for human consumption and consumption of food by animals other than man," Wilkinson added. "At the very least, we would like a letter from FDA to be placed in the rule-making docket addressing the clarification."
Defined as an ingredient by the Association of American Feed Control Officials since 1989, vegetable oils and PHOs have a long history of safe use as an animal feed ingredient for multiple species.
In addition, vegetable oils, some of which are PHOs, provide essential fatty acids in the diets and rations of livestock, poultry, aquaculture and companion animals, AFIA said.