Turn to the nation's most objective and informative daily environmental news resource to learn how the United States and key players around the world are responding to the environmental...
By Steven Gibb
Aug. 12 — After blocking partially hydrogenated oils and caffeinated alcoholic beverages, the Food and Drug Administration says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” reviews.
The agency released its GRAS final rule (RIN:0910-AH15) Aug. 12 for its food additive program, switching reviews from a more formal but slower “petition-based” process to a voluntary “notification” process, which it says establishes “uniform criteria for describing the basis for a conclusion that a substance is GRAS under the conditions of its intended use.”
According to the FDA's review of its notification pilot program, “experience also has shown that streamlining our evaluation of conclusions of GRAS status will enable us to evaluate more, and higher priority, substances.”
But the change has prompted swift reaction from food safety advocates, who say industry should not be allowed to convene their own GRAS panels and then submit the results to the agency.
“FDA should not trade effective regulation for efficient regulation,” said Cristina Stella, an attorney with the nonprofit advocacy group the Center for Food Safety. “We're taking a close look at the final rule and evaluating our legal options,” she said.
The agency points to its treatment of partially hydrogenated oils and caffeinated alcoholic beverages as evidence the voluntary GRAS pilot notification program was, and will continue to be, effective.
The agency states that there “is no longer a consensus among qualified experts that PHOs are GRAS for any use in human food,” and that it “informed the companies who were marketing these caffeinated alcoholic beverages that caffeine, as used in the companies’ products, is an unsafe food additive, and therefore the products are adulterated.”
The FDA also states that since 1998, it has processed 638 GRAS notices, compared to the previous decade where the agency issued 25 GRAS affirmation petitions.
Under the former petition-based process the agency would publish an order in the Federal Register listing the substance as GRAS, and issue a corresponding regulation that prescribes the safe conditions of its use. If it determined that it was not GRAS, then the agency would notice that in the Federal Register.
Stella says advocates preferred the former process, saying at least “it required more on the part of FDA and industry” to ensure a safe food supply.
And Jessica Almy, deputy director of nutrition policy at the Center for Science in the Public Interest, says the final rule is “deeply disappointing in that they've had 19 years to address this and still haven't gotten to critical conflict of interest ground rules for industry's secret safety determinations.”
Agency spokesperson Lauren Sucher says “FDA can question the basis for an independent GRAS conclusion and take action as appropriate. The FDA has the authority to review and evaluate data on substances added to food in order to ensure safety.”
And the agency also asserts that its scientific criteria for quality data are more rigorous and transparent than under the previous program. “Unless both criteria, i.e., ‘generally available’ as well as ‘generally accepted’, are satisfied, there would be no basis for a conclusion of GRAS status.” It also eliminated the need for complete agreement among risk reviewers in the final rule, compared with the proposed rule. The final rule “uses the term ‘generally recognized' rather than the term ‘consensus,' ” according to the agency.
Calls to the Grocery Manufacturers Association for comment were not returned.
To contact the reporter on this story: Steve Gibb in Washington at email@example.com
To contact the editor responsible for this story: Larry Pearl at firstname.lastname@example.org
The final rule is available at http://src.bna.com/hHD.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)