Why new food regs only seem to be 'on hold'
by Laurie Gorton
Stalled. That’s the fate of most pending federal food regulation efforts. Depending on the outcome of the national election to be held almost a month after this issue goes to press, their fate might even be described as “in limbo.”
However, regulatory actions this year did alter school food service program rules, and the choice of some ingredients for organic foods did change. Approval of a food additive petition granted an increase in the permitted level of vitamin D. Formulators will also need to track changes in food safety regulations because they could affect sourcing, tracking and handling of ingredients.
It’s not just the feds. California’s Proposition 37 ballot initiative proposes mandatory labeling of GMO content in foods. And Canada’s food safety authority is in the middle of reorganizing its food safety regulation efforts.
Complex legalities …
Where do these rules come from? Administrative law governs the preparation of most food regs. This means that after the legislature (the US Congress) passes a bill relating to processed foods and the executive (the President) signs it into law, then executive branch agencies write the rules that put the law into effect. In rare cases, Congress pens the regulations into the actual law, as it did with the Food Allergen Labeling and Consumer Protection Act (FALCPA), which went into effect Jan. 1, 2006.
Food presents complex regulatory problems, with many cooks in the kitchen, so to speak. For one thing, the agencies writing the rules solicit public comment to make sure all stakeholders get their say. Sometimes, as now, the Administration stipulates that science must be the basis for decisions. These factors combine to slow the rulemaking process to crawl along at a snail’s pace.
Those stakeholders are important. Individual citizens and companies as well as consumer groups get their facts and opinions heard, and so do the regulated industries. Strong lobbying by associations carries a lot of weight with the agencies as well as the Administration and Congress.
… and political angles
Congress does get impatient with such delays and occasionally writes specific deadlines into laws. But even those deadlines can slip. That’s why the 2010 Dietary Guidelines for Americans were actually announced in 2011. That’s also why release of major rules implementing the Food Safety Modernization Act (FSMA), set for this July, have not proceeded beyond fairly minor matters.
And sometimes, politics interferes. Administrative law clearly gives rulemaking responsibility to the agencies, not the legislature. But Congress can haul even the most fiercely independent agency into hearings to explain its reasoning and actions. That’s why Presidential election years like 2012 rarely see announcements of major regulatory changes.
The feds aren’t the only ones regulating foods. States and cities get into the act, too. Massachusetts, for example, now requires restaurants to display in staff areas a food allergy awareness poster, developed by the Food Allergy and Anaphylaxis Network. The state law also mandates language on menus and menu boards that reads, “Before placing your order, please inform your server if a person in your party has a food allergy.” New York, NY, and St. Paul, MN, approved similar poster requirements.
Here and now
So, what are the baking and snack food industries facing in current regulatory matters?
If your company sells to school food service operators, you’ve already wrestled with the new school meal pattern that the US Department of Agriculture (USDA) put into effect July 1 for the National School Lunch Program (NSLP). Specifically, it states, “Half of grains must be whole-grain-rich.” This goes for lunch offerings for the 2012-13 school year, while breakfast foods must meet that standard for 2013-14. But by 2014-15, “all grains must be whole-grain-rich” at both breakfast and lunch. Other regulations govern the sodium and fat content of foods served at school.
The problem, of course, is how to define “whole grain rich” and how to measure “half of grains.” For now, without an official Food and Drug Administration (FDA) or USDA definition of whole grains, food processors can fall back on the advice of the Whole Grains Council and AACC International. Both organizations offer cogent descriptions of what constitutes a whole grain. As for “half of grains,” the consensus seems to be 51% of the grain content, rather than half of the total formula.
NSLP guidelines also affect competitive foods, those served in school food courts and vending machines. Proposed rules are due out soon, and observers expect them to be consistent with the 2010 Dietary Guidelines for Americans. The Snack Food Association (SFA) said it did not expect the proposed rule to be released until after November’s election.
One of the few food reg actions to see the light of day this year was the 5-year review by USDA’s National Organics Standards Board (NOSB) of nonorganic ingredients suitable for use in foods carrying organic labels.
Ingredients not certified as organic find their way into organic foods because they serve safety, nutritional or functional purposes. Action in June by NOSB removed two such substances and altered exemptions for a few others.
Of most significance to bakers, the 2012 review amended the approval of yeast to specifically indicate that yeast used in foods labeled “organic” should be certified-organic, but the board let stand the use of conventional yeast in products labeled less restrictively as “made with organic (specified ingredients or food group[s]).” The amendment said that nonorganic yeast may be used when organic yeast is not commercially available. These changes, published in the Federal Register of June 6, go into effect Oct. 21 and apply only to foods carrying “organic” labels. It covers autolysate, bakers, brewers, nutritional and smoked yeasts.
Is GRAS greener?
At one time, discussion of food regs focused almost exclusively on food additive petitions with their high threshold of scientific proof to guarantee the safety of materials new to human consumption before they could be legally used in foods. The Generally Recognized as Safe (GRAS) exemption to premarket approval covers compounds long used in foods and those supported by expert opinion as safe.
In a 1997 proposed rule, FDA switched to self-affirmation, saying it could no longer devote resources to the voluntary petition process. The agency reopened its proposal for comments in 2010 but has not yet published a final rule. In the meantime, notification has become the de facto method for GRAS declarations. At the time, FDA said its Center for Food Safety and Applied Nutrition received an average of 26 self-affirmation notices per year between 1999 and 2009.
Whether offered as petition or notification, GRAS statements require good documentation of an ingredient’s safe use, just not the clinical rigor of a food additive petition.
More D, some nano
Late this summer, FDA raised the level of vitamin D permitted in bread and baked foods to 400 IU per 100 g, up from 90 IU previously, when using vitamin-D-enriched bakers yeast. The agency granted a food additive petition submitted on behalf of the US baking industry by Lallemand, Inc., Montreal, QC, in December 2009. The approval ran in the Federal Register of Aug. 29.
A number of other food regs are moving forward. For example, FDA circulated a draft guidance document about use of nanotechnology in April. It describes factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may: affect the identity of the food substance, the safety of the use of the food substance, and the regulatory status of the use of the food substance or warrant a regulatory submission to FDA.
Although FALCPA dictated most of the regulations that apply to declaration on food packages of any allergen contents, it left up to FDA the delicate matter of setting threshold minimums. That’s where gluten-free labeling got stuck. In 2007, FDA proposed guidelines that set the limit at 20 ppm gluten in foods labeled gluten-free. Although FDA logged many public comments, it has not yet acted to finalize this threshold.
Coming, but how soon?
FSMA, signed into law in January last year, set ambitious deadlines for FDA to issue guidance documents and start rulemaking. Since then, the flow of proposed rules and guidance documents has moved forward — but at a slower pace than the legislation anticipated.
The seafood industry topped the list, followed by imported foods. Proposed rules concerning these activities have been circulating since April last year. The dietary supplement industry received a draft guidance document about expectations regarding new dietary ingredients in June 2011. Since then, the pace has slowed, with the most significant action being an interim final rule about records access that came out this February.
The Independent Bakers Asso-ciation reported to its members on July 6, “As of this week, the foreign supplier verification program was supposed to be established, and one of the law’s most important elements, the preventative controls requirement, was supposed to take effect.” Neither has been accomplished as of press time.
While not a food reg as such, user fees are a contentious FSMA issue. With Congress seeking to cut federally budgeted programs overall, the Administration’s budget calls instead for such charges to fund the sweeping new law. Industry strongly opposes these fees, which have never been charged to food manufacturers before and which industry groups describe as a “food safety tax” imposed on consumers and food makers.
In August last year, FDA published a notice about fees for facility inspection, effective in August 2012. As things now stand, no registration fees will be charged for FDA inspection of domestic food processors, but if problems are found, fees will be charged for reinspections.
SFA contacted Michael Taylor, deputy commissioner for foods at FDA, about the July 3 effective date for FSMA rulemaking, a date written into the law. He answered that the agency won’t enforce compliance with preventive controls until after final regs are issued, but he also replied that FDA is committed to “full and timely implementation of FSMA.”
Some years ago, FDA announced it would evaluate nutrition labeling for processed foods. Several front-of-pack labeling schemes have been floated, but none officially adopted as mandatory. The agency continues to study how to fine-tune the Nutrition Facts panel to better serve consumers. The most recent change added disclosure of trans fat content in 2006.
Some advocacy groups want to see “added sugars” noted on the nutrition panel. In July, FDA announced plans to conduct an experimental study on consumer response to added-sugar labeling. This idea raised biting criticism from the food industry and strenuous opposition. The American Bakers Association, for example, noted, “Labeling of added sugars would contradict FDA’s historic science-based approach to labeling.” It also questioned why FDA would proceed when the agency would not have the authority to enforce such a policy.
These are only some of the food regs recently put into effect or now pending.
Is there too much regulation of the food industry? Probably. Will a change of Administration with the fall elections cut that back? Not likely. That’s because food regulation is far more than a matter of political philosophy. It affects public health. Food is intensely personal to consumers, and even the most ardent regulation basher can take a contrarian “don’t mess with Texas” attitude when it comes to the rules governing foods on the family’s plate.