Kelly Damewood – Food Safety Website Breaking news for everyone's consumption Tue, 31 Jul 2018 02:35:02 +0000 en-US hourly 1 Kelly Damewood – Food Safety Website 32 32 Safely Integrating Urban Agriculture With Urban Living Fri, 02 May 2014 05:02:11 +0000 Continue Reading]]> I was involved in urban agriculture before I heard of “urban agriculture.” In 2009, I worked on a farm and helped a community garden in Portland, OR. At that time, growing food within the city limits was not uncommon for a food-loving city like Portland. But now you can find community gardens, backyard homesteads, and even profitable farms in cities across the country. And cities are certainly eager to support urban agriculture for a number of reasons such as to educate children on nutrition, provide food to disadvantaged families, lay the foundation for healthy lifestyles, and help new farmers break into the business. So, now the term “urban agriculture” has special meaning and purpose as momentum builds around programs, funding, and infrastructure designed to facilitate food production within city limits. But, while growing food within city limits is exciting for urban dwellers, it also raises some unique food safety issues. As these projects continue to develop, it may be worthwhile to identify and consider some of the more important food safety issues associated with urban agriculture. It all starts with the soil Growing food in cities means growing food in places inherently plagued by pollution. So, while tilling up a vacant lot for a garden may sound like a no-brainer, urban growers may be surprised to find layers of deeply buried trash and random discarded items in that lot or even in their own backyards. And, while the solution to a polluted site may be as simple as digging up and throwing away trash, sometimes growers will need to take further steps to remedy the soil. For example, growers probably do not want to plant directly into soil where old rusty metals and fence posts with lead paint have been lingering for decades. In fact, a recent study by Johns Hopkins University’s Center for a Livable Future notes that gardeners can be exposed to soil contaminants in a number of ways such as ingestion, inhalation, skin contact, or consuming produce grown in contaminated soil. And soil ingestion is even riskier for children, who are more prone to putting their hands in their mouth and who are generally more sensitive to the effects of contaminants. Moreover, the Johns Hopkins study, which surveyed 70 gardeners from 15 community gardens in Baltimore, MD, found that many gardeners were naïve about how to safely grow food in potentially contaminated soil. That said, soil contamination should not by any means stop urban agriculture development. Information and guidance on soil safety is available from the Johns Hopkins Center for a Livable Future. And the U.S. Environmental Protection Agency (EPA) has a guide for redeveloping contaminated land for urban agriculture projects. Thus, food safety risks associated with urban soils can generally be remedied as long as urban farmers and gardeners are aware of the issues, use the information available, and work with cities to redevelop the land for safe food production. Caring for healthy animals As part of the urban agriculture movement, cities have begun to allow more backyard animals such as goats and chickens. But, not all city dwellers are happy about livestock on neighboring plots of land, and they generally raise concerns about unsightliness, noise, and potential property destruction. City dwellers may also be concerned about animal welfare and public health. To be clear, my opinion is that urban farmers and gardeners can absolutely keep livestock safely within the city limits. However, my experience has been that urban livestock keepers are also more likely to be novices. As a result, I have seen some unfortunate situations where people underestimate the amount of attention baby goats need or the dedication it takes to milk a goat every day. More often, I have seen the novice backyard chicken keepers who fail to give their chickens enough space, clean out manure, or to take care of anaerobic, overgrazed land. Some also underestimate the cost of feed and neglect to properly nourish their livestock. Of course, these are the worst-case scenarios. I point them out because unhealthy animals are more likely to cause foodborne illnesses. For example, a malnourished goat will shed more readily, which increases the likelihood of goat hair (which may have bacteria and feces on it) landing in the milk. In turn, if the owner consumes the milk, or shares it with his or her children, and a foodborne illness is contracted, then the goat becomes a public health risk. Many cities have regulations to keep these unfortunate husbandry practices in check. But some animal welfare advocates have suggested that urban agriculture ordinances have the potential to include more stringent animal welfare standards. So, at least from a food safety perspective, stronger animal welfare standards might make sense, not only for the sake of the animals, but also for public health. Spraying respectfully Like any neighbors, urban farmers and gardeners may find cause for disagreement. But, because urban food production is often nestled in close quarters to other landowners and leasers, urban food producers have a particular interest in what their neighbors are using to control pests, weeds, or fungal diseases. From a food safety perspective, urban growers who are weary of contamination from runoff or overspray by their neighbors might want to take precautions such as checking the community garden policies and discussing application times with neighbors. Also, growers should take heed of where children and animals play since both are sensitive to soil amendments and fertilizers. ]]> 2 Two Apolitical Ways to Support Local Food Safety Fri, 25 Apr 2014 05:02:43 +0000 Continue Reading]]> You’ve heard it before: “Support your local farmer,” “Eat local,” “Buy local,” etc. But have you heard the term “Support local food safety?” We could argue about the definition of “local” or whether you should support local foods. But, ultimately, if the phrase “Support your local farmer (or coop, or food truck, or deli, or butcher, or whatever)” resonates with you, then chances are you have devoted time, money and energy to food entrepreneurs in your community. In light of the fact that foodborne illnesses are some of the most devastating, yet most preventable, health risks in our communities today, perhaps we should also consider supporting our local food entrepreneurs by ensuring that they have everything they need to provide the safest food possible. These days, everyone wants to pick a side. Should your state pass raw milk legislation? Should your county expand cottage food laws? Should farmers in your community be exempt from Food Safety Modernization Act (FSMA) rules? In truth, safe food should not be controversial. Everyone wants to buy safe food, and everyone wants to sell safe food. So, perhaps the best and most efficient use of our time, money and energy is to consider what noncontroversial actions we can take right now on a local level to reach the common goal of safe food. For example, here are two basically apolitical and noncontroversial ways communities can step up to support local food safety. 1.  Clean up website access and streamline printed material. Put yourself in the shoes of a beginning farmer, producer, processer, brewer, coop, food truck, restaurant, etc. Now, go find what you need to be in compliance with federal, state and county food regulations and codes. Chances are that finding this information is a mess of outdated .pdfs, poorly worded manuals and vague “questions and answers” buried in a mess of hotlinks. But, if food-related diseases affect tens of millions of people and kill thousands, then why are we not doing everything in our power to make food safety information as clear, accessible, straightforward, comprehensive and streamlined as possible? Obviously, plenty of entrepreneurs have successfully navigated through the laws and information. But plenty have not. And just because a business exists does not mean it is operating to its fullest potential or even that it is in full compliance with the law (as demonstrated by frequent outbreaks and violations). Again, why not do everything we can to make compliance as simple as possible for our local food producers? At this point, after years of outbreaks and recalls, it seems inexcusable for any state or county agency, regardless of limited resources and time, to have anything less than perfect web and print food-safety content for all scales and all types of food industries. 2. Create a central, community-specific forum for information. Let’s say that I am a new, relatively inexperienced farmer who leases land on the outskirts of Portland, OR. Blackberry bushes line my field, so I decide to make jam, infused alcohol, syrups, or whatever value-added product Portland local foodies want to buy from me. And, in fact, selling this value-added product may keep me financially afloat this season. Where do I go for information? Maybe I start at the Extension Service to learn how to safely can jam. But do I look at the Oregon Department of Health website, the Multnomah County website, or even a Portland municipal website to learn if I can legally sell my jam? Does it matter if I want to sell to restaurants, stores, or at the farmers market? May I can my jam at home? Or do I need a certified kitchen? What is a certified kitchen? Should I label my jam? And if I suspect that past tenants have sprayed these blackberry bushes with pesticides, can I still harvest and sell them this year? Will my landlord be liable if my jam makes someone sick? Again, the diligent producer will find this information and sell safe blackberry jam. But a less-savvy, less-ambitious producer may cut corners and sell the jam without finding most of this information. And, before that producer’s illegal jam sales are stopped, someone could have been unnecessarily exposed to a foodborne disease. So, perhaps we should ask our community officials to work with web designers to gather all relevant food-safety information into a single forum. Food entrepreneurs could then look to their community-specific forum to find information from Extension Services, departments of health, cottage food laws, county food-handling codes, etc. And this forum should also include links and summaries of federal food-safety information as well. Ultimately, it is up to cities, towns, counties and communities to create these forums. While it does not make sense for a federal or state agency to undertake such region-specific projects, it does make sense for local food communities. Time and money aside, foodborne illnesses are too serious, and too preventable, to not implement a project that consists primarily of research and website organization. Of course, no matter how well-organized and how accessible food-safety information may be, some people will still cut corners. But, right now, the incentive to avoid digging through red tape and navigating the maze of information out there is unnecessarily high for local food producers. Update: In a recent constituent update, FDA announced a Food Code Reference System for FDA’s Food Code. This reference system may provide solutions to states and local agencies looking for streamlined, accessible information. The update states: “The FDA Food Code – a model that has been widely adopted by state, local, tribal and territorial regulatory agencies – provides FDA’s best advice for a uniform system of provisions to address the safety and protection of food offered at retail and in food service. The food code assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. Regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy. “The new Food Code Reference System, a searchable database that answers questions users may have about the Food Code and the application of its model regulations, will help to promote nationwide consistency and increase transparency about the Food Code.” ]]> 5 Controversy Continues Over Listing Evaporated Cane Juice on Ingredient Labels Mon, 21 Apr 2014 05:01:40 +0000 Continue Reading]]> Recent action by the U. S. Food and Drug Administration (FDA) may smooth the path for food manufacturers to continue to declare sweeteners derived from cane syrup (such as sugar) as “Evaporated Cane Juice” (ECJ) on food labels, at least for the foreseeable future. Last month, FDA announced that it was reopening comments for 60 days on its 2009 draft guidance for declaring ECJ as an ingredient. The announcement states that FDA reopened comments to obtain more information on ECJ and to better understand the difference between ECJ and other sweeteners. FDA’s announcement comes amid controversies over the use of ECJ in place of sugar on food labels. In Northern California, for instance, class-action plaintiffs sued food manufacturers, alleging that ECJ is another name for sugar. And, while food companies may want to use the term ECJ rather than sugar to make their products seem healthier, FDA regulations require food labels to reflect common or usual names of ingredients. Reopened Commenting May Stall or Dismiss ECJ Lawsuits So far, the most important issue in the ECJ lawsuits has been the relationship between FDA’s draft guidance and primary jurisdiction. Primary jurisdiction allows courts to dismiss a case without prejudice, e.g., without declaring one side a winner, when the issue is within the special competence of an administrative agency and the agency is taking steps to address an issue. Put differently, a court can dismiss a case on primary jurisdiction grounds and defer to an agency working on the issue. Prior to FDA reopening the commenting period, it was unclear whether courts should dismiss the ECJ cases on primary jurisdiction. On one hand, class-action plaintiffs argued that FDA has already resolved the ECJ labeling issue because it has clearly and continually held that sweeteners derived from cane syrup should not be labeled as ECJ. On the other hand, industry argued that a 2009 draft guidance, which is not binding on industry, is not a final resolution of the issue. The reopened commenting period may put a fork in the class-action plaintiffs’ arguments. In Swearingen v. Santa Cruz Natural Inc., for example, a case out of the federal District Court for the Northern District of California, Judge Susan Illston held: “In light of the March 5, 2014 [notice of reopened commenting], the Court finds it appropriate to apply the doctrine of primary jurisdiction. The notice states that the FDA has not resolved the issue of whether ECJ is the common or usual name of the ingredient at issue and that the FDA is engaged in active rulemaking on the issue.” But not all district court judges are following Judge Illston’s reasoning, according to Arnold (Arnie) I. Friede, a food and drug law attorney with Sandler Travis & Rosenberg and a former associate chief counsel in FDA’s Chief Counsel’s Office. “Given the divergence of views by different district court judges on whether ECJ cases should be dismissed on primary jurisdiction grounds, it seems reasonable to believe that the matter will be up before the U.S. Court of Appeals for the Ninth Circuit in the not-too-distant future,” Friede said. No Changes to ECJ Regulations are Likely in the Near Future FDA reopened the draft guidance for 60 days, but it is unclear what the agency’s actions on the ECJ issue will be after comments close. “The agency expects to issue final guidance, although I cannot predict a date at this time,” said Arthur Whitmore with FDA’s Office of Foods and Veterinary Medicine. Given FDA’s long to-do list, some are skeptical of whether the agency will take action to resolve the ECJ issue anytime soon. “As a practical matter, and now that it has reopened the comment period on the draft ECJ guidance, it is probable that FDA will not get to this for a very long time, if ever, particularly given other competing priorities in the food arena,” Friede said. So courts are dismissing ECJ cases on primary jurisdiction grounds, thanks to the reopened commenting period. Yet it seems that FDA will not likely resolve the ECJ issue on its own, at least for now. “As a practical matter, if courts dismiss these ECJ cases on primary jurisdiction grounds until FDA resolves the issue, the cases pretty much disappear,” Friede explained. “Depending on one’s perspective, that may or may not be a good thing.” ]]> 1 Tribes Still Troubled by FDA’s ‘Inadequate’ Consultation Policy Mon, 14 Apr 2014 05:03:32 +0000 Continue Reading]]> With less than 30 days notice, the U.S. Food and Drug Administration (FDA) finally set a date for face-to-face consultation with American Indian tribes and pueblos on its proposed rules under the Food Safety Modernization Act (FSMA). On March 27, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor sent a letter to tribal and pueblo leaders informing them of a consultation to be held on Wednesday, April 23, from 8:30 a.m. to 11 a.m. MDT at the Indian Pueblo Cultural Center in Albuquerque, NM. FDA’s stated agenda includes a discussion of seven proposed FSMA rules and its intent to create an Environmental Impact Statement (EIS) for the Produce Safety Rule. Additionally, FDA officials indicated that they would answer questions and hear feedback on all seven proposed rules. Concerns over Notice and Agenda for April Meeting Over the past 10 months, tribal representatives had asked FDA for face-to-face consultation on FSMA rules. But now that FDA has finally set a date, some representatives are dismayed by the meeting’s short notice as well as the expansive amount of material agency officials propose to cover in a single meeting. “A two-and-a-half-hour meeting in one location to digest and consult on hundreds of pages of rules is wholly inadequate,” said Janie Simms Hipp, director of the University of Arkansas School of Law Indigenous Food and Agriculture Initiative, and former senior adviser for tribal relations to Secretary of Agriculture Thomas Vilsack. A-dae Romero, an attorney specializing in food and agricultural law and a member of the Cochiti Pueblo, also expressed concern over the content and length of the meeting. She noted that, according to FDA’s stated agenda, a substantial amount of the two-and-a-half-hour meeting is devoted to background and explanations of the proposed rules, leaving little time for feedback and questions. “The amount of information that FDA proposes to cover with over 24 different tribes in New Mexico (and possibly other tribes from other states) is appalling,” said Romero. In addition to the April 23 meeting in New Mexico, FDA plans to conduct a consultation with the Navajo Nation on April 22, FDA spokesperson Catherine McDermott told Food Safety Website. Doyle Forrestal from Region VIII of the U.S. Department of Health and Human Services confirmed that a consultation meeting is scheduled for April 22 in Window Rock, AZ, at the Navajo Museum. Implementation and Formal Consultation Issues Romero and Hipp emphasized that tribes are deeply troubled by FDA’s apparent reluctance to comply with formal consultation requirements. Executive Order (EO) 13175 requires federal agencies to consult with tribes when it promulgates regulations with tribal implications. And the U.S. Department of Health and Human Services (HHS), FDA’s parent agency, has a consultation policy to implement EO 13175, which states: “Before any action is taken that will significantly affect Indian Tribes it is the HHS policy to the extent practicable and permitted by law, consultation with Indian Tribes will occur.” Despite EO 13175 and HHS’s consultation policy, FDA has only held one formal FSMA consultation thus far, which was a two-hour webinar held last November. “Meaningful consultation will mean different things to different tribes and their members, but face-to-face meetings with tribes are certainly a critical component of formal consultation,” Hipp said. FDA has also held several phone calls, webinars and meetings since developing FSMA rules. But both Romero and Hipp noted that these meetings do not constitute formal consultation. “FDA is a subsidiary of HHS. So is its sister agency, the Indian Health Service (IHS), which has a very good template for formal Tribal Consultation. But, for some unknown reason, FDA is choosing not to follow a well-established Tribal Consultation Policy of HHS,” Romero said. In addition to the lack of face-to-face consultation, Hipp pointed out that FDA did not attempt to consult with tribes during the development stage of its proposed rules. “What would have been more appropriate is for FDA to have planned consultation immediately after FSMA was enacted and coordinate a comprehensive approach to meeting their obligations. They didn’t do so, and we are now at a juncture where ‘hurry up and check the box’ is their approach,” she said. ]]> 0 Industry Associations Hope FSMA Rules Won’t Duplicate Marketing Agreements, Orders Mon, 07 Apr 2014 05:01:30 +0000 Continue Reading]]> National and regional marketing agreements and orders may give the U.S. Food and Drug Administration (FDA) some options as it continues to issue and revise rules to implement the Food Safety Modernization Act (FSMA).

In comments to the FSMA proposed rule for produce safety, a number of industry associations asked FDA to take into account food-safety programs that already exist under federal and state marketing agreements and orders.

For instance, the California Leafy Green Products Handler Marketing Agreement (LGMA) wants to ensure that FSMA does not add extra layers of inspections, audits, and documentation, which LGMA already requires of its members.

“[W]e are already verifying that members are in compliance with our standards. If our standards don’t already encompass or exceed what is in FSMA, then we will make sure they do,” said Scott Horsfall, chief executive officer of LGMA.

Horsfall further explained that his organization supports FSMA and is not asking for an exemption. Rather, LGMA is seeking more of a “partnership” with FDA.

The Almond Board of California seems to have taken a slightly different approach and has asked FDA to consider an exemption or variance for almonds.

In the Almond Board’s comments on the proposed rule for produce safety, the group notes that the California almond industry is subject to a federal marketing order issued and enforced by the U.S. Department of Agriculture (USDA). The marketing order requires a minimum 4-log reduction of Salmonella bacteria in almonds before they enter commerce.

As such, the Almond Board’s comments suggest that a rule for produce safety would be duplicative and unnecessary for almonds, which are essentially a low-risk food by virtue of the mandatory kill step requirement created and enforced by USDA.

The Scope of Marketing Agreements and Orders

Notably, marketing agreements and orders have some key differences. Membership to marketing agreements, whether at the state or federal level, is voluntary. But marketing orders set mandatory standards for all affected parties.

So, while membership with the LGMA is voluntary, once a member joins LGMA, compliance with their standards is mandatory. Notably, LGMA, in combination with Arizona Leafy Green Products Shipper Marketing Agreement, encompasses 90 percent of the leafy greens entering commercial markets.

In contrast, all almonds grown in California, which make up 99 percent of all commercial almonds in the U.S., are subject to the California almond marketing order.

What will be the Relationship between Marketing Agreements and FSMA?

At this point, FDA is not poised to create industry-specific variances and exemptions, at least not based on marketing orders and agreements.

“FDA does not intend to grant a blanket exemption to growers or signatories of marketing orders,” a spokesperson for the agency told Food Safety Website. “Alternatives to certain requirements would be permitted when adequate and documented scientific data or information support such alternatives.”

Moreover, FDA officials are both aware of, and willing to work with, existing or new compliance programs. As the FDA spokesperson stated, “[I]t is worth noting that rigorous food safety programs under national or regional marketing agreements can be an important tool for fostering compliance with the produce safety rule.”

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Food Ingredients: Trade Secrets vs. Public Disclosure Mon, 17 Mar 2014 05:01:19 +0000 Continue Reading]]> Can a food manufacturer determine that an ingredient is generally recognized as safe (GRAS) and maintain trade secrets information on that ingredient? The answer to this question may be more perplexing than Congress originally intended when it created the GRAS exemption to food additives in 1958. At that time, food ingredients were more simple and processing less obscure. But, today, many food manufacturers rely upon expensive technology and science to formulate their products. And, as food has become more complicated, the balance between trade secrets and public disclosure has become more complicated. On one hand, manufacturers must maintain trade secrets to protect their investments. On the other hand, consumers want to know what ingredients are in food products, as well as how those ingredients are made. Now, as groups such as the Center for Food Safety and the Natural Resources Defense Council turn the spotlight on the GRAS process, the balance between trade secrets and public disclosure for food ingredients may become increasingly relevant. Public Availability is Key to GRAS Determinations Not all food ingredients make it to market the same way. Most notably, the U.S. Food and Drug Administration (FDA) must review and approve food additives. In contrast, FDA does not have to review or approve GRAS substances, although FDA does have a voluntary GRAS notification process. So, before a manufacturer adds an ingredient to its product, it first determines whether the substance is GRAS — in other words, it makes a “GRAS determination.” And the key difference between food additives and GRAS ingredients is the availability of safety information; their safety standards are the same. “Ingredients added to food must be safe for use in food,” explained a FDA spokeswoman to Food Safety Website. “The difference lies in the availability of the safety information; for the use of an ingredient to be GRAS, the safety information must be publicly available and there must be consensus among food safety experts.” Thus, publicly available safety information is key to GRAS determinations. Trade Secrets Limit Voluntary GRAS Notifications  Although public availability is key to GRAS determinations, some manufacturers maintain trade secrets on GRAS ingredients. For instance, Robert McQuate, CEO of GRAS Associates, LLC, a food ingredient-consulting firm, says that about half of his clients do not voluntarily submit their GRAS determinations to FDA for review. GRAS information submitted to FDA becomes publicly available, he explains, so the main reason his clients do not submit GRAS determinations is to protect their trade secrets. “Confidentially is a significant issue, especially for smaller or medium-sized companies that are particularly sensitive to competition,” McQuate adds. What are Appropriate Trade Secrets for GRAS Ingredients? GRAS determinations are premised on public availability, yet some manufacturers still have trade secrets for certain GRAS ingredients. This somewhat paradoxical outcome may be attributed to the nature of the trade secret — that is, whether a trade secret is appropriate for a GRAS ingredient may depend upon whether the trade secret relates to the process of creating the ingredient or the actual ingredient itself. “The process is not what goes into the food. What matters is what becomes a component of the food. How you get there, that in itself is not something that is subject to the GRAS review,” says Mark Itzkoff, an attorney at Olsson Frank and Weeda who represents food manufacturers and other food interests. But another explanation for trade secrets on GRAS substances may be that some manufacturers are adding ingredients as GRAS instead of as food additives. “Food additive petition allows you to submit confidential information and to be able to keep it confidential,” explained Tom Neltner, who researches and publishes studies on the GRAS process with the Natural Resources Defense Council. “If people don’t know what it really is, it can’t be generally recognized.” FDA’s Clarification  In an email exchange, a FDA spokeswoman clarified that a manufacturer may be able to make a GRAS determination and maintain non-critical trade secrets information for that substance: “If the company’s trade secret information is critical to its GRAS determination, then the use of the ingredient is not eligible to be GRAS. . . . If the company’s trade secret information is not critical to its GRAS determination, then the use of the substance may be considered eligible for GRAS,” the FDA spokeswoman explained (italics and bold are her own). Additionally, she clarified that if trade secret information is critical, then the manufacturer has the option to submit the substance for review as a food additive, which has trade secrets protections: “Trade secret, confidential commercial or financial information submitted as part of a food additive petition is not available for public disclosure.” ]]> 2 Is the GRAS Process Broken? Wed, 26 Feb 2014 06:01:01 +0000 Continue Reading]]> From spices to preservatives, U.S. food manufacturers have access to thousands of globally sourced substances to enhance the flavor, texture, and appeal of their products. But some question whether the U.S. Food and Drug Administration (FDA) adequately regulates the safety of these abundant substances. Groups such as The Pew Charitable Trusts and the Natural Resources Defense Council (NRDC) are spearheading efforts to reform the food additives regulatory process. These groups are especially critical of the “generally recognized as safe” (GRAS) process for adding substances to food. “This system is fundamentally broken,” said Tom Neltner, who has extensively studied and issued reports on the GRAS process with Pew and who recently transitioned to NRDC. But not everyone agrees that the GRAS process is broken, such as Robert McQuate, CEO of GRAS Associates, LLC. McQuate worked directly on GRAS evaluations in FDA’s GRAS Review Branch in the late 1970s and early 1980s before launching a food ingredient consulting firm specializing in GRAS determinations. McQuate says the GRAS process does not leave the public overly vulnerable. He cites FDA’s recent proposal to de-GRAS partially hydrogenated oils (PHOs), the major source of trans fat in processed food, as a prime example of how the process does protect the public. “If FDA sees that there is an issue that adversely affects public health, even if [the substance] has previously enjoyed GRAS status, FDA does have the authority and capability to make changes,” he says. While most agree that FDA’s proposal to de-GRAS PHOs is a step in the right direction, some suggest that the time it took the agency to take action shows that the current process is flawed.  “We shouldn’t have to wait a decade for something to be officially de-GRASed when it’s been known for a decade that it shouldn’t be in the food supply,” says Neil Fortin, director of the Institute for Food Laws & Regulations at Michigan State University’s College of Agriculture and Natural Resources. To McQuate, FDA’s actions with regard to PHOs reflect diligence as well as a systematic process. He explains that safety determinations are not cut and dried. For example, unlike a straightforward test for the acidity of a solution, safety determinations require scientists to analyze an accumulation of information in a lot of different areas. That information is not easily deciphered and requires professional judgment calls, he says. But, timing aside, some have questioned FDA’s expansive reliance on professional judgment calls. While professional judgment may be a necessary part of safety determinations, some suggest FDA should also update its review process. For instance, Pew has suggested that FDA update its science, require companies to submit GRAS notifications, and implement a systematic review process for existing GRAS substances. And FDA’s expansive reliance on professional judgment compounds conflicts of interest issues as well, according to Neltner. “When a company hires people, whether consultants or employees, who make the safety decisions, then it’s a conflict of interest,” he says. Neltner emphasizes that a conflict of interest does not mean that a manufacturer is intentionally putting something dangerous on the market. Rather, the conflict is a bias that may shift the decision of whether a substance is safe. “Where you have both a lot of professional judgment and conflicts of interests, now you have a recipe for a problem, for bad decisions,” explains Neltner. “If you had wonderful data — if all these chemicals were robustly studied — then there is less room for professional judgment. But that’s not the case with GRAS.” Mark Itzkoff, an attorney at Olsson Frank and Weeda who has been a food lawyer for 25 years working on GRAS determinations, says conflict of interest is probably less of an issue than some reports suggest. In his experience, expert panels are careful with their reputation and do credible research. “Part of the system is depending upon people to do the jobs they were hired to do — to provide expert independent opinions,” says Itzkoff. In 2010, the U.S. Government Accountability Office (GAO) issued a report on the GRAS process. In addition to conflict-of-interest issues, the report noted several shortcomings of GRAS and suggested FDA update the process. Since the GAO report, FDA has reopened comments on the 1997 proposed rule, which outlines the GRAS program currently used by manufacturers. But FDA is not likely to make any changes or issue a final rule in the very near future. According to an FDA spokeswoman, FDA is aware of calls to finalize the proposed rule, but the agency is working on other priorities, including implementation of the Food Safety Modernization Act (FSMA) and nutrition-related activities. ]]> 1 What About Marijuana Food Safety? Thu, 20 Feb 2014 06:02:39 +0000 Continue Reading]]> A considerable paradox exists in U.S. food policy. Although the federal government has named food safety as a top priority, an entire pocket of the food industry remains largely unregulated by, or at least largely under the radar of, most federal agencies. That pocket is marijuana-infused food. The term “marijuana-infused food” may spark memories of brownies from days past, but, today, marijuana food is a robust industry. Now manufacturers make everything from marijuana beverages to candies and mints. In fact, significant portions of state-legal marijuana are consumed as food rather than by inhalation. Thus, marijuana-infused food is a legitimate, thriving, and growing sector of the food industry. As such, some degree of regulation is inevitable. Any food, regardless of whether it contains marijuana, poses public health risks if poorly prepared, mislabeled, or made with unsafe substances. But the difference between marijuana food and other products is that marijuana remains a federally illegal substance. And, for the most part, states have historically relied on federal law, federal agencies, and federal funding to help govern food safety. So, as states continue to legalize marijuana, they may also have to regulate in areas where they have traditionally relied on federal funding or expertise. Is Marijuana Food Safety a Federal Enforcement Priority? In 2013, Deputy Attorney General James Cole issued a memorandum, e.g., the 2013 Cole Memo, stating the U.S. Department of Justice’s (DOJ) updated policy on marijuana enforcement. The 2013 Cole Memo lists eight priority enforcement areas and suggests that DOJ will leave marijuana enforcement to states so long as states adequately regulate and enforce DOJ’s eight listed priorities to the extent necessary to ensure public safety. The eight priorities encompass obvious public safety risks such as preventing distribution to minors, drugged driving, and violence. At first glance, the list of priorities seems comprehensive. But the 2013 Cole Memo does not mention food labeling, food testing, or any kind of food safety regulation. Failing to mention food safety seems like an odd oversight for several reasons. First, marijuana food is a significant part of the marijuana industry. Second, federal agencies have announced food safety as a priority, and the U.S. Food and Drug Administration (FDA) has begun implementing the Food Safety Modernization Act (FSMA), the most comprehensive food safety law to date. Finally, DOJ announced that it was bringing criminal charges against the Jensen brothers for their cantaloupe farm’s role in the 2011 Listeria outbreak just one month after issuing the 2013 Cole Memo. This suggests that DOJ is concerned about food safety and willing to engage in these types of issues. Yet it did not list food safety as a priority for marijuana enforcement. Does it Matter if Marijuana Food Safety is a Federal Enforcement Priority? The 2013 Cole memo’s failure to mention food safety does not mean that there will be no liability for marijuana food contamination. First and foremost, all manufacturers are required to produce safe food. Second, the memo clearly emphasizes that states must ensure public safety, and food safety certainly falls within that realm. Finally, the memo is just guidance; it does not have the effect of law. And some question the strength of the guidance because U.S. prosecutors may interpret and follow the memo at their discretion. Nevertheless, the federal government clearly announced its intention to step back and let states take control of marijuana enforcement. DOJ clearly set forth what it considers top public safety priorities in relation to marijuana, but it did so without mention of food safety. Can States Adequately Regulate Marijuana Food on Their Own? Just because the federal government did not specifically tell states to regulate marijuana-infused food does not mean that states will not do so. Indeed, last year Colorado created the first comprehensive set of marijuana food regulations, and it has already implemented the first stages. So the interesting question is not whether states will regulate marijuana food. If Colorado is any indication, states will come up with some type of regulatory scheme. The interesting question is whether states are equipped to regulate food safety entirely on their own. States are not new to food safety. They have long been responsible for food safety regulations such as facility inspections and food-handling codes. But they have never been responsible for the kind of farm-to-fork regulations such as those Colorado recently passed. Indeed, the average consumer may underestimate just how much federal law is behind food products. From food processing to food labeling, federal agencies, or at least federal funding, play a pivotal role in food safety enforcement. Does Marijuana Food Safety Affect Federal Marijuana Policy? Marijuana food safety might put a hitch in DOJ’s plan to leave the bulk of marijuana enforcement to states. DOJ expects states to create “sufficiently robust” regulation and enforcement schemes. But is it realistic to expect states to create sufficiently robust regulatory and enforcement schemes for marijuana food? For now, it seems the answer may be partly related to convoluted legal issues such as preemption and federal jurisdiction. But the answer also heavily depends upon Colorado’s successes or failures. While Colorado anticipates adjustments and changes to its marijuana food regulations, it has already taken full responsibility for regulating marijuana food within the state. And, if Colorado does successfully regulate marijuana food from farm to fork with no help from the federal government, it will be a significant accomplishment and perhaps even a framework for other states with legal marijuana food industries. ]]> 4 Tracing Food Controversies Back to GRAS Mon, 10 Feb 2014 06:01:59 +0000 Continue Reading]]> Update: This article has been edited to remove references to caramel coloring. What do trans fat, caffeine and genetically modified organisms (GMOs) have in common? Each of these distinct, seemingly unrelated food controversies actually shares a common origin: the generally recognized as safe (GRAS) process. In fact, a wide range of food controversies — from sweeteners to energy drinks — are directly related to GRAS. GRAS is a legal term describing certain food ingredients that are safe enough to enter the market without prior government approval or restrictions. GRAS allows foods to enter the food system through a streamlined process. Under the streamlined process, companies, rather than the government, determine whether an ingredient is GRAS. The self-determined GRAS status of an ingredient is significant because companies can immediately put GRAS ingredients on the market; no government agency has to sign off on their safety. The majority of ingredients in the U.S. food system today are added as GRAS. As a result, the GRAS process also underlies most food-related controversies. The following list demonstrates a wide range of issues that trace back to GRAS.  A List of GRAS Controversies Trans Fat: The trans fat controversy concerns human health and heart disease. Trans fat increases the risk of heart disease, which is the leading cause of death in the U.S. Partially hydrogenated oils (PHOs), a major source of trans fat in processed foods, are GRAS. So, despite the known health risks of trans fat, companies have used PHOs in processed foods for years with little to no government involvement. Only recently has the U.S. Food and Drug Administration (FDA) proposed to step in and de-GRAS PHOs. If FDA does de-GRAS PHOs, companies will have to work more closely with FDA and obtain its approval before adding PHOs to food in the future. GMOs: GMOs are arguably the most controversial substances added to food today. The term “substance” may not adequately describe GMOs. More accurately, GMOs are the result of scientific methods used to introduce new traits or characteristics to organisms. Although studies have not linked GMOs to human heath, some consumers nonetheless believe that GMOs have negative human and environmental health consequences. Most GMO debates focus on labeling; however, GMO ingredients may be legally added to food via the GRAS process. In a 1992 Policy Statement, FDA clarified that it will treat GMO substances as “the same or substantially similar” to substances commonly found in food. Thus, if a non-GMO version of an ingredient can be added as GRAS, then, in some cases, so can its GMO counterpart. For example, soybean oil is GRAS. Thus, companies can use soybean oil derived from GMO soybeans without having to do any additional safety testing or obtain any special governmental approval. Notably, FDA does have a voluntary consultation process for GMO ingredients. So before a GMO ingredient is added via the GRAS process, the FDA has likely reviewed its safety. In the case of soybean oil, FDA has reviewed and approved the safety of GMO soybeans. Nanotechnology: Nanotechnology refers to a technology where scientists manipulate nanomaterials, e.g. materials too small to be detected by regular microscopes. Nanotechnology is an emerging technology that has many potential uses in food such as extended shelf life and flavor enhancement. So far, nanotechnology has not received the same attention as GMOs. Yet the controversies are similar. Like GMOs, studies have not definitively linked nanotechnology to human health. But some consumer groups, such as Friends of the Earth, have raised concerns about potential human and ecological consequences. Also similar to GMOs, companies may be able to add nanotechnology versions of GRAS substances without any additional review or special approval. FDA issued draft guidance for the food industry, which suggested that most nanotechnology ingredients likely do not qualify as GRAS. But the guidance is a suggestion, not a requirement. So, ultimately, companies still decide whether to treat nanotechnology substances as GRAS. If a company does determine that a substance is GRAS, then it can add it to food without informing FDA or doing any additional safety testing. Sweeteners: Today’s sweeteners come in all different forms, and each form seems to have its own controversial characteristics. For instance, High Fructose Corn Syrup (HFCS) is a liquid sweetener that has replaced traditional sugar in most processed foods in the U.S. Studies have potentially linked HFCS to diabetes. To avoid the negative press on HFCS, in 2012 the Corn Refiners Association asked FDA to change the official name of HFCS’s GRAS determination to “corn sugar.” FDA declined. Artificial sweeteners are substances that have been formulated to replace sugar; they generally contribute the same sweetness as sugar at smaller amounts. Although artificial sweeteners may have been added as GRAS substances in the past, the FDA currently regulates these substances as food additives, not GRAS. This means that FDA must approve the use of these substances before a company can put them on the market. But at least one sweetener, Stevia, is added to food as GRAS. Even the most basic sweetener, sugar, is a controversial substance directly related to GRAS. Consumer groups, especially those concerned about obesity and children’s health, have criticized the high amounts of sugar used in food today. Sugar was one of the first GRAS substances, but, over the years, companies have greatly increased the amount of sugar added to processed foods. So, while most consumers do not question the GRAS status of sugar altogether, some question whether very high levels of sugar qualify as GRAS. Salt: Salt raises blood pressure, which has a strong relationship to the risk of cardiovascular disease. Like sugar, some groups have questioned the GRAS status of salt as companies continue to add increasingly large amounts of salt to processed foods.  Monosodium glutamate (MSG): MSG is a notoriously controversial food substance, but the controversy seems to have died down over the years. MSG is the sodium salt of glutamic acid, which is an amino acid. MSG occurs naturally in many foods, but it can also occur through human manipulation. Some consumers claim to have allergic reactions to MSG, and some groups claim that MSG may contribute to neurological and physiological disorders. MSG first entered the food system as GRAS. After people raised issue with it, FDA reviewed its safety, but MSG remains GRAS. Caffeine: Like sugar and salt, the controversy surrounding caffeine is more related to the levels of use than the risks of the substance itself. Caffeine is one of the original GRAS substances, but companies are using such high levels of caffeine in their energy drinks that FDA has stepped in and is now questioning the safety of caffeine at those levels.  Another abuse of caffeine as GRAS occurred when companies mixed it with alcohol. Eventually, FDA stepped in and declared that caffeine mixed with alcohol is not GRAS and therefore requires premarket approval. This declaration led to the notorious change in the well-known Four Loko beverage. Conclusion This list of food-related controversies is not exhaustive, nor does it begin to cover every GRAS substance. But it demonstrates the reach and impact of the GRAS process on the U.S. food system, as well as links a wide range of issues to a common legal source. ]]> 7 The GRAS Process: How Companies Legally Add Ingredients to Food Thu, 30 Jan 2014 06:01:29 +0000 Continue Reading]]> Do you ever wonder how controversial ingredients end up in your food in the first place? For instance, why are energy drink companies allowed to add novel ingredients such as botanical extracts to their products? And why were companies ever allowed to use partially hydrogenated oils (PHOs), a major source of artificial trans fat, in processed foods? In other words, can companies add whatever ingredients they want? Or does the federal government have a say in the matter? If you presumed that the federal government approves and monitors food and beverage ingredients, then you are somewhat right. But you are also somewhat wrong. On one hand, food ingredients are subject to federal regulation. On the other hand, federal regulations give companies significant independence to determine which ingredients are safe. The U.S. Food and Drug Administration (FDA), the agency most responsible for food ingredients, has made several recent announcements about what companies can and cannot put into their products. Specifically, FDA is concerned about the safety of energy drink ingredients and PHOs. But to understand FDA’s announcements on these issues, it is helpful to understand the legal process surrounding food ingredients. So here is a basic breakdown of how companies legally add new substances to food and beverages.  Three Paths to Food  To most consumers, food is made with ingredients. But for the purposes of the law, food is made with substances. If a company wants to add a substance to a food or beverage for distribution in interstate commerce, e.g. across state lines, then it must comply with the Federal Food, Drug, and Cosmetics Act (FD&C). Under the FD&C, a substance legally enters the U.S. food system via one of three paths: 1) as a food additive, 2) as a listed exception, or 3) as generally recognized as safe (GRAS). 1) Food Additives A company adds a substance as a food additive when the substance is within the definition of food additive. The definition is inclusive: a food additive is any substance intentionally added to food except for specifically listed exceptions and GRAS substances. Thus, the other two paths for substances to enter the food system, e.g. via the listed exception or GRAS path, are actually exceptions to the food additive path. Of the three paths, the food additive path is the most burdensome because it requires pre-market approval. Pre-market approval means that FDA must review and approve the food additive as well as set restrictions before a company can use it. And companies bear the burden of proving the food additive’s safety. 2) Listed Exceptions A company adds a substance as a listed exception when it falls within a specific list of exceptions to the definition of food additive. Examples include pesticide chemicals, color additives, new animal drugs and dietary substances. A company must meet certain requirements before it can add these listed substances to its products. But, generally, those requirements are less onerous than the requirements for food additives. 3) GRAS Most commonly, companies add substances as GRAS. GRAS substances are substances that are “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.” Of the three paths, GRAS is the quickest way to add a new substance because it does not require pre-market review or approval. The GRAS process was created to give companies a quicker, more efficient method of adding substances to their products. The underlying rationale is that not all foods, especially those with a history of safety, require the level of FDA involvement required for food additives. The GRAS process permits companies rather than FDA to determine whether a substance meets the definition of GRAS or not. But the definition of GRAS begs key questions such as: Who are qualified experts? What is “adequately shown”? What is “safe”? And what are the “intended uses?” FDA has not clarified most of these questions. Thus, companies have a significant degree of discretion over which ingredients they add without pre-market approval because companies make their own GRAS determinations. And they make the determinations based upon a mostly unclarified standard. Two Routes to GRAS Companies determine whether a substance is GRAS via one of two available routes. The first route is available for substances that have been used in food before 1958. Substances used in food before 1958 are GRAS if there is a substantial history of consumption of the substance in food by a significant number of consumers. The second route is available if the substance was not used in food before 1958. If so, then the company makes the GRAS determination through scientific procedures. According to FDA, this route “requires the same quantity and quality of scientific evidence as required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.” FDA has not fully clarified either of these standards, so companies can, and do, use their discretion to determine whether a substance is GRAS.  One Step to Approval After a company makes a GRAS determination, it has basically has one step left before putting the substance on the market: it may voluntarily submit its GRAS determination for review. Although companies make their own GRAS determinations, FDA does have authority to review these determinations. FDA has never issued a final rule on this authority, but it did propose a voluntary review process. And, for the most part, the voluntary review process controls how GRAS determinations are made today. Here is the process: First the company makes a GRAS determination. Then it voluntarily sends FDA notification of that determination. The notification includes a description of the substance, its conditions of use, and the basis of the determination. It also includes information about the physical properties, including toxicology. Next, FDA evaluates the GRAS determination based on the information submitted. FDA may use published or unpublished studies if they are available, but it will not likely conduct its own independent research. Finally, FDA issues a letter, which will include one of three responses: 1) FDA does not question the determination, 2) FDA concludes the determination does not have a sufficient basis, or 3) FDA has ceased to evaluate the determination based upon your request. The response is not an official approval or disapproval. It is more like a suggestion: either FDA thinks the GRAS determination is OK or the agency thinks the company needs more information. While the review process is completely voluntary, FDA does have authority to de-GRAS a substance. If FDA exercises this authority, then the company must add the substance via the food additive path and obtain pre-market approval.  Summary  For the most part, substances are added to food either as food additives or as GRAS. The difference between the two paths is significant: FDA must sign off on food additives, but companies can use GRAS substances without FDA approval. Notably, companies make their own GRAS determinations, which they may or may not voluntarily submit to FDA for review. FDA can de-GRAS a substance and therefore require pre-market approval if it chooses to exercise that power. ]]> 1