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Regulatory Issues

President Trump, USDA Secretary Perdue Hold Farmers Roundtable

U.S. Secretary of Agriculture Sonny Perdue today joined President Trump for a “Farmers Roundtable” at the White House to address issues facing the American agriculture community, as the President signed an Executive Order establishing an Interagency Task Force on Agriculture and Rural Prosperity. The roundtable discussion allowed representatives from all corners of American agriculture to raise concerns and share ideas, just as the task force begins its mission “to promote economic development and revitalization, job growth, infrastructure, innovation, and quality of life issues for rural America,” according to the President’s order. The session capped a busy first day in office for Perdue, who was sworn in by Associate Justice of the Supreme Court Clarence Thomas as the 31st U.S. Secretary of Agriculture before greeting employees at the U.S. Department of Agriculture (USDA) and travelling to the White House for the roundtable.

“The people who are on the front lines of American agriculture don’t have the luxury of waiting to tend to their crops and livestock, so there was no better time to convene this meeting of the minds than on my first day,” Perdue said. “President Trump has made it clear that addressing the needs of rural America will be a top priority, and the message that we want to send to the agriculture community is that we are here, we are working hard, and we are on their side.”

Farmers Roundtable

perdue-trump-farmers-roundtable_originalThe Farmers Roundtable featured more than a dozen farmers and representatives of the agriculture community who discussed with President Trump and Secretary Perdue a variety of topics, including agricultural trade, regulatory reform, rural investment and infrastructure, labor issues, and the Farm Bill. Participants in the roundtable included:

• Lisa Johnson-Billy, farmer and former Oklahoma House member, Lindsay, Oklahoma
• Luke Brubaker, Brubaker Farms, Mount Joy, Pennsylvania
• Hank Choate, Choate’s Belly Acres, Cement City, Michigan
• Tom Demaline, Willoway Nurseries, Avon, Ohio
• Zippy Duval, President of American Farm Bureau Federation and a farmer from Greensboro, Georgia
• Valerie Early, National FFA Central Region Vice President and former 4-H member, Wykoff, Minnesota
• Lynetta Usher Griner, Usher Land and Timber, Inc., Fanning Springs, Florida (also farms in the state of Kansas)
• A.G. Kawamura, Orange County Produce, Newport Beach, California
• James Lamb, Lamb Farms and Prestage Farms, Clinton, North Carolina
• Bill Northey, Iowa Secretary of Agriculture and farmer, Spirit Lake, Iowa
• Jose Rojas, Vice President of Farm Operations for Hormel, Colorado Springs, Colorado
• Terry Swanson, Swanson Farms, Walsh, Colorado
• Maureen Torrey, Torrey Farms, Elba, New York
• Steve Troxler, North Carolina Commissioner of Agriculture and farmer, Browns Summit, North Carolina

“The Farmers Roundtable provided the chance for the President to hear directly from the people on the front lines of American agriculture about what they are dealing with every day,” Secretary Perdue said. “By hosting this discussion, the president has demonstrated his awareness of the plight of American farmers, ranchers, foresters, and producers, his intention to seek input, and his determination to help.”

 

President Trump’s Executive Order

President Trump’s Executive Order established the Interagency Task Force on Agriculture and Rural Prosperity “to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities.” As Secretary of Agriculture, Perdue will serve as the task force’s chairman.

“It is in the national interest to promote American agriculture while protecting and supporting the rural communities where food, forestry, fiber, and renewable fuels are grown,” the text of the Executive Order reads. “It is further in the national interest to ensure that regulatory burdens do not unnecessarily encumber agricultural production, constrain economic growth, hamper job creation, or increase the cost of food for Americans and our customers around the world.”

The task force will examine and consider, among other issues, current barriers to economic prosperity in rural America and how innovation and technology may play a role in long-term, sustainable rural development. The panel will attempt to strengthen federalism by working with state agencies charged with implementing economic development, agricultural, and environmental programs, while also emphasizing regulatory flexibility for farms and small businesses. With a dependence on sound science, task force members will examine crop protection tools used by farmers and also address concerns regarding labor needed for livestock and year-round agricultural jobs. Additionally, the group will focus on tax policies that allow family farms to remain intact, while also protecting against federal takeover of state-adjudicated water rights, permitting and licensing, and conservation requirements beyond what is provided in law. Finally, members will look to improve food safety and the implementation of food safety laws, but also recognize the unique nature of farming and the diverse business structures of farms.

“It used to be that people in agriculture feared disease and drought as the greatest threats to their livelihoods and their mission of feeding America and the world,” Perdue said. “While those hazards remain, too often now it is the government – through interference and regulation – that poses the most existential threat to American farming. We aim to put a stop to that.”

The task force will seek input from stakeholders in the agricultural community and is required to issue a report with recommendations for legislative or administrative actions within 180 days. The task force will consist of representatives from the following cabinet agencies and executive branch departments:

• Secretary of the Treasury;
• Secretary of Defense;
• Attorney General;
• Secretary of the Interior;
• Secretary of Commerce;
• Secretary of Labor;
• Secretary of Health and Human Services;
• Secretary of Transportation;
• Secretary of Energy;
• Secretary of Education;
• Administrator of the Environmental Protection Agency;
• Chairman of the Federal Communications Commission;
• Director of the Office of Management and Budget;
• Director of the Office of Science and Technology Policy;
• Director of the Office of National Drug Control Policy;
• Chairman of the Council of Economic Advisers;
• Director of the Domestic Policy Council;
• Director of the National Economic Council;
• Administrator of the Small Business Administration;
• United States Trade Representative;
• Director of the National Science Foundation; and
• Heads of such other executive departments, agencies, and offices as the President or the Secretary of Agriculture may, from time to time, designate.

Animal Welfare Rules at Stake for Organic Livestock

By Lorrie Baumann

The U.S. Department of Agriculture is getting ready to release new regulations intended to ensure that consumers who buy organic meat, eggs and dairy products are getting products that came from animals that were treated humanely. At stake is possible adverse reaction from consumers who believe that organic certification already includes animal welfare rules – which it does – but who might be disappointed in the way that the rule is interpreted and applied by various organic producers. “This whole question of animal care and animal welfare is really important,” said Organic Trade Association Executive Director Laura Batcha, who cited a recent study funded by OTA which found that among the randomly selected consumer families with children in the home who were surveyed, the Millennial generation takes into consideration, not just possible pesticide contamination, but also animal welfare, environmental benefits and possible exposure to antibiotics as criteria for their decisions to buy organic items.

The organic industry wants to get ahead of that potential backlash by clarifying the existing standards so that the rules mean the same thing to all organic farmers and can be enforced consistently and fairly across the nation. “What we’ve heard from the National Organic Program was that they’re intending to finalize the rule by the end of the year,” said Nate Lewis, the Organic Trade Association’s Farm Policy Director.

The proposed rule is opposed by the American Farm Bureau Federation, National Cattlemen’s Beef Association, National Pork Producers Council and the U.S. Poultry & Egg Association, which argue that the Organic Foods Production Act of 1990 doesn’t give the USDA the authority to prescribe practices to promote animal welfare. “With regard to livestock, the National Organic Program’s coverage should be limited to feeding and medication practices,” Indiana Pork Advocacy Coalition wrote in its comment on the proposed rule. “Animal welfare standards not relating to feeding and mediation are not within the scope of the [Organic Food Production] Act and should be removed from this proposed rule.” Organic industry advocates are anticipating that once the final rule is issued, its opponents may sponsor a Congressional lobbying effort to attach riders onto next year’s national budget and appropriations bills that could prohibit the USDA from spending money to enforce the rule.

Lewis anticipates that under the final rule, farmers will have one year to comply with most of its provisions, three years to comply with the rules for outdoor space requirements and five years to comply with the rules about indoor stocking densities. The three-year delay for the outdoor space requirement will give farmers who need to add land to their operations enough time to meet the three-year requirement for organic certification, and the five-year delay for indoor stocking densities will give poultry farmers enough time to get their money’s worth out of the barns they’ve already built, which are, on average, seven years old. They have a depreciation life of 12 years, so a five-year delay in the requirement that they provide more space will mean that they get the full 12 years of life that are allowed by depreciation rules.

The regulations for organic livestock already require that the animals must be raised in an environment that allows animals to express natural behaviors such as spreading their wings and having the space to lie down naturally. They must be provided with adequate health care and protection from conditions that can jeopardize the animals’ wellbeing, such as predators and blizzards. The proposed rule is designed to clarify those existing requirements so they’re enforceable and transparent, “bolstering consumer confidence and strengthening the market for organic products,” according to the USDA, which published the proposed rule in April of this year.

The USDA received more than 6,000 public comments on the proposed rule, which would apply only to animals for which farmers receive organic certification, a voluntary program – it wouldn’t set up a mandatory standard for other livestock operations. According to the USDA, “the proposal aims to clarify how organic producers and handlers must treat livestock and poultry to ensure their health and wellbeing throughout life, including transport and slaughter.” It addresses the areas of the animals’ living conditions, health care, transport and slaughter. Among other things, it would clarify the existing regulation that organic livestock must have year-round access to the outdoors. This proposed rule specifies that “outdoors” means that the animals have to be allowed to go out into areas where they can see and feel the sun overhead and the soil beneath their feet – access to an open-air shelter or a porch with a concrete floor and a roof overhead wouldn’t qualify. Other provisions would set minimum standards for how much space is required for each chicken or turkey in a poultry barn, would require that organic pigs have dirt to root around in and would prohibit the transportation of sick, injured or lame animals for sale or slaughter and the use of cattle prods on sensitive parts of the animal.

The proposed rule follows recommendations from the National Organic Standards Board, a federal advisory committee of 15 citizens appointed by the Secretary of Agriculture that includes representation from the various stakeholders involved in the organic industry, including farmers, handlers, a retailer, a certifier, scientists, a natural resource conservationist and a consumer. The Board has been working on development of animal welfare standards for 10 years, Lewis said. “It’s all very transparent.”

The rule’s supporters include the OTA, which represents organic businesses, including growers, shippers, processors, certifiers, farmers’ associations and others involved in producing and selling organic products across the 50 states, and by The Humane Society of the United States, the country’s largest animal protection organization, which said in its comments on the proposed rule that “The HSUS supports higher animal welfare standards for the National Organic Program (NOP) and supports finalization of the proposed rule. In some areas, however, we advocate for stronger changes or wording clarification.”

Perdue Farms, which is the largest provider of organic-certified broiler chickens in the U.S., also supports the proposed rule, except that the company would prefer that the USDA lengthen the amount of time it would give broiler operations to reduce their indoor stocking rate from the 6 pounds (of poultry) per square foot that Perdue says is the current industry standard recognized by the animal welfare certifier Global Animal Partnership to the proposed rule’s level of 5 pounds per square feet to three years instead of the one-year timeframe specified in the rule. To adjust to the 5 pounds per square foot rule, the family farmers who supply Perdue Farms’ chickens will need to add at least the equivalent of 65 additional barns at a cost of more than $25 million to their operations. They won’t be able to do that with only one year’s notice, so if the rule goes into effect with the one year timeframe, they’d have to reduce their flocks, which would effectively reduce the country’s supply of organic broiler chicken by 20 percent, according to Perdue.

Nevertheless, “Perdue supports the NOP’s desire to strengthen what it means to carry the Organic seal. These proposed standards will significantly differentiate organic growing practices from conventional operations and meet consumer expectations that Organic production meet a uniform and verifiable animal welfare standard. We are with you; we need the 3 year timeframe to make it happen,” Perdue said in its comments to the USDA.

KIND Bars Healthy Again

By Lorrie Baumann

The Food and Drug Administration has decided that the agency will not enforce a regulation that the agency has interpreted to limit the use of the word “healthy” on food labels in a way that excludes products like some of KIND’s nut and seed bars. The new guidance from the FDA represents only the agency’s current thinking on this topic, and it’s intended to fill a gap between changing understanding about the role of fats in a healthy diet and a regulation that many said was stuck in the past.

Under the new guidance, FDA will allow foods to say they’re “healthy” on their labels if they’re not low in total fat but have a fat profile that’s predominantly mono and polyunsaturated fats or contain at least 10 percent of the daily value of potassium or vitamin D in the amount of the food that would be customarily consumed. “We’re encouraged by the speed of progress within the FDA and see this as a notable milestone in our country’s journey to redefine healthy,” said KIND Founder and CEO Daniel Lubetzky.

This change in thinking comes partly as a result of KIND’s urging the agency to take another look at the issue after the FDA sent the company a warning letter in March that the labels of its KIND Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, KIND Plus Peanut Butter Dark Chocolate + Protein and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants bars were misbranded because the labels included the word “healthy.” Under the FDA rules at that time, a food had to contain no more than 15 percent of its calories from saturated fat, and the agency noted that the products didn’t meet that criterion. The FDA had a few other quarrels with the labels – among them that KIND had listed its address as its post office box instead of its street address. KIND fixed its labels to comply with FDA requirements, resulting in a stand-down from the agency with a closeout letter on April 20. “The FDA concluded that KIND satisfactorily addressed the violations contained in the warning letter,” according to the agency.

Following receipt of the closeout letter, KIND requested confirmation that it could use the phrase “healthy and tasty” in text clearly presented as the company’s corporate philosophy rather than in the context of an actual nutrient claim for any particular product. “The FDA evaluates the label as a whole and has indicated that in this instance it does not object,” the agency decided, and then followed up with a notice that the newest nutrition research, reflected in the “2015-2020 Dietary Guidelines,” as well as a citizen petition requesting a reevaluation of regulations regarding nutrient content claims suggested that the time had come for the agency to take another look at the issue.

KIND reinstated the word “healthy” on its wrappers. “Earlier this year, the FDA closed out a warning letter issued to KIND in March 2015 affirming that we could use healthy on our wrappers again – just as we had it before – in connection with our corporate philosophy,” said Justin Mervis, KIND’s Head of Regulatory Affairs.

The agency’s next step will be a re-evaluation of the regulatory criteria for use of the implied nutrient claim “healthy” in light of the latest nutrition science and the current dietary recommendations and the seeking of input on how to update the existing regulations for this claim. ”The FDA has posed a number of important questions for comment, and in our continued efforts to advocate for public health, we’re actively convening experts to help provide answers grounded in current nutrition science,” Lubetzky said.

In the meantime, KIND won’t be taking advantage of the FDA’s decision not to enforce current rules, according to Mervis. “At the moment, we have no plans to use healthy in other contexts in reliance of the FDA’s enforcement discretion,” he said. “For us, healthy has always been more than just a word on a label – it’s a commitment to making wholesome snacks that consumers can feel good about putting in their body.”

USDA Proposes Rule Requiring Wider Access to Healthy Food

 

U.S. Department of Agriculture (USDA) Under Secretary for Food, Nutrition and Consumer Services Kevin Concannon has announced a proposed rule designed to provide Supplemental Nutrition Assistance Program (SNAP) participants increased access to healthy foods by requiring stores that accept SNAP to stock a wider array of food choices.

“USDA is committed to expanding access for SNAP participants to the types of foods that are important to a healthy diet,” Concannon said. “This proposed rule ensures that retailers who accept SNAP benefits offer a variety of products to support healthy choices for those participating in the program.”

The 2014 Farm Bill required USDA to develop regulations to ensure that stores that accept SNAP offer a broader variety of healthy food choices. The stocking provisions in the proposed rule would require SNAP-authorized retail establishments to offer a larger inventory and variety of healthy food options so that recipients have access to more healthy food choices. SNAP retailers would be required to offer seven varieties of qualifying foods in four staple food groups for sale on a continuous basis, along with perishable foods in at least three of the four staple food groups. The staple foods groups are dairy products; breads and cereals; meats, poultry and fish; and fruits and vegetables. In addition, the proposal calls for retailers to stock at least six units within each variety, leading to a total of at least 168 required food items per store.

This proposed rule is one of many ways USDA is working to expand access to healthy foods for SNAP recipients. USDA has piloted the use of incentives to purchase healthy foods at point of sale in various venues, including farmers markets and small groceries where the incentive provided for additional purchase of local produce. The 2014 farm bill provided $100 million for Food Insecurity Nutrition Incentive (FINI) grants to expand this effort, which USDA awarded to grantees in the spring and fall of 2015. USDA has also worked to increase SNAP participants’ access to farmers markets and direct marketing farmers, resulting in over 6,000 authorized locations – an eight-fold increase since the beginning of this administration.

USDA is working to ensure that access to food retailers is not hindered for SNAP participants as a result of this rule. Comments and suggestions on the proposed rule are encouraged to help USDA determine when, where, and if any flexibility should be provided to prevent reductions in SNAP client food access.

The proposed rule also underscores USDA’s authority under the Food and Nutrition Act to publicly disclose information about SNAP retailers disqualified or sanctioned for program violations. Information to be disclosed under provisions of the proposed rule would be limited to the name and address of the store, the owners’ and officers’ names, and the nature of the violation for which the retailer was sanctioned.

“SNAP violations are a serious matter,” Concannon said. “Public disclosure of this information is intended to serve as a deterrent against retailer fraud. The information would provide the public with insight into the integrity of these businesses and individuals.”

As the nation’s first line of defense against hunger, SNAP helps put food on the table for millions of low income families and individuals every month and is critical in the fight against hunger. SNAP is a vital supplement to the monthly food budgets of about 45 million low-income individuals. Nearly half of SNAP participants are children, 10 percent are elderly and more than 40 percent of recipients live in households with earnings.

SNAP plays an important role in reducing both poverty and food insecurity in the United States—especially among children. SNAP is an effective and efficient health intervention for low-income families with a positive impact on children beginning before birth and lasting beyond childhood years, improving health, education, and economic outcomes. Over 260,000 retailers nationwide are currently authorized to redeem SNAP benefits.

Comments on the proposed rule will be received for 60 (calendar) days dating from February 16. For more information see the Federal Register Notice.

 

 

FDA Listens to Raw Milk Cheese Producers

Following the release of a surprise statement by the U.S. Food and Drug Administration (FDA) expressing respect for the artisan cheesemaking community and announcing that FDA is “pausing its testing program for non-toxigenic E. coli in cheese,” FDA Deputy Director for Foods and Veterinary Medicine, Michael Taylor, met with raw milk cheese producers on February 12 to learn more about the concerns of the American artisan cheese industry.

This Listening Session was held at FDA’s Center for Food Safety and Applied Nutrition, where Taylor was joined by Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, and a number of pertinent FDA staff. In opening remarks, American Cheese Society (ACS) Executive Director, Nora Weiser, expressed that “ACS’s desire to preserve and protect traditional cheesemaking practices; ensure safe, diverse products for consumers; and work with regulators to avoid undue and unnecessary barriers to growth are shared by many allied industry groups.” Weiser went on to name over 20 industry groups that support ACS in this direction, including numerous regional cheese guilds, international cheese organizations, and other dairy industry groups.

Seven ACS members, all raw milk cheesemakers from around the country, lent their voices to advance the dialogue and understanding that are needed to ensure continued growth of the artisan cheese sector. Presenting cheesemakers focused on several key issues:

  • A need for transparency in rule-making, including the process that leads to policy change, as well as discussion with stakeholders to understand real-world implications early in the rule-making process
  • Collaborative engagement between regulators and cheesemakers including sharing of best practices, data, and science-based information
  • Concern over the uncertain climate for raw milk cheesemakers, in particular regarding potential changes to the 60-day aging rule for raw milk cheeses
  • Building trust after years of interactions that focused on enforcement of rules rather than enhancement of safety outcomes
  • Impact of the Food Safety Modernization Act (FSMA) on artisan, farmstead, and specialty cheesemakers
  • Recognition of the value and visibility of specialty cheese among consumers; its importance in strengthening rural economies; and its role in growing the entire dairy and cheese sector.

Taylor emphasized that “we have to work together, and ACS is positioned for leadership in helping FDA understand what works for your product.” He went on to explain that preventive controls (PC) are about industry knowing what is needed and assessing what history has shown is successful. In response to ongoing concerns over changes to the 60-day aging rule, Taylor assured the group that any change to the rule will not be a surprise to stakeholders, and that this open dialogue is a prelude to any future rule-making or comment process. He stated that we must “look at raw milk cheese in [the] context of the PC framework.”

Mayne agreed, stressing the importance of science. She pledged that FDA will seek outside consult from academia and science in approaching artisan cheese safety. She sees moving forward in three steps: dialogue, which was furthered at the Listening Session; data, which must be shared openly; and scientific engagement, with technical discussions informed by what cheesemakers are doing.

Spurred by Taylor and Mayne, those present agreed that the next step is to pull together a group of relevant stakeholders, technical experts, and appropriate FDA staff to convene and discuss what preventive controls might look like for raw milk cheesemaking, and how testing can play its appropriate role in verifying controls. Jeremy Stephenson, cheesemaker at Spring Brook Farm in Vermont and member of the ACS Board of Directors, captured the theme of the meeting when he stated, “Concrete, measurable steps need to be taken on the part of FDA at every level to give the cheesemaking community confidence that regulators are operating in the spirit of FSMA. We need and value good regulation both to protect our customers as well as our collective industry.”

House Votes to Ease FDA Menu Labeling Rules for Supermarkets

Food Marketing Institute (FMI) commended the U.S. House of Representatives for approving on a bipartisan basis (266-144-1) legislation that offers workable solutions to fix flaws contained in the Food and Drug Administration’s (FDA) final chain restaurant menu labeling regulations that were expanded in 2015 to apply to grocery stores.

FMI President and CEO Leslie G. Sarasin said, “The Common Sense Nutrition Disclosure Act of 2015 (H.R. 2017) is not about being ‘for’ or ‘against’ the inclusion of nutrition information on menus. Instead, the bill injects some common sense into the rule by avoiding a one-size fits all system and allowing supermarkets to provide this important information to their customers in ways that are most accessible and useful to the customers for whom it is intended.”

She continued, “FMI has fervently pursued legislation because FDA has not been able to resolve through regulation the supermarket industry’s recorded concerns and needed clarification. With the quickly approaching deadline for compliance, FMI members desperately need this helpful bi-partisan legislative resolution.”

Importantly, the bill does not exempt supermarkets or any other retailers from the nutrition information requirement.  Instead, it offers practical suggestions for menu labeling regulations in a grocery store setting along with flexible disclosure options. Provisions of the Common Sense Nutrition Disclosure Act of interest to the supermarket industry include:

  • Allowing use of a menu or menu board in a prepared foods area or next to a salad bar instead of requiring individual labeling of every item;
  • Preserving local foods or fresh items that may only be sold at one or two store or restaurant locations;
  • Allowing an establishment to take corrective actions within 90-days prior to federal, state or municipal enforcement and thereby provide some degree of liability protection; and
  • NOT modifying or weakening FDA’s or state officials’ current oversight/enforcement authority.

Sarasin commented, “We appreciate the support of such an impressive and diverse group of Members of Congress – they are true champions of solving problems for the 1,225 businesses and 40,000 stores FMI represents.”

KIND Asks FDA to Reconsider Label Requirements

 

By Richard Thompson

 

KIND bars are healthy and the Food and Drug Administration should allow the labels to reflect that, according to KIND, LLC. Last year, the FDA sent a warning letter to KIND stating that the company’s labels on four of its products were misleading, resulting in label changes to comply with FDA regulations. In December, though, KIND sent a citizen’s petition to the FDA requesting a new look at how the term “healthy” is defined. While the FDA reviews the company’s request, KIND asserts that by updating the definition of “healthy” to reflect current dietary and nutritional understanding, not only will its products warrant the use of the term, but consumers won’t continue to be confused about what foods are truly healthy to eat.

“Under FDA’s current application of food labeling regulations, whether or not a food can be labeled ‘healthy’ is based on specific nutrient levels in the food rather than its overall nutritional quality,” reads KIND’s citizen petition. “This is despite the fact that current science no longer supports those standards.”

Said Joe Cohen, SVP of Communication at KIND, “We’re proud of the ingredients in our products, which contain wholesome ingredients like fruits, nuts, seeds and whole grains.” He added, “We will continue to work with the FDA to ensure our products are in compliance with the regulations.”

“Without commenting specifically on the KIND citizen petition,” said Doug Balentine, Ph. D., Director of the Office of Nutrition and Food Labeling at the FDA, “The FDA recognizes that a great deal of scientific research has been conducted since the regulation defining the term ‘healthy’ was developed and we understand the interest in potentially redefining the term.” The agency’s ultimate determination will be based on the reevaluation of food labeling terms as additional scientific research and other data becomes available based on public health impact.

For the last 20 years, the definition of what’s healthy has been changing as more recent research shows that nutritional content is not the only indicator in determining what a healthy food is. Scientific evidence found in the U.S. Government’s “2010 Dietary Guidelines” and the “Scientific Report of the 2015 Dietary Guidelines Advisory Committee” – both of which KIND heavily refers to in its citizen petition – concludes that eating a healthy diet is constituted by the maintenance of caloric intake for a healthy weight and that a healthy eating pattern emphasizes nutrient-dense foods and vegetables like fruit, nuts and whole grains.

According to KIND, the best way to rectify consumers’ confusion over nutritional content and healthful qualities of a product would be to create a dietary guidelines statement on the packaging that informs on the “usefulness of a food, or a category of foods, in maintaining healthy dietary practices” without making an explicit nutrient content claim or a statement about a particular nutrient.

Until a decision is made, KIND says that a “dietary guidance statement” from the FDA is in order so that food companies can better label their products with information that indicates the usefulness of a food “that is not subject to the requirements in FDA’s nutrient content claim regulations unless it is an implied nutrient content claim.”

The FDA appears to disagree, and Balentine said that there is more to labeling restrictions than how one company is affected by them. For now, companies need to continue following the standards laid out by the FDA so that the term means the same thing from product to product. Said Balentine, “That’s the only way that consumers can trust what’s on the label.”

 

 

FDA Suspends E. coli Testing in Cheese

The federal Food and Drug Administration is bowing to cheesemakers who claim that in applying a standard for non-toxigenic E. coli in cheese that they claim is arbitrary and unscientific, the agency could be, in effect, limiting the production of raw milk cheeses without demonstrably benefiting public health.

“In response, we want to first acknowledge our respect for the work of the artisan cheesemakers who produce a wide variety of flavorful, high-quality cheeses using raw milk and our appreciation for the great care that many take to produce raw milk cheeses safely. We understand the concerns expressed by some cheesemakers, as well as lawmakers, and intend to engage in a scientific dialogue on these issues,” read’s the FDA’s statement announcing the change, issued on February 8.

The FDA has been testing raw milk cheeses for the presence of non-toxigenic E. coli because that’s been thought to indicate fecal contamination. The FDA says that the bacterium is used as an indicator of fecal contamination by other public health agencies in the U.S. and other countries as well as by the FDA. “The FDA’s reason for testing cheese samples for non-toxigenic E. coli is that bacteria above a certain level could indicate unsanitary conditions in a processing plant,” the FDA says.

FDA recently sampled and collected data on 1,200 imported and 400 domestic raw milk cheeses, according to the American Cheese Society. The FDA notes that the sampling it has conducted to date shows that the “vast majority of domestic and imported raw milk cheeses” are meeting the FDA’s criteria.

The FDA will also hold a listening session later this week in Washington, D.C. to hear directly from ACS raw milk cheesemakers. ACS President, Dick Roe, and ACS Executive Director, Nora Weiser, will be joined by seven raw milk cheesemakers from around the country, who will share their stories and speak to the impact of raw milk cheese regulatory changes on their businesses. The seven cheesemakers who will be addressing the FDA include: 

  • Gianaclis Caldwell, Pholia Farm Creamery and Dairy (Oregon)
  • Lynn Giacomini Stray, Point Reyes Farmstead Cheese (California)
  • Andy Hatch, Uplands Cheese Company (Wisconsin)
  • Mateo Kehler, Jasper Hill Farm (Vermont)
  • Jeremy Little, Sweet Grass Dairy (Georgia)
  • Marieke Penterman, Holland’s Family Cheese (Wisconsin)
  • Jeremy Stephenson, Spring Brook Farm and Farms for City Kids Foundation (Vermont)
Michael Taylor, Deputy Director for Foods and Veterinary Medicine, and FDA colleagues will be present to hear from these producers, and they will have an opportunity to ask questions and engage in candid dialogue.

Looking ahead, with the FSMA preventive controls rule now final, the FDA plans to take another look at what role non-toxigenic E. coli should have in identifying and preventing insanitary conditions and food safety hazards for both domestic and foreign cheese producers. Changes in the safety criteria the FDA is using will consider what the cheesemakers and other experts have to say about the use of a single bacterial criterion for both pasteurized and raw milk cheese, and the use of non-toxigenic E. coli as an indicator organism.

 

FDA Proposes New Rule for Gluten-Free Fermented Foods

The U.S. Food and Drug Administration has released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten.  Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance that:

  • the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and
  • the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and
  • where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins.  Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18. To electronically submit comments to the docket, visit www.regulations.gov and type docket number “FDA-2014-N-1021” in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number “FDA-2014-N-1021” on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

FDA Releases Foreign Supplier Verification Program Final Rule

 On November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule for Foreign Supplier Verification Programs (FSVP) for Food for Humans and Animals. This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA).  Most importers will be required to comply with FDA’s FSVP rule in May 2017 (18 months after publication).

FDA defines an FSVP as a program that verifies “that [importers’] foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.”  The FSVP rule covers importers of food and beverages, which FDA defines as “the U.S. owner or consignee of a food offered for import into the United States.” If there is no U.S. owner or consignee, the exporter’s U.S. agent is the importer.

Importers must create an FSVP for each food imported from each foreign supplier.  If they import the same food from two different suppliers, that will require two FSVPs.  One element of an FSVP is a hazard analysis.  Importers must determine potential biological, chemical, and physical hazards posed by each food they import.

Importers must also evaluate the performance of each of their foreign suppliers and use that evaluation to approve suppliers.  This includes evaluating each supplier’s history of compliance with FDA food safety regulations, “including whether the foreign supplier is the subject of an FDA warning letter or import alert.”  Importers should only import from approved foreign suppliers.

For approved foreign suppliers, importers must determine appropriate supplier verification activities, conduct those activities, and conduct corrective actions.  Examples of verification activities may include annual on-site audits of a supplier’s facility, sampling and testing, and review of a supplier’s food safety records.  Importers should choose verification activities that appropriately fit the risks of each supplier. Importers may designate a third party to conduct a hazard analysis, a supplier risk evaluation, or to perform verification activities on their behalf.

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