2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

By Robert A. Hahn

The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded.  It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans.  Interested persons may submit comments on the DGAC report until May 8, 2015.

Some aspects of the DGAC report have been controversial.

  • More than any previous committee, the 2015 DGAC wades heavily into the policy arena. Its report includes a number of controversial policy prescriptions such as the following:
    • FDA should revise the Nutrition Facts label to include a mandatory declaration for Added Sugars, in both grams and teaspoons per serving, as well as a % Daily Value based on a DV of no more than 10% of total calories (e., 50 g);
    • FDA should create a standardized front-of-pack (FOP) nutrition label that would appear on all food products and that would provide clear guidance regarding a food’s healthfulness;
    • FDA should establish mandatory national standards for the sodium content of foods;
    • Federal nutrition assistance programs, including Food Stamps (the Supplemental Nutrition Assistance Program), should be aligned with the Dietary Guidelines; and
    • Governments should use economic and tax policies to encourage the production and consumption of healthy foods and reduce consumption of unhealthy foods (g., by taxing sugar-sweetened beverages, snack foods, and desserts; by restricting marketing of certain foods to children and teens).

We expect USDA and HHS to take these policy recommendations under advisement, but not include them in the Dietary Guidelines.

  • For the first time, the DGAC report includes a chapter devoted mainly to the issue of sustainability. While the committee offers a justification for addressing environmental sustainability in a document about nutrition, some have questioned whether environmental issues are within its mandate.
  • While acknowledging that virtually all foods can be part of a healthy dietary pattern, the DGAC strongly favors a diet higher in vegetables, fruits, whole grains, low and non-fat dairy products, seafood, legumes, and nuts and lower in red and processed meats, sugar-sweetened foods and beverages, and refined grains.  There is a concern that some of the complexities of previous nutritional recommendations may be lost in this emphasis on a healthy dietary pattern.  For example, the emphasis on whole grains might lead some consumers to neglect enriched refined grains, which also play a significant nutritional role.  The emphasis on reducing consumption of red and processed meats may cause some consumers to overlook lean meat as a good source of heme iron, even though the report notes that iron is a nutrient of concern for adolescent girls and premenopausal women.

While these controversial aspects of the DGAC report have received the most attention, there are some other interesting findings and recommendations in the report worth noting:

  • While continuing to recommend reductions in intake of sodium and saturated fat, the 2015 DGAC backs away from the sharper reductions recommended by the 2010 committee. Whereas the 2010 DGAC recommended no more than 1,500 mg/day of sodium, the 2015 DGAC recommends no more than 2,300 mg/day.  Whereas the 2010 DGAC called for gradually reducing saturated fat to <7% of total calories, the 2015 DGAC only recommends reducing saturated fat to <10% of total calories.
  • The report deflates some of the recent concerns expressed by FDA and members of Congress about caffeine. The DGAC concludes that U.S. caffeine intake does not exceed what is currently considered to be a safe level in any group.
  • The DGAC concludes that there is limited and inconsistent evidence that calorie labeling on menus and menu boards affects food selection or consumption.
  • For commonly consumed fish species (g., cod, trout, salmon), the DGAC found that farm-raised seafood contains as much or more of the omega-3 fatty acids EPA and DHA as the same species caught in the wild.

The 2015 Dietary Guidelines is expected to be released in the fall.

The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling

By Marshall L. Matz, as published in Agri-Pulse

The March edition of the National Geographic Magazine, in its cover story entitled “The War on Science,” notes that “there’s no evidence that GMO’s are harmful to human health.” A recent Pew poll found that 90% of all scientists believe GMO’s are safe but only 37% of the public agrees. In short, the public is skeptical and is seeking more information about foods made with genetic engineering. We live in an era of transparency, open data and the world-wide web. It is difficult to deny consumers the right to know what is in their food. And given the safety of genetic engineering, there is no reason to block that information.

The question on the table is how to do this in a nationally-uniform, unbiased manner? To allow each of fifty states to have its own labeling scheme would be confusing, very expensive, bad public policy and, in my opinion, unconstitutional. It would be as crazy as having fifty different Dietary Guidelines or fifty different Nutrition Facts panels on the foods we buy.

Secretary VilsackAgriculture Secretary Tom Vilsack has a better idea: a smartphone application that can scan a bar code on the food package and tell the consumer what is in the product. He took his idea to Congress last month. His idea is a very modern and clever solution to address the desire for more information about the foods we consume.

There is only so much room on the food label. So, Secretary Vilsack is suggesting a symbol on the food label that connects to a database that can tell those consumers who want such information whether there is an ingredient in the food produced with genetic engineering. According to a recent edition of the Economist, “about half of the adult population owns a smartphone; by 2020, 80% will. Smartphones have also penetrated every aspect of daily life.” For those without smartphones, there could be in-store computers or scanners.

Dr. Cathy Enright, VP for Agriculture at the Biotechnology Industry Organization (BIO), posted a blog last month that said:

“I also support a right-to-know. In 21st century America, consumers are increasingly asking questions about how their food is grown and made. We all need to be working together to provide that information, in a way that doesn’t misinform consumers. Have you seen USDA Secretary Vilsack’s idea….using a bar code or other code on a food package or sticker?”

Last year, Cardinal Peter Turkson, speaking on behalf of the Vatican, said we must use biotechnology to feed the world’s expanding population, but also supported the idea of transparency to provide information to consumers who desire such information. The Vatican seems to be in agreement with the Secretary and those who believe in both the safety of genetic engineering and the moral imperative of using science to feed the hungry, but also the consumers’ right to know.

Nutrition FactsUSDA and HHS will issue a new edition of the Dietary Guidelines for Americans later this year. The Dietary Guidelines Advisory Committee and the FDA are seeking to put more information on the actual food label. It is time to use technology to expand the physical size of the label.

Every industry seems to be using technology to the maximum possible extent. The food industry should follow suit. There are questions that would still have to be resolved as with any app: who would maintain the data base? What would be the definition of genetic modification and would there be some threshold that triggers the GE designation? What happens with foods that used a GE ingredient where it was then processed out of the product and there is no trace in the final food?

These are all challenging questions that would have to be resolved. But this much is clear, there must be federal preemption of state labeling schemes and a uniform national system established. To date, the labeling campaign has been pushed as an attack on genetic engineering as a part of the larger war on science. Information should be provided, not as a scare tactic and warning, but just as factual information for those who care.

Perhaps there is a better idea than the Vilsack App, but this idea sure deserves serious attention. On March 5th, at the House Agriculture Appropriations Subcommittee hearing to review the FDA budget, Dr. Hamburg reiterated that FDA does not see mandatory labeling as appropriate if there’s not a significant change to the product. If the process changes the nature of the product, then it would have to be labeled. She also said FDA supports individual companies that want to voluntarily label products and plans to issue a guidance to guide them in the near future. Dr. Hamburg should include the Vilsapp as a way of providing consumer information and include it in the guidance that FDA issues.

The Wall Street Journal recently published a guide to some of the terms being used on supermarket egg cartons. They include Organic, Cage-Free, Free-Range, All Natural, Pasture Raised, and Vegetarian Fed and Omega-3. The Vilsapp could help the confused consumer better understand these terms as well.

In short, the Vilsapp is a creative idea that could provide the transparency deemed important by consumers and also preempt the need for state legislation. The need for state preemption is paramount and was emphasized by all of the witnesses at the House Agriculture Hearing on March 24th.

Dr. Nina Fedoroff, the Senior Science Advisor at OFW Law, concluded her testimony with the following: “We will need to produce more crops per drop of water and square meter of land” in order to feed 9 to 10 billion of people. Genetic modification is not a magic bullet but is safe and an important part of the arsenal needed to defeat food insecurity.

A patch quilt of different state labeling schemes would be a barrier to global food security. Transparency and full disclosure is reasonable but it must be done with a national system that is based on sound science and provides objective information.

Mr. Collin Peterson, the Ranking Member, summed it up best: “When it comes to labeling, we need to be able to find a smart way to balance the consumer demand with what we know about the safety of the foods that our farmers produce.” Sounds like a Vilsapp.

Marshall Matz, formerly Counsel to the Senate Select Committee on Nutrition and the Senate Committee on Agriculture, specializes in agriculture and nutrition at OFW Law.

Dietary Guidelines – Confused About Caffeine

By OFW Law founding principal Richard L. Frank, sitting in for former USDA Secretary John R. Block

The news wires have been buzzing lately about the recently released scientific report of the Dietary Guidelines Advisory Committee. One of the hottest topics for discussion is how out of step the report is on a number of issues, including the Committee’s dive into political matters like sustainability, soda taxes, and “added sugar” labeling. These topics are outside the jurisdiction of the Dietary Guidelines and should be addressed by Congress or the FDA.

Today, I want to discuss caffeine consumption. Caffeine is something that has never been addressed before by the Dietary Guidelines for Americans and probably for good reason. First, caffeine is safe…and safety is outside the mandate of the Dietary Guidelines. It is a topic that fits firmly within the jurisdiction of the FDA. Secondly, America seems to know what it’s doing when it comes to caffeine. 85% of Americans consume caffeine every day – and they have done so safely for generations.

In the Committee’s conclusions on caffeine, they suggest that 3 to 5 cups of “Morning Joe” are just fine – up to a moderate intake level of 400 milligrams per day for healthy adults. Inexplicably, however, they seem to suggest that energy drinks with the same amount of caffeine should be avoided.

The Committee’s approach is troubling for a number of reasons, the least of which is that many coffee house chains serve coffee beverages that contain twice as much caffeine per fluid ounce as a standard energy drink. A typical small can of a leading energy drink contains 80 mg caffeine, which is roughly the same as a regular cup of coffee or a 20 ounce bottle of cola.

Why is the Committee treating caffeine in coffee differently from the caffeine in energy drinks? This is puzzling when we consider that caffeine is caffeine is caffeine – whether found in coffee, tea, cola, or energy drinks.

The report acknowledges that the largest sources of caffeine among both adults and children come from coffee, tea, and soda. So why is caffeine in coffee okay, while tea and soda are ignored and energy drinks are vilified? Possibly it’s politics!
The Dietary Guidelines should provide a practical and achievable set of dietary and nutrient recommendations, based on balance, variety, and moderation. It should not delve into political topics that are outside its mandate.

If the Dietary Guidelines are to address topics like caffeine, it should be done holistically and in an unbiased way. Consumers need to understand caffeine in context and be provided information with respect to all sources to enable them to make informed dietary decisions; otherwise they will get confused.

Let’s hope that the USDA and HHS take the lead on the important task of finalizing the 2015 Dietary Guidelines for Americans in a scientific, rather than a political and an emotional, way.

Who Regulates the Advertising of Your App?

By Mason Weeda

We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app.  The Federal Trade Commission (FTC) may also be watching how you promote your app.  In fact, on February 23, 2015 the FTC announced that it reached settlements with two firms marketing melanoma detection apps.  The agency was unable to reach a settlement with a third developer and intends to pursue a judgment through litigation.  Both apps claimed to provide an “automated analysis of moles and skin lesions for symptoms of melanoma and increase consumers’ chances of detecting melanoma in its early stages.”  In sum, the FTC alleged in its complaints that the mobile app developers lacked adequate evidence to support such claims.

FTC authority coincides with other agencies in many respects, see e.g. here, and here.   And there is nothing really new with the FTC taking action against mobile app developers.  In 2011, the FTC filed complaints against developers of “acne cure” apps that claimed to treat acne through a light emitted from the device if you held it close to your face. The FTC alleged that those claims were unsubstantiated.

The FTC regulates many types of advertising and protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. Under the Federal Food Drug and Cosmetic Act, the Food and Drug Administration (FDA) has regulatory authority over the labeling of all medical devices. Labeling includes any “written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article…”   Sections 502(q) and 502(r) of the FD&C Act authorize FDA to regulate the advertising of certain devices, which are known as restricted devices.  Section 502(r) also states that restricted devices are not subject to FTC’s broad authority over advertising under 15 U.S.C. § 52-55.

Dr. Jeffery Shuren, Director of FDA’s Center for Devices and Radiological Health, summarized the FTC/FDA division of authority best: “FDA regulates the advertising of restricted medical devices while the FTC regulates the advertising of non-restricted devices.”   A device becomes a “restricted device” when:

  1. FDA by regulation restricts a device to sale, distribution or use only upon the authorization of a practitioner licensed by law to administer or use such device, or upon other conditions that FDA prescribes in the regulation, if FDA determines that there cannot otherwise be reasonable assurance of the device’s safety and effectiveness.  (Note that prescription devices may or may not be restricted devices).
  1. FDA requires, as a condition of approval of a Class III device, that its sale and distribution be restricted, but only to the extent that the sale and distribution of the device may be restricted by a regulation.
  1. FDA establishes, as part of a performance standard promulgated in accordance with section 514(b) of the FD&C Act, requirements that restrict  the sale and distribution of a device, but only to the extent that the sale and distribution of the device may be restricted by a regulation.

Based on FTC’s description of the melanoma detection apps, it appears that the app developers are likely required to obtain premarket approval (PMA).  FDA’s Mobile Medical Application Guidance provides that the Agency intends to actively regulate mobile apps that “use the mobile platform’s built in features, such as… a camera, to perform medical device functions.”  The melanoma apps use the device platform (i.e. the camera) to collect and review an image for use in providing a diagnosis.   Furthermore, this type of app appears to perform the same medical device functions of an “optical diagnostic device for melanoma detection” which FDA classifies as Class III under product code OYD, which requires a PMA.  In addition, FDA premarket approval letters indicate that “optical diagnostic devices for melanoma detection” are restricted devices pursuant to 21 C.F.R. § 801.109.

It appears that FDA would, upon premarket approval, treat these types of melanoma apps as restricted devices and therefore would have authority to regulate the app’s advertising.  However, it remains that these app developers never submitted a premarket application or received premarket approval from FDA.  Therefore, the Agency was not able to require, as a condition of approval, that their sale and distribution be restricted.  As such, FDA does not have the ability to regulate the advertising of these apps.

The instant FTC complaints and settlements appear relatively minor compared the potential FDA issues involving marketing a product without approval. More importantly, FDA is in no way foreclosed from taking action so we will see if and when FDA acts in the coming months against the app developers.

No Horsing Around – Nevada Federal Judge Dismisses Burro Suit Against Interior Dept.

By Stewart D. Fried

The serious environmental problems caused by unchecked wild horse populations on western rangelands are well known to state and local governments, Native American tribes, ranchers and farmers.  Efforts, however, to prompt the U.S. Department of Interior (“Interior Dept.”) and its Bureau of Land Management (“BLM”) to address widespread environmental damage and other impacts caused by wild horse overpopulation have been largely unsuccessful.  Environmental and other issues caused by thousands of wild horses on federal lands are perhaps most pronounced in Nevada.  The Silver State is estimated to be home to nearly half of the country’s wild horse population.   Because BLM is not doing enough to address exponential population growth, wild horse herd sizes are increasing by 20% annually.

The Wild Free-Roaming Horse and Burros Act, 16 U.S.C. §1331 et seq., (“Wild Horse Act”) governs the Interior Dept.’s duties with respect to wild horses on federal lands.  The Wild Horse Act mandates that the Interior Dept. protect and manage wild horses and burros, including the responsibility to “maintain a current inventory of wild free-roaming horses and burros on given areas of the public lands.” 16 U.S.C. §1333(b)(1).  Under the Wild Horse Act, a “natural ecological balance” among wild horse and burro populations, domestic livestock, wildlife and vegetation must be achieved.

In order to achieve that balance, the Interior Dept. determines whether Appropriate Management Levels (“AMLs”) should be achieved by the removal or destruction of excess animals.  BLM describes as “the number of wild horses and burros which can graze without causing damage to the range.”  In establishing AMLs, BLM relies on studies of grazing utilization, trends in range condition, weather data and other factors.  BLM also takes into consideration populations of wildlife, permitted livestock and wild horses and burros in the area. Id.  BLM sets AMLs following public involvement through an in-depth environmental analysis and decision process. Id.  In enacting the Wild Horse Act, Congress expressly required the Interior Dept. to “immediately remove excess animals” from the range so as to achieve AMLs when it is determined that “an overpopulation exists on a given area of the public lands and that action is necessary to remove excess animals.”  16 U.S.C. §1333(b)(2).

With these seemingly clear statutory mandates in mind, several Nevada counties, farming and ranching associations and other interested parties have attempted, with limited success, to prompt BLM to address the problem of wild horse overpopulation on Nevada rangelands.  Based on BLM’s inaction and ever-worsening damage to public resources and increased threats to private water rights, the Nevada Association of Counties and the Nevada Farm Bureau (“Counties”) sued the Interior Dept. in federal court in Reno during December 2013, alleging constitutional violations and seeking judicial review under the Administrative Procedures Act (“APA”).

On February 12, 2015, Federal District Court Judge Miranda Du issued her opinion in Nevada Association of Counties v. Interior Dept., dismissing the Counties’ complaint with prejudice.  Judge Du concluded that she lacked subject matter jurisdiction over the case because the Plaintiffs’ amended complaint “failed to identify a final agency decision” by BLM that was being challenged.  The Court noted that the Wild Horse Act does not provide for a private cause of action and that any challenge to federal action brought under the APA must be based either on “final agency action that warrants judicial review or any inaction that may be compelled.”  Order, at 4.

The crux of the Court’s decision was founded on its determination that the plaintiffs “sought review of flaws in the entire program” to “compel compliance with the Act and refashion [BLM’s] management of wild horses and burros in Nevada.” Id., at 7.  In describing the Counties’ lawsuit as a “programmatic attack” on the entire BLM program, the Court focused on the Plaintiffs’ failure to allege that BLM failed to set “a single AML or inventory” or any another specific final agency action.  Judge Du also dismissed the Counties’ constitutional claims because the amended complaint failed to allege a property interest that was taken or otherwise affected by BLM’s mismanagement of wild horses, or how BLM’s responses to the Plaintiffs’ notices that wild horses were outside designated management areas or were interfering with water access fell short of due process.

The dismissal of the Counties’ lawsuit is the latest chapter in a lengthy and still unfinished book about wild horses on the Western range.  Although BLM has removed over 100,000 wild horses during the past decade from federal lands, the equine overpopulation problem continues to expand in every state and most tribal lands from the Cascades to the Mexican border.  Congress has again foreclosed horse slaughter as an option for reducing herd size, despite a thriving market abroad and several domestic facilities that received (or were eligible to receive) FSIS grants of inspection during 2012.  While an appeal of the decision is possible, this is likely an uphill battle it would need to be filed in the generally unfriendly Ninth Circuit Court of Appeal.

In light of the District Court’s decision, states, tribes and other stakeholders may need to go back to the drawing board.  Because Judge Du took issue with the Plaintiffs’ failure to identify particular BLM decisions with respect to specific inventories or AMLs, next steps could include identification of specific herd management areas where BLM has failed to conduct inventories or set AMLs or identifying herd management areas where severe erosion and other ecological damage exists, conducting wild horse herd population surveys in those areas (assuming data does not already exist), and then filing petitions with BLM seeking the establishment of inventories or AMLs and demanding that the Bureau conduct removal activities in accordance with the Wild Horse Act.  This will take considerable time and effort, all while wild horse populations will continue to increase and environmental and other harms from equine foraging, especially to water quality, will not be addressed.  What is clear is that there likely will be no swift resolution to the environmental and animal welfare problems associated with this hotly-debated symbol of the West.

A copy of the District Court’s decision in Nevada Association of Counties v. U.S. Department of Interior can be found here.

So Which USDA Regulations Would You Like to Change?

By Roger R. Szemraj

We know that people often disagree with any number of the different regulations that have been put in place for the administration of USDA’s programs – agricultural program operations, nutrition programs, rural development programs, energy programs, conservation programs, and the list goes on.

Well, now is the chance to speak up.

In the Federal Register for Tuesday, March 17, USDA asks for “…public comment to assist in analyzing its existing significant regulations to determine whether any should be modified, streamlined, expanded, or repealed.”   The notice does go on to suggest several questions for consideration:

  • Which regulations have become outdated, and how can they be modernized to accomplish the regulatory objectives better?
  • Do agencies currently collect information that they do not need or use effectively to achieve regulatory objectives?
  • Which regulations, reporting requirements, or regulatory submission or application processes are unnecessarily complicated or could be streamlined to achieve regulatory objectives in ways that are more efficient?
  • Which regulations, submission and application processes, or reporting requirements have been overtaken by technological developments?
  • Can new technologies be used to modify, streamline, or do away with existing regulatory or reporting requirements?
  • Which regulations provide examples of how regulatory flexibility techniques have worked well? In general, who has benefited from the regulatory flexibility?
  • What types of regulatory flexibility have worked well?
  • What regulations would be improved through the addition of regulatory flexibility techniques?
  • How would regulatory flexibility lower costs and burden? How would regulatory flexibility improve benefits?

USDA goes on to say, “This is a non-exhaustive list that is meant to assist in the formulation of comments and is not intended to limit the issues that commenters may choose to address,” and part of a “continuing process of scrutiny of regulatory actions.”

Comments are requested on or before May 18, 2015.  So have at it!

Trade is Critical to Rural America; Agriculture is Key to TPA

By Marshall L. Matz and former USDA Secretary John R. Block

Trade policy may present an opportunity for the Obama Administration and the Congress to work together in a bipartisan manner but it is sure not unanimous.   While Agriculture Secretary Vilsack and U.S. Trade Representative’s Chief Agriculture Negotiator Darci Vetter are making the case for Trade Promotion Authority (TPA), Senator Ron Wyden, the Senior Democrat on the Senate Finance Committee, is arguing for more negotiating transparency to be required by TPA before signing on.  In addition, while there is very strong support for TPA in the agriculture community, it is not unanimous.

TPA is a critical tool in the effort to complete the 12-country Trans-Pacific Partnership (TPP), and down the road the European Union Transatlantic Trade and Investment Partnership (TTIP) negotiations.  These trade agreements support U.S. jobs while helping American agriculture compete more successfully in the global marketplace. TPA will help ensure that America’s farmers, ranchers, and food processors receive the greatest benefit from the TPP, TTIP, and future trade negotiations.

These agreements could have an important economic impact on specific commodities and American agriculture more generally.  Secretary Tom Vilsack recently spoke out on the importance of trade to agriculture:

“It is no surprise that agricultural producers are joining the chorus of voices calling on Congress to renew Trade Promotion Authority. The past six years were the strongest period for agricultural exports in the history of our nation, despite the fact that many other countries’ markets are not as open to American products as our markets are to theirs. New trade agreements that help level the playing field for agriculture will build on the success we’ve seen in the agricultural economy since 2009 and help producers create more new jobs across the country. What makes the agricultural economy stronger makes our entire nation’s economy stronger. It is imperative that Congress act on Trade Promotion Authority early this year.”

Fiscal years 2009 to 2014 represented the strongest six years in history for U.S. agricultural trade, with U.S. agricultural product exports totaling $771.7 billion. Agricultural exports last fiscal year reached $152.5 billion, the highest level on record and supported nearly one million jobs here at home, a substantial part of the nearly 11.3 million jobs supported by exports all across our country.

USTR’s Office of Agricultural Affairs has overall responsibility for U.S. government trade negotiations and policy development and coordination regarding agriculture.  Darci Vetter and other USTR officials, works closely with relevant U.S. government agencies, particularly USDA, as appropriate.

In a recent letter to Congress a broad range of groups outlined the benefits of trade as follows:

“As a result of trade agreements implemented since 1989, when the U.S. began using bilateral and regional trade agreements to open foreign markets to our goods, U.S. agricultural exports have nearly quadrupled in value and now stand at a record $152.5 billion (fiscal 2014).  During that period, earnings from U.S. agricultural exports as a share of cash receipts to farmers have grown from 22 percent to over 35 percent.

“These farm and food exports have a positive multiplier effect throughout the U.S. economy.  Every $1 in U.S. farm exports is estimated to stimulate an additional $1.27 in business activity.  Off-farm activities and services include purchases by farmers of fuel, fertilizer, seed and other inputs as well as post-production processing, packaging, storing, transporting and marketing the products we ship overseas.  Exports of $152.5 billion in fiscal 2014 therefore generated another $194 billion in economic activity in the U.S., bringing the total benefit to the economy to $347 billion.”

The chart below shows the percentage of production that was exported, by commodity, in the most recent year for which there are numbers:

Commodity Percent
Wheat 50%
Corn 11%
Soybeans 62%
Beef 14%
Pork 26.5%
Diary 15.4%

In short:

1. Exports are critical to the agriculture economy; and

2. Agriculture’s political power may be the key to passage of TPA and the trade agreements being negotiated.

While only one percent (1%) of all Americans farm and the conventional wisdom is that agriculture has lost power, production agriculture still has an important role to play in making the case for expanded trade and TPA, as the farm economy has a major impact on all those who live in rural America.  From farm implement dealers to car dealers to rural bankers and the local coffee shops, what is good for farmers is good for rural America.

TPA gives us an opportunity to put economics before politics.  The farm groups who have signed the TPA letter to Congress are well positioned to make the case for expanded trade with both Democrats and Republicans bridging the urban-rural divide in America.

Marshall Matz specializes in agriculture policy at OFW Law.  He was formerly (Democratic) Counsel to the Senate Committee on Agriculture, Nutrition and Forestry.  John R. Block was Secretary of Agriculture under President Reagan.

The Drones are Coming! FAA Releases Proposed Rule on Small Unmanned Aircraft Systems

By John G. Dillard

Mention the word “drone” and most people think of our nation’s military activities in the Middle East. However, over the last few years, unmanned aircraft is finding its way into new civilian applications. Small drones, which are also known as unmanned aerial vehicles (UAVs) or small Unmanned Aircraft Systems (sUAS), when equipped with sophisticated cameras, can be invaluable surveying tools.

Agriculture is one such industry that is particularly suited to benefit from drone technology. The rise of precision agriculture and prescriptive planting places a high premium on accurate, real-time data. Farmers and crop consultants have typically relied on satellite technology or images gathered by airplanes to assist their precision agriculture needs. UAVs equipped with multi-spectral cameras can deliver images that are much more precise than satellite data at a fraction of the cost of manned aircraft flight.

Many in agriculture are taking advantage of this technology. Farmers and crop consultants are using drones to monitor crop health, survey irrigation systems, and spot-check problem areas in fields that can often be missed by on-the-ground scouting. However, these UAV operators have been operating in what can most generously be described as a legal “gray area.” Since 2007, FAA has taken the position that any commercial use of unmanned aircraft is unlawful.

In 2012, Congress passed the FAA Modernization and Reform Act. One of the provisions of this Act required FAA to integrate unmanned aircraft into the national airspace system by September 30, 2015. The agency is taking an incremental approach to this mandate, and will certainly miss Congress’ deadline.

FAA’s first proposed rule on unmanned aircraft, “Operation and Certification of Small Unmanned Aircraft Systems,” was published in the Federal Register on February 23, 2015. The proposed rule would govern how sUAS (the agency’s preferred terminology) could be operated and the certification requirements for operators.  Major components of the proposed rule include:

  • Operation of sUAS. FAA proposes allowing the operation of sUAS flown within the visual line-of-sight of an operator. Operations must be conducted while maintaining a constant visual line-of-sight. Visual observers may be used to assist the operator in maintaining a visual line-of-sight, so long as the operator is capable of seeing the sUAS. sUAS may be operated with an altitude ceiling of 500 feet in unrestricted (Class G) airspace and with Air Traffic Control approval in some classes of restricted airspace.
  • Certification of sUAS operators. sUAS flights must be operated by a certified airman. FAA is proposing the creation of a sUAS rating for its existing airman certification program. Pilot licenses will not be required for sUAS operators. Certification will primarily be based on passage of an initial aeronautical knowledge exam. Operators will need to renew their certification every two years.
  • Registration and display of registration markings. FAA’s proposal requires sUAS to be registered with the agency. FAA also proposes to require sUAS to display their registration number.
  • Exemptions for airworthiness certificates. Section 332(b)(2) of the 2012 FAA Reauthorization Act enables FAA to consider whether the airworthiness certification requirements applicable to manned aircraft should also apply to sUAS. Based on the relatively lower risks that accompany sUAS, the agency decided to exempt sUAS from the airworthiness certification requirement.
  • Micro UAS. The agency is requesting comments on whether it should create a subclass of sUAS known as Micro UAS. Micro UAS would weigh less than 4.4 pounds and be subject to less stringent requirements for operating conditions and operator certification. Many agricultural drones would fall under this Micro UAS category.

To assist in understanding this rule and the potential implications for agricultural drone use, OFW has prepared a complimentary memorandum. This memorandum provides a comprehensive analysis of FAA’s proposed rule and how it will impact agricultural applications of UAV technology.

Click here for a free copy of OFW Law’s analysis of FAA’s proposed sUAS rule.

GM Opponents are Science Deniers

Climate change is real and GM technology is safe, but those in denial want to undermine the public understanding of science with misinformation and pseudo-debate

By Nina Fedoroff, Peter Raven and Phillip Sharp, as published in The Guardian

The authors are former presidents of the American Association for the Advancement of Science (AAAS)

Barely a week goes by, it seems, without some new attack on science. For years, oil and coal lobbies have orchestrated assaults on climate scientists, while the religious right continues to oppose the teaching of evolution in US schools, questioning the basic tenets of evolutionary biology.

Denialism does its damage by driving a wedge between science and society, undermining public understanding of science with misinformation and confusing pseudo-debate. The effects can be seen not just in climate change mitigation efforts, but in peoples’ health – witness the recent US upsurge in childhood measles concentrated in areas where there is opposition to vaccines. No wonder the latest survey of scientists by the Pew Research Center found scientists increasingly pessimistic about how their work is viewed in the wider society.

In the latest organised attack on science, 14 senior US scientists are being targeted by anti-GM lobby group US Right to Know (USRTK), an offshoot of the failed California GM labelling campaign Yes on 37. USRTK is using the Freedom of Information Act (FoIA) to demand access to years of private emails and other correspondence of these scientists, undoubtedly aiming to undermine their credentials and sully their names in public.

As three former presidents of the American Association for the Advancement of Science, we know how important it is for scientists to engage meaningfully in societal debates about their work. But we also know how important it is for scientists to be able to speak freely in conducting their work, both publicly and privately. USRTK’s attack is reminiscent of ‘Climategate’, where the release of private emails did immense, unwarranted damage to the reputations of climate scientists. Now the vocal anti-GM lobby appears to be taking a page out of the Climategate playbook.

The facts are clear: the scientific consensus on the safety of foods derived from GM plants is equivalent to that on global climate change driven by human activities. The AAAS has issued statements on both subjects, underscoring that climate change is real and that GM technology is safe. Numerous other learned societies and public bodies have reached the same conclusions and continue to be attacked by science deniers on both issues.

USRTK’s statements are unambiguous – it views any scientist with the temerity to speak out in public on biotechnology as part of “the PR machine for the chemical-agro industry.” Hence its FoIA requests focus on any email exchanges with biotech companies such as Monsanto, Syngenta, and DuPont, as well as other organisations, including the Grocery Manufacturers Association and the Council for Biotechnology Information. These researchers have denied receiving hidden funding from these groups, yet a good deal of damage can be done with private communications quoted out of context.

Ironically, USRTK is less eager to reveal its own agenda and funding. Its website reveals only one donor, the Organic Consumers Association (OCA), a group that seeks to turn US agriculture 100% organic and eliminate GM crops. It is clearly promoting the interests of the organic food business, now a $63bn (£42bn) dollar industry.

The OCA has a clear game plan – to drive increased sales of higher-priced organic produce by convincing consumers that conventionally farmed foods are swimming in pesticide residues, that GM crops are dangerous, and that biotechnology companies that sell GM seeds are evil. But OCA does not restrict its anti-science activities to agriculture. Its website is also riddled with anti-vaccine misinformation, for example that “it is important to know how to protect your children and yourself with homeopathic and natural alternatives to vaccines to build your natural immunity” and other such dangerous nonsense.

Moreover, OCA’s assertion that we can feed the world organically and without modern technology is nothing short of delusional. We live on a finite planet with a human population of 7.2bn, a number that is increasing by almost 100,000 per day. Our ability to minimise the effects of famine has depended on the application of science and technology to agriculture since the time of the Industrial Revolution two centuries ago. The key innovations have been in genetics and plant breeding, synthetic fertilisers, and farm mechanisation.

A recent meta-analysis concluded that adoption of GM crops since 1996 has reduced chemical pesticide use by 37%, increased crop yields by 22% and increased farmer profits by 68%. Moreover, the gains were larger for developing countries than developed countries. We need more science, not less, if we are to feed the coming world of 9.5bn in 2050 without further destroying fragile ecosystems and driving more species to extinction.

Hostile challenges to intellectual enterprises such as universities and the people who practice science within them are hugely detrimental to our ability to make rational, evidence-based decisions in free societies.

If we allow ideologically-motivated campaigners to harass and threaten our leading thinkers and intellectual institutions, there will be less progress than we could otherwise achieve. Our civilisation can do better than that. We want to be able to vision a healthy, sustainable and vibrant future. But we can’t get there without science.

Nina Fedoroff is an Evan Pugh Professor at Penn State University; Peter Raven is Director Emeritus of the Missouri Botanical Garden and Phillip Sharp is Institute Professor in the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology

Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat!

By Jonathan M. Weinrieb

The White House (via the Department of Commerce) has released a “discussion draft” of consumer privacy legislation intended to codify President Obama’s 2012 Consumer Data Privacy In A Networked World: A Framework For Protecting Privacy And Promoting Innovation In The Global Digital Economy.  The 2012 Framework included a Consumer Privacy Bill of Rights and called for baseline protections for consumers and greater certainty for businesses founded on the following principles:

  • Individual control over personal data;
  • Transparency regarding an entity’s privacy and security practices;
  • Respect for context in which consumers provide/businesses collect the data;
  • Security and responsible handling of personal data;
  • Consumer access to data to ensure accuracy;
  • Focused collection to ensure reasonable limits on the data collected and retained; and
  • Accountability for companies handling that data.

Although each of those laudable notions is reflected in the Bill, in the view of the FTC and many privacy advocates, the draft Consumer Privacy Bill of Rights Act of 2015 (the “Bill” or “Act”) comes up short of the consumer protection–minded goals of the 2012 framework.  We see other problems as well.

Ostensibly, the Bill is intended to “establish baseline protections for individual privacy in the commercial arena and to foster timely, flexible implementations of these protections through enforceable codes of conduct developed by diverse stakeholders.”  Act, § 1.  In other words, those subject to the Act would be permitted a safe harbor by establishing (and adhering to) their own codes of conduct.  See generally Act, § 301 (Safe Harbor Through Enforceable Codes of Conduct).

For its part, the FTC would enforce the Act via civil fines; however, those fines are contingent on the number of days over which a violation occurs – not the number of affected individuals or monetary impact.  A one-day violation could not exceed $35,000 in fines, regardless of whether the violation affected ten, 10,000, or 10,000,000 individuals.  See Act, § 203(a)(1).  A compounding issue is that the Act would apply to non-profit entities, Act, § 4(b), however, the FTC can only bring an action against a for-profit enterprise.

Of particular concern, the draft raises a number of issues given HHS’s Office for Civil Rights’ (OCR) recent and ongoing implementation of the HITECH Act and regulation of medical privacy under the HIPAA Privacy Rule.  Following are a smattering of the issues that we see.

First and foremost, the Bill’s preemption language is confusing in the context of HIPAA.  It provides that “[t]his Act preempts any provision of a statute, regulation, or rule of a State or local government, with respect to those entities covered pursuant to this Act, to the extent that the provision imposes requirements on covered entities with respect to personal data processing.”  Act, § 401(a) (emphasis added).  It goes on to state, however, that “[n]othing in this Act may be construed to modify, limit, or supersede the operation of privacy or security provisions in Federal laws . . . .”  Act, § 404(d)(1).  The federal HIPAA Privacy Rule does not preempt more stringent state laws and regulations that are otherwise consistent with the federal rule.  Accordingly, it appears that the Act would preempt an otherwise permissible (and arguably “stronger”) state medical privacy law – yet leave HIPAA alone.  Such a result would seemingly be at odds with the underlying intent of the federal Privacy Rule.

In certain respects, the draft Bill appears incredibly broad.  As alluded to above, it applies to a “covered entity” – i.e., anyone who “collects, creates, processes, retains, uses, or discloses ‘personal data’.”  Act, § 4(b).  That suggests that both HIPAA Covered Entities and Business Associates would be subject to the Act.

“Personal data” includes, but is not limited to: a first name (or initial) and last name; a postal or email address; a telephone or fax number; a social security number; any biometric identifier; or any other “unique persistent identifier.”  Act, § 4(a)(1).  It specifically excepts, however, “de-identified data” from the definition of personal data, but fails to square the concept of de-identified data with HIPAA.  Whereas the Privacy Rule sets forth two very specific methods by which to de-identify data (see Statistical and Safe Harbor methods), the Bill simply allows a covered entity to “alter . . . personal data . . . such that there is a reasonable basis for expecting that the data could not be linked as a practical matter to a specific individual or device . . . .”  Act, § 4(a)(2)(A)(i).  It is unclear how such a standard would be consistently and reliably implemented.

The Act also introduces a similarly amorphous concept in “Respect for Context.”  In a rather confusing bit of draftsmanship, the Bill calls for a covered entity to perform a risk analysis when it “processes personal data in a manner that is not reasonable in light of context . . . .”  Act, § 103.  If it determines that the manner is not reasonable in the particular context, it would appear to contemplate affirmative consumer opt-in – as opposed to opt-out – for such processes.  Such provisions could be read to stand at odds with HIPAA’s authorization requirements and broad exceptions for face-to-face communications and refill reminders (an exception to the definition of “marketing”).

By way of further example, and particularly with respect to reconciling the Act with HIPAA, a covered entity would not include one that collects, creates, processes, retains, uses, or discloses the personal data of fewer than 10,000 individuals in a 12-month period, or has fewer than 5 employees.  That exception alone would likely sever the world the HIPAA Covered Entities in two.

The Bill also exempts seemingly broad categories of data (e.g., “customary business records”) from certain requirements such as data minimization and individual control.  “Customary business records” include data “typically collected in the ordinary course of conducting business and that is retained for generally accepted purposes for that business . . . .”  Act, § 4(j).  Put bluntly, it is difficult to conjure categories of data that would not fit comfortably into that exemption.

Furthermore, in somewhat striking contrast to HIPAA’s concept of Breach, the Bill defines “privacy risk” in subjective fashion – i.e., as that which could “cause emotional distress, or physical, financial, professional or other harm to an individual.”  Act, § 4(g).  OCR did away in 2013 with its similar subjective “risk of harm” standard in favor of a more objective risk assessment: “[a]n impermissible use or disclosure of protected health information is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the protected health information has been compromised based on a [formal] risk assessment . . . .”  45 C.F.R. § 164.402 (emphasis added).

Finally, there is no provision in the Bill that would require FTC rulemaking.  As written, and without agency regulation and guidance, the Bill will almost assuredly spawn significant consumer and stakeholder confusion.

In our view, which appears largely consistent with various media reports and fellow bloggers, the current Bill is unlikely to go anywhere in Congress.