John Block: GMOs Under Assault

By John R. Block

We can’t seem to silence or satisfy the loud scream of opposition to GE crops. The reason probably is that up until now we have ignored them. It’s time to stand up and set the record straight.

GE food is safe and even beneficial according to 88% of scientists. We have conducted more than 1,000 studies. We have been eating GE food for more than 20 years – no one has gotten sick.

The fact is that for thousands of years, farmers have been improving crops through selective breeding. That process alters genes. We have found that in the laboratory we can do it faster.

Never mind the facts, the critics are beating the drums. Three states have passed labeling laws. Vermont is in the lead as they begin to implement their law. It sounds simple. Just label the food if it has GMO products in the food.

It’s not that simple. Vermont has a long list of exemptions. Animal products are exempt – beef, pork, chicken, dairy. But keep in mind the animals were fed GMO corn and soybean meal.

Trying to get out ahead of everyone, Chipotle recently announced that it has gone GMO free. But it’s not really free. The soft drinks are made with GMO corn sweetener. The burritos have GMO corn-fed beef, pork, chicken, and GMO sour cream.

The U.S. Congress is considering as many as 30 bills to deal with the GMO debate. You may wonder where all of this noise is coming from. Yes, there are individuals that sincerely are concerned about GMO safety. However, the organic companies (some of them are huge) are helping to push the false argument about risk. If they succeed, they can sell more product and make more money.

This debate is not over. You will soon read about the next step in plant technology – gene editing. Gene editing is a more precise way to alter plant traits.

The leading critics of GMOs are totally inconsistent. First, they support the science on global warming, but ignore the science on GMOs. Next, they pretend to care about the poor, but genetic engineering helps the poor by keeping the cost of food down. The world will not produce enough food without new technology. Finally, if they want to reduce the use of chemicals and energy, GE also does that.

Stay tuned.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

Recapping Round 1 of the Vermont GMO-Labeling Lawsuit

By John G. Dillard

Millions across the globe tuned into this weekend’s Mayweather-Pacquiao bout, which was billed as “the fight of the century.” However, the pay-per-view event was not the only high stakes fight to report on from last week. Far away from the glitz and glamor of Las Vegas, a federal court in Vermont issued a much-anticipated opinion in what will be one of the true fights of the century for the American food industry – whether state governments can mandate GMO labels.

On April 27, 2015, Chief Judge Christina Reiss of the U.S. District Court for the District of Vermont issued an opinion that mostly favored the State of Vermont and the positions of GMO-labeling advocates. In the case, Grocery Manufacturers Association v. Sorrell (No. 5:14-cv-117), the Grocery Manufacturers Association, Snack Food Association, International Dairy Foods Association, and National Association of Manufacturers (the “Plaintiffs”) are challenging Vermont’s Act 120, which requires that certain foods sold at retail stores in Vermont bear mandatory labeling if they contain genetically-engineered ingredients. Act 120 also prohibits manufacturers from advertising or labeling foods that contain genetically-engineered ingredients as “natural” or “all natural.”

Both supporters and opponents of mandatory GMO-labeling have been keeping a close eye on this lawsuit. This is because Act 120, if it survives litigation, will make Vermont the first state in the country to require that certain foods containing ingredients produced with genetic engineering bear mandatory labels. GMA v. Sorrell is the test case for this issue, which will certainly reach the Second Circuit Court of Appeals and, possibly, the Supreme Court.

The Plaintiffs challenged Act 120 from several angles. First, the Plaintiffs asserted that Act 120’s GMO-labeling mandate was unconstitutional under both the First Amendment and the Constitution’s Commerce Clause. The Plaintiffs also argued that the GMO-labeling mandate was preempted by the Federal Food, Drug, and Cosmetic Act (FFDCA), the Nutritional Labeling and Education Act (NLEA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA). Furthermore, the Plaintiffs asserted that the ban on “natural” labeling is unconstitutional under the Commerce Clause and the First Amendment.

The State of Vermont filed a motion to dismiss the Plaintiffs’ case on August 8, 2014. Subsequently, the Plaintiffs sought a preliminary injunction that would halt implementation of Act 120 while the Court decides whether to issue a permanent injunction invalidating Act 120. Chief Judge Reiss heard oral arguments on both of these motions on January 7, 2015, and issued an 84-page opinion in the case last Monday.

GMO-Labeling Mandate

The Plaintiffs challenged Act 120’s GMO-labeling mandate under the First Amendment, Commerce Clause, and Supremacy Clause. Here is how the Court addressed these issues:

  • First Amendment. The Plaintiffs alleged that Act 120’s GMO-labeling mandate violated the First Amendment’s protections against unlawfully-compelled speech. The Court held that “strict scrutiny” was not warranted in this case and dismissed the Plaintiffs’ complaint to the extent that it argued strict scrutiny applied. Instead, the Court held that the proper standard is most likely the “reasonable relationship” test. Under this test, also known as the Zauderer test, the Court held that for the purposes of preliminary injunction, the Plaintiffs were not likely to succeed on their First Amendment complaints. The Court reasoned that unless Vermont’s “legislative findings” prove unfounded at the permanent injunction stage of this litigation, the State has demonstrated a reasonable relationship between the state’s interest and the GMO-labeling mandate.
  • Commerce Clause. The Plaintiffs argued that Vermont’s labeling measure violates the Constitution’s Commerce Clause because the state-based labeling measure would create an undue burden on interstate commerce, ultimately resulting in a 50-state patchwork of labeling laws. The Court was not convinced, noting that there were no other states with conflicting labeling laws. The Court dismissed the Plaintiffs’ complaint to the extent that it alleged the GMO-labeling mandate was unconstitutional under the Commerce Clause.
  • Supremacy Clause. The Plaintiffs asserted that the GMO-labeling mandate was preempted by the FFDCA, NLEA, FMIA, and PPIA. The Court was not convinced by the Plaintiffs’ arguments with regards to the FFDCA or the NLEA. However, the Court agreed that the FMIA and PPIA expressly preempted state standards for “[m]arking, labeling, packaging, or ingredient requirements in addition to, or different than, those mandated by federal law.” This means that processed and packaged foods that are subject to USDA inspection, such as canned soups or frozen dinners containing meat or poultry products, cannot be subject to state GMO-labeling mandates. Vermont has already conceded this issue in its final rule, which implements Act 120.

“Natural” Labeling Prohibition

The Plaintiffs also challenged Act 120’s prohibition on advertising and labeling of products containing genetically-engineered ingredients as “natural,” “all natural,” or words of similar import. The Plaintiffs argued that this prohibition violated the First Amendment. The Court sided with the Plaintiffs on the First Amendment argument, reasoning that prohibitions on commercial speech are subject to “intermediate scrutiny” under the Central Hudson test. The Court held that Vermont has failed to demonstrate a “substantial” state interest in prohibiting these labels. The Court also held that the “natural” labeling prohibition violated the Commerce Clause to the extent that it attempted to regulate advertising that occurred outside of Vermont.

Although the Court largely sided with the Plaintiffs on the “natural” labeling prohibition, Chief Judge Reiss did not grant a preliminary injunction on this matter, citing to a lack of proof of “irreparable harm” on the part of the Plaintiffs.

Next Steps

This first round of the litigation is certainly a setback for those in the food industry that oppose state-level GMO-labeling mandates. However, this is only the first round. The Plaintiffs have not announced their next steps. At this point, they may either (1) seek an interlocutory appeal of this decision at the Second Circuit Court of Appeals, or (2) move forward to the permanent injunction stage of this litigation.

In the meantime, support is growing for the proposed Safe and Accurate Food Labeling Act of 2015, which would preempt state GMO-labeling measures and set standards for when GMO labels could and could not be required. However, no votes have been taken on this measure and it is uncertain whether the measure has a chance of being enacted into law.

OFW Law will continue to monitor developments in this case.

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.

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

114th Congress – What to Expect in Ag and Food

By Michael J. Marshall

As the 114th Congress begins in earnest, there is rough sledding ahead this winter over the gulf between the governing philosophies of the President and the new Congress.

Not to belabor the obvious, but early indications are that Republican victories have altered the President’s willingness to deal only very modestly, if at all.  With just two years to go in his final term, President Obama seems determined to push his agenda on a number of fronts. Nevertheless, Americans tend to be eternal optimists, so many are hoping the Administration and Congress will be able to compromise on at least some important issues.  Exactly what is open for negotiation remains to be seen.

In my post-election blog, I asked, “What now?” and answered my own question with, “quite a lot.”  We can’t entirely predict which cards the President will ultimately choose to play.   We’ve already seen him out of the gates early on immigration and Cuba policy, both of which are of great interest to agriculture.

There are a few fig leaves being exchanged.  At the other end of Pennsylvania Avenue, Senate Majority Leader Mitch McConnell (R-KY) doesn’t appear to be too bent out of shape yet.  He is keeping his composure, says he doesn’t take politics personally, and may be interested in sharing Kentucky Bourbon with the President.  Would Joe Biden be there for the Bourbon Summit like he was for the Beer Summit?

My colleagues and I were sitting around last week handicapping the year ahead with our esteemed colleague, former Secretary of Agriculture Jack Block, who served under President Reagan and has seen a few turnovers in this town.  With his own tone of optimism, he advised, in essence, “Pay attention, stay alert, do your work, because when things are moving, you never know when something might actually pass that the President will sign.  Strange things do happen.”

OFW is taking a close look at the prospects for action across a broad range of issues that affect agriculture and food, areas where there has traditionally been bipartisanship, but also ones that may be affected by other reforms. There are a number of issues that have the potential to move.  Here are a few:

Trade

Trade is at the top of the agenda on almost everyone’s list, and appears to be within the realm of the possible despite some significant obstacles.  The impact of a U.S.-Asia Trans-Pacific Partnership (TPP) trade deal, a U.S.-Europe Transatlantic Trade and Investment Partnership (TTIP) deal, and/or Fast Track Trade Promotion Authority, which would make it easier for the Executive Branch to negotiate trade agreements, would be enormous in terms of opening markets for the entire food and Ag value chain.

We can expect the Generalized System of Preferences, which cuts tariffs on goods from developing countries, maybe (hopefully) a Miscellaneous Tariff Bill which would cut duties on agricultural goods not made in the U.S., and almost certainly the reauthorization of the African Growth and Opportunity Act (AGOA) later this year.  Expect the Administration and Congressional Democrats to push for more Trade Adjustment Assistance for workers adversely affected by trade as a pre-condition to move these initiatives forward.  The World Trade Organization (WTO) will consider the U.S. appeal of an adverse country of origin labeling (COOL) ruling. That appeal will require the USDA to submit recommendations, and this could be met with Congressional action to bring the U.S. into international compliance.  If so, the Ag world will be at the table as it was during the omnibus process which resulted in favorable language for producers.

Nutrition/Dietary Guidelines

The “independent” Dietary Guidelines Advisory Committee (DGAC) is expected to release its report to the Secretaries of Agriculture and Health and Human Services this month.  The DGAC report is widely expected to contain some controversial nutritional recommendations and, for the first time, recommendations regarding the sustainability of the food supply.  As many OFW clients know, the DGAC guidance has enormous implications across a broad spectrum of federal programs, from our military to school lunch nutrition standards, to menu and nutrition labeling.

We expect robust debates surrounding added sugars, so-called “high-dose caffeine” beverages, meat, whole grain labeling, sodium, and the mandate for fruits, vegetables and whole grains in the school lunch program.

Environment

One of the elephants in the room inside the Ag community, and I am not talking Republicans, is the role of climate change, or put another way, the environmental impact and sustainability of foods. Notwithstanding language in the recent omnibus suggesting to the DGAC that sustainability is outside the scope of its mandate, no other issue looms larger in the policy sifter within this Administration than the environmental impact of any given policy.  What is the carbon footprint of your Chicken Caesar Salad?  You should know…and some believe it should be listed on the food label.

Expect sustainability to be one of the bases for the dietary recommendations in the DGAC report.  Even if USDA and HHS decide to dial back the Advisory Committee’s ambitions on sustainability, it’s no stretch to say that some in the Administration support the views of the DGAC.

Also, environmentally speaking, we can expect the EPA to continue to look for administrative ways to stretch the Clean Water Act and the Clean Air Act, putting agricultural production in the cross hairs.  If you find a policy that seems immune to the environmental agenda, you can be pretty sure they are working on it.

Food Safety Modernization Act

FDA will issue several of the key regulations implementing FSMA this year, including final rules on preventive controls, fresh produce safety, and foreign supplier verification.  As FDA begins rolling out final rules and enforcing them, Congressional oversight will assume greater importance.  In addition, if the FSMA final rules are promulgated as, or close to, currently written, several segments of the food industry are likely to seek Congressional action on technical amendments to FSMA.

Tax Reform

There is little doubt that tax reform will at least be attempted by Republicans.  While there are too many hurdles that will keep a comprehensive measure from satisfying the President, the Ag world will be looking to extend tax credits for farmers and, if some form of a reform bill does reach the President’s desk, we can expect many players to work to make some of those provisions more permanent.

GMO Labeling

Following Vermont’s passage of a GMO labeling requirement and several close votes on ballot initiatives, we expect the debate over the need for requiring manufacturers to disclose when their foods contain genetically modified ingredients to intensify in Congress this year. This is one of the biggest policy battles playing out for agricultural producers, food manufacturers and, of course, the biotech community.

Expect Republicans to support Rep. Mike Pompeo’s (R-KS) bipartisan Safe and Affordable Food Labeling Act, which would prevent states from setting their own standards and guarantee the authority to label GMOs remains squarely with FDA.  The competing bill, sponsored by Rep. Peter DeFazio (D-OR), would mandate the labeling of all foods containing genetically modified ingredients, a problematic and costly prospect that would have enormous implications for the agriculture supply chain even as the science has consistently shown no material difference between GMOs and their conventional counterparts.  Moreover, the DeFazio bill doesn’t have federal preemption, so GMO detractors would likely continue the push for a state-by-state patchwork of labeling laws that would severely hamper interstate commerce.  A number of Democrats joined Republicans in rallying around Pompeo’s bill at a Dec. 10 hearing of the House Energy and Commerce Health Subcommittee.  While both bills died at the end of the last Congress, they are widely expected to be reintroduced in the 114th.

The worldwide debate over GMOs also rages on.  Biotechnology is a vital tool that the world will need to meet the challenge of global food security, international development goals, the eradication of hunger and extreme poverty, and ironically the environmentalists’ interest in greener agriculture.  While there could be compromise in the area of food labeling, further progress seems unlikely until the scientific facts and public perceptions of GMOs are reconciled.

Feed the Future

The President’s Feed the Future initiative, looking to improve global food security in Africa by boosting agricultural productivity and alleviating extreme poverty and hunger, should be reauthorized with bipartisan support this year.    This will provide a moment of bipartisan comity.

Budget and Appropriations

On top of everything else, budget and appropriations likely completed “in regular order,” as they say around Washington will mean that for the first time in a long time, the President will propose and the Congress will pass spending bills.  Appropriations will follow authorizations of government operations.  The process will be open to amendment and that means everything is on the table, including agricultural entitlements. There will be a reconciliation process when the House and Senate meet to work out differences.

Right off the bat we expect that the numbers that will be given to the Ag Committee will suggest that cuts are coming.  We anticipate a lot of shuffling ahead of this to lessen the impact on one program or the other, but there will not be easy solutions.

Budget positioning will be crucial to our clients as cuts will be needed to conform to the top line.  We expect food stamps (SNAP) and crop insurance to be targeted along with several other programs that the committee will look at in order to fit under the caps.

Happy New Year.  2015 has strong potential to break the pattern of the past several years in many respects.  We’re off to an aggressive start and we can expect it to continue as both the President and Republicans forge ahead and try to demonstrate they can lead.

2014 And 2015

By Arthur Y. Tsien

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking.

Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devices, agriculture, and the like.

In January, the Food and Drug Administration (FDA) published its long-awaited, long-overdue draft guidance on the promotion of drug and biologic products in interactive social media.  The draft guidance, formally entitled “Fulfilling Regulatory Requirements for Post-Marketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” is long on process (how and when to make required submissions to FDA), and short on substance.  Presumably, draft guidances that will address FDA’s views on the substantive content of drug and biologic promotion through social media will follow.

The Agricultural Act of 2014, almost universally known as the 2014 Farm Bill, became law in February.  The Farm Bill is the primary agriculture and food policy tool of the federal government. Enacted every five years, plus or minus (mostly plus), the Farm Bill addresses a broad range of substantive programs administered by the U.S. Department of Agriculture (USDA), including commodity programs, rural development, foreign agriculture and trade, conservation, renewable energy, forestry, nutrition, and other topics.  Unbeknownst to the average American, the Supplemental Nutrition Assistance Program (commonly known as “food stamps”) and other nutrition assistance programs represent by far the biggest expenditure of funds under the Farm Bill.

In March, FDA proposed to update its “Nutrition Facts” nutrition labeling requirements, which have largely been unchanged for over 20 years.  The proposed changes appear to be significant for industry, as FDA estimates the compliance price to be $2 billion.  Even if the proposed changes are not readily noticeable to more casual observers (like me), they are surely of major interest to my colleagues who spend their time looking at the back or side panels of pasta sauce jars or cereal boxes.

In April, President Obama appeared to signal his support for the important role that biotechnology plays in modern agriculture.  Mr. Obama did so in a letter to the granddaughter of Dr. Norman Borlaug, the Nobel laureate who is often recognized as the “Father of the Green Revolution.”

In May, Vermont became the first state to require labeling of genetically engineered foods.  Effective in 2016, Vermont will require the affirmative labeling of foods containing ingredients that are commonly referred to as “genetically modified organisms” or “GMOs.”  The legislation may be vulnerable to a constitutional challenge under the First Amendment.  It, and the prospect of similar legislation in other states, may also serve as the impetus for federal legislation that would preempt some or all state labeling laws related to GMOs.

In June, the U.S. Supreme Court decided Pom Wonderful LLC v. Coca-Cola Co.  The Court held that a company may bring a private lawsuit against a competitor under the Lanham Act to challenge the competitor’s food label, even if the competitor’s label technically complies with FDA requirements.  In essence, the Pom Wonderful decision means that FDA food labeling requirements are a floor, but not a ceiling.  It appears that Pom Wonderful is limited to FDA-regulated products where FDA does not approve or mandate specific labeling, such as food and beverage products.

The Biologics Price Competition and Innovation Act became federal law in 2009, creating a regulatory pathway for FDA approval of “biosimilar” products.  In July, FDA finally accepted the first biosimilar application under that statute.

In August, Grocers Manufacturers Association (GMA) announced an industry initiative that is, in its view, designed to improve the process and transparency for making “generally recognized as safe” (GRAS) determinations for food ingredients.  GMA’s GRAS initiative is intended to respond to criticism about the widespread use of the GRAS process, including FDA’s GRAS notification pilot program, as a mechanism for the review and marketing of new or modified food ingredients.

September marked the 30th anniversary of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.  Hatch-Waxman is the legislative foundation for the modern generic drug industry in the United States.  Today, generic drugs account for about 80 percent of all prescriptions filled in the U.S.  My personal musings on 30 years of Hatch-Waxman can be found here.

In October, the World Trade Organization ruled in favor of Canada and Mexico, rejecting USDA’s mandatory country-of-origin labeling (COOL) requirements for meat products.  The current U.S. labeling rules, which went into effect in 2013, require meat sold at the retail level to identify the country or countries where the animal was born, raised, and slaughtered.  The USDA COOL requirements were upheld by the D.C. Circuit earlier in 2014.  The U.S. has appealed within WTO; a decision early in 2015 is expected.

In November, OFW Law celebrated its semiseptuagennial anniversary.  Phil Olsson and Rick Frank founded Olsson and Frank in 1979 as a two-lawyer shop.  Fast-forward 3½ decades to 2014.  OFW Law now has nearly 40 lawyers and Policy Advisors, and is one of the few remaining FDA/USDA law and lobbying boutique firms.  Phil’s and Rick’s musings on the past 35 years can be found here.  We look forward to our second 35 years of providing outstanding client service, with creative solutions to difficult problems.

In December, FDA published two companion final rules regarding the labeling of foods sold in chain restaurants and in vending machines.  Covered chain restaurants (and similar chain retail food establishments) will have to declare the caloric content of standard menu items on menus and menu boards and make other nutrition information available on the premises.  Restaurants that are not covered by the final rule may voluntarily register with FDA to receive the protection of federal preemption from inconsistent state and local menu labeling laws.  Foods sold in vending machines will also have to declare caloric content.  Most packaged foods sold in vending machines likely will provide caloric information in the form of a “front-of-pack” label that can be viewed by prospective purchasers.

*          *          *

Enough looking back.  Let’s briefly turn our attention to looking forward, to see what 2015 may have in store for us.  The following come to mind:

  • FDA final rules under the Food Safety Modernization Act (FSMA) on produce safety, preventive controls for human food, preventive controls for animal food, and foreign supplier verification, presumably by the court ordered deadlines in 2015. (Other FSMA final rules have 2016 deadlines.)
  • FDA’s first biosimilar approval. There is no track record here, so no one knows quite what to expect.  For whatever it’s worth, FDA review of biosimilar applications is subject to user fee performance goals, much like user fee performance goals for a variety of other products that require FDA premarket approval.
  • Additional FDA guidance on drug and biologic promotion through social media, hopefully addressing the substance of what FDA considers acceptable and not acceptable.
  • Federal GMO labeling legislation to preempt some or all state requirements in this area.
  • The WTO’s final decision on USDA’s COOL requirements.
  • The extent of cooperation between President Obama and the Republican Congress. Personally, I’m skeptical that they can work together towards less gridlock and more bipartisanship going forward.

*          *          *

Thanks for reading!  Best wishes to one and all for a wonderful 2015, personally and professionally.  May 2015 be better than 2014!

10 Things to Watch in 2015

By John Dillard

2014 was certainly an interesting year to be involved in agriculture. We got to see supply and demand in full effect. Good weather sent grain prices tumbling while continuing tight supplies have kept cattle prices soaring. The Republicans made strong gains and will enter 2015 with control of both the House and Senate.

While I have not spent the $27.68 necessary to acquire a crystal ball on Amazon, I do feel the need to join the crowded field of writers, bloggers and seers that are making predictions for the upcoming year. Accordingly, I have compiled a list of the 10 legal and policy issues that I see facing agriculture in 2015.

1.  Drones

2014 was supposed to be the year when the Federal Aviation Administration (FAA) would release its proposed rules for integrating commercial drones into the national airspace. Because of this, I received a little flack for leaving drones off of last year’s list. However, FAA has continued to blow past every deadline that it has set for itself. Hopefully, this can be attributed to the agency trying to get the job done right the first time.

I am confident that FAA will release its proposed regulations for small drones (< 55 lbs.) some time in early 2015. The agency has acknowledged that it considers agricultural uses relatively low-risk and it understands that many farmers are moving ahead with adopting the technology regardless of the absence of regulations. Once FAA proposes its regulations for small drones, we’ll have a better idea of how the final rules will look in terms of operator qualifications, aircraft requirements, and allowable operations. This will be welcome news for those looking to capitalize on this new technology and the farmers and consultants that have been “recreationally” monitoring their crops for the past couple years.

2. The “Waters of the U.S.” Rule

While many hoped that Congress would use the recent “CROmnibus” (ugh) bill to stop EPA and the U.S. Corps of Engineers from implementing a broad definition of “waters of the United States,” the legislation failed to do so. This means that EPA and the Corps will continue to move forward on this measure. The agencies received almost half a million comments during the public comment period, with most in opposition to the new power grab. EPA and the Corps are expected to finalize the rule sometime in the first half of 2015. Once the rule is finalized, there will almost certainly be a lawsuit filed to enjoin the rule.

Read the rest of John’s article, “10 Things to Watch in 2015” at AgWeb.com.