The NAS is Examining GE Crops

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By Marshall Matz and Dr. Nina Fedoroff, as published in Agri-Pulse

The new study on genetically engineered (GE) crops now being conducted by the National Academy of Sciences (NAS), Board on Agriculture and Natural Resources, deserves your attention. It has the potential to impact the agriculture economy, food prices and global food security.

The NAS is committed to sound science and has been a consistent supporter of GE technology. Its 2010 report on GE technology stated: “To date, crops with traits that provide resistance to some herbicides and to specific insect pests have benefited adopting farmers by reducing crop losses to insect damage, by increasing flexibility in time management, and by facilitating the use of more environmentally friendly pesticides and tillage practices.”

While President Obama has spoken clearly on the importance of biotechnology and GE, the public, many in Congress and in the State Houses are once again questioning the safety, acceptability and necessity of GE crops. Hence, the opinion of the NAS is very important.

There have been several open meetings to date, the most recent having taken place January 15-16. The public meetings are webcast live and recorded versions are accessible here. The next meeting in March will examine food safety.

The study’s objectives:

“Examine the history of the development and introduction of GE crops in the United States and internationally, including GE crops that were not commercialized, and the experiences of developers and producers of GE crops in different countries.

“Assess the evidence for purported negative effects of GE crops and their accompanying technologies, such as poor yields, deleterious effects on human and animal health, increased use of pesticides and herbicides, the creation of “super-weeds,” reduced genetic diversity, fewer seed choices for producers, and negative impacts on farmers in developing countries and on producers of non-GE crops, and others, as appropriate.

“Assess the evidence for purported benefits of GE crops and their accompanying technologies, such as reductions in pesticide use, reduced soil loss and better water quality through synergy with no-till cultivation practices, reduced crop loss from pests and weeds, increased flexibility and time for producers, reduced spoilage and mycotoxin contamination, better nutritional value potential, improved resistance to drought and salinity, and others, as appropriate.

“Review the scientific foundation of current environmental and food safety assessments for GE crops and foods and their accompanying technologies, as well as evidence of the need for and potential value of additional tests. As appropriate, the study will examine how such assessments are handled for non-GE crops and foods.”

The study is being conducted by the National Research Council (NRC), the operating arm of the NAS, a private, nonprofit institution chartered by Congress to provide science, technology, and health policy advice to the government. The NAS Act of Incorporation was signed by President Abraham Lincoln on March 3, 1863 with 50 charter members. President Lincoln created USDA and the land grant universities the previous year, 1862.

The NAS is not part of the U.S. government. The National Research Council enlists leading scientists, engineers, and other experts to answer scientific and technical issues facing the United States and the world. Members of study committees serve as volunteers and are not paid for their service. As of 2013, the National Academy of Sciences included some 2,200 members.

The NRC website gives the following explanation for the current study: “Consumers in the United States and abroad get conflicting information about GE crops. Proponents tout the benefits while opponents emphasize the risks. There is a need for an independent, objective study that examines what has been learned about GE crops, assesses whether initial concerns and promises were realized since their introduction, and investigates new concerns and recent claims.”

While GE technology is not a magic bullet in the fight for global food security, it is a critical component, along with improved hybrid seeds, modern irrigation, mechanization, crop loss technology, fertilizers and communication devices. Perhaps most important of all are extension services that can deliver these technologies to smallholder farmers.

The NAS study deserves your attention and input. The study has the potential to be quite important in the current debate on GMO’s and the public’s confidence in the integrity of GE technology.

The NAS is accepting comments here.

Click chart to enlarge it.

 

Marshall Matz, formerly Counsel to the Senate Committee on Agriculture, specializes in global food security at OFW Law.

Dr. Nina Fedoroff, the former Science and Technology Adviser to the Secretary of State, is the Senior Science Advisor at OFW Law.

Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor

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We are pleased to announce that Dr. Nina Fedoroff, a renowned plant molecular biologist, has joined OFW Law as Senior Science Advisor focusing on agriculture policy, global food security and government affairs.  The former Science and Technology Adviser to the Secretary of State, Dr. Fedoroff has long been involved in regulatory issues surrounding genetic modification of organisms (GMOs) by modern molecular techniques.

Please click the announcement, below, to enlarge it.

Nina Fedoroff Announcement

John Block: Wish List

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By John R. Block

Last year in January, I presented my wish list for 2014. Let’s take a look at how that worked out.

Wish No. 1: “Get a farm bill passed.” To my surprise, we did.

Wish No. 2: “Deal with our immigration problem.” Well, the Congress didn’t, but President Obama did a little bit. The fact is – the Congress must fix our immigration problem. Unfortunately, I don’t look for that to be done this year.

Wish No. 3: “I want Congress to pass a budget.” They didn’t deal with our budgetary and spending in “regular orders” last year. It was a mess. Our only discipline was a sequestration law which served as a “hammer lock” on discretionary spending, which is only 20% of our budget. This year, the Republican Congress is promising “regular order” of budgeting and appropriation. My fingers are crossed that they can do it.

Wish No. 4: “Hope the ag industry would come together to support and protect modern agriculture.” They are doing better, but protecting genetic engineering and new technology is still under heavy attack. The war on GMOs is anti-science. That’s the same crowd that uses science to justify their climate changes argument.

Wish No. 5: “Write a free trade agreement.” Didn’t get it done, but I think we can this year.

Wish No. 6: “Upgrade our locks and dams on our rivers.” Not yet, but Congress passed bipartisan legislation to get it done. I am optimistic.

Wish No. 7: I said, “God help us to end this draught.” He did, except for California. We raised record crops in most of the country last year.

Tax reform is on my wish list this year. I think we have a 50% chance of doing something. I am also wishing for money to fix our roads and bridges. And, I hope we can find a way to stop EPA’s effort to regulate everything. Over-regulation freezes our economy.

I would like to see the battle with Canada and Mexico over country of origin labeling (COOL) ended. Congress and Secretary Vilsack should get it done. Are they going to wait until Canada and Mexico start implementing sanctions on our exports?

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.

CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents

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By Mason Weeda

Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.  CDRH lists 28 guidance documents in total.  The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to publish “as resources permit.”   CDRH is required by the Medical Device User Fee Amendments of 2012 to publish these lists.

The “A-list” includes the following final and draft guidances:

  1. Applying Human Factors & Usability Engineering to Optimize Medical Device Design (Final);
  2. 510(k) Submissions for Medical Devices that Include Antimicrobial Agents  (Final);
  3. Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (Final);
  4. Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Final);
  5. Framework for Regulatory Oversight of Laboratory Developed Tests (Final);
  6. FDA Notification and Medical Device Reporting for Laboratory Developed Tests (Final);
  7. Coronary Drug Eluting Stents-Nonclinical and Clinical Studies (Final);
  8. Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements (Final);
  9. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Final);
  10. Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications (Final);
  11. Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile (Final);
  12. Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing Biocompatibility (Final);
  13. General Wellness Products (now published in Draft);
  14. Medical Device Accessories (now published in Draft);
  15. Medical Device Decision Support Software (Draft);
  16. Benefit-Risk Factors to Consider When Reviewing IDE Submissions (Draft);
  17. UDI Direct Marking (Draft);
  18. Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements (Draft);
  19. Adaptive Design for Medical Device Clinical Studies (Draft); and
  20. UDI FAQs (Draft).

The “B-list” includes the following:

  1. Finalizing various existing draft guidance documents;
  2. Medical Device Interoperability (Draft);
  3. Transfer of Ownership of a Premarket Notification: Questions & Answers (Draft);
  4. Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing) (Draft);
  5. Patient Access to Information (Draft);
  6. 3D Printing (Technical) (Draft);
  7. Manufacturing Site Change Supplements (Draft); and
  8. Use of Symbols in Labeling (Draft).

Significantly, CDRH acknowledges that it is not realistic for FDA to publish all guidances on both the “A-list” and the “B-list” by January 2016 and that priorities may change throughout the year.

The Agency also published a third list, containing final guidance documents that were issued in 2005, 1995, and 1985 and are now subject to retrospective review.  CDRH will conduct “a staged review of previously issued final guidances in collaboration with stakeholders,” and it is seeking feedback on whether such guidance documents should be revised.  These guidance documents are:

1985 Final Guidances include:

  1. Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF – 90KB) (1/20/1985);
  2. User Instruction Hazard Warnings (Laser Notice 35) (PDF – 63KB) (2/5/1985);
  3. Policy on Warning Label Required on Sunlamp Products (PDF – 71KB) (6/25/1985);
  4. Low Power Laser Exemption (Laser Notice 36) (PDF – 101KB) (8/23/1985); and
  5. Walk-In Workstations (Laser Notice 37) (PDF – 86KB) (10/21/1985).

1995 Final Guidances include:

  1. Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters (PDF – 896KB) (3/15/1995);
  2. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians’ Office Laboratory and Home Use (7-13-1995);
  3. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment (7/26/1995);
  4. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes (7/26/1995);
  5. Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (7/26/1995);
  6. Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Immersion Hydrobaths (7/26/1995);
  7. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables(7/26/1995);
  8. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems (7/26/1995);
  9. Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators (7/26/1995);
  10. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices (7/26/1995);
  11. User Instruction for Medical Products (Laser Notice 44) (PDF – 123KB) (8/11/1995);
  12. Labeling of Laser Products (Laser Notice 45) (PDF – 90KB) (8/15/1995); and
  13. Guidance On The Content Of Premarket Notification [510(k)] Submissions For Protective Restraints (Text Only) (12/1/1995).

2005 Final Guidances include:

  1. Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (1/14/2005);
  2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005);
  3. Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (7/27/2005);
  4. Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features (8/9/2005);
  5. Guidance for Industry – Review Criteria for Assessment of C Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays (9/22/2005);
  6. Guidance for Industry and FDA Staff: Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions (10/26/2005);
  7. Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 C.F.R. § 1040.30) (11/6/2005);
  8. Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures (11/10/2005); and
  9. Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s (11/17/2005).

FDA has established a docket for comments on any or all of the proposed FY2015 guidance documents or guidance documents subject to CDRH’s focused retrospective review.  FDA invites stakeholders to submit comments on the guidance documents listed, the relative priority of guidance documents for Agency attention and/or suggestions that CDRH revise or withdraw a final guidance document that issued previously in 2005, 1995 or 1985.

Gas Tax

Public Policy, USDA • Tags: , , , , , , , , , , , , ,

By John R. Block

How many of you out there think that we would be well-advised to spend some money repairing our roads and bridges? What about our locks and dams and seaports that carry our grain to countries around the world? Are you aware that our Federal Highways Trust Fund will be running out of money this spring? What should we do?

Our roads are in serious need of repair. Some of our bridges are not safe. One of this country’s greatest advantages in competing with other countries for market share happens to be our infrastructure. Whether we are talking about roads, rail, or water, we have been able to compete with anyone. We’re going to fall behind if we don’t take care of our transportation system.

The timing is right. We’re pumping oil and gas like never before. The world is awash in oil. Gasoline prices at the pump have dropped almost 50%. See where I’m going? We could raise the federal gas tax. It stands now at 18.4 cents per gallon and hasn’t been raised in more than 20 years. If you don’t want to call it a tax, call it a “user fee.” We use our roads, bridges, and waterways. Their upkeep is not free.  A “user fee” is fair. When gasoline prices were pushing $4 per gallon, politically this idea wouldn’t sell, but we have a new equation now. With a sharp drop in gasoline prices, now under $2 per gallon in half of our pumps, let’s get it done.

Senator Bob Corker (R-TN) said, “If we’re going to do it, now is the time.” Senator Dick Durbin (D-IL) supports an increase in the tax.

To some, this might sound like a “no brainer,” and I think it is. However, getting this accomplished will not be easy. I called it a “user fee” but when you call it a tax increase, a lot of members of Congress get nervous. Will their constituents make them pay a price in the next election? The Members need to do what is right for the country. I feel that with the collapse in gas prices, the voters will support the investment. It would also be a good idea to tie the increase to inflation. Then we wouldn’t have to come back for more money in the next few years.

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.

114th Congress – What to Expect in Ag and Food

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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.

John Block: Cabinet Luncheon 2014

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By John R. Block

Before Christmas, I hosted the annual Cabinet Secretaries lunch at the famous Blair House. The Blair House is right across the street from the White House. It provides overnight lodging for dignitaries visiting the President. In fact, the Blair House is where President Reagan held his first Cabinet meeting in January 1981 before he had been inaugurated. He couldn’t use the White House then because Jimmy Carter was still in there. At that first meeting, I asked President Reagan to lift the Soviet grain embargo and about had my head taken off by Secretary of State Alexander Haig. He wanted concessions from the Soviets first.

This year at the Cabinet luncheon, we had about 50 Cabinet members and their spouses. Looking back, I recall when we held our first Christmas Cabinet luncheon at the Madison Hotel. At that luncheon, we only had six members of the Reagan Cabinet and Vice President Bush. We’ve never missed a year since then, and now we invite Cabinet members from both parties.

This year, we had Secretaries from the Reagan, H.W. Bush, Clinton, George W. Bush, and Obama years. The Department of Agriculture was well represented with Dan Glickman, Ann Veneman, Mike Johanns, and Yours Truly in attendance. We had Secretaries of State, Defense – Secretaries of everything. There was a clear impression that the attendees were convinced that they could do a much better job of running the government than today’s White House crowd.

Every year, each Cabinet member is asked to make a prediction for the new year. Some are serious and some are just funny.

Barbara Franklin predicted that trade promotion authority legislation would pass and be signed by President Obama. I hope she is right.

Ray LaHood said that a Republican governor will win the nomination to run for President in 2016. We have a lot of governors wanting the nomination.

Mike Johanns said that if Hillary Clinton decides not to run, Governor Jerry Brown (CA) would win the Democratic nomination.

Craig Fuller, with tongue in cheek, said that in 2015, 45% of the attendees would arrive by Uber.

Ed Harper predicted that the President will sign legislation for the trans pacific trade bill. That would be great.

I was reminded that, last year, I predicted that we wouldn’t get a farm bill, but we did. I’m happy that I was wrong.

There was a very positive, up-beat attitude in the room. We all felt that if we were back in the chairs, we would be able to solve the nation’s problems.

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.

Two Obama Nutrition Leaders Move On

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By Marshall L. Matz

Dr. Janey Thornton, the USDA Deputy Under-Secretary for Food, Nutrition and Consumer Services, has resigned her post effective at close of business Friday, January 9, 2015.  She will be returning to Kentucky to turn her attention to important family needs.  Also, Sam Kass has left the White House as Executive Director of Let’s Move! and Senior Policy Advisor for Nutrition Policy.

Over the nearly past six years, these two individuals have demonstrated their commitment to improving the nutrition of our nation’s children by encouraging better nutrition habits, motivating physical activity, and pursuing significant changes in school lunch, school breakfast and all foods served throughout schools.

Debra “Deb” Eschmeyer will replace Kass as the White House Executive Director of Let’s Move! and Senior Policy Advisor for Nutrition Policy.  Janey’s successor is yet to be named.  But two things are certain: both of these individuals will be vitally important as Congress moves ahead with the reauthorization of child nutrition programs this year, and both will have big shoes to fill.

John Block: Look Back at 2014

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By John R. Block

Year 2014 is history now. It seemed like a lot of bad things happened. After fighting in the Middle East for more than a decade to neutralize the terrorists and bring stability to Iraq, overnight Islamic State militants took over half of Syria and Iraq. The sacrifices made over there have gone up in flames. Last year, Russia took Crimea away from Ukraine. Look at West Africa and we have worried that their Ebola epidemic could engulf the whole world.

Economies in Europe seem to be falling back into recession. The U.S. economy is gaining traction, but our national debt now exceeds 18 trillion dollars and rising. Throughout 2014, our Congress and the President failed to deal with most of our biggest problems. Looking back, most people would say, “We really had a bad year.”

However, some good things did happen – especially from agriculture’s perspective. The U.S. economy is experiencing healthy growth. Five percent is solid growth. Interest rates are lower than they have been in my lifetime. Inflation is about 2% – ideal. Remember in the early 80s, we were paying 15% to 18% to borrow money to buy seed and fertilizer?

2014 wasn’t a bad year for agriculture with net farm income at almost 100 billion dollars. Although not a record, it is still in the upper range. Exports have been booming the last two years in the 140 billion dollar range. Livestock prices have been at record levels most of 2014, while grain prices have fallen. Not surprising since we just harvested a record crop.

Looking to the future, we see a hungry world out there that will need more food. Agriculture is a growth industry. We are in the food business.

In November, we elected a new Congress. Republicans now control both House and Senate. They are committed to pass trade promotion authority, protect agriculture against over-regulation, pass the Keystone pipeline, push for tax reform; will they be able to work with President Obama? We shall see. It takes two to tango.

Still on the plus side, President Obama is opening the door to Cuba.

I almost forgot – one more positive for 2014 – maybe the Congress didn’t get much done, but they did pass a farm bill. That wasn’t easy. The bill is far from perfect, but the safety net is in place.

My grade for 2014 is a B+. Not bad and with the U.S. economy leading the world, maybe 2015 will surprise us.

Happy New Year!

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.

A Flurry of End-of-Year Activity from FDA on Food

FDA, Public Policy • Tags: , , , , , , , , , , , , , ,

By Robert A. Hahn

In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food.  Coming in under the wire in 2014 were:

  • A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015.  FDA is also requesting that industry organizations interested in participating in the selection of non-voting industry representatives to the Food Advisory Committee should notify FDA in writing of their interest by January 7, 2015.
  • A notice requesting nominations for voting members to FDA’s Food Advisory Committee. Nominations are due by January 30, 2015.
  • A final rule establishing January 1, 2018 as the uniform compliance date for food labeling regulations issued between January 1, 2015 and December 31, 2016.
  • A response to objections to FDA’s final rule approving advantame as a non-nutritive sweetener and flavor enhancer for use in foods generally, except for meat and poultry products. FDA determined that the final rule approving advantame should not be modified and confirmed the final rule’s May 21, 2014 effective date.
  • A final guidance document on labeling of certain beers subject to FDA labeling jurisdiction – Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. Under the guidance, beers that are not made from both malted barley and hops but instead made from substitutes for malted barley, such as sorghum, rice, or wheat, or are made without hops (other than sake, which is classified as a wine), are not “malt beverages” under the Federal Alcohol Administration Act.  Such beers must comply with FDA labeling requirements, but are also subject to certain Alcohol and Tobacco Tax and Trade Bureau (TTB) labeling requirements (g., the Government Health Warning Statement about consumption of alcoholic beverages).
  • A final guidance document on labeling of processed and blended seafood products made primarily with fish protein – Compliance Policy Guide Sec. 540.700 (Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein).
  • A notice announcing the availability of a revised draft guidance document on the level of coli in crabmeat at which the agency will consider crabmeat products to be adulterated (i.e., 3.6 Most Probable Number per gram (MPN/g) of E. coli) – Compliance Policy Guide Sec. 540.275 (Crabmeat – Fresh and Frozen – Adulteration with Filth, Involving the Presence of the Organism Escherichia coli). To be considered before FDA begins work on a final guidance, comments must be received by February 17, 2015.
  • An update on other pending food labeling matters – Update for Industry on Certain Proposed Rules, Draft Guidance and Petitions Related to Food Product Labeling.  This update includes some interesting tidbits about the current status of matters FDA did not complete in 2014.  For example, FDA completed data collection for a consumer study on “whole grain” label statements, and is now considering comments received on FDA’s 2006 draft guidance and developing a final guidance document on this subject.  Missing is any mention of the status of a final guidance document on “non-GMO” label statements, which FDA had promised to issue in 2014.

Some notable end-of-year announcements related to food made by other federal agencies include:

  • An announcement of a public workshop on “Options for Consideration of Chronic Disease Endpoints for Dietary Reference Intakes” to be held on March 10 and 11, 2015 by the Dietary Reference Intakes (DRI) Committees of the U.S. and Canada. The workshop will evaluate the scientific issues involved in using chronic disease endpoints to set DRIs.  The DRI Committees are also requesting public comments on the specific questions posed in the workshop announcement.  Comments are due January 30, 2015.
  • Recommendations of the Presidential Task Force on Combating Illegal, Unreported and Unregulated Fishing and Seafood Fraud.  The recommendations submitted to President Obama by the Task Force include: work with Congress to pass legislation implementing the 2009 Agreement on Port State Measures to Prevent, Deter, and Eliminate Illegal, Unreported and Unregulated (IUU) Fishing; direct the Secretaries of Agriculture, Commerce, Health and Human Services (HHS), Homeland Security, and Interior and the Attorney General to develop a strategy to collect, share, and analyze information and resources to prevent IUU and fraudulently labeled seafood from entering U.S. commerce; direct the Secretaries of Agriculture, Commerce, HHS, and Homeland Security to standardize and clarify rules on identifying the species, common name, and origin of seafood; direct the Task Force to establish a regular forum with harvesters, importers, dealers, retailers, processors, and non-governmental organizations to improve collaboration in combating IUU fishing and seafood fraud; direct the Task Force to develop a list of the types of information and operational standards needed for an effective seafood traceability program; and direct the Task Force to establish the first phase of risk-based traceability program to track seafood from point of harvest to entry into U.S. commerce.  Comments on the recommendations are due by January 20, 2015.