Statement by Senator Bob Dole on Nutrition Report

Contact: Marshall Matz (202) 789-1212; mmatz@ofwlaw.com or Marion Watkins (202) 654-4863; marion.watkins@alston.com

“As co-author with Senator George McGovern of the original 1977 ‘Dietary Goals for the United States’ report, I commend the USDA, HHS and its Dietary Guidelines Advisory Committee for continuing to focus attention on human nutrition.  The Committee’s recently-released report notes the staggering numbers of Americans struggling with obesity and/or preventable chronic diseases.

The science of human nutrition is constantly evolving, making it important to update the U.S. government’s dietary guidelines every five years.

While I agree with much of the report, I believe the Committee exceeded its mandate when it made dietary recommendations based on environmental concerns of “sustainability.”  I urge the Secretary of Agriculture and the Secretary of Health and Human Services to omit those recommendations in issuing their final guidelines.  The science of nutrition can be confusing to the average consumer.  Integrating environmental considerations into dietary recommendations lessens the report’s impact and usefulness.”

FSIS Poised to Take Action in Response to Increase of Recalls Due to Undeclared Allergens and the Failure to Present Imported Products for Re-inspection

By Brett T. Schwemer

The Food Safety and Inspection Service (FSIS) recently posted on its website a Summary of Recall Cases in Calendar Year 2014.  Comparing this summary with the summaries from 2013 and 2012, a few things immediately stand out.  On a positive side, meat and poultry product recalls for pathogens (Shiga toxin-producing E. coli, Listeria monocytogenes, and Salmonella) and other contaminants collectively decreased in 2014 from years 2012 and 2013.  However, on the negative side, there was a significant increase in recalls in 2014 for undeclared allergens and recalls classified as “other,” which upon closer examination, appear to be largely related to the failure of importers to present imported meat and poultry products to FSIS for re-inspection at the point of entry (otherwise known as a “Failure to Present” (FTP)).  With these trends continuing into 2015, establishments should expect FSIS to respond aggressively.

Undeclared Allergen Recalls

Recalls for undeclared allergens rose from 25 in 2013 to 43 in 2014, a whopping 72 percent increase.  Seven of the recalls in 2014, which occurred at the very end of the year, can be attributed to meat and poultry establishments purchasing cumin that were unknowingly contaminated with peanut protein.  However, the rest appear to be situations where meat or poultry processors failed to properly identify and control incoming ingredients, failed to prevent cross-contamination during processing or failed to ensure that finished products were properly packaged and/or labeled. In short, these recalls were largely preventable.

FSIS has grown frustrated with the continued increase in recalls due to undeclared allergens and has vowed to take action.  Last month, the agency advised the industry that it will be soon be issuing new instructions to inspection program personnel on how to verify that meat and poultry products are correctly labeled.  The new instructions will purportedly contain additional inspection tasks related to label and formula reviews, and provide guidance on what can result in an undeclared allergen in product and what procedures can be adopted in an allergen control plan.  Obviously, if undeclared allergens are found and product has entered commerce, the agency will request a recall.

In anticipation of these new instructions, establishments would be well advised to reassess their current allergen control programs and other procedures to ensure that meat and poultry products are properly labeled with all ingredients listed.  This reassessment should be conducted in light of the FSIS “Compliance Guidelines for Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control and Declaration Through Labeling.”  These guidelines contain certain “best practices” identified by the agency for ensuring that hazards associated with ingredients of public health concern are properly identified, that they are prevented and/or controlled, and that all ingredients are properly declared on product labels.  In addition to these guidelines, establishments should also consider guidance provided by the Food Allergy Research and Resource Program of the University of Nebraska regarding how to develop effective allergen control programs.  Finally, our firm has posted a series of blogs entitled “Steps to Prevent Allergen Recalls – Practice Tips.”

Establishments should also anticipate that, with an increase in inspection tasks related to label review, there will be a heightened risk that inspection personnel will take regulatory control actions for perceived labeling deficiencies that do not arise to a public health concern.  Given that a substantial amount of labels are generically approved these days, many establishments may not be able to point to an FSIS approved label to convince inspection personnel not to take action.  To that extent, it would behoove establishments to get to know officials from the FSIS Labeling and Program Delivery Staff and maintain emergency contact information for these officials in the event that a labeling dispute arises with inspection personnel or there is a need for an emergency temporary label approval.

FTP Recalls

As noted above, 2014 also experienced a dramatic increase in FTP recalls – 6 in 2014 compared to 1 each in 2012 and 2013.  Just two months into 2015, there have already been 7 FTP recalls.

Similar to the recalls for undeclared allergens, it is our understanding that most of the FTP recalls were avoidable.  Pursuant to FSIS regulations, after Customs and Border Protection (CBP) verifies that imported meat and poultry product meets CBP and Animal and Plant Health Inspection Service requirements and releases the shipment, the importer of record is required to have the product presented to FSIS for re-inspection at an official FSIS import inspection establishment.  Unfortunately, in many of the recalls, the importer of record (or broker) failed to ensure that the product was delivered to an official FSIS import inspection establishment for re-inspection or the import inspection establishment inadvertently released the shipment in commerce without the requirement being met.

The increase in FTP recalls, however, is not solely attributable to an increase in mistakes by importers, brokers and import inspection establishments.  Beginning about 7 months ago, FSIS began increasing verification of its import requirements by reviewing data in its Public Health Inspection System (PHIS) twice a week to identify potential FTPs. This increased verification directly correlates to the increase in recalls.

In response, FSIS has indicated that it will continue to, and potentially increase, its review of PHIS data in 2015 to detect FTPs.  If a FTP is detected and product has already entered commerce (i.e., off-loaded at a location other than the official import inspection establishment or other approved located designated on the import inspection application), the agency will likely require the importer of record to conduct a Class I recall of any associated product.   The agency can also withdraw inspection services at the official import inspection establishment until the establishment can provide additional measures to ensure imported product is re-inspected.  Finally, the agency may request CBP to issue a Notice of Redelivery to the importer of record, broker and/or official import establishment demanding that the uninspected product be returned to the custody of CBP. If product is not redelivered to CBP, CBP can initiate action to assess penalties and liquidated damages (additional information regarding FTPs and the actions that FSIS will take in response can be found in the agency’s Prior Notification and Failure to Present: Compliance Guideline for Importing Meat, Poultry and Egg Products to the United States).

Given the increase in verification activities relating to FSIS import requirements and the consequences for failing to meet these requirements, importers of record, brokers and official import inspection establishments would be well advised to work together to implement a system of controls designed to ensure that all imported meat and poultry products are re-inspected at the point of entry.  This should include measures to ensure that the importer of record or designated agent applies for inspection of imported product as far as possible in advance of the anticipated arrival of each consignment, but no later than when entry is filed with CBP, in accordance with FSIS’ prior notification requirement.  It should also include improved means of communication between the respective parties regarding when amenable meat and poultry products may be in a shipment of product and thus require inspection.  Finally, official import inspection establishments should consider implementing more stringent procedures for identifying and controlling imported meat and poultry product that are to be held pending FSIS re-inspection, such as the implementation of new inventory control systems designed to prevent meat and poultry product from being “released” from inventory until re-inspection is complete.  Additional recommendations for adopting an effective hold or retention program can also be found here.

Following the basic recommendations above should go along way towards reducing the number of recalls for undeclared allergens and FTPs each year.  However, if the industry ignores these recommendations and such recalls continue to rise, the industry should fully expect the agency to take additional measures to control what they view as a purely preventable situation.

Global Child Nutrition Foundation to Honor Secretary Vilsack on April 16th

By Peter B. Matz

Secretary VilsackThe Global Child Nutrition Foundation is proud to announce Secretary of Agriculture Tom Vilsack as the recipient of the 2015 Gene White Lifetime Achievement Award for Child Nutrition.

Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition at GCNF’s Annual Gala Reception. Now in its 12th year, the Gala has become a signature Washington event with high-caliber honorees and speakers. It will take place on Thursday, April 16, 2015, in Washington, DC, at the Ronald Reagan Building and International Trade Center.

The highlight of the evening will be the presentation of the Gene White Lifetime Achievement Award for Child Nutrition to the Secretary. Over 200 executives from industry and high-level government and NGO officials will come together for the event.

The Gala raises funds for GCNF’s efforts to end child hunger by helping developing countries establish sustainable school feeding programs. At this moment, over 350 million hungry children live in extreme poverty throughout the world. School feeding programs nourish children, provide an incentive for children to go to school, and help lift children, their families and their communities out of poverty.

Global Child Nutrition Foundation’s Annual Gala Reception honoring

U.S. Department of Agriculture Secretary Tom Vilsack

Thursday, April 16 2015

5:30pm-7:30pm

The Ronald Reagan Building and International Trade Center

1300 Pennsylvania Avenue Northwest, Washington, DC 20004

More information at www.gcnf.org

Secretary Tom Vilsack

Throughout his long and distinguished career in public service, Secretary Vilsack has demonstrated his commitment to the nutritional well-being of children at home and abroad. As Governor of Iowa, Vilsack created the Iowa Food Policy Council to advance local food systems, enhance family farm profitability, and combat hunger and malnutrition.  At USDA, Secretary Vilsack is a key Cabinet leader on global food security and served as one of the primary architects of President Obama’s Feed the Future Initiative launched in 2009. Under his leadership, USDA has contributed to improved global food security by focusing on capacity building to improve markets information, food safety systems, basic and applied research and innovations in agricultural productivity.

In 2013, Secretary Vilsack led U.S. efforts on the Global Open Data for Agriculture and Nutrition, which seeks to support global efforts to make agricultural and nutritionally relevant data available, accessible, and usable for unrestricted use worldwide in order to improve consumer health and expand economic opportunities for farmers. Building on those efforts, in 2014, Secretary Vilsack led the launch of U.S. participation in the Global Alliance for Climate-Smart Agriculture, a global effort to share knowledge and practices to address climate change and its impact on agriculture and chart a new path forward towards greater global food security.

Secretary Vilsack continues to be a strong voice for improving the nutritional quality of domestic child nutrition programs and has focused USDA’s McGovern-Dole School Feeding Program on meeting rigorous nutrition and literacy goals. Child nutrition programs in the United States have become global models of excellence under Secretary Vilsack’s leadership and commitment.

FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

By Neil F. O’Flaherty

There is good news for certain sectors of the medical device industry.  FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps).  In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA announced the availability of two new guidance documents which are intended to put industry on notice of FDA’s policy change.  The guidance documents are currently available on FDA’s website:

  1. “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices,” (MDDS guidance) available here; and
  1. “Mobile Medical Applications,” available here.

Previously, MDDS and medical image storage and communication devices, and similar mobile medical apps, were regulated by FDA as Class 1, 510(k)-exempt devices.  As such, they were subject to FDA’s medical device labeling, medical device reporting, establishment registration, product listing and Quality System Regulation requirements, among others. The policy change greatly decreases the regulatory burden on these types of devices by not requiring manufacturers and other responsible parties for these types of devices to comply with these requirements.

The MDDS guidance provides that FDA does not intend to enforce compliance with the regulatory requirements that apply to MDDS, medical image storage devices and medical image communication devices.  The September 25, 2013 version of the “Mobile Medical Applications” guidance has been updated to be consistent with the MDDS guidance.  In relevant part, the updated  version deletes the example of Mobile Apps that would be regulated as an MDDS and adds that it intends to use enforcement discretion for apps that are “intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 21 CFR 880.6310).”  The guidance also provides an example of when a mobile app meets the definition of an MDDS and gives other examples of where FDA will use enforcement discretion.

Although this is good news for industry, FDA has strict definitions of what it considers an MDDS device, a medical Image storage system and a medical image communication system.  Before taking advantage of the decreased regulatory burden in regulatory and business planning (e.g., commercializing new products, modifying treatment of existing products, etc.), firms need to truly make sure that FDA would view their device as falling into one of these categories.  Wrongly relying on your device falling into one of these categories could translate into an FDA compliance action against your company.

For those firms which have a good basis for claiming their product falls into one of these categories, it is important to document why in a written regulatory rationale.  In this way, if FDA or a third-party ever questions your conclusion, you can use the rationale to convince FDA or the party that you are correct or to at least demonstrate your “good faith” deliberations.

The NAS is Examining GE Crops

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

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

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

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

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

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.