Salmonella in Raw Products – Can FSIS Request a Recall?

By Barbara J. Masters, D.V.M.

I am often asked whether or not the Food Safety and Inspection Service (FSIS) can request a recall for meat or poultry products merely because the products test positive for Salmonella.  The answer to that question today is no.  However, there are times FSIS can request a recall of raw meat and poultry products for Salmonella.  If at any point FSIS determines there is specific product (specific lot, specific product date) in commerce making people sick, it will ask for a voluntary recall of that specific production of product, regardless of whether there is a positive test result.

What is important to understand is that for outbreak recalls, FSIS will use the same thought process regardless of whether the pathogen is considered an adulterant or not.  FSIS would look for the following four factors as part of the outbreak investigation:

  • There are related illnesses (an outbreak) as determined by the DNA analysis of samples from case patients;
  • The evidence supports the conclusion that the likely source of the illnesses was a specific product;
  • The plant produces that specific product; and
  • A specific production of that plant’s product was purchased by, or available to, the case patients at the time and location of the illnesses.

If all of these criteria are met, FSIS will request a recall of the product implicated in the outbreak.  In this circumstance, FSIS is not relying on a positive test result (from the product) to request the product be removed from commerce, rather they are relying on evidence that the specific product has been implicated in causing an outbreak.

In summary, today, FSIS can request an establishment to conduct a voluntary recall for products that test positive for an adulterant (e.g., E. coli O157:H7), but not for product that tests positive for Salmonella.  However, in the case of a foodborne outbreak, FSIS applies the same rules to all pathogens.  If the evidence supports that a specific production of product is the likely source of the illnesses in the outbreak, FSIS will request a voluntary recall (not based on test results of the product).

About Dr. Masters

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.

John Block: Bird Flu

By John R. Block

There is no industry more volatile or more uncertain than agriculture. The drought came and Texas and Oklahoma ranchers had to sell their cattle – not enough feed. Beef prices shot up. We still don’t have enough beef. The pork industry was hit with a swine disease. Thousands of baby pigs died. That resulted in a pork shortage and those prices shot up.

Now, we have bird flu. Who would have predicted? The H5N2 virus has killed 47 million chickens. We should be producing enough eggs to meet domestic demand and be able to export more than 30 million eggs per month. Not now. Iowa has been hurt the most – losing 30 million birds. That’s half the laying hens in the state.

The price of eggs has doubled. Egg processors making cakes, cookies, Krispy Kreme donuts, etc. are crying for eggs. For the first time in 10 years, we have authorized imports. Seven European countries have been approved to import shell eggs. Government officials say it will take as long as 2 years to get our production of eggs back to where it was before the virus.

This is not the first time we have been hit with a bird flu virus. When I was Secretary of Agriculture in the early 80s, we had our last bad bout with bird flu. That was a disaster then. But this time is much worse.

The Department of Agriculture oversees these problems. Farmers are compensated for the birds that die or are destroyed. According to Secretary Vilsack, the cost could exceed a half billion dollars. We are losing a lot of birds, including egg-laying hens, broilers, and turkeys. It will take a lot of money and time to rebuild the business.

Stopping the spread of the virus will not be so easy. Canadian geese in the state of Michigan have tested positive. They fly everywhere. In the meantime, the industry is looking for a vaccine to protect against the virus. None approved as of yet.

There is no industry more essential to mankind than food production. There is no industry more uncertain. And yet, our farmers and ranchers persist and get the job done. Did you know that this spring world food prices fell to their lowest level since 2009?

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.

Device Firms: What You Should Know About The 21st Century Cures Act

By Mason Weeda

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21.  Known as the 21st Century Cures Act (“Act”), the stated aim of the legislation is to modernize and personalize health care, encourage innovation, support research, and streamline the U.S. health care system to promote the delivery of better and faster “cures” to more patients.

In support of this goal, the Act would change the review of medical devices determined to be “breakthrough,” establish a third-party option for the inspection of medical device manufacturers, make changes to certain Humanitarian Device Exemption (“HDE“) requirements, institutionalize FDA’s ongoing efforts regarding the regulation of medical software applications, and loosen some clinical investigation requirements.  Significantly, the legislation also indicates an ongoing Congressional interest in the restrictions FDA has placed on the dissemination of truthful and nonmisleading off-label information.

Breakthrough Device Pathway

The Act would support faster “cures” by creating a “priority review” pathway for those devices that meet the definition of a “breakthrough device.”  These “breakthrough devices” include those that “represent breakthrough technologies… for which no approved alternative exist,” offer “significant advantages over existing approved or cleared alternative,” and are “otherwise in the best interest of patients.”

Upon a sponsor’s request, FDA would determine whether a device meets the “breakthrough device” designation using specified criteria.  If a device receives such designation, it would be eligible for expedited review by a team of staff that will interact with the device sponsor.  During this process, the Act would require FDA to “take steps to ensure that the design of clinical trials is as efficient as practicable, such as through adoption of shorter or smaller clinical trials, application of surrogate endpoints and use of adaptive trial designs and Bayesian statistics.”  Likewise, the agency would also be required to “facilitate … expedited and efficient development and review of the device through utilization of postmarket data collection.” Although these are laudable goals, the Act does not impose any specific timelines in which an “expedited review” must be completed or otherwise quantify how much existing review times will be reduced.

Third-Party Inspections of Device Manufacturers

The Act also contains provisions that could allow FDA to conserve its inspectional assets and speed up approval of modified versions of existing devices by allowing for the use of third party inspectors to conduct the necessary establishment inspections.  The theory being that creating a “quick” method to inspect facilities in these circumstances would promote the earlier availability of improved “cures.”

Under the provisions of the Act titled “Medical Device Regulatory Process Improvements,” Congress would require FDA to establish a “third-party quality system assessment” program, where accredited third parties would inspect manufacturers for compliance with the Quality System Regulation (“QSR”) (21 C.F.R. Part 820).  However, use of such third-party inspections would be limited only to QSR inspections necessary as the result of submissions involving “device related changes” and would not be available in other types of establishment inspections.

Changes to Humanitarian Device Exemptions

This section of the Act would double the number of patients that must suffer from a disease in order for FDA to consider it a “rare disease.”    Presently, the HDE pathway is intended to incentivize and encourage the development of devices to treat “rare” diseases or conditions affecting small patient populations when the device manufacturer`s research and development costs would otherwise exceed its market returns.  It does so by significantly reducing the clinical data that would be necessary for the manufacturer to generate to support the efficacy of the device that would otherwise be required by FDA in a traditional marketing application. To qualify for an HDE, the disease or condition must presently affect fewer than 4,000 individuals in the United States per year. The Act seeks to encourage additional development making “cures” more widely available by increasing this number to 8,000 individuals.

Medical Software

In an apparent effort to “modernize” the technology involved in health care, the Act would create a definition of “health software,” which generally would not be regulated unless it:

  • is intended for use to analyze information to provide patient-specific recommended options; or
  • FDA determines that it poses a significant risk to patient safety.

This provision continues to allow FDA some flexibility as to how it may regulate software.  The Act also would require the agency to review existing regulations and guidance regarding software, including the classification of software, standards of verification and validation, review of software, and quality system for software, among others.

Clinical Trials

The Act would also make it easier for sponsors conducting clinical investigations by requiring the Department of Health and Human Services (“HHS”) to harmonize its requirements applicable to clinical investigations with FDA’s own requirements. This supports the Act’s goals by significantly reducing the regulatory burden imposed on sponsors who must presently ensure that their clinical investigations meet the often duplicitous requirements imposed by both HHS and FDA controls.  The Act also would make it easier for sponsors to meet Institutional Review Board (“IRB”) requirements by allowing the use of non-local IRBs to review medical device trials, including Investigational Device Exemptions (“IDE”) and HDEs. Permitting the use of non-local IRBs support the Act’s goal of “quicker cures” by eliminating the “log jam” and delays sometimes associated with the use (and overuse) of local IRBs by giving sponsors additional options that are potentially faster than the traditional ones.

Promotion

Lastly, and without limitation, the Act’s section on “Facilitating Responsible Communication of Scientific and Medical Developments,” provides that FDA “shall, within 18 months, issue draft guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.”  This provision appears to be in response to the Coronia Case (U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012)), which holds that representatives of pharmaceutical manufacturers have a right under the First Amendment to make truthful statements regarding their products, even if such statements indirectly promote drugs for uses not approved by FDA.  The Act does not provide further direction on this topic, but Congress is clearly nudging FDA to update its position on off-label promotion which may affect medical device manufacturers.

It may be an uphill battle for Congress to agree on all topics involved in the 308 pages of 21st Century Cures Act.  However, as reported by the House Energy and Commerce Committee Press Releases, the bill appears to have support from industry and consumer groups, which may help bring Congress together.

How Much Rain Has Fallen In Texas?

By Charles W. Stenholm

In the month of May, Texas received over 35 trillion gallons of rain.  See the graphic, below, to put that into perspective.

Many prayers were answered as we went from extreme drought to an overabundance of rainfall.  Truly a blessing!  It is much more difficult to do without water than deal with having too much.  Just wish the loss of life and property could be avoided.  We did, however, see many of the benefits of investing in flood control pay some dividends.

TX Rainfall

Click graphic to enlarge.

Why Adesina’s Election is Important for Agriculture

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

In a surprise upset, Dr. Akinwumi (Akin) Adesina was elected to be the next President of the African Development Bank (ADB), defeating seven rivals in six rounds of voting.  Adesina holds a PhD in agriculture economics from Purdue and has been serving as the Minister of Agriculture in Nigeria since 2011.

Adesina is the first agriculture economist to become President of the ADB.  He is a dynamic leader with a passion for rural development (and bow-ties).  According to The Guardian, under his leadership in Nigeria, “food production increased by 22 million tons and food imports dropped more than a third,” creating some three million jobs.

The ADB is one of Africa’s largest lending institutions, making Adesina one of the continent’s most prominent financial leaders. Africa now has six of the world’s fastest growing economies and, as agriculture becomes more efficient, the economy will grow even faster. Over 65% of the population farms or is engaged in agriculture. However, yields are so low that feeding a family takes 70% the its disposable income and Africa must spend $35 billion to import food.

Adesina’s goal is to make Africa globally competitive.  Upon his election he said, “A big thing for us in Africa is to create an inclusive model with jobs for Africa’s youth, jobs for Africa’s women, revive Africa’s rural areas and have regional integration for shared prosperity.” He also noted that “there is no developing Africa without empowering women.”

The challenge Adesina faces will not be easy.  Political stability varies widely in Africa’s 54 sovereign nations as does infrastructure, education and health care, but things are clearly changing and changing fast.

Adesina will have some important allies to work with in his new capacity:

  • The Chairperson of the African Union, Dr. Nikosazana Diamini- Zuma, is asking all African countries to invest at least 10% of their respective national budgets in agriculture.  The program, called the Comprehensive Africa Agriculture Development Program (CAADP), is having an impact.
  • Dr. Agnes Kalibata, the new President of the Alliance for a Green Revolution in Africa (AGRA) holds a doctorate from the University of Massachusetts in entomology.  She was the Minister of Agriculture in Rwanda and was widely considered to be one of the most successful agriculture ministers in sub-Saharan Africa.  At AGRA, Dr. Kalibata is working with African experts in some 18 counties to fulfill the vision of food self-sufficiency.
  • Strive Masiyiwa, the Chairman and CEO of Econet Wireless, is the “Bill Gates of Africa” according to Forbes, but is focusing the attention of Africa’s private sector on agriculture through his work with AGRA and Grow Africa.
  • Former Secretary General Kofi Annan, Chairman Emeritus of AGRA,  says “it’s time to turn hoes into tractors,” and is committed to helping through the Kofi Annan Foundation.

These African leaders are working closely with the G-7, G-20 and key leaders closer to home here in the United States. Those leaders include: Gayle Smith, who is an Assistant to President Barack Obama and Senior Director at the National Security Council. In that capacity, Smith is responsible for global development and helped to craft the Camp David Accords creating a commitment to African agriculture.

During the Clinton Administration, Smith was Senior Director for African Affairs at the National Security Council.  President Obama has now nominated Smith to be the next Director of the Agency for International Development (AID). Smith is well-qualified for the AID position and hopefully, the U.S. Senate will quickly confirm her nomination.

While there are many others committed to growing Africa out of poverty, in the U.S., special recognition must also go to Pamela Anderson at the Bill and Melinda Gates Foundation and Judith Rodin at the Rockefeller Foundation.

All of these people are coming together for Africa. The Renaissance is underway and the election of Dr. Akin Adesina is the latest very important development. According to Dr. Adesina, “The kind of Africa we need today is an Africa where the young people want to stay, not a place they want to move away from…and an Africa we can all be proud to call home.”

As Adesina knows, agriculture development must be at the center of the African Renaissance. As modern seeds and inputs, along with education, reache the stallholder farmers, production and profitability will improve. That will drive the African economy to new levels of success and, in the process, move Africa and the world toward food security.

The African Development Bank made an inspired choice.

Marshall Matz specializes in agriculture and food security at OFW Law in Washington, D.C.  He also serves as the DC representative for the Alliance for a Green Revolution in Africa.