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.

Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.

Tonight: Global Child Nutrition Foundation Honors USDA Secretary Vilsack

By Peter B. Matz

Secretary Vilsack

Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition. GCNF’s Annual Gala has become a signature Washington event, bringing together executives from industry as well as high-level officials from both government and NGO’s.  It will take place tonight, from 5:30-7:30 PM, at the Ronald Reagan Building and International Trade Center in Washington, DC.  Details below.

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.

2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

By Robert A. Hahn

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

Some aspects of the DGAC report have been controversial.

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

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

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

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

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

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

So Which USDA Regulations Would You Like to Change?

By Roger R. Szemraj

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

Well, now is the chance to speak up.

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

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

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

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

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.

Two Obama Nutrition Leaders Move On

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.

10 Things to Watch in 2015

By John Dillard

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

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

1.  Drones

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

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

2. The “Waters of the U.S.” Rule

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

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