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.

Food Defense Plans

By Barbara J. Masters, D.V.M.

One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.”  The Agency has a FY 2015 target of 90% of all establishments having a functional food defense plan. Since 2006, annual surveys have been conducted to measure progress.  The largest establishments currently exceed the goal (97% have a functional plan) while the very small establishments are not yet at the target.

The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to implement measures to protect the food supply from intentional contamination.  A proposed rule to address hazards resulting from intentional contamination was issued on December 24, 2013.

Both FSIS and FDA have taken substantial measures to assist the food industry in the development of food defense plans.  The FSIS webpage includes a tool that an establishment can download to select the specific elements appropriate for their facility.  FDA maintains an on-line food defense plan builder free to all users.  Once a plan is documented, the establishment must implement the plan.  Steps to implementing a food defense plan include:

  • Testing the plan (e.g., check locked doors, take unannounced walks around the perimeter), and
  • Reviewing and maintaining the plan (review and update as needed).

Food defense plans should be tailored to the facility.  Small establishments do not need to make the plan overly burdensome.  For example, a plant that only employs family members would not need background checks on employees as a critical element.  However, this establishment could document the use of door locks and outdoor lighting at key locations in the facility.

Areas to be considered in a food defense plan are: outside security, inside security, personnel security measures and incident response security measures.

When I go visit any establishment, I am always asked to show my identification.  I am always escorted during the visit, and I see emergency plans posted at every facility.  These are all elements of a food defense program.  If these elements for secure food are already in place, it is logical that they could easily be documented and verified by the establishment.

I encourage those plants that are not currently maintaining a functional food defense plan to review the FSIS and FDA websites.  I challenge them to consider that they very likely already have all the elements in place for a food defense plan – the plan just needs to be documented.  By documenting the plan – the establishment is taking the necessary steps to ensure all team members are aware of the program and are taking steps to consistently implement it.

If by maintaining a functional food defense plan we can contribute to a safer and more secure food supply, then I am certain we are all in favor of meeting this objective.

Food Facility Registration Rules To Be Updated by FDA

by Michael J. O’Flaherty

FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply, added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Among other actions taken to implement the Bioterrorism Act, pursuant to section 415 the agency established regulations requiring that food facilities register with FDA. These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA) of 2011 amended section 415 of the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. As amended, section 415 also requires food facilities to renew their registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. FDA has issued a number of guidance documents to assist the industry in complying with the food facility registration requirements. See generally Guidance for FDA Staff: Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food (June 2014); Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition) (rev. Nov. 18, 2014); Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide (rev. Dec. 17, 2014); and Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (rev. May 18, 2014)..

Under FDA’s present regulations, certain food facilities, including retail food establishments, are exempted from the requirement to register. The proposed rule would amend the regulatory definition of a “retail food establishment” in a way that would expand the number of establishments that are subject to the exemption. A retail food establishment is currently defined as an establishment that sells food products directly to consumers as its primary function. An establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The proposed rule would clarify that, in determining the primary function of an establishment, the sale of food directly to consumers from an on-farm establishment includes sales by the establishment at such direct sales platforms as roadside stands, farmers’ markets, and Community Supported Agriculture (CSA) programs. Based on currently available data, FDA estimates that there are approximately 71,000 farms that only sell food products directly to consumers in ways that include farmers markets, roadside stands, and CSA programs. [Note: Inasmuch as the amended definition would exempt additional establishments from the requirement to register, these establishments also would not be subject to the requirements of the FSMA preventive controls rulemakings, which apply to facilities that are required to register.] See generally Questions and Answers for Farmers on FSMA Proposed Rule for Food Facility Registration (rev. Apr. 8, 2015).

For food facilities that are not exempt from registration, the proposed rule would add new provisions to the current regulations to codify certain requirements of FSMA that were self-implementing and effective upon enactment of FSMA. Those requirements are:

  • Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
  • Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year.
  • All food facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

In addition, the proposed rule would add certain new requirements, including:

  • All food facility registrations would be required to be submitted to FDA electronically; however, this requirement would not take effect before January 4, 2016.
  • Registrations would be required to contain the type of activity conducted at the facility for each food product category.
  • The proposed rule would provide for measures to verify certain information submitted in registrations.
  • The proposed rule would identify additional circumstances under which FDA will cancel registrations (i.e., FDA independently verifies that the facility is not required to register; information about the facility’s address was not updated in a timely manner; the registration was submitted by a person not authorized to submit it).

Public comments on FDA’s proposed rule may be submitted electronically or by regular mail until June 8, 2015.

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.

FDA Announces National Kick-Off Meeting on FSMA Implementation

By Robert A. Hahn

FDA will hold a “National Kick-Off Meeting on Implementation of the Food Safety Modernization Act (FSMA)” on April 23-24, 2015, in Washington, D.C.

The agency has sent out a save-the-date notice to subscribers to its FSMA webpage, but the notice contains few details.  FDA says that meeting specifics, including registration information, will be made available in March via a Federal Register notice and an announcement on FDA’s FSMA webpage.

We have learned that the public meeting will include opening presentations by the FDA implementation teams for the major pending FSMA rulemakings (including Preventive Controls, Produce Safety, Foreign Supplier Verification Programs, and Intentional Adulteration), as well as breakout sessions during which FDA will seek input from stakeholders.

Despite the use of the word “kick-off” in the meeting title, don’t worry that you somehow missed publication of the FSMA final rules and that FDA is about to “kick-off” implementation.  That is not the case.  FDA has not issued any of the 7 foundational FSMA final rules.  The agency remains under the following court-ordered deadlines for publication of the final rules:

August 30, 2015

  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food

October 31, 2015

  • Produce Safety
  • Foreign Supplier Verification Programs
  • Accreditation of Third Party Auditors

March 31, 2016

  • Sanitary Transportation of Food

May 31, 2016

  • Intentional Adulteration

Although we won’t know the compliance dates until FDA actually publishes the final rules, it is likely that the earliest date that any businesses would need to comply with any of the final rules would be August 2016.  To help you make plans, a rough compliance timeline appears below.

FDA’s decision to hold such a public meeting while it is still drafting the final rules is interesting.  It suggests that the agency is finding certain issues challenging and is willing to present its current thinking and seek feedback before proceeding with the final rules.

Projected Timeline for Compliance with FSMA Final Rules*

2016

August

  • All businesses (except for small and very small businesses) must comply with Preventive Controls for Human Food rule
  • All businesses (except for small and very small businesses) must comply with Preventive Controls for Animal Food rule

2017

March

  • Businesses (except small businesses) must comply with Sanitary Transportation of Food rule

April

  • Importers must comply with FSVP rule (However, if the imported food is subject to the Preventive Controls for Human Food rule or the Preventive Controls for Animal Food rule, the importer must comply with the FSVP rule 6 months after the date that its foreign supplier is required to comply with the relevant preventive controls rule. If the imported food is a raw agricultural commodity (RAC) that is subject to the Produce Safety rule, the importer must comply with the FSVP rule 18 months after the date of publication of the FSVP rule or 6 months after the foreign supplier is required to comply with the Produce Safety rule, whichever is later.  If the imported food is a RAC that is not subject to the Produce Safety rule, the importer must comply with the FSVP rule 18 months after the date of publication of the FSVP rule or 6 months after the effective date of the Produce Safety rule, whichever is later.)

July

  • Businesses (except small and very small businesses) must comply with Intentional Adulteration rule

 

August

  • Small businesses must comply with Preventive Controls for Human Food rule
  • Small businesses must comply with Preventive Controls for Animal Food rule

December

  • Farms (except for small and very small farms) must comply with Produce Safety rule (However, such farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)

2018

March

  • Small businesses must comply with Sanitary Transportation of Food rule

July

  • Small businesses must comply with Intentional Adulteration rule

August

  • Very small businesses must comply with Preventive Controls for Human Food rule
  • Very small businesses must comply with Preventive Controls for Animal Food rule

December

  • Small farms must comply with Produce Safety rule (However, small farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)

2019

July

  • Very small businesses must comply with Intentional Adulteration rule

December

  • Very small farms must comply with Produce Safety rule (However, very small farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)

*This timeline contains projections or estimates of FSMA compliance dates based on the following assumptions: (1) FDA will publish the final rules on or around the court-ordered deadlines listed above; and (2) the final rules will contain the same compliance dates as the proposed rules.  This timeline may need to be updated as each final rule is issued.

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.

114th Congress – What to Expect in Ag and Food

By Michael J. Marshall

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

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

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

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

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

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

Trade

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

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

Nutrition/Dietary Guidelines

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

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

Environment

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

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

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

Food Safety Modernization Act

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

Tax Reform

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

GMO Labeling

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

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

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

Feed the Future

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

Budget and Appropriations

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

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

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

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

2014 And 2015

By Arthur Y. Tsien

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Raw Milk Debate

By Jolyda O. Swaim

Recently, with the ahead-of-print release of the Center’s for Disease Control’s (CDC) study, “Increased Outbreaks Associated with Nonpasteurized Milk, United States, 2007–2012” which will be published in January in the Emerging Infectious Diseases journal, there have been numerous articles and blogs supporting each side of the raw milk issue – that it is the “best thing since sliced bread” or that all states should ban it as the Food and Drug Administration (FDA) did in 1987 with regards to interstate shipment.

The CDC article states that “US outbreaks caused by nonpasteurized milk increased from 30 during 2007–2009 to 51 during 2010–2012.  Most outbreaks were caused by Campylobacter spp. (77%) and by nonpasteurized milk purchased from states in which nonpasteurized milk sale was legal (81%).  Regulations to prevent distribution of nonpasteurized milk should be enforced.”   CDC maintains a section on its webpage that discusses the risks associated with drinking raw milk.

I grew up on a small farm where we had dairy cows.  My mom is a nurse and while we used milk from the cows, it was always boiled for our safe drinking.  Although I believe adults have the right to decide what they want to eat or drink, everyone should base those decisions on facts.  There are adequate facts to support the nutritional value of pasteurized milk and the risk of raw milk.  That said, based on my personal experience as a former microbiologist at a county lab that was approved for milk testing, and knowing how small a dose is needed of pathogens such as E. coli O157:H7 to cause illness – you won’t find any raw milk in my possession.

In fact, I am really not much of a milk drinker anyway – though my twin is!  I will admit that if she wanted to drink raw milk – I would probably make sure she had the facts and let her make that decision (of course Mom would surely have something to say).  But she is a healthy adult and can make her own decision.  However, I would take issue if she decided to provide it to her grandchildren.

While an argument can be made that the risk of contracting a disease is low if good practices are followed on the farm and the raw milk is tested under a rigorous testing program, the cost can be huge if it is your child who happens to be the one who comes down with, for example, hemolytic uremic syndrome (HUS).  The causative pathogen is usually E. coli O157:H7 and it is a potentially fatal foodborne disease characterized by diarrhea (sometimes bloody) and severe abdominal pain. Kidney failure and related complications may also result.  And while many other pathogens take 1000’s of cells before any illness will result – E. coli O157:H7 can cause disease with 5-10 cells.

Young children and elderly or immunocompromised people are more subject to serious complications as their immune systems are not as highly developed as an adult, or respectively, their systems are weakened.  And while cases may be few, I refuse to see any child connected to me die or have to undergo a kidney transplant because they had been served raw milk.

While adults can make their own choices on the facts they gather, I hate to see them make the same choices for children as I cannot imagine the pain they will experience if it turns out to be that one in a million time that there were a few pathogen cells present, and they and their child’s lives are changed forever.  It has been said that pasteurization is one of public health’s most effective food safety interventions ever developed; a simple way to protect those we love.

FDA Announces New Surveys of Foodborne Illness Risk Factors in Restaurants, Retail Food Stores, and Foodservice Institutions

By Robert A. Hahn

FDA has published notices announcing that, over the next 10 years, it plans to conduct surveys on the occurrence of foodborne illness risk factors in restaurants, retail food stores, and foodservice institutions (e.g., hospitals, schools).

Pursuant to the Paperwork Reduction Act, FDA is required to provide a 60-day notice of a proposed collection of information before submitting it to the Office of Management and Budget for approval.  FDA is requesting comments, which are due February 9, 2015 and February 17, 2015, respectively.  See 79 Fed. Reg. 73596 (Dec. 11, 2014) (Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types) and 79 Fed. Reg. 75158 (Dec. 17, 2014) (Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types).

The restaurant survey will span 10 years (2013-2022) and will include data collections in 2013-14 (data already collected and currently being analyzed), 2017-18, and 2021-22.  It will cover both full-service restaurants and fast food restaurants; the latter category includes both quick service restaurants and fast casual restaurants.  FDA’s 25 Regional Retail Food Specialists will contact a random sample of restaurants in its sampling zone, but industry participation is voluntary.

The retail food store and institutional foodservice study will also span 10 years (2015-2025), and will include data collections in 2015-16, 2019-20, and 2023-24.  It will cover: supermarkets and grocery stores that have a deli department or operation, public and private schools for grades K-12 that serve prepare and serve meals to students, and hospitals and long-term care facilities that prepare and serve meals to highly susceptible populations.  The survey will not cover facilities that handle only prepackaged foods or that conduct low-risk food preparation activities.  In the case of grocery stores, FDA will collect data on: deli departments, seafood departments, cheese departments, fresh produce departments, salad bars, pizza stations, and other areas where foods are prepared and offered as ready to eat.  Each of FDA’s 25 Regional Retail Food Specialists will contact a random sample of retail stores and foodservice establishments in its sampling zone, but industry participation is voluntary.

The two studies will look at “foodborne illness risk factors,” which are preparation practices and employee behaviors that are most commonly reported as contributing factors to foodborne illness outbreaks at the retail level.  The five key risk factors are: food from unsafe sources, poor personal hygiene, inadequate cooking, improper holding/time and temperature, and contaminated equipment/cross-contamination.

The objectives of the studies are to:

  • Identify foodborne illness risk factors that need priority attention;
  • Track trends in the occurrence of foodborne illness risk factors over time;
  • Examine potential correlations between the operational characteristics of food establishments (g., corporate ownership versus independent ownership) and the control of foodborne illness risk factors;
  • Examine potential correlations between the elements of a regulatory retail food protection program (g., inspection frequency, grading, posting of scores) and the control of foodborne illness risk factors; and
  • Evaluate the impact of industry food safety management systems (g., written standard operating procedures, training) on the control of foodborne illness risk factors.

FDA intends to use the study results to:

  • Assist FDA in developing retail food safety initiatives and policies;
  • Identify retail food safety work plan priorities to assist with allocation of resources;
  • Track changes in the occurrence of foodborne illness risk factors in retail and foodservice establishments; and
  • Inform recommendations to industry and to state, local, tribal, and territorial regulators.

Although not stated by FDA, the survey results could lead to changes in the Retail Food Code.

These studies represent a continuation of FDA’s previous 10-year studies of retail food safety risk factors initiated in 1998.  In 2010, FDA released two reports on those studies: FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009) and FDA Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (1998-2008).