EPA Steps Up Criminal Enforcement Efforts Against Livestock Farmers

By John G. Dillard

Ignorance of the law excuses no man.  Not that all men know the law, but because ‘tis an excuse every man will plead, and no man can tell how to refute him.

That sentiment, expressed by John Selden, a 16th Century English judge, still holds true today.  However, with all due respect to our country’s forbearers, we operate under a more complicated set of laws than the English did in the 1500s.  With a few exceptions, most activities that were crimes in the Old World, such as theft, are still considered criminal today.  However, in our modern society, the spectrum of activities that can result in criminal liability has expanded well beyond anything Mr. Selden ever contemplated.  This is especially true in the area of environmental crimes.

Livestock operators should be aware that EPA is stepping up its criminal enforcement activities against Concentrated Animal Feeding Operations (CAFOs).  Just this month, EPA released a Criminal Enforcement Alert announcing that it was targeting CAFOs for criminal enforcement if the CAFOs discharge without a permit.  In the bulletin, EPA announces that it will criminally prosecute CAFO owners for knowing and negligent discharges of pollutants from their operation.

Read the rest of this post on John Dillard’s AgWeb.com Blog – Ag in the Courtroom.

Not Dead Yet – The Paper PI Lives On

By Tish Eggleston Pahl

In the 1984 film Ghostbusters, Dr. Egon Spengler declared to Janine Melnitz, “Print is dead.”  A quick search of print is dead (electronic search, of course) reveals dozens of books and articles declaring that if traditional print communications are not actually deceased, they are decidedly on life-support.

Pharmacy pic

In pharmaceutical and healthcare regulation, electronic communications are the standard.  Submissions to FDA are made electronically, comments are filed electronically, drug registration and listings are submitted electronically, drug product labeling is submitted electronically and posted electronically at drugs@fda, Daily Med, and on manufacturer websites and numerous other portals.  Health records are electronic; prescriptions are electronic.  Prescription drugs move from manufacturers to wholesale distributors to healthcare dispensing and retail sites via electronic ordering systems.

In keeping with this spirit of fostering electronic communication, the Food and Drug Administration Safety and Innovation Act (FDASIA) mandated that the General Accounting Office (GAO) study the benefits and efficiencies of electronic patient labeling of prescription drugs as a complete or partial substitute for patient labeling in paper form.  The study was also to assess the implementation costs to the different levels of the distribution system, logistical barriers to utilizing a system of electronic patient labeling, and any anticipated public health impact of movement to electronic labeling.

The GAO has now completed the study and, at odds with the well-established movement away from paper, released a very frustrating report, Electronic Drug Labeling – No Consensus on the Advantages and Disadvantages of Its Exclusive Use.

Prescription drugs are distributed by their manufacturers with the full prescribing information attached, commonly referred to as the “PI.”  See, e.g., 21 C.F.R. § 201.100; 72 Fed. Reg. 15,701 (April 2, 2007).  This PI is intended for healthcare practitioners (as GAO notes in Table 1 of its report) and can be very, very long in printed format.  It is most commonly printed front and back on lightweight paper, in a tiny 6 point font, accordion folded, affixed to the drug package.  A typical PI may stretch to 24 inches in length, or more when unfolded.  This PI accompanies the drug from the manufacturer, through distribution, to the pharmacy, long-term care facility, hospital, physician office, or other dispensing site.

Pharmaceutical companies have worked for many, many years with FDA and pharmacies on programs to move away from printed PIs.  In 2007, FDA held a public meeting to address the feasibility of electronic distribution of the PI.  As FDA stated in the Federal Register notice announcing the meeting,

Although the information in the PI is a valuable resource, it is often not readily accessible when a healthcare provider who has not physically received the drug makes a treatment decision or discusses treatments with a patient.  Additionally, the PI may not contain the most current information, because the PI accompanying the drug’s distribution may have been printed and distributed prior to more recent labeling changes.  As the healthcare system advances into the 21st century, we are considering how dissemination of the prescribing information contained in the PI can take advantage of technological advances in the electronic transmission of information.

72 Fed. Reg. at 15,702.

Regrettably, and out of step with years of steady work and the inexorable movement toward electronic communications, GAO concludes in its July report that there is still no consensus on eliminating the paper PI.  Relying upon stakeholder interviews (including those whose business is to print the PIs), the report states that some physicians and pharmacists might be uncomfortable accessing electronic PIs or unable to do so, and notes that there is no reliable data source.  However, there is no information in the report documenting how often practitioners actually unfurl and attempt to read the tiny print paper PIs they receive now.  Assuming that practitioners are even using the printed PI provided by the manufacturer, it seems likely that supposed access difficulties could be resolved in ways that are efficient and without inconvenience to healthcare practitioners.

The report also conflates two pieces of information that should be kept separate and distinct: (1) the PI that accompanies the drug product as it moves from manufacturer to the dispensing site; and (2) the other printed information that a patient can or must receive from his or her pharmacist at time of dispensing.   As discussed, the first type of information, the PI, is intended for the healthcare practitioner.  The second type of information is intended for the patient.  The cartoon above, from an FDLI Update article in September/October 2005, is only slightly hyperbolic, vividly illustrating the ongoing problems with the state (and volume) of the information patients receive from pharmacies about their prescription drugs.

The GAO report does a good job of describing the current, messy state of patient-directed, in-pharmacy communications, with overlapping requirements for distribution of Medication Guides, patient package inserts (PPI), and Consumer Medication Information (CMI), now referred to as Patient Medication Information (PMI).  As the timeline accompanying the report indicates, FDA has been working since 1995 to figure out how to improve the information patients receive in the pharmacy.  The current iteration involves possibly consolidating Medication Guides, PPIs, CMIs, and PMIs into a single document that is being pilot tested under the auspices of the Brookings Institute.

For those who hoped to see a more environmentally friendly, efficient, modern solution to the volumes of printed prescription drug information, that goal seems as elusive now as it was 20 years ago.  Print is dead, unless it’s the PI.


Hot Dogs on the Hill

Charlie and Jim SundbergFormer Congressman and OFW Law Senior Policy Advisor Charlie Stenholm (D-TX) greets six-time Major League Baseball Gold Glove Award winning catcher Jim Sundberg, who spent 12 years with the Texas Rangers, at the American Meat Institute’s (AMI) Annual Hot Dog Lunch on Capitol Hill.  The 2013 Hot Dog Lunch was co-hosted by House Agriculture Committee Chairman Frank Lucas (R-OK) and Ranking Member Collin Peterson (D-MN).  See the AMI press release here.

Will FSMA Court-ordered Deadlines Set a Precedent?

By Philip C. Olsson and Robert A. Hahn

The Obama Administration recently announced that it will delay the employer health insurance mandate under the Affordable Care Act (aka “Obamacare”) until 2015.  When questioned about the delay, White House Press Secretary Jay Carney said “people who suggest that there’s anything unusual about the delaying of the deadline, implementation of a complex, comprehensive law, are deliberately sticking their heads in the sand, or just willfully ignorant about past precedent.”  But, Mr. Carney may himself have been forgetting one very recent precedent.

On June 21st, the U.S. District Court for the Northern District of California ordered FDA to meet specified deadlines for several major regulations implementing the Food Safety Modernization Act (FSMA).  Specifically, the court ordered FDA to:

  • Publish proposed rules by November 30, 2013;
  • Close comment periods for those proposed rules by March 31, 2014; and
  • Issue final rules by June 30, 2015.

The court was less clear about which rulemakings were covered by its order, but the court-ordered deadlines appear to apply to the following:

  • Foreign Supplier Verification Programs (FSMA section 301(a))
  • Accreditation of third party auditors (FSMA section 307)
  • Preventive controls for animal feed (FSMA section 103)
  • Sanitary transportation of food and feed (FSMA section 111)
  • Prevention of intentional contamination (i.e., “food defense”) (FSMA section 106(b))

The June 30, 2015, deadline for issuance of final rules apparently would also apply to the final rules on:

  • Preventive controls for human food (FSMA section 103)
  • Produce safety standards (FSMA section 105).

FDA has 60 days to decide whether to appeal the court order, and has not yet made any official announcement regarding its intentions.  There has been speculation that FDA may wish to use the court order as a weapon in its intra-administration battles with OMB over the rulemakings in question.

In FDA’s world, statutory deadlines have in the past not meant very much.  To give just one example, the FD&C Act requires FDA to decide whether to approve drug applications within 180 days, something which the agency rarely does, and the courts have not required FDA to comply with this statutory deadline.  See, e.g., In re Barr Laboratories, Inc., 930 F.2d 72 (D.C. Cir. 1991) (refusing to grant a petition for a writ of mandamus compelling FDA to promptly approve or disapprove 23 abbreviated new drug and antibiotic applications).  This is not to suggest that the agency does not do its best to meet deadlines imposed by Congress given its limited resources.  However, FDA has a long history of not complying with statutory deadlines without being seriously called on the carpet…. until now.

Does this court order represent a sea change?  Will statutory deadlines for other FDA actions besides rulemaking (say, drug applications) need to be taken more seriously going forward?  Will this court order have broader implications for the timeliness of FDA decision making generally?  Even where there is no statutory deadline, will the courts impose time limits?

There is evidence that the courts are unwilling to abandon any notion of timeliness, even in the absence of a statutory deadline.  Last year, another federal court, the U.S. District Court for the Southern District of New York, ordered FDA to finalize proceedings to withdraw its approval of three animal drugs, penicillin and two tetracyclines – proceedings which the agency had initiated in 1977.  Natural Resources Defense Council, Inc. v. FDA.  The NRDC suit alleged that agency action had been unlawfully withheld or unreasonably delayed in violation of the Administrative Procedures Act, 5 U.S.C. § 706(1).  The district court’s decision is currently on appeal to the Second Circuit.

And, returning to where we started, will the courts be willing to consider enforcing statutory deadlines for other agencies involved in implementing other massive, complex pieces of legislation, such as the Affordable Care Act and the Dodd-Frank financial reform legislation?   It’s possible this court order could have far-reaching implications for the Executive Branch.

USDA’s National Appeals Division: A Checklist for Farmers

By Kenneth D. Ackerman

Farm producer and USDA program customers increasingly are turning to USDA’s National Appeals Division (NAD) as the best option when they find themselves facing an adverse decision from a USDA agency.   NAD offers a far quicker, more user-friendly, and more inexpensive way to get an objective “second opinion” compared with suing the agency in Federal court or under formal legal arbitration.

NAD has built a corps of hearing officers in 57 locations around the country, able to reach almost any local area.  In 2012 alone, farmers and USDA program users filed  2,197 cases with NAD.  NAD hearing officers also conducted 1,003 in-person or telephonic hearings and record reviews, and issued 1,760 determinations.  According to NAD statistics, the outcome in these cases was favorable to appellants in 36 percent of the cases.

Before bringing a case to NAD, it is important first to do your homework.  Here is a quick checklist of questions to ask yourself:

  1. Is your gripe actually against USDA?.

NAD can only hear appeals from adverse decisions by USDA agencies like FSA, RMA, NRCS, or Rural Development.  Make sure your complaint isn’t against someone else, such as a crop insurance agent, or a farm seed or equipment supplier.  Do you have an actual letter from USDA turning you down on something, or a ruling against you?  If not, then NAD may be the wrong place to go.

  1. Does the gripe involve you personally?

NAD appeals must involve an agency decision involving an individual.  You, the farmer or program user, must personally sign the appeal.  (Your lawyer can’t do it for you.)  NAD generally can NOT hear complaints against rules of “general applicability,” that is, general policy pronouncements that apply to everyone.  If FSA or RMA makes a program-wide decision you don’t like, then call your Congressman, not NAD.

  1. Are the rules on your side?

NAD decisions must be consistent with agency regulations.  NAD can only exercise discretion to the same extent as the agency.  If an agency like FSA can apply “equitable relief,” then so can the NAD Director.  Since RMA cannot, then neither can NAD in RMA cases.  A NAD hearing officer cannot rule your way simply because they like you or think you got a raw deal.  You must base your argument on the rules.  Read them very closely before you go forward.

  1. Are you ready to tell your story?

The NAD gives you the choice to present your case in either: (a) a face-to-face, in-person hearing with a hearing officer, (b) a hearing by telephone conference call, or (c) a simple review of the paper records.  Usually, the most effective method is the in-person hearing, where you can tell your own story in your own words.  Think, in advance, what you want to say, and be ready to answer questions.  Don’t worry too much whether you are a “good talker.”  If you organize your material well and tell the truth, the hearing officer will put aside any “style points.”

  1. Do you have good records?

In a NAD appeal, you, the farmer, have the burden of proving that USDA made a mistake in applying its program rules.  Records are essential.  When you file an appeal, the USDA agency must send you a full official “record,” including all documents it used to reach its decision.  But this often only tells half the story, the agency’s half.  To show how the agency went wrong, you often need more.  If your own records have gaps, make a quick visit to your local USDA office (or crop insurance agent on RMA issues).  Beyond agency forms, see if you have diaries, letters, e-mails, bank statements, or anything else to prove your version of events.

  1. Do you have witnesses?

Often, the strongest way to tell your story is with witnesses, and NAD allows to you present both fact witness as well as subject matter experts.  In some cases, you can even request a NAD subpoena requiring the attendance of agency staff to answer questions.

  1. Have you followed all the preliminary procedures?

FSA usually allows farmers to bring their disputes first to a local County Committee, which often can be the most friendly, helpful forum for solving a problem, usually followed by an appeal to the State Committee.  NAD will check to see that you followed these internal review channels, giving the agency a fair chance to correct the problem first.  Many agencies offer “mediation,” where you and the agency meet with a neutral facilitator or try and reach an informal solution before filing an appeal.

  1. Should you hire a lawyer?

Farmers or program participants do not need a lawyer to bring a case before NAD.  NAD hearings are designed to be informal, avoiding technical rules of evidence that can trip up non-experts.   But lawyers can still be very helpful.  A lawyer can help analyze agency regulations, point out weaknesses in your case, organize your presentation at the hearing, and be a good advocate.  If you are concerned about cost, make sure the lawyer gives you a budget in advance and defines his role carefully.  Sometimes, you can lower the cost by doing most of the work yourself, and just have the lawyer check it at the end, or connect to the hearing by phone.  Also, make sure the lawyer is familiar with USDA programs specifically.  Don’t count on the hearing officer to do your homework for you or to be your advocate.  Their job is to be neutral.

  1. Should you appeal even if you might not win?

In any litigation, there is always risk – even if, in your own eyes, the case seems crystal clear.  Cases sometimes are decided on unexpected or narrow technical grounds – despite you or your lawyer doing a first rate job in telling your story.  Always be realistic about the chance of losing (and always distrust a lawyer who minimizes it).  Usually, the biggest factor for farmers in deciding whether to spend the time and money for a NAD appeal is the amount in dispute.  If an FSA adverse decision might cost a farmer $100,000 or more in lost program payments on other damages, it makes sense to spend the $20,000 or so to hire a lawyer and appeal.  If the case involves a much smaller amount, then perhaps it makes sense to appeal without a lawyer, or simply skip it.

  1. Is it better just to sue USDA in court?

Before you can sue a USDA agency in Federal court, the rules require that you first appeal your adverse decision to the NAD – at least through the hearing officer state – to obtain a final agency determination.  The NAD system gives farmers and USDA program users a first bite at the apple that is relatively quick and inexpensive.  NAD rules require a hearing within 45 days, and a decision 30 days after that.  An appeal to the Director could add another 45 days or so to the process.  The cost, even with a lawyer, is a fraction of formal litigation or arbitration.

Whether it makes sense for you depends on your unique individual circumstances.   We’re here to help, and would be happy to discuss with you any situation and answer your questions.   Please contact me at kackerman@ofwlaw.com

Reviewing Regulatory Noncompliance – It is Good For Your Business

By Barbara J. Masters, D.V.M.

Based on our experience reviewing a number of noncompliance records, we recommend that when USDA’s Food Safety and Inspection Service (FSIS) documents regulatory noncompliance at your facility, you review it with a “fine tooth comb.”  To successfully review a noncompliance record (NR), you must first know your food safety programs and the governing regulations.  You should review each noncompliance to determine if your program failed, if you failed to follow your program, or if you have a basis to appeal all or part of the noncompliance.

The description of the noncompliance should be clear and concise while accurately describing the regulatory failure.  If there are inaccurate facts, these should be appealed.  If there is a repeat occurrence or a developing trend of noncompliance, this will be documented as well.  Preventive measures that were previously proffered and not implemented will be documented in the NR, and should be a red flag that FSIS is documenting management has failed to follow through on previous commitments.

FSIS documents each regulation that pertains to the noncompliance.  The establishment should review each citation and ensure that it pertains to the documented noncompliance.  FSIS will use these failed regulations to determine future inspection activity at the establishment.  If the citations are accurate, the establishment needs to determine the root cause of the failure and make necessary corrections.  If there are citations that do not belong, they can be appealed.

FSIS will also include any linkage to previously issued NRs.  Again, the establishment should verify the accuracy of the linkages.  If the linkages are correct, the establishment needs to determine the root cause of the failure and make necessary corrections.  If there are linkages that are not correct, they can be appealed. 

Anytime the establishment appeals, they should use supporting information to dispute the facts or the conclusions in the NR.  Scientific articles, written statements, information from the manufacturer, previous AskFSIS questions, photographs, and other support should be included.  Absent a basis, factual, scientific or regulatory, the Agency will not rescind an NR on appeal.

Reviewing noncompliance records can be very helpful for an establishment.  They can serve as an early warning tool in preventing repetitive noncompliance.  Establishments can objectively appeal inaccurate information in a timely manner.  Establishment management can stay current on Agency information by staying engaged with the latest regulatory information.