California Court Decision May Have Major Implications for Farmers Using Drain Tiles

By Stewart D. Fried and John G. Dillard

A federal judge in the Eastern District of California recently held that certain crop and forage operations that utilize subsurface drain tiles may be required to obtain a National Pollutant Discharge Elimination System (NPDES) permit.  In Pacific Coast Federation of Fisherman’s Associations v. Glaser, the District Court denied the U.S. Bureau of Reclamation and San Luis & Delta-Mendota Water Authority’s motion to dismiss, rejecting the argument that operations that utilize drain tiles are not required to obtain NPDES permits based upon the “return flows from irrigation” exemption in the Clean Water Act (CWA).

Under the CWA and its regulations, a point source is required to obtain an NDPES permit if it discharges pollution into navigable waters, tributaries and other waters of the United States.  Point sources are “discernible, confined and discrete conveyance[s]” from which pollutants are discharged — typically pipes, ditches, tunnels, conduits, and wells, and also concentrated animal feeding operations (CAFOs).  In its regulations, the U.S. Environmental Protection Agency has defined “irrigation return flow” as “surface water, other than navigable waters, containing pollutants which result from the controlled application of water by any person to land used primarily for crops, forage growth, or nursery operations.” 40 C.F.R. §125.53(a)(2) (1976)(emphasis added).

An NPDES permit may saddle the permittee with costly conditions designed to reduce pollution levels.  Recognizing the burden that NPDES permits could place on agricultural operators, Congress provided that “agricultural stormwater discharges and return flows from irrigated agriculture” are not point sources of pollution.  Traditionally, farmers utilizing drain tiles have not been required to obtain NPDES permits.

In Pacific Coast Federation, the drain tiles served two purposes, drainage of irrigation water and groundwater.  The tiles drained (surface) water applied to irrigated cropland and also prevented groundwater from saturating the root zone of irrigated crops. The groundwater in this part of California’s Central Valley contains naturally high levels of selenium, a trace mineral that can be considered a pollutant.  Both the irrigation water and groundwater are carried away by the drainage tile and empty into the San Luis drain into Mud Slough, a navigable water.

The Fisherman’s Associations argued that the use of drain tiles was not exempt from NPDES permit requirements because the irrigated water contained groundwater pollutants (selenium), as well as return flows from irrigated agriculture.  The Bureau and the Authority asserted that the suit should be dismissed because Congress intended to exempt all agricultural drain tile operations from obtaining NPDES permits.  The District Court rejected that argument, noting that the return flow exemption “focuses expressly on surface water and noticeably omits any reference to groundwater or subsurface drainage.”

The Court’s decision can be construed as a signal that it intends to narrowly interpret what constitutes “return flows from agriculture.”  On the other hand, the standards governing motions to dismiss require courts, at the early stages of a case, to “make every inference in favor of [a] plaintiff.”  The Court also commented that “[o]n a fully developed record, drainage may be determined to be part of the irrigation process.”

While this litigation is in its infancy, this case could have major implications for farmers that utilize drain tiles.  While many agricultural producers do not have to contend with groundwater reaching subsurface drain tiles, farmers in areas with high water tables may find themselves subject to NPDES permit requirements.  Ultimately, Pacific Coast Federation stands for the dangerous proposition that a lawsuit which alleges that tiles that drain polluted groundwater mixed will not likely be subject to dismissal based upon the CWA’s irrigation return flow exemption.

The AgFDAblog.com will be monitoring this case and reporting on developments as they happen.

The District Court’s opinion is available here.

FSIS Takes “Notice” Regarding Preventing Allergen Recalls

By Barbara J. Masters, D.V.M.

This summer, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued a Notice (35-11) in response to an increase in recalls due to undeclared allergens in meat and poultry products.  FSIS also hosted a webinar and posted associated materials on its website, available by clicking here.

Even after FSIS issued this Notice and hosted the webinar for industry, there have been over thirty additional allergen recalls of meat and poultry products since last July.  The primary causes of these recalls have been identified as:

  • The incoming ingredients were reformulated or changed but the label was not updated;
  • Establishments simply used wrong labels; and
  • Establishments reformulated products but failed to change the labels.

Establishments have the responsibility to properly label all ingredients.  There is a particular concern regarding allergens due to the potential health impact for some consumers.  Establishments should consider these ingredients in their hazard analysis and have an allergen control plan.  A few tips for ensuring success in preventing an undeclared allergen recall include:

  • Reviewing the current label stock and discarding old labels.  If the old labels are not available in inventory – they will not be used by mistake;
  • Maintain good communication with ingredient suppliers.  Make sure you are notified if they make changes to any of their ingredients;
  • Have procedures in place to review the labels of purchased ingredients to ensure they are consistent with ingredient specifications;
  • Ensure that any “may contain” statements have been carried through from incoming ingredients to final labels;
  • Restrict label and ingredient access to appropriate personnel; and
  • Monitor/verify – conduct periodic audits.

It is critical that the product bears the appropriate label and that the ingredients in the product match the ingredients on the label.  This is key to ensuring that the product is properly labeled.

We hope this information is helpful in ensuring that you are successful in implementing your allergen control plan.

OFW Law Drug and Health Care Privacy Practices

By Jonathan M. Weinrieb

OFW Law’s Drug and Health Care Privacy Practices focus on advising our clients regarding every aspect of the regulatory process related to bringing a product to market, post-marketing compliance, and issues central to the privacy of personal health information.  Specific areas of focus include the following:

Prescription Drugs/Drug Exclusivity Counseling

For over 20 years, we have advised clients on how to bring generic drugs to market under the Hatch-Waxman Amendments and Medicare Modernization Act amendments to the Federal Food, Drug, and Cosmetic Act.  We aid clients in their approval and market entry strategies – including New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and 505(b)(2) applications – by advising them on questions concerning clinical development, application processes, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions.

OTC Drugs

We routinely advise firms on marketing products under over-the-counter (OTC) tentative and final drug monographs.

Approval Process

OFW Law assists clients with development, submission, and approval requirements related to the conduct of human clinical research for drugs and biologic products, including new chemical entities, well-characterized proteins, and antibodies, and the development, submission, and approval of NDAs and Biologic License Applications (BLA).  We also advise institutions clients on clinical development, informed consent, and Institutional Review Board oversight.

Controlled Substances

Our attorneys have comprehensive experience serving clients involved with the manufacture and distribution of drugs that also are designated controlled substances or listed chemicals, the oversight of which falls under a parallel regulatory scheme administered by the U.S. Drug Enforcement Administration (DEA) and the states.

Drug Distribution

Our representation of clients does not stop once a product is on the market.  After drugs leave their place of manufacture, they enter a complex distribution chain and our attorneys are especially knowledgeable about the pharmaceutical distribution chain. We provide a wide-variety of legal advice concerning the marketing and distribution of drug products, including: drug importation and re-importation; “pedigree” issues arising under the Prescription Drug Marketing Act of 1987 (PDMA) at the federal and state levels; additional state requirements; the secondary market; repackaging; and combating counterfeiting and diversion.

Marketing and Promotion

We routinely advise clients on issues involving the marketing and promotion of FDA-regulated products, including review of promotional materials, sales representative conduct and practices, institutional promotion, direct-to-consumer promotion, and pharmacy- and physician-based communications.  In addition, we provide counsel regarding Federal Trade Commission (FTC) regulations. OFW Law also has been involved in the negotiation, development, and implementation of corporate compliance programs.

Anti-kickback/Beneficiary Inducement

We routinely advise on clients’ business arrangements to assure that they do not violate the requirements of the anti-kickback and beneficiary inducement statutes.

Enforcement and Compliance

OFW Law represents clients on the entire range of issues related to marketed products, including labeling, advertising, recordkeeping, reporting obligations, inspections, current good manufacturing practices, warning letters, and recalls.  Our extensive experience enables us to act as effective intermediaries between regulators and the regulated industry during and after facilities inspections with regard to 483s and Untitled and Warning Letters.

Human Cell and Tissue Products

OFW Law has extensive knowledge of FDA’s regulatory program for human cell and tissue products (HCT/P). We advise clients on the establishment registration, product listing, donor screening and testing, and current good tissue practices, labeling, and reporting requirements for HCT/Ps.

Privacy of Personal Health Information

We advise clients on a wide-range of issues centered on the requirements for maintaining the privacy of personal health information, including the applicability of federal and state privacy requirements on communications programs focused on individual patients based on their personal information.  This advice encompasses the myriad legal and regulatory requirements that apply to providers of health care products and services, from individual health care practitioners to non-physician health care providers, major pharmaceutical manufacturers, and medical device companies in matters including the privacy of Protected Health Information (PHI) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Legislative Advocacy

OFW Law attorneys often represent drug and health care clients before Congress, federal agencies, and state legislatures.

Updated FSIS Guideline Refocuses Attention on Listeria Control

By Brett T. Schwemer, as published in the October 2012 issue of The National Provisioner.

This summer, the focus of the U.S. Department of Agriculture’s (USDA) Food Safety Inspection Service (FSIS) has clearly been on the control of Shiga-toxin producing E. coli and Salmonella in certain raw meat or poultry products.  However, a recent FSIS Notice announcing the availability of a revised FSIS Listeria Guideline should serve as a reminder that control of Listeria monocytogenes (L.m.) in post-lethality ready-to-eat (RTE) meat and poultry products continues to be a high priority for the agency.

The revised Listeria Guideline replaces previous versions of the Guideline and Q&As (last updated in 2006), and provides recommendations that establishments producing post-lethality RTE products can follow to meet the requirements of 9 C.F.R. Part 430 (the Listeria Rule).  Although the revised Guideline does not contain any major changes to previous recommendations, it has been reformatted and expanded to assist establishments in complying with the Listeria Rule.  Key expansions include:

  • A new appendix (Appendix 2.1) regarding validation of post-lethality treatments and antimicrobial agents;
  • A detailed description of the type of escalated actions that establishments can take during intensified cleaning and sanitation following positive Listeria samples (pg. 2-48);
  • A new appendix (Appendix 2.3) providing suggested employee training programs for implementing the Listeria rule;
  • FSIS’ expectations for Listeria sample collection and laboratory analysis (pgs. 3-9 to 3-12); and
  • Recommendations for identifying and addressing Listeria trends (pgs. 4-8 to 4-9).

FSIS also announces in the Guideline that the agency intends to increase the number of product samples it takes under its routine Risk-based L.m. (RLm) and intensified verification testing (IVT) programs from 3 to 5 samples per sampling unit and intends to composite the five 25 g product samples, increasing the analytical test portion from 25 g to 125 g.  As this will certainly increase the possibility of FSIS finding positive L.m. product results, it is imperative that establishments now take the time to review the revised Guideline carefully and reassess their Listeria control programs to ensure they are doing everything possible to detect, and eliminate, Listeria in their post-lethality environments.

Based on our experience, establishments should pay particular attention to two aspects of their Listeria control program.  First, they should ensure that the frequency and amount of sampling in their post-lethality RTE environment is adequate to detect Listeria that may be present (even if this means surpassing the minimum recommendations in the Guidelines). Establishments will be better off from a regulatory perspective if they find (and eliminate) Listeria before FSIS does.   Second, establishments need to ensure they have procedures in place to identify the potential root cause for each Listeria finding and take corrective and preventive actions based on the potential cause.  Too many establishments simply “clean and sanitize” when Listeria positives are found without identifying a potential cause.  Adequate preventive actions can only be taken when a cause is identified and eliminated.  Establishments should also follow the advice contained in the Guideline for identifying and adequately addressing Listeria trends in their plants.

The FDA Regulatory Challenges of Software Interoperability and Part 806

By Casper E. Uldriks

The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the industry have understood and used software validation principles ever since the enactment of the Medical Device Amendments of 1976.  The growing use of multiple software-based devices, in conjunction with each other, steps outside the original software validation paradigm envisioned by FDA decades ago and may not be adequate now to accommodate current software interoperability uses.

As healthcare becomes more sophisticated and technologically more complex, the use of different types of manufacturers’ software-controlled devices with each other has become routine. This practice poses new demands on making changes to software programs to correct interoperability problems related to a risk to health or making changes to improve software programs in anticipation of interoperability demands. This issue becomes more pronounced with the advancement of sophisticated software programs for clinical use and  mobile applications.

As the issue of device and software interoperability becomes more pronounced, firms face the common question of how to manage unexpected problems with software interoperability.  This raises the question of whether FDA will characterize such related software changes as a reportable correction or removal under 21 C.F.R. Part 806.  Software modifications to mitigate or resolve a risk to health have been and likely will continue to be reportable as a correction or removal. However, what if an interoperability problem has not yet manifested itself in a firm’s software, but the firm can anticipate such a problem based on another firm’s experience?  Is a preemptive modification exempt from corrections and removals as a product improvement under 21 C.F.R. § 806.1(b)(1) or is the modification reportable because a risk-to-health problem exists, even though it was identified through another firm’s experience?

FDA faced this same question when it participated in developing a consensus standard for the configuration of hospital beds to reduce a risk of serious injury or death. FDA consulted with various national healthcare organizations to develop agency guidance concerning hospital beds and how to reduce patient entrapment, a serious risk to health, which was a common problem throughout the industry.  During the implementation of the guidance in 2006, FDA entertained the idea that such changes were reportable under Part 806.  Eventually FDA did not require a report under Part 806 but was close to doing so.   Likewise, software interoperability has become a common issue within the device industry.  Whether or not FDA can or will work with the device industry to develop some guidance is an open question.  The question remains whether FDA would expect a report of a correction or removal where any guidance leading to software changes is a joint effort between FDA and the stakeholders.  However, the landscape is different now. The use of software increases daily; it is not static, as was the case with hospital beds. The burgeoning use of mobile applications is a prime example. This drives the risks to health to a more complicated and broader level and could drive FDA in another direction.

The FDA and industry may be well served by identifying the regulatory consequences of implementing any guidance on software interoperability issues. The uncertainty of how Part 806 would apply can be avoided by openly addressing it in the development of any guidance concerning device software interoperability.

What’s Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

By Neil O’Flaherty

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not sufficiently document their rationale, even if the correct thought process is utilized.  Fairly simple steps can be taken to institute the correct thought process with appropriate documentation.

1. Establish a Standard Operating Procedure (SOP)

Device companies usually do a good job of establishing written SOPs to cover regulatory requirements under the Quality System Regulation (21 C.F.R. Part 820). However, many device firms neglect to establish SOPs to control compliance efforts in other FDA device regulatory areas, including 510(k)-related obligations.  An SOP that standardizes the regulatory thought process for product changes helps to assure more consistent decisions by the company’s regulatory affairs professionals.  It also serves as a basis for training relevant individuals in the decision-making process.  A 510(k) SOP should also be cross-referenced in other appropriate SOPs, e.g., an engineering change order SOP, to serve as a “trigger” to alert relevant company employees that the 510(k) decision-making process should be utilized in making product changes.  Device companies can sometimes overlook the need to assess the need for additional 510(k) clearance in pursuing product changes.

2.  Cross-Reference the Appropriate Materials in Your SOP

Citing to 21 C.F.R. Sec. 807.81(a)(3) in your SOP is a good start.  It’s the legal standard for when product changes do or do not require additional 510(k) clearance.  The problem is that this regulation is not specific enough to cover all of the potential fact scenarios. To account for this, FDA has issued a guidance document that further expands on the concepts found in Section 807.81(a)(3).  The guidance document  is entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device (510(k) Memorandum No. K97-1) (Jan. 10, 1997).   Firms should incorporate the guidance document into their 510(k) decision-making SOP and follow it. Doing so helps companies to align their internal thought process with FDA’s and to reduce the risk of future, and potentially expensive, compliance problems.  However, one most remember the guidance document is just that–a guide–and that it does not provide the answer to the product change question or address the device modification circumstances in every instance.  One needs to apply common sense and reason beyond the literal written questions and considerations of the guidance document in many cases to truly assess the need for additional 510(k) clearance.

3. Document Your Decision to the Fullest When Your Decision is Not to File a New 510(k)

Many times device companies will only “fill out” the relevant product change flowcharts attached to the guidance document.  The flowcharts address the general type of product change at issue as well as labeling, technology/design and materials changes.  While the flowcharts serve a purpose, they should not substitute for a well-written regulatory rationale, utilizing the relevant facts and the guidance document’s concepts, which explains in more detail the firm’s rationale for not filing a new 510(k) submission.  This allows a company to demonstrate that it went through a thorough, thoughtful and “good faith” process in reaching its decision, even if FDA disagrees.

The above steps can greatly improve a firm’s ability to identify, deliberate on, and document its 510(k) decision-making.  They also put a firm in a better position to defend its decisions in the face of FDA scrutiny if it later becomes necessary.

Abraham Lincoln’s Convention: Chicago 1860, by Kenneth D. Ackerman…Now Available!

Abraham Lincoln’s Convention: Chicago 1860, compiled and presented by OFW Law’s very own Kenneth D. Ackerman, is now available!  An eBook original and part of a series called History Shorts/Original Voices, it tells the story of Lincoln’s surprise nomination primarily through the eyes of newspaper writers, giving it the immediacy of the moment, with annotations, background, and updated formatting.

Every president is shaped by his nominating convention. Lincoln’s in 1860 not only was one of the most important, but also the most exciting in America up to that point. In a three day, three-ballot carnival of music, fireworks, and politics drawing some 40,000 people, Lincoln and his friends outwitted the leading celebrities of their party, capturing the prize with nerve, ambition, and brass tacks. They played the kind of hardball politics that usually made reformers cringe. Still, it gave us one of the best presidents in American History.

To check out Ken’s Viral History Blog, click here.