NRDC Steps Up Fight Against GRAS Notices

By Mark L. Itzkoff

In a recent blog post, we discussed the realignment among some public advocacy groups that resulted in several researchers moving from the Pew Charitable Trusts (Pew) to the Natural Resources Defense Council (NRDC).  At the time, we noted that the review process for food ingredients that are generally recognized as safe (GRAS) had been a focus of the PEW researchers, and that this development might have serious complications for companies who voluntarily submit GRAS Notices for FDA review.  The exact nature of these complications is now becoming clear.

As detailed in the blog post cited above, substances that are GRAS for a specific application are not subject to the pre-market clearance requirements in the Federal Food, Drug, and Cosmetic Act, (FFDCA), 21 USC §§ 321(s), 342(a)(1)(C)(i),. 348.  Under the GRAS Notification Program, a company may submit information notifying FDA tit has made a determination that a substance is GRAS, and providing the basis for the determination.  If FDA concludes that the information in the Notice provides a sufficient basis for the GRAS determination and information otherwise available to FDA does not lead the agency to question the safety of the proposed use, FDA will issue a letter stating that it has “no questions” regarding the Notice.  (FDA, About the GRAS Notification Program, (March, 2009).

On March 29, 2013, McCormick & Company (McCormick) submitted a GRAS Notice (GRN 466) informing FDA that the company had determined that the emulsifier polyglycerol polyrinioleic acid (PGPR) is GRAS for additional emulsifier applications (PGPR is the subject of 4 previous GRAS Notices). Specifically, McCormick determined that PGPR is GRAS for use in condiments and spreads, flavors and cheese powders used to produce snack foods.

On October 18, NRDC submitted a 7-page letter commenting on the GRAS Notice. In its letter, NRDC enumerates several concerns regarding the scientific procedures used to “justify” the GRAS determination, specifically questioning the dietary exposure calculation, the validity of the toxicology studies used to support the determination and reiterating a concern from a recent Pew study regarding the potential conflict of interest of the scientist who prepared the determination. (For more information on the Pew study, see our August 27, 2013 blog post.)  NRDC concludes that “the claim that PGPR is GRAS for the intended uses is incorrect.”

The purpose of this blog post is to discuss some of the general policy issues related to the GRAS Notification Program raised in the NRDC letter.   NRDC’s comments regarding the scientific/technical basis for the GRAS determination are questions more properly addressed by the Notifier.

At the beginning, we note that comments on GRAS Notices are highly unusual and it is unclear what NRDC intends to accomplish with its letter.  While one objective may be to encourage FDA to require more supporting data from the submitter, that does not appear to be the only purpose.  NRDC does not ask FDA to take specific action, such as requesting additional data or issuing a letter stating that the Notice does not provide a sufficient basis for the GRAS determination.  In addition, it is our understanding that the NRDC intends to file similar comment letters on other GRAS Notices currently under review.  Thus, it is likely that the October 18 comment letter is part of a long-term strategy to have FDA or Congress modify or eliminate the GRAS Notification Program, rather than an effort targeted at one self-affirmed GRAS ingredient.

One specific NRDC area of concern detailed in the letter is the so-called “conflict of interest” that was the subject of the Pew Study.  Both the Pew Study and the NRDC comments claim that a conflict of interest arises when the scientist performing the GRAS review or members of a panel (a “GRAS panel”) are employed by the Notifier or by a consultant that is paid by the Notifier.  Specifically, they claim the conflict of interest is prohibited under FDA’s draft guidance policy, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees.

The policy set forth in that guidance document does not and should not apply to scientists performing GRAS determinations.  As the title of the document makes clear, the guidance is intended to apply only to scientists participating in FDA Advisory Committees.  A GRAS Panel is not an advisory committee; in fact, since the Notifier makes the determination, the GRAS Panel is actually formed to advise the Notifier, not FDA.  Members of FDA advisory committees are either regular government employees or special government employees, while the scientists performing a GRAS determination are employed by either the Notifier or an agent of the Notifier.  It is an essential element of the GRAS Notification Program that the GRAS determination has been made by the Notifier, not by FDA (see 21 CFR 170.36(a)(1) proposed).  Thus, it is appropriate that any person preforming the determination be compensated by the Notifier.

Further, FDA has announced that it is preparing a guidance document addressing conflict of interest in GRAS determinations, and it is likely that the restrictions set forth in the new document will differ significantly from those in the guidance for advisory committees.  NRDC should wait and comment on the new guidance document, rather than ask FDA to impose conflict of interest requirements that were not developed or intended to address the personnel involved in the preparation of GRAS determinations.

Another motive for the NRDC comments may be to establish the basis for future lawsuits against either FDA or individual food processors.  NRDC states that the FDA “no questions” letters that are issued when the agency has completed its review of a GRAS Notice and has not identified any problem with the Notice is “an agency action.”  Agency action is a prerequisite for most lawsuits against a government agency.

Finally, we note that instead of strengthening the GRAS Notification Program the NRDC comments may actually undermine it.  By submitting the comments, NRDC is publicly questioning both the actual safety of PGPR and McCormick’s determination that there is a consensus in the scientific community that would concur with the safety assessment. While it is well established that the “general recognition” required for GRAS status does not require a unanimous opinion among the scientific community and that a “mere conflict among experts” does not preclude GRAS status (see FDA, The GRAS Proposal, 62 Fed Reg 18938, 39 (April 17, 1997)), public debate over the safety of a food ingredient is likely to deter some food processors from its use.  Rather than risk being pulled into a public debate over the GRAS Notification Program, ingredient suppliers may opt to market their products based on self determinations without notifying FDA of the determinations.  This would mean that FDA would have less information on food ingredients and where/how the ingredients are used.

FDA Released its Proposed Animal Food Rule: What’s in it?

By Jolyda O. SwaimJohn G. Dillard, and Barbara J. Masters, D.V.M.

FDA published its proposed animal food rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, in the Federal Register yesterday. The proposed rule, which FDA promulgated pursuant to section 103 of the Food Safety Modernization Act (FSMA), will require entities in the livestock feed and pet food industry to adopt food safety practices similar to those in the human food industry. The provisions included in the proposed rule will bring about sweeping changes to how food safety issues are addressed. However, FDA has hinted that the final version of the animal food rule may contain even more obligations for animal food entities.

As the rather wordy title of the rule suggests, the proposed rule requires animal food facilities to undertake a two-pronged approach to food safety. First, the proposed rule establishes Current Good Manufacturing Practices (CGMPs) for animal food operations. The CGMPs outline food safety practices that must be followed to prevent contamination or adulteration of animal food. Second, the rule also requires most animal food facilities to engage in Hazard Analysis and Risk-Based Preventive Controls (HARBPC). The HARBPC are the “teeth” of the proposed rule and are designed to require facilities to hold themselves accountable for food safety issues.

In case you haven’t had a chance to read all 103 pages of the Federal Register that pertain to the proposed animal food rule, here is a brief summary.


FDA proposes that the animal food rule will apply to all animal food entities that are required to register as a food facility under section 415 of the Food, Drugs, and Cosmetics Act. Farms are exempt from the new rule; however, if a farm processes ingredients onsite that were not grown on the farm, then they must register.

The proposed rule also contains modified (lower) requirements for (1) entities that FDA deems “small businesses” and “very small businesses”; (2) grain elevators; (3) low-risk livestock feed processing and packing activities undertaken by small and very small businesses; (4) canned pet food manufacturers; and (5) facilities solely engaged in the storage of packaged animal food.

Current Good Manufacturing Practice

The proposed rule used the new human food CGMPs as a starting point for animal food; however the two proposed CGMPs are not identical. One notable exception is that animal food processors will not have to address allergens. The areas that the new CGMPs cover include: hygienic personnel practices and training; facility operations, maintenance, and sanitation; equipment and utensil design, use, and maintenance; processes and controls; and warehousing and distribution.

Hazard Analysis and Risk-Based Preventive Controls

The HARBPC portion of the rule would require animal food facilities to adopt a science and risk-based approach to implement animal food controls that are necessary to protect animal and human health. The approach is inspired by HACCP systems, but it could be viewed by some as going even further by requiring preventive controls in areas that are not critical control points.

HARBPC revolves around the preparation of and compliance with a written food safety plan. The written food safety plan must include:

  1. A Hazard Analysis, which identifies animal and product-specific hazards which may occur and determines which are reasonably likely to occur;
  2. Preventive Controls, which are designed to minimize or prevent the hazards that are reasonably likely to occur;
  3. A Recall Plan, which assigns responsibilities for the various scenarios that could occur during a recall;
  4. Monitoring procedures to verify the preventive controls are consistently performed;
  5. Corrective Actions that will be performed if it is discovered preventive controls are not performed or are ineffective; and
  6. Verification to ensure the preventive controls are effective, including records review, calibration of instruments, and ensuring corrective actions are effective.

Many of the activities conducted pursuant to the HARBPC requirements must be conducted by someone FDA deems a “qualified” individual. The HARBPC portion of the proposed rule is also accompanied by substantial recordkeeping requirements.

Items That May Make Their Way into the Final Rule

FDA has requested comment on a few items that it did not include in the proposed rule. We take this as a hint that these items may make their way into the final version of the rule. These include:

  1. Supplier Verification: FDA is interested in receiving comments on whether the final rule should include requirements for supplier verification for some or all forms of animal food. This could include supplier approval and verification schemes and on-site audits.
  2. Finished Product and Environmental Testing: The proposed rule does not require facilities to engage in finished product testing, but FDA is requesting comments to determine if, when, and how product testing should be incorporated into the final rule. Additionally, FDA is interested in receiving comments on whether facilities should be required to engage in environmental testing for pathogens such as Salmonella spp. or Listeria spp.
  3. Responses to Customer Complaints: FDA is requesting comments on whether the HARBPC food safety plan should include a procedure to address customer complaints.

Deadline for Comments

The deadline for submission of public comments to the docket is February 26, 2014. FDA will also hold three public meetings to discuss the proposed rule with the public. The meetings will be held on: November 21, 2013 in College Park, Maryland; November 25, 2013 in Chicago, Illinois; and December 6, 2013 in Sacramento, California.

Eight Is Enough: EPA’s Dust and Feathers Discharge Argument Goes Down the Drain

By Stewart D. Fried and John G. Dillard

In a decision with broad implications for production agriculture, a West Virginia federal judge concluded that Clean Water Act (CWA) permits are not required solely on the basis of dust, feathers and chicken litter from poultry barns that are washed from a farmyard to river and streams by rainfall.

In Lois Alt, d/b/a Eight Is Enough v. EPA¸ the District Court concluded that stormwater runoff containing dust, feather, manure/litter, and dander particles discharged from Alt’s poultry house exhaust fans that landed outside the production area were agricultural stormwater discharges exempt from CWA permit requirements.  The decision was yet another setback for EPA’s lengthy efforts to require Concentrated Animal Feeding Operations (CAFOs) to obtain National Pollutant Discharge Elimination System (NPDES) permits despite the absence of discharges of pollutants from chicken and hog barns into navigable waters.

EPA’s Efforts to Regulate Discharges from Alt’s Poultry Houses

The CWA generally prohibits the discharge of pollutants from “point sources” to “waters of the United States.”  Pursuant to EPA regulations and guidance, “waters of the United States” include non-navigable rivers, streams and tributaries, as well as adjacent wetlands. While CAFOs are deemed point sources under the CWA, Congress specifically exempted “agricultural stormwater discharges” from the definition of “point sources” of pollution. 33 U.S.C. §1362(14).

For over a decade, EPA has attempted to require CAFOs to obtain NPDES permits.  However, because permits are only required for point sources that discharge pollutants and because CAFOs are generally designed to not discharge pollutants, federal courts have twice invalidated EPA regulations that sought to impose broad permitting requirements on CAFOs. See Waterkeepers Alliance, Inc. v. EPA, 399 F.3d 486 (2nd Cir. 2005) and National Pork Producers Council v EPA, 635 F.3d 738 (5th Cir. 2011).  As a result of these circuit court decisions, EPA may only seek to require a CAFO to obtain an NPDES permit following “actual discharges” from their operations.

During 2011, EPA issued an Administrative Compliance Order (ACO) to Lois Alt, the owner of an eight-house broiler operation in West Virginia.  In its ACO, EPA determined that Alt violated the CWA by discharging pollutants without a permit, and sought to compel her to obtain a NPDES permit or face civil penalties of to $37,500 per day and criminal proceedings. Rather than apply for a permit and facing possible imprisonment, Lois filed suit in federal court in one of the first post-Sackett challenges to an ACO, seeking a declaration that EPA exceeded its authority in determining that she violated the CWA.  American Farm Bureau Federation and West Virginia Farm Bureau intervened on Alt’s side; Waterkeeper Alliance and Center for Food Safety did so in support of EPA’s position.  EPA, appearing to recognize the significance of an adverse judicial decision, attempted to “moot” the case by withdrawing the ACO against Alt.  However, based upon EPA’s prosecution of other farmers around the country on similar grounds, the District Court declined to dismiss the case.

Poultry House Discharges Washed Away By Rainfall Are Exempt from NPDES Permit Requirements

Alt, aided by the Farm Bureaus, argued that the agricultural stormwater exemption applied to runoff from the “farmyard” — areas outside a farm’s production barns, manure storage, and composting areas.  Alt asserted that only discharges from a CAFO’s production area are subject to NPDES permitting requirements and that a farmyard was not part of a CAFO.

Not surprisingly, EPA and the environmental groups contended that the farmyard was within the “production area” of a CAFO and that any runoff from the production area should be deemed a discharge from the CAFO.  EPA also argued that the agricultural stormwater exemption only applied to runoff from a CAFO’s associated crop fields that were operated in accordance with a comprehensive nutrient management plan and that dust, feathers and other exhaust fan discharges that landed on a farmyard were ineligible for the exemption.

Although the Court rejected Alt’s argument that a farmyard is not part of a CAFO, Chief Judge John Preston Bailey concluded that a CAFO’s “production areas” are limited to those used for housing animals and the storage of manure/litter, mortalities and raw materials.   Chief Judge Bailey also determined that because no definition for “agricultural stormwater discharge” is contained in the CWA or EPA’s regulations, its “ordinary meaning” should apply.  The dust, feathers and litter discharged from Alt’s operations were indisputably agricultural in nature and would have remained in place but for the precipitation event which conveyed stormwater (which included the discharged materials) to a watercourse subject to federal jurisdiction.  Based thereon, the Court concluded that runoff from areas outside of a facility’s production area is an agricultural stormwater discharge, which is exempt from NPDES permitting requirements.

The District Court’s ruling, if upheld on appeal, presents yet another setback for EPA in its continuing efforts to require production agriculture facilities to obtain NPDES permits.  While immediate effects of the decision should benefit the poultry and swine industries, other livestock sectors will likely benefit.  Crop producers may as well given that the elimination of dust in agricultural production is virtually impossible. Although EPA and state environmental agencies have long sought to exert greater control over farming operations, requiring poultry and other livestock producers to obtain NPDES permits based on emissions of dust and other airborne particles incidental to production agriculture goes well beyond the original intent of Congress in enacting the Clean Water Act.

A copy of the October 23, 2013, opinion in Lois Alt v. EPA, Civil Action No. 2:12-CV-42 (N.D. W. Va.) is available here.

Rambo Takes on American Agriculture

By Gary H. Baise

“The ecological and economic importance of the Chesapeake Bay is well documented….And yet, nutrient pollution and sedimentation remain a critical concern.” So says Judge Sylvia H. Rambo, U.S. District Court judge in Pennsylvania.

Judge Rambo, in a 99-page opinion filed on September 13, 2013, challenged and dismissed the arguments of the American Farm Bureau on behalf of farmers saying “the court concludes that the framework established by the bay partnership in developing the bay TMDL is consistent with the provisions of the CWA (Clean Water Act) and APA (Administrative Procedures Act).”

Judge Rambo’s decision changes the playing field for American agriculture.

The opinion says that the court must give deference to EPA’s unlimited interpretation of its power pursuant to the CWA. EPA is able to use scientific models which apparently have major flaws and is excused for using those models. EPA can work for years on a proposed regulation and only give farmers 45 days to comment. And to add insult to injury, EPA does not have to make an effort to ensure that all documents are in the file to review before issuing a new regulation which is law.

Read the rest of this post on Gary’s Blog – Defending Agriculture.

My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

By Evan P. Phelps

Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document lifted much of the regulatory uncertainty regarding which types of mobile apps FDA would and would not be actively regulating. Some of the regulated MMAs are developed (i.e., manufactured) by entities that have little to no prior experience in FDA regulation. Consequently, there is some question regarding which FDA requirements will apply to them as device manufacturers.

Ultimately, the total sum of a device manufacturer’s FDA regulatory obligations will depend on how FDA views the risks associated with their particular device and may or may not include requirements for marketing authorizations prior placing the MMA in commercial distribution. However, all medical device manufacturers are subject to the following requirements, known as  medical device “general controls.” These general controls include the following:

  • Establishment Registration (21 C.F.R. Part 807, Subpart B) – Finished device manufacturers are required to register their establishments with FDA.  In order to register its establishment, a finished device manufacturer must complete an on-line application (FURLS) on FDA’s website. Registration provides FDA with information on the location of the establishment, as well as other administrative information.  FDA uses establishment registrations to keep apprised of who and where the regulated entities are and to schedule inspections of their establishments.  There is also an annual registration requirement and registration fees for manufacturers in some cases.
  • Medical Device Listing (21 C.F.R. Part 807, Subpart B) – Finished device manufacturers must list with FDA those finished medical devices they place into commercial distribution in the United States.  Listing of devices is accomplished on FDA’s FURLS website and entities are required to provide information on the products which the finished device manufacturer places into U.S. commercial distribution.
  • Quality System Regulation (21 C.F.R. Part 820) – In most cases, finished device manufacturers must comply with FDA’s Quality System Regulation (QSR), which covers the methods used in, and the facilities and controls used for, the design, manufacture, packaging, storage, and installation of medical devices and contains system requirements in areas of concern to all manufacturers of finished devices.  Among other requirements, it covers the following general areas:
    • Management responsibilities;
    • Design controls;
    • Document controls;
    • Purchasing controls;
    • Production and process controls;
    • Corrective and preventive action;
    • Labeling and packaging;
    • Handling, storage, distribution and installation;
    • Records;
    • Servicing;
    • Complaint handling; and
    • Organization and personnel.

Importantly, manufacturers are subject to only those requirements of the QSR that are applicable to the operations they perform.

  • Medical Device Reporting (21 C.F.R. Part 803) – Finished device manufacturers are required to comply with FDA’s medical device reporting regulation.  This regulation requires manufacturers to have written operating procedures for fulfilling reporting and recordkeeping requirements related to adverse events involving their medical devices.  A manufacturer is required to report to FDA information which reasonably suggests that one of its devices may have caused or contributed to a death or serious injury, or that its device has malfunctioned, and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
  • Medical Device Labeling (21 C.F.R. Part 801) – Medical devices offered for commercialization in the United States must comply with applicable medical device labeling requirements.  Certain labeling requirements apply to all medical devices.  For example, the label of every device in package form must “specify conspicuously the name and place of business of the manufacturer, packer, or distributor.” 21 C.F.R. § 801.1(a).
  • Corrections and Removals (21 C.F.R. Part 806) – Finally, certain removals or corrections of medical devices in the field (i.e., recalls) must be reported to FDA, and there are recordkeeping requirements for device removals and corrections.

One of the first orders of business for members of the MMA industry that find themselves as newly-minted FDA-regulated entities should be to audit their own policies and procedures to assess their current state of compliance with these FDA requirements. Usually, the most efficient way to do so is with the assistance of an experienced FDA-regulatory firm/consultant who can also assist the company in establishing FDA-complaint systems.

Ken Ackerman’s Latest History: Abraham Lincoln’s Spoiled Son

Journal of the Abraham Lincoln AssociationHow hard was it for Robert Todd Lincoln-oldest son of the great president who won the Civil War, ended slavery, and today tops most polls as most admired leader in American history-to make a mark in life as anything except being his father’s son? Pretty darn hard.”

OFW Law’s Ken Ackerman takes on The Chosen Son, the latest revisionist book on Abraham Lincoln’s quarrelsome and controversial oldest son, in the newest issue of The Journal of the Abraham Lincoln Association.  See Ken’s review essay here.

Citizen Suit Goes Down The Drain in Farm Tile Case

By Stewart D. Fried and John G. Dillard

Farm tile drains are not a point-source of pollution under the Clean Water Act, even if the outflows contain contaminated groundwater.  So ruled Judge Kimberly J. Mueller of the U.S. District Court for the Eastern District of California in dismissing a citizen suit that sought to require some farmers to obtain National Pollutant Discharge Elimination System (NPDES) permits for outflows from tile drains.

The Court’s decision in Pacific Coast Federation of Fisherman’s Associations (PCFFA) v. Glaser, centered on the Clean Water Act’s (CWA) exemption for tile drain outflows.  Judge Mueller concluded that Congress, in enacting the CWA, clearly intended that “return flows from irrigated agriculture” are not point sources of pollution.  Point sources are required to have NPDES permits if they discharge into jurisdictional waters.

The plaintiffs in PCFFA argued that the exemption does not apply if tile drain outflows include components that are not the result of irrigated agriculture.  The plaintiffs contended that tile drain outflows should not be exempt in areas with high water tables because of their tendency to collect groundwater, which could be contaminated with pollutants.

The federal defendants, U.S. Bureau of Reclamation and its regional director, argued that Congress intended a broad interpretation of the tile drains exemption, and that it should apply to all tile drain outflows from areas that receive irrigation.  This position is also consistent with EPA and US Army Corps of Engineers policies on tile drain outflows.

In this case, the plaintiffs complained about pollution in water downstream from irrigated cropland in the San Joaquin Valley of California. The fields in question had relatively high water tables and contained heavy metals, such as selenium. Tile drains, in general, are a valuable agricultural tool because they drain surface water and prevent groundwater from saturating crop roots.  Here, the outflow contained not only surface irrigation water, but also selenium-contaminated groundwater. This mixture of irrigation water and groundwater then flowed downstream.

Judge Mueller sided with the federal government, holding that Congress intended for the exemption for return flows from irrigated agriculture to apply broadly to exempt outflows from farms that use irrigation instead of “focusing on what the components of a particular flow are on any given day.” Under Judge Mueller’s reasoning, if a tile drainage system serves only irrigated cropland, it is not a point source.

This decision is a positive result for production agriculture because it confirms the proposition that owners of agricultural tile drain systems are not required to obtain an NPDES permit under the federal Clean Water Act.  If the court held otherwise, thousands of farms would likely be required to obtain and comply with NPDES permits – a costly and onerous proposition.

Although the Court sided with the federal defendants and included favorable language in the opinion, Judge Mueller dismissed the plaintiffs’ complaint on the basis that they only plead facts based upon outflows from irrigated fields which are exempt from NPDES requirements.  The Court, however, granted the Plaintiffs leave to file an Amended Complaint; not surprisingly, they did, alleging that a substantial portion of the tile drain outflows originate from water sources that are unrelated to irrigated crop production. How the Court will address that narrow factual issue remains unclear.  The decision will likely turn on whether the plaintiffs can prove that the tile drain system services and receives pollutants from non-cropland uses.

We will keep you updated on new developments in this case as they occur.

The order dismissing the PCFFA case can be found here.

Bienvenue Aux Etats-Unis!

By Tish Eggleston Pahl

Welcome to the US!

With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees to operate, and so much important business on hold due to the intransigent federal budget showdown, it’s not surprising that the States have stepped up to fill the vacuum.  One example is the State of Maine.  Yesterday, Governor LePage declared a civil emergency and L.D. 171, Maine’s Act to Facilitate the Personal Importation of Prescription Drugs From International Mail Order Pharmacies, went into effect.  As of October 9, 2013, licensed retail pharmacies located in Canada, the United Kingdom, Northern Ireland, Australia, or New Zealand may now export prescription drugs to Maine for residents’ personal use.  Further, any entity that contracts to provide or facilitate this export is exempt from the state licensure required of other pharmacies and entities under the Maine Pharmacy Act.

L.D. 171 was introduced in the Maine legislature on the belief that making it possible for Maine residents to mail order prescription drugs from foreign pharmacies could reduce health care costs (see here and here).  It passed the Maine legislature in June 2013, though Governor LePage declined to sign it.  L.D. 171 became law on June 27, 2013, and became effective 90 days after the close of the legislative session.  (Text and disposition of the law are here.)

Not surprisingly, retail pharmacy and pharmaceutical company stakeholders vigorously opposed L.D. 171 and, just last month, they sued the State in federal district court to stop it.  You can read the full Complaint and their motion for a preliminary injunction.

Drug ImportsPlaintiffs argue that the Maine law violates the Foreign Commerce Clause of the U.S. Constitution (Art. I, § 8, cl. 3), which mandates that the U.S. federal government act as one voice in foreign trade and forbids state interference.  They further assert that the federal Food, Drug and Cosmetic (FDC) Act and FDA’s implementing regulations create a “comprehensive framework” that prohibits the importation of unapproved drugs into the U.S.  If that sounds like a preemption argument to your sensitive ears, you’re correct.  Plaintiffs claim the Maine law directly conflicts with federal prohibitions on importation of unapproved drugs in the FDC Act and the Medicaid Prescription Drug, Improvement and Modernization Act (MMA).  They further argue “field preemption” – that the FDC Act and MMA were intended to “occupy the field of pharmaceutical importation” without leaving any room for state legislative activity.  Plaintiff’s Motion for Preliminary Injunction at 18-22.

The State of Maine both responded to the plaintiffs’ prayer for injunctive relief and filed a separate motion to dismiss the Complaint in its entirety.  The State counters that it is simply declining to enforce its own laws as to certain foreign pharmacies that choose to sell to Maine residents.  Further, the State continues, plaintiffs do not have standing to challenge L.D. 171 because the law does not apply to them.

The parties jointly asked for oral argument the week of November 4.  Today, the Wall Street Journal is reporting mixed reactions by Maine employers.  The Maine State Employees Association is waiting until the lawsuit is resolved before it begins ordering drugs through CanaRx, a Canadian prescription drug supplier.  Others, such as the City of Portland and Hardwood Products, are planning to take advantage of the law immediately.  Outlets have reached out to FDA for comment on whether it will step into the fray – unfortunately, given the government shut down, no one has been able to respond.

Bienvenue Aux Etats-Unis!

Universities Salute World Food Prize Commitment to Sound Science & Biotechnology

By Marshall L. Matz

As I mentioned last week, a major coalition of farm, food and anti-hunger organizations joined 30 institutions of higher education in praising the World Food Prize Foundation for shining a spotlight on agricultural biotechnology with this year’s World Food Prize theme, “The Next Borlaug Century: Biotechnology, Sustainability and Climate Volatility.”  This morning, three Universities followed up with an op-Ed in the Des Moines Register.   David Chicoine, president of South Dakota State University, Steven Leath, president of Iowa State University, and Phyllis Wise, chancellor of the University of Illinois at Urbana-Champaign, all agree:

“Because of modern approaches to genetic research, plant breeding is now more precise and predictable. After 20 years of widespread use of GM crops in the United States, no related food safety risks have emerged and foods can be fortified in ways that can’t be done through traditional breeding…In addition, GM is enabling farmers to produce more using less land, fertilizers, chemicals, fuel and water. The positive impact on the environment can be immeasurable. In short, the genetic modification of seeds does not degrade the environment; it helps to sustain the environment.”

To view the op-Ed in its entirety, click here.

To view the original letter and list of signatories, click here.

Building the Relationship

By Barbara J. Masters, D.V.M.

In a time when there is an information vacuum, I would encourage all meat and poultry establishment operators to “build the relationship” with their FSIS inspection program personnel (IPP).  While these individuals have a specific job to perform, verification and enforcement of the regulations, we all have the same goal – the shipment of safe and wholesome food from every facility.

Many of us would be surprised at the information we might learn if we truly began to communicate at the “weekly meetings” that are to be held at every establishment.  For example, during this period of government shutdown, while the IPP are “on the job,” are you aware they will be receiving their last paycheck this week (and it will only include pay through September 30, 2013)?  Yes, that’s right; they are currently working with the uncertainty of when they will receive their next paycheck.

When discussing more substantive issues, there may be a similar realization that the IPP may not be provided with all the information that you think they receive.  For example, the IPP does not receive the FSIS Constituent Update, a frequent source of information for industry on FSIS happenings.  Additionally, the IPP likely does not receive a copy of Federal Register Notices to review; simply they receive FSIS Directives and Notices, which are the instructions for verification based on those Federal Register Notices.  As you can see, we might be entering this meeting from different exposures to information.

I share this as a challenge.  Use a different lens this week.  Look at things from a different angle.  Try to consider that the IPP may not have all the information that you have seen (particularly this week!).  See if you can use the government shutdown as an opportunity to “build the relationship” and improve communication with the IPP at your establishment.  After all, something good should come of this shutdown!

Before joining OFW Law, Dr. Masters served as Acting Administrator and then Administrator for the United States Department of Agriculture Food Safety and Inspection Service (FSIS) from March 2004 through January 2007.