June 4, 2013
This is the first article in a three-part series that examines developments in and the future of the FDA Food Safety Modernization Act.
By Will Woodlee, Esq.
Spring has sprung, and the U.S. Food and Drug Administration (FDA) once again finds itself investigating a multi-state outbreak of produce-related Salmonella infections. As of this writing, the ill total 81, 16 of whom have required hospitalization. Fortunately, FDA has not attributed any deaths to these Salmonella infections.
The outbreak has stretched across 18 states, from California to Massachusetts, and officials have traced the infections to cucumbers imported from Mexico and distributed by an Arizona firm. FDA has since placed products from the two Mexican producers on an Import Alert. This action effectively halted importation of the operations produce absent evidence that each shipment is not contaminated.
The cucumber case provides a particularly apt example of the potential consequences of FDAs long-delayed implementation of several key provisions of the FDA Food Safety Modernization Act (FSMA"). Heralded as the first major overhaul of the U.S. food safety laws in more than 70 years, FSMA has not yet had a fair opportunity to deliver on its lofty aims. Twenty-nine months into the implementation process, the agency still has much work to do in changing the U.S. food safety system from one of reaction to one of prevention. FDA has failed to meet a number of its statutory deadlines for publishing the most critical FSMA regulations due to resource limitations, the complexity of its rulemaking assignments, and perhaps other factors. The missing rules would establish:
· Science-based minimum standards for conducting hazard analyses and implementing preventive controls at food facilities (deadline for final rule: July 4, 2012);
· Science-based minimum standards for the safe production and harvesting of certain fruits and vegetables (deadline for proposed rule: January 4, 2012; deadline for final rule: one year after close of comment period for proposed rule); and
· Requirements for risk-based foreign supplier verification programs to be used by food importers (deadline for final rule: July 4, 2012).
All three sets of regulations are critical to realizing FSMAs paradigm shift. The law technically required that food facilities and importers implement preventive controls and foreign supplier verification programs by July 4, 2012, and January 4, 2013, respectively. However, in a trio of June 2012 letters to industry groups, FDA revealed the agency would not enforce these requirements without having implementing regulations in place. In addition, FSMA does not require compliance with any produce-safety standards until FDA establishes the particular requirements by regulation. In that it involved contaminated fresh produce imported from a foreign country, the recent cucumber outbreak underscored the need for final regulations for importers and growers.
Milestones Reached for Two Major Rulemakings
In recent months, FDA has made progress on two major FSMA rulemakings. After exceedingly long review periods at the White Houses Office of Management and Budget (OMB"), two lengthy proposals were released in January 2013one on hazard analysis and preventive controls requirements for human food facilities and one on produce-safety standards. The first proposes that covered firms have written food-safety plans that identify potential unintentionally introduced hazards, take steps to address them, verify the steps effectiveness, and outline the process for correcting any problems that may arise. The proposal also focuses on delineating the scope of the requirements and of the various facility and activity exemptions (e.g., for facilities solely engaged in the storage of certain packaged foods).
In the second proposal, FDA proposes produce-safety standards intended to address a number of areas of risk, including:
· Agricultural water;
· Biological soil amendments;
· Health and hygiene;
· Domesticated and wild animals; and
· Equipment, tools, and buildings.
The produce proposal likewise focuses on issues of scope, including what types of products are coveredmost fruits and vegetables while they are in their raw or natural (unprocessed) stateand what products are not (e.g., raw agricultural commodities that are rarely consumed raw, such as beets, figs and potatoes).
The proposal also includes a unique set of standards applicable to sprouts, which present a special concern with respect to human pathogens . . . because of the warm, moist, and nutrient-rich conditions required to produce [them], the same conditions that are also ideal for the proliferation of pathogens if present." Between 1996 and 2010, 34 outbreaks were associated with contaminated sprouts, the most of any produce type.
The publication of each proposal opened an initial 120-day comment period during which stakeholders could review and submit written responses to the draft regulations. Following calls to extend the periods, FDA recently announced stakeholders will have until September 16, 2013, to submit written or electronic comments on all aspects of both proposals. The agency apparently agreed with the requestors that, without the extensions, interested parties might not have sufficient time to develop a meaningful or thoughtful response to" each proposal. This development may result in FDA issuing final regulations later than it otherwise would have, though the agency asserted it could provide the public an additional 120 days to comment without significantly delaying rulemaking on these important issues."
These proposals represent significant progress toward implementing produce-safety standards and requirements for hazard analyses and preventive controls. However, FDA has much work to do to finalize the regulations. Further, with proposed staggered compliance dates beginning a year after publication of the hazard analysis and preventive controls final rule, it could be years before FDA begins enforcing these regulations.
Timetable for Additional Progress on Horizon
Just days before FDA published notices extending the comment periods for both proposals, a federal district court in California ruled FDA unlawfully withheld" agency action by missing FSMA deadlines for promulgating regulations in seven areas. Filed by two advocacy groups, the underlying lawsuit criticized FDAs failure to timely issue the hazard analysis and preventive controls, produce-safety standards, and foreign supplier verification program rules, among others. The court easily found the agency violated the law. However, it noted [t]he question with regard to injunctive relief is less straightforward."
The standard remedy in so-called failure to act" cases is a court order compelling the withheld agency action within a specified timeframe. In this case, however, Judge Phyllis Hamilton recognized that ordering FDA to complete its delayed rulemakings by arbitrary," court-determined deadlines could actually undermine FSMAs purposes if the agencys haste produced insufficiently considered" regulations.
The judge instead ordered the plaintiffs and FDA to meet, confer, and prepare a joint written statement setting forth proposed deadlines, in detail sufficient to form the basis of an injunction." After originally ordering the parties to submit their statement by May 20, the court has extended the deadline to June 10. The filing should provide some clarity on when the public can expect to see proposals for the other rulemakings at issue in the lawsuit. These include regulations regarding:
· The foreign supplier verification program requirements (a proposed rule has been under OMB review since November 28, 2011);
· Science-based minimum standards for conducting hazard analyses and implementing preventive controls at animal food facilities (a proposed rule has been under OMB review since December 5, 2011);
· Prevention of intentional adulteration of food (according to FDAs court filings, the agency is reviewing an advanced notice of proposed rulemaking);
· Sanitary food transportation practices (according to FDAs court filings, the agency is reviewing draft codified and preamble language); and
· Accreditation of third parties to conduct food-safety audits (a proposed rule has been under OMB review since November 24, 2012).
Precisely how the parties proposal will account for potentially prolonged OMB reviews of each remaining set of proposed and final regulationsthe norm thus far for major FSMA rulemakingsis unclear.
FDA Meets Mandates, Asserts New Authority
While FDAs delays in churning out required FSMA regulations have garnered much of the attention, FDA has met other FSMA mandates and begun to hone and employ some of its new enforcement authorities. For example, FSMA imposed demanding facility inspection requirements on the agency. The law requires that FDA inspect:
· Each high-risk" domestic facility once between 2011 and 2016 and once every three years thereafter;
· Each lower-risk domestic facility once between 2011 and 2018 and once every five years thereafter; and
· At least 600 foreign facilities by January 2012 and double that number each year for five years (i.e., 1,200 in 2013, 2,400 in 2014, and so on).
In its one-year progress report, FDA noted it had met its initial mandate for foreign inspections, classified registered facilities by risk level, and conducted enough domestic inspections to claim that [a]t this rate the Agency will most assuredly meet the domestic food inspection frequency mandates defined in FSMA."
On the subject of facilities, FDA has implemented FSMAs food facility re-registration requirement following a brief delay and a one-month extension of the December 31, 2012, deadline. FSMA required facilities to renew their registrations with FDA before the close of 2012 and created an obligation to renew them again every two years thereafter. The revamped registration program permits FDA to suspend a facilitys registration if the agency finds food manufactured, processed, packed, or held there has a reasonable probability of causing serious adverse health consequences or death." Because the law requires facilities to have active registrations to ship food in interstate commerce, the FDA registration effectively functions as a federal license that the government may revoke for safety reasons.
The provision granting FDA the new suspension authority took effect automatically, without the promulgation of implementing regulations. Indeed, in late November 2012, the agency issued its first suspension letter. The suspension stemmed from an outbreak of Salmonella Bredeney infections traced to contaminated nut butters produced at a New Mexico plant. The firm has since entered into a consent decree, and, in early 2013, FDA announced it was reinstating the firms registration.
FDA has also fully implemented FSMAs enhancement of the agencys administrative detention authority. The agency often uses administrative detention as an adjunct to its seizure authority, the use of which requires a court proceeding. Before FSMA, FDA could detain a food based on credible evidence" that it presents a threat of serious adverse health consequences or death." FSMA lowered the bar by allowing detention based on a reasonable belief" that a food is adulterated" or misbranded." Thus, FDA may now detain food based, for example, on a labeling violation that does not impact the foods safety.
In 2011, FDA published an interim final rule revising its administrative detention regulations to correspond to FSMAs amendment of the authorizing statute. In February of this year, FDA published a final rule that adopted the interim revisions without change. Stakeholders had submitted comments seeking changes or clarifications to these rules (e.g., restricting the authority to the FDA Commissioner and relevant FDA center directors), but FDA declined to take the requested actions. Closing the loop, FDA has since issued a revised version of its Small Entity Compliance Guide on administrative detention.
More Pressure Expected
FDAs FSMA failures tend to capture the bulk of the headlines, and perhaps rightly so, because the delayed rules represent the foundation of the prevention-focused law. Nevertheless, the agency deserves some credit for its limited progress, especially since Congress provided FDA with just a fraction of the resources the Congressional Budget Office deemed necessary to implement the law. However, as long as food-borne illness outbreaks continue to occur, FDA will face increased pressure to do more with less, and faster. With a court-ordered schedule for issuing FSMA regulations on the horizon, FDA may soon face even greater pressure to perform.
Will Woodlee practices law with Kleinfeld, Kaplan & Becker, LLP, in Washington, DC. He primarily counsels and advocates on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, and tobacco companies on federal and state regulatory matters. He frequently writes and speaks about the FDA Food Safety Modernization Act, and he served as editor of The Food Safety Modernization Act: A Comprehensive, Practical Guide to the Landmark Legislation.
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