(This blog post by Dr. David Acheson was published June 12, 2014, on The Acheson Group blog and is republished here with his permission.) On May 25, 2011, the Center for Science in the Public Interest (CSPI) petitioned USDA to declare certain strains of antibiotic-resistant (ABR) Salmonella in ground meat and poultry to be adulterants. Three years later, USDA has not yet responded. Sound familiar? It becomes even more familiar-sounding with the news that CSPI has sued USDA for “unreasonable delay” in responding to the petition. As CSPI states in its suit, “more than three years after CSPI’s petition, FSIS has neither granted nor denied the petition, and it has taken no action to declare ABR Salmonella an adulterant. Therefore, to protect public safety and prevent needless death and injury, CSPI seeks a declaration that defendants have acted unlawfully by withholding action on CSPI’s petition and an order requiring defendants to act thereon.” Precedent has already been set by the success of similar unreasonable delay suits, such as that filed by CSPI against FDA for lack of response to a petition for the revocation of approval of non-therapeutic use of antibiotics in animal production, as well as that of the Center for Food Safety (CFS) and the Center for Environmental Health against FDA over delayed publication of FSMA rules, and CFS suing FDA over the 1997 Generally Recognized As Safe (GRAS) proposal for its failure to follow rulemaking requirements and finalize the regulation. Unfortunately, through their prolonged procrastination without explanation, the agencies are bringing the lawsuits down on themselves — not to mention the activist angst, consumer controversy, and federal frustration that preceded the lawsuits. The agencies can claim lack of resources, and there’s no question that that is at issue. However, as is often the case in any aspect of business or life, the procrastination and lack of action has caused further burning of resources than if issues were addressed as they came to light. In fact, the problem seems to often be more a lack of decision-making and communication than simply of inaction. The Salmonella issue is exactly that, and likely comes down to no one at USDA wanting to be responsible for making the decision. If the agency were to accept the CSPI request and declare specific types of Salmonella to be an adulterant, it would make the consumer group happy, but USDA would have an awful lot of work to do in setting new rules, levels, oversight, etc., and it would certainly not make the industry happy. If it were to reject the request, it would be depicted by CSPI as not being protective of public health. But if USDA were to let the petition languish — as it did — then no decision would have to be made, no pushback would occur from either consumers or the industry, and life, thus, would not get overly complex. Except it now has, and the agency will need to expend further resources not only to answer the original petition, but also to answer the lawsuit. Additionally, with CSPI alleging that USDA “is failing to protect the public from dangerous antibiotic-resistant strains of Salmonella in ground meat and poultry” through its inaction, the agency has not avoided the negative fallout, and, with media coverage of the lawsuit by everyone from Reuters to NBCNews to foodpoisoningbulletin.com, it has certainly not evaded the publicity. As for the lawsuit against FDA for FSMA delays: We understand FDA’s inability to meet the original congressional timeline, as we see it as having been unrealistic. But couldn’t FDA had communicated this back at the beginning, explaining why it was unrealistic and proposing an alternative timeline? Additionally, a better direction of resources throughout the process could potentially have kept the development of the rules moving at a better pace, kept the lawsuit at bay, and not brought on the additional expenditure of resources for the lawsuit — although we do recognize that a big part of the FSMA delay in the early years was not of FDA’s making. With such precedents being set, what’s next? There are plenty of hot topics for which unreasonable delay could be cited:
- GMO labeling is a highly controversial topic. With draft guidance pending since 2001, the issue is now being taken over by the states, to the consternation of industry. (See our April newsletter GMO Labeling: Consumer Right or Wrong.)
- The Egg Safety Rule passed in 2010 took a full decade to enact, and Sanitary Transport, which has now reached the proposed rule stage through FSMA, dates back to 1990, with accountability vacillating between the Department of Transportation and FDA and finally landing on FDA in 2005 with no action until recently.
- Nutrition Facts labeling is a discussion in and of itself, but suffice it to say here that once something has languished unchanged for more than 20 years — as have these standards — why issue FDA’s Proposed Changes to the Nutrition Facts Label in 2014 when USDA’s five-year dietary guidelines are due to be issued in 2015, with the potential of causing new changes?
I don’t question that FDA needs more resources, but it can become difficult for any agency to validate its need for further resources when there exist all too many examples of inefficient handling of those it has. But, as I look at these lawsuits, I have to say the game has changed. Gone are the days when an agency received a petition, especially from a consumer organization, and the optimal course of action was to do nothing. Inaction today will buy you a greater resource burn down the road, along with media attacks and cries of inefficiency and inappropriate public health priorities. So it seems to me that, moving forward, food safety agencies need to respond to petitions in a timely way, even if that is to say, “No, because we need more data,” and then kick it back. But at least there will have been a response, which has to be better than where we are today.