Although the presidential campaigns, ads, and debates have been starkly lacking (or purposely avoiding?) mention of food safety in general or the Food Safety Modernization Act in particular, the election is having an unquestionable impact on the lack of movement of FSMA regulations, and the results of the election will, no doubt, affect the final rules.
This is due to the vast difference between the two candidates. Not toward food safety—taking a stand against food safety would be like self-injecting your party with Salmonella. Rather, the Obama and Romney campaigns vastly diverge in their view of the federal government’s role in regulating business.
As we all know by the three rules that have been lingering on the desk of OMB for almost year, the specifications of FSMA must undergo review and approval by OMB prior to being issued even as proposed rules. Because OMB is an office of the President, the review must take into account and be consistent with the views of the President.
In this case, Obama and the Democratic party are viewed as “pro-consumer” and feel that businesses need government oversight in order to best protect consumers, so the FSMA rules would most likely tend to favor federal oversight and put the burden on business. On the other hand, Romney and the Republican party tend to favor “small government” and believe that businesses should be able to police themselves with minimal interference from the government.
Thus, because many aspects of FSMA place additional burdens on businesses, it is likely that any
announcement of new rules before the election could be used by the Republicans as evidence that Democrats are against businesses. For that reason, there is certain political incentive for the Obama administration to delay the release of rules until after November 4.
Our Post-Election Predictions
While we do expect that, once the election is over, we will see more rapid implementation of FSMA, we predict that the results will definitely impact the final published rules.
If Obama wins:
We expect that the rules that are currently under review by OMB will be released in a medium time frame, assuming that any economic impact issues and international trade issues around the rules are addressed.
We would also expect that FDA will proceed with implementing other aspects of FSMA.
We do not anticipate any significant increase in federal funding.
We do anticipate a greater push to have industry fund more aspects of FSMA.
If Romney wins:
There is a small window (November to January) during which the Obama administration could publish the proposed rules without any interference from the Republicans.
We anticipate that the proposed rules will be published in that narrow window in order to “establish a mark in the sand” laying out the current administration’s position on preventive controls and foreign supplier verification.
But, if they wait, the leadership at FDA (and the Department of Health and Human Services, within which FDA rests) will likely change, impacting publication.
Additionally, OMB’s review for consistency with the new President’s view could be vastly different and may require rewriting of some sections of the proposed rules to be more flexible and less prescriptive toward industry. However, it is important to remember that the basic principles of FSMA (preventive controls and stricter US import requirements) were initiatives that began under the previous Republican administration under George W. Bush.
Government- or Industry-Policed?
In the absence of information from either candidate about their stand on FSMA, the United Fresh Produce Association asked the two candidates for response to questions on a number of produce-related issues, including food safety. In response to questions on how food safety events can be conducted so as to protect public health without placing undue costs and liabilities on industry, and if they believe federally mandated food safety programs are of benefit and should be federally funded:
Obama noted his creation of the Food Safety Working Group and the passage of FSMA – “giving FDA the resources, authority, and tools they need to make real improvements to our food safety system.” He concluded by saying “Effectively managing risk is important to all producers, and having an acceptable food safety program is in the best interest of consumers, buyers, and the farmers themselves. And I am committed to working to ensuring that food safety regulations do not place an unreasonable burden on the food industry.”
(In other words, Obama favors a government-centric program.)
Romney’s response stated, “American farmers and producers, specifically the produce industry, have a long history of taking responsibility for food safety. …Governor Romney believes preventative practices are best developed by growers, handlers, processors, and others in the supply chain with specific knowledge of the risks, diversity of operations in the industry, and feasibility of potential mitigation strategies.”
(In other words, Romney believes that industry has a better sense of what they should do than the government does.)
Besides the fact that politics are causing headaches and wheel-spinning for the industry through the hold-up of FSMA rules, they are also costing FDA some sorely-needed resources. One area was reflected in our September 6 newsletter in which we discussed the joint lawsuit filed against the FDA by the Center for Food Safety (CFS) and the Center for Environmental Health. As “an action for declaratory and injunctive relief regarding the failure by [FDA] to promulgate final regulations by mandatory deadlines contained in the FDA Food Safety and Modernization Act (FSMA),” FDA’s need to spend time and resources on responding and conducting any other needed action will take resources from food safety or FSMA-focused initiatives.
Additionally, we have “heard” that in order to be prepared for either of the above political outcomes, a number of different versions of each of the rules are currently being developed. And it’s not simply a matter of “find and replace” words or phrases, but because so much is interwoven and interdependent, entire rules need to be reviewed and various options drafted. I sincerely hope this is not really the case since that would be a huge waste of scarce resources.
Our Final Predictions
Will we see anything more from FSMA before the November elections? No … it is very unlikely.
Will FSMA begin to move once the election is past? Yes … most likely within the next few months; depending on who is elected, it could be faster. (See above.)
Will the final rules be different depending on who is in the White House? Yes … most definitely.
Will the Outcome of the Presidential Election Impact FSMA? No Doubt. by David W. K. Acheson is licensed under a Creative Commons Attribution-ShareAlike 3.0 Unported License.