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S. 510: Laws without Effective Timelines?

“Maybe I’m just cynical.”  

“Maybe I’m naïve about the inner workings of the legislative process.”  

“After all, I’m still a fresh-faced-recent-law-school-graduate.  What do I know about creating meaningful legislation that will change the American food supply for the better?”

These were all thoughts that danced through my head as I set out to create a realistic picture of the effectiveness of the food safety bills currently in the House and Senate.  The stated goal of these bills is to “amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.”  One should hope that our legislators’ plan is at least to amend the existing law for the better.  Semantics aside, while I do believe that our congress men and women are legitimately concerned with the safety of our food, I fear that delays, workarounds, and politics as usual may prevent these bills, if enacted, from generating the safe food supply that we deserve.

I began my analysis of the bills’ effectiveness with Senate Bill 510, the FDA Food Safety Modernization Act.  (Note: this article pertains to the pre-Senate markup version of the bill.)  After reading the bill multiple times, I began to wonder just how soon we might see actual changes, overhauls, and improvements to the FDA if the bill is signed into law.  After all, a bill, even with the best intentions, cannot effect change if the provisions it contains offer no clear timelines.  

A slight digression: contrary to what some who aren’t familiar with the political process might believe, laws generally do not go into effect as soon as a bill is signed.  Some provisions might offer a clear enforcement timeline, say, six months, for example.  Other provisions, however, may appear to offer a timeline, but in reality offer a mere promise to think about a reform at some point in the future.  These latter provisions usually require an agency to propose an administrative rule, a process that could take years to complete and may yield final results that are much less sweeping than the original proposed rule.

With this in mind, I did a quick survey of S. 510, attempting to figure out how soon each provision might become effective if the bill was signed into law today.  What I ended up with was a table of the general timeline under which we will see results from each provision.

Food Safety Modernization Act Timeline.jpgI divided the table into three time categories: (1) provisions that will become effective immediately after the bill is signed; (2) provisions that may take up to a year or more to become effective; and (3) provisions with no definite timeline attached.  One caveat: this was by no means a scientific study.  Some provisions contain specific elements that will go into effect at varying times.  The table does, however, provide a general overview of timelines within the bill.  That being said, let’s move on to the figures.  It will greatly help if you follow along with the table as you read the rest of the article.

The final distribution between the 30 provisions of the bill was as follows: 11 provisions go into effect immediately; 11 provisions go into effect within a year or more; and 8 provisions have no definite timeline attached.  

The provisions that go into effect immediately are typically somewhat subtle rewordings of current law.  For example, Section 101 gives the Secretary greater deference to order records inspections based on his or her reasonable belief that food items related to a product associated with an outbreak present a health threat.  This is in contrast to the current wording which limits the authority solely to the type of food thought to be directly associated with the outbreak.    

The provisions that go into effect within a year or more typically involve slightly more sweeping changes than the provisions that are effective immediately.  Examples of these changes include new performance standards and the foreign supplier verification program.  These provisions typically allow for a one to two year window before they are required to be implemented.  This, of course, is understandable due to the need to plan the changes and to allow industry time to budget and adjust.

The final set of provisions, those that have no timeline attached, are the ones that we must take with a grain of salt.  The reason for this has more to do with the procedures of administrative law than it does with Congressional intent.  When a federal agency–the FDA in this case–promulgates any administrative rule, the agency must follow the Administrative Procedure Act, which states that the agency must go through a specific notice procedure and allow for public comment.  This process, although established to keep the public informed and allow for public participation in the rulemaking process, dramatically lengthens the time span associated with establishing a new rule.  It may also serve to alter proposed rules from their original form.  For these reasons, the provisions of S. 510 that call for proposed rulemaking really offer no clear timeline for implementation, nor do they even guarantee that the final rule will mirror that which is proposed in the Act.  

Even more tenuous, other provisions with no timeline simply call for reports to Congress with no clear directive for legislation.

It is worth noting that a few sections of S. 510, despite offering clear timelines, do not guarantee that any actual food safety measures will be enacted.  Section 204 implements a traceback and recordkeeping pilot program that is simply to be followed by a report to Congress and proposed rulemaking.  Similarly, Section 205 just calls for a review of surveillance capacities with no proactive directives.

Where does all of this talk of timelines leave us?  Am I just being too critical of the Food Safety Modernization Act?  After all, change doesn’t happen overnight.  I think my cynicism about the effectiveness of these bills has its roots in my belief that most of these changes are long overdue.  Don’t get me wrong–there are surely provisions within S. 510 that show a strong desire for change.  Take Section 201 for example, entitled “Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report.”  This provision specifically states:

Beginning on the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall increase the frequency of inspection of all facilities.

That single sentence really struck me.  For once, in this 119 page mess of bureaucratic language, most of it too cumbersome to hold any non-industry person’s attention, there is a single very clear directive.  Maybe, just maybe, if the entire bill was authored with such clear objectives, based on non-ambiguous timelines, skeptics like me would regain just a bit of faith in the legislative process.  

Call me an idealist, but the strategy of generating sweeping change and making it resonate through simple, direct language is a tried and true political tactic.  If anything, it would at least make me, and many of the other 299,999,999 members of the American general public, feel just a bit more assured that the people in charge were doing all they could to make our food safer right
now, instead of years down
the line.  In the end, isn’t that worth it?

© Food Safety News
  • http://www.almconsult.com MIke Domingos

    Extremely insightful. I have read the bill on a few occasions (not the markup one either) and also found disappointment in the clarity of the bill. I do believe in this bill and in the “intent” of it…I also agree that more difinitive policy should be written and in todays world of technology and capability, happening sooner is feasible. I saw the CEO of Google on CNN and he stated that computing power capability increases at 1.8 times per year or that in 10 years our computing power will be 100x what it is today….surely we don’t have to wait years to implement many of the procedures and policies discussed in the bill. I am a member of the produce industry and have been for over 30 years….the industry is concerned about food safety as well and is not afraid to move forward as well, just as it has done in the past on numerous occasions. For example, when the Bio-Terrorism Act of 2002 was passed requiring the one step up, one step down verification by food handlers…that was already in place with the majority of the industry so for many companies the only NEW requirement in that was that if requested by the FDA, that information had to be provided within 24 hours. Legislation, preventive measures, traceability and other areas are needed…we now import about 15% of our food supply from over 150 countries into over 300 ports in the U.S….we do need better information and policy, sooner rather than later.