What happened when observers pointed out that the Congressional Budget Office estimated it would cost $1.4 billion over 5 years to implement FSMA even though Congress only gave FDA a $50 million boost for this year? Silence. What happened when industry and consumers complained that FDA had failed to propose new rules before the one-year anniversary of FSMA, thus violating the law? Silence. And what do we hear now, nearly five months after a draft of proposed rules were sent to the Office of Management and Budget (OMB) for review? Silence.
Stakeholders from all sides of the issue are urging FDA to move forward with the new rules as quickly as possible. Industry wants to prepare now for the changes they know are coming. Consumers who think that the rules will increase safety are also interested in moving the rules along. Given that all stakeholders want to review the new rules currently bogged down at OMB, why the delay? First, take a look at the rules that are currently mired in regulatory review limbo:
- Preventive control rules for human food facilities
- Preventive control rules animal feed facilities
- New standards for growing practices on farms
- Foreign supplier verification proposed rule
These rules could be as simple as a few tweaks to FDA’s existing safety rules that will be fairly cheap and simple to implement. On the other hand, as hinted at by the inclusion of entirely new rules for farming practices, they could be a comprehensive set of additional procedures that will add significant costs and delays to the existing regulatory scheme. Which will it be? One need only note OMB’s five-month delay to guess that the holdup is because the new rules are going to be controversial.
Will the new rules be “job killers” for a certain industry? Maybe the new rules require large technology investments by producers, as we have discussed before, and will force out smaller businesses who cannot afford such outlays? Whatever the problem, one thing is for sure: the rules will have a significant impact on the cost of food in America and, at most, a questionable influence on improved food safety.
What could be controversial about a few new food safety rules? Plenty. The American consumer is already suffering under high food costs, and the implementation of new regulations will only exacerbate things (more rules = higher overhead = higher final costs.) New regulations also tend to consolidate the food industry, making it more difficult (thus more expensive) to import lower cost food and food components. The majority of food companies are small businesses – who are going to get hit by higher taxes and now, significantly higher costs. Large food companies are more vertically integrated and have the ability to absorb regulatory changes. They also have lobbyists who are able to help keep the changes in line with their existing systems, minimizing the overall impact — but the midsize and smaller companies will take the hits and will have to pass the costs along to the consumer.
Bear in mind that this is all being done under a proposed statutory regime that makes false presumptions about how food moves in international sales and distribution channels resulting in minimal food safety benefit. To be clear, the delay in the rulemaking is not causing more outbreaks, not causing more illnesses, not making food unsafe. But it does, in our opinion, indicate that these rules must be pretty comprehensive – enough so that OMB is afraid to release them.
We’ll see – or maybe, just like in the song below, we will continue to listen to thousands of rule makers and politicians “talking without speaking, hearing without listening,” all because OMB doesn’t dare disturb the sound of silence.
“Hello darkness, my old friend
I’ve come to talk with you again
Because a vision softly creeping
Left its seeds while I was sleeping
And the vision that was planted in my brain Still remains
Within the sound of silence”
-The Sound of Silence by Simon and Garfunkel
Sources
Key FSMA Rules Continue to Languish at OMB, Months After Deadline
http://www.consumersunion.org/pub/core_food_safety/018397.html
