The FSMA prohibits the manufacture of organic and dairy based foods without a license (a registration) from the FDA. It requires FDA to hire over 16,000 new federal agents to inspect food facilities. It authorizes FDA to revoke registrations if it thinks there is a reasonable possibility that a food could cause injury without need for proof that the finished product is unsafe to consume. It permits FDA to conduct reinspections and charge the party inspected fees without limit to that party. It prohibits direct access to the courts in appeal of agency actions, requiring a hearing before this biased agency’s own administrative law judges. The FSMA is the latest example of federal tyranny that threatens the lives, liberties, and property of the American people. It must be repealed.
FOOD SAFETY MODERNIZATION ACT OF 2011
1. FOOD FACILITIES MUST NOW BE REGISTERED WITH THE FDA (NO LONGER DO WE HAVE A RIGHT TO PRODUCE FOODS IN THE COUNTRY INDEPENDENT OF A LICENSE FROM THE FDA
Under section 102 of the FSMA food facilities are required to register with the FDA. Section 102 permits the FDA to suspend the registration of a food facility,making it illegal for the facility to manufacture food, if the food manufactured, processed, packed, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. As a result, the FDA can suspend registration, and the continued right to produce food, if it thinks there is any risk of adulteration whether the finished product is contaminated or not.
2. THE FSMA PLACES A BARRIER IN FRONT OF ALL THOSE SEEKING JUDICIAL REDRESS
Those against whom FDA takes action under the FSMA are denied the right to independent judicial redress. They must first proceed before the FDA itself in an administrative hearing. Administrative hearings are notorious for their failure to protect the rights of the accused. Here the agency that accuses is also the agency that tries the accused and a fair trial is likely not possible.
3. THE FSMA PLACES INCREASED BURDENS AND COSTS UPON THE FOOD INDUSTRY
Under the FSMA, food facilities must create written hazard analysis of critical control points and preventive controls that FDA deems adequate or it will close down all operations. Section 103 requires owners, operators, or agents in charge of food facilities to “evaluate hazards” that could affect food. They are then required to develop preventative controls to prevent those hazards, and maintain records of monitoring. Under the FSMA the FDA is given authority to develop regulations concerning “science-based minimum standards” for conducting the hazard analysis and documenting the measures. If the FDA finds a company’s efforts unsatisfactory, it can prevent the sale of foods in interstate commerce even if the finished product is perfectly safe to consume.
In addition, the FSMA will increase FDA activity in the food industry. Section 201 requires that FDA: (1) allocate resources to inspect facilities and articles of food imported into the United States based on risk profiles; and (2) increase the frequency of inspection of all facilities.
Finally, the FSMA will increase costs on the food industry. The FSMA is estimated to cost 1.4 billion over the 2011-2015 period to enact and enforce. See CBO Cost Estimate for S. 510 Food Safety Modernization Act, available at http://www.cbo.gov/ftpdocs/117xx/doc11794/s510.pdf (last visited March 14, 2011). This excessive price tag is a result of the FSMA’s requirement, under section 401, that FDA hire no fewer than:
- 4,000 NEW INSPECTORS IN FY 2011
- 4,200 NEW INSPECTORS IN FY 2012
- 4,600 NEW INSPECTORS IN FY 2013
- 5,000 NEW INSPECTORS IN FY 2014
The specific administrative costs to the private industry that will be associated with FSMA compliance are still in question because they are dependent on the specific regulations and fees established in the future. However, there are estimated costs in the hundreds of millions of dollars. See Katz, Diane, New FDA Powers: The Wrong Remedy for a Phony Crisis, available at http://www.heritage.org/research/reports/2010/11/new-fda-powers-the-wrong-remedy-for-a-phony-crisis (last visited March 14, 2011). Compliance costs are expected to increase because the FSMA authorizes the FDA to begin collecting fees from those inspected whenever it conducts:
- FACILITY REINSPECTIONS
- FOOD RECALLS
- IMPORT REINSPECTIONS
In the FY 2012 budget, the FDA estimates the amounts of fees from the previous year that it will be able to include in its 2012 budget. As demonstrated from the table below the FDA expects to generate approximately $100 million in revenue from the collection of administrative fees. See Table below. While the majority of the fees come from the Importer user fees, the FDA also expects to generate $27 million from fees associated with food recalls and reinspections of food facilities. See id. These costs will only increase the cost of food and supplements for the public at large and increase the burdens on an already depressed market. SeeKilman, S. and Pleven, L. Prices Soar on Crop Woes, available at http://online.wsj.com/article/SB10001424052748704803604576077751817700340.html (last visited March 14, 2011) (estimating “retail food prices in the U.S. to rise between 3.5% and 4% this year, compared to about 1.5% in 2010”).
FY 2012 Resource Table (Dollars in Millions)
|Voluntary Qualified Importer Program (VQIP) User Fee||$0.000||$0.000||$71.066||$71.066|
|Food Export Certification User Fee||$0.000||$0.000||$1.267||$1.267|
|Food Reinspection User Fee||$0.000||$0.000||$14.700||$14.700|
|Food Recall User Fee||$0.000||$0.000||$12.364||$12.364|
|International Courier User Fee5||$0.000||$0.000||$0.756||$0.756|
See FDA FY 2012 budget, available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM243370.pdf (last visited March 14, 2011).
4. FDA—LONG HISTORY OF CORRUPTION
The FDA is a captive of the drug industry. It is well documented that unsafe drugs have received approval over the safety objections of FDA medical reviewers.
“FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.”
—Dr. David J. Graham, Associate Director, FDA Office of Drug Safety
“Even if a product doesn’t work or we don’t know how it works, there is pressure on managers that gets transmitted down to reviewers to find some way of approving it. There’s been a cultural shift at the FDA, and the pharmaceutical industry is now viewed as the client.”
—Dr. David B. Ross, FDA Medical Reviewer
Yet, rather than reduce agency funding and remove its resources and power to abuse, Congress has dramatically increased FDA funding and expanded the agency’s powers.
 FY 2012 Fee budgets reflects FDA’s estimate of the amount it will collect as FDA begins to implement the Food Safety Modernization Act.