This is a very important action alert, on a subject that has received scant attention. We at WAPF urge you so submit comments.
Sally Fallon Morell
The Food Safety Modernization Act (FSMA) directed FDA to collect fees on businesses that have to be re-inspected because of some noncompliance. In theory, this makes sense: the government is short on money and businesses that have a problem should pay the costs for it. But this new requirement could unfairly penalize small businesses and even force them out of business.
FDA has published its intention to charge $224 per hour per employee for re-inspections. The same fee will apply whether you are a multi-billion dollar agribusiness or start-up artisanal producer. This hourly fee will be imposed not only for the time that FDA inspectors are actually at the facility, but also for all of their preparatory work, traveling, and paperwork.
The fees for a single re-inspection could easily run several tens of thousands of dollars.
The fees could be imposed even if the facility never caused any foodborne illnesses.
There is a chance to change this, though! The Food Safety Modernization Act also directed FDA to consider provisions for small businesses. The agency has invited public comments on “whether a reduction of fees or other consideration for small business was appropriate, and if so, what factors the Agency should consider for each. In addition, the Agency requested public comment on how small business should be defined or recognized.”
The deadline for comments is NOVEMBER 30, 2011.
Please submit your comments to FDA today through the online system:
NOTE: the government’s online system can be difficult to navigate and there is a time limit. We encourage you to write your comments and save them in a document on your computer, then copy and paste them into the online comment form. Also, although only some of the information fields are marked as being “required,” some people have experience problems when they left fields blank. So for the fields that are not required, you may wish to put “NA” (not applicable) in them to avoid potential problems.
Below are some brief sample comments to help you if you’re not sure what to say. Please personalize the comments with a sentence or two about why this issue is important to you. If you own a small food business, we strongly encourage you to expand on them and explain the impact that these sorts of fees could have on your business.
Re: Docket No. FDA-2011-N-0529
I strongly urge FDA to provide reductions in fees for small businesses. Start-ups and very small businesses, such as those grossing under half a million dollars annually, should be completely exempt from fees. Other small businesses should qualify for reduced fees, based both on their gross income and on whether they direct-market to consumers. In addition, the agency should ensure that its fee structure does not penalize rural businesses.
You can read FDA’s notice at: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0529-0012
You can read the comments submitted jointly by the Weston A Price Foundation, Farm and Ranch Freedom Alliance, and the Farm-to-Consumer Legal Defense Fund at http://farmandranchfreedom.org/sff/111016-Comments-FDA-fees.pdf