Learn how the pending rules could impact your farm and speak up! Comments will be accepted through May 16th, 2013.
by Jason Foscolo, Esq
Recent regulations from the Food and Drug Administration have the potential to dramatically affect the way farmers conduct their business. On January 16, 2013, the FDA debated a series of sweeping regulations for all produce growers in the United States. These rules, implemented under the much-talked about Food Safety Modernization Act of 2011, will establish science-based regulations for the growing, harvesting, packing, and holding of produce on all but the smallest domestic farms.
New standards are being proposed in 6 key areas of agricultural production:
1. Worker Training and Hygiene
Agricultural workers will be required to receive qualifications and training on hygienic food-handling practices. Growers, harvesters, and packers will be required to establish hygienic preventative practices that will prevent people from contaminating produce with the microorganisms most likely to make consumers sick, such as Listeria or Campylobacter.
2. Agricultural Water
Producers will have to establish inspection requirements, maintenance procedures, and sanitation standards for agricultural water, which is defined as any water that is intended to contact the harvestable portion of produce.
3. Biological Soil Amendments
Producers will have to classify biological soil amendments of animal origin as “treated” or “untreated”, require scientifically valid, controlled, physical and/or chemical processes that satisfy new microbial standards, and establish minimum application intervals for treated and untreated amendments.
4. Domesticated Animals
New rules will govern growing areas to which domesticated animals have access. At a minimum, an adequate waiting period between grazing and harvesting will be required in order to limit the consumer’s potential exposure to microbial hazards introduced by livestock into produce.
5. Equipment, Tools and Buildings
There will be new standards relating to maintenance and sanitation of tools and equipment that come into contact with produce, as well as requirements for buildings used in produce operations.
Regulations introduce a new set of standards applicable to the production of sprouts which cover their cultivation and handling, and which mandate the periodic testing of their growing environment for pathogens.
There are many nuances to these new production requirements. For example, the new standards do not apply to produce which is rarely consumed in-the-raw, such as artichokes, asparagus, or eggplant. The new rules also do not apply to products that receive a commercial “kill-step,” such as a heat treatment that will significantly reduce the presence of microorganisms in the final product.
The new rules also carve out certain limited exemptions for small farms. Farms with annual average sales of less than $25,000 during the previous three years are exempt from the proposed rules. In addition, “small businesses,” such as those with average annual total sales of less than $500,000 in the previous three years, who derive the majority of their sales from typical “direct market” sales within their state or within a 275 mile radius, also are exempt from the regulation. Larger farms will have the opportunity to “phase-in” their compliance with the new regulations over a period of years.
There are several good reasons for anyone in the agricultural industry to read these proposed rules, which can be accessed through the Food and Drug Administration’s website. This proposal constitutes a major overhaul of our system of food production that will impact all but the smallest-scale producers, so there is a good chance that the food safety rules will affect your finances.
Members of the public also have the opportunity to submit their thoughts and comments on these proposed rules by mail or electronically at www.regulations.gov. Government agencies actually read the comments, and it is not uncommon for well-informed and well-stated commentary to affect final policy decisions. You have until May 16, 2013 to tell the FDA what you think of the new rules and how they will affect your business. Be sure to reference Docket Number FDA-2011-N-0921 when you submit your comments.
Jason Foscolo is the principal attorney at Jason Foscolo LLC, the law firm dedicated to the needs of farmers and food entrepreneurs. If you have any questions or concerns about this article, please contact him through his website at www.foodlawfirm.com.