#fixFSMAFamily farms will be greatly impacted by the FDA’s proposed rules associated with the new Food Safety Modernization Act. Today, Pennsylvania Farmers Union submitted comments on behalf of our membership and we wanted to share those with you. We welcome your feedback as we are hopeful there will be a second-round comment period. If you are still planning on making comments today but need some help, National Sustainable Agriculture Coalition has a handy walkthrough for you!

Comments on the Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption Docket No. FDA – 2011-N-0921 and the Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Human Food Docket No. FDA -2011-N-0920

Submitted at Regulations.gov by: Pennsylvania Farmers Union

The Pennsylvania Farmers Union (PFU), a membership organization, is committed to enhancing the quality of life of family farmers throughout our Commonwealth.  Our 600 members include farmers, foresters, horticulturalists, consumers, farm organizations and cooperatives.

The Food Safety Modernization Act (FSMA) and the associated rules being established by the Food and Drug Administration (FDA) have the potential to fundamentally reshape local food markets. We have serious concerns the proposed rules will impede local food access and growth in a market that is flourishing right now. We are concerned for the future of family farms, many of which are viable for the first time in a generation (and are increasingly being stewarded by younger farmers, many of whom are women, minorities and veterans). Diversified farms, often offering the full range of fresh fruits, vegetables, dairy, eggs and meat, are most at risk of having their futures be jeopardized.

Any rules relevant to the FSMA must:

  • Be scale and market appropriate
  • Be based on sound science
  • Be administered by agencies that understand farming systems (in particular diversified and aggregating, whole-systems practices)
  • Be reasonable and affordable with regard to documentation requirements

We have a deep appreciation for and applaud the FSMA’s focus on prevention. That said, our members have serious concerns about the associated rules as proposed by the FDA.

Feedback we have received from our members reflect the following concerns:

  • The need for a second comment period after an initial drawing up of rules based on the current comment period. The rules associated with FSMA stand to have such a significant impact on farmers, it is imperative that extremely careful consideration be given to ensure a thoroughly thought-out set of rules.
  • The lack of clarity with regard to the definitions of “farm” and “facility”, as well as “farming activities” and “manufacturing activities”, potentially subjecting farms that pose minimal safety risks to an inappropriate level of regulation.
  • A basic lack of understanding on the part of FDA of diversified farm systems and emerging and innovative markets in the farming sector
  • Lack of clarity with regard to “mixed type facilities” and under which set of rules any specific farm falls: Produce Safety and/or Preventative Control
  • Exemptions, particularly as they relate to diversified systems, food hubs and aggregating cooperatives
  • Impacts on Community Supported Agriculture (CSA) programs and cooperative food distribution systems
  • Rules regarding retail food establishments, specifically that they don’t include CSAs and farmstands
  • Gross sales thresholds that clearly do not reflect an understanding of, and in fact penalize, diversified and flexible farming operations
  • Rules that conflict with GAP and NOP programs
  • Issues of competition that put domestic producers at a disadvantage compared to those importing food from other countries
  • Application interval requirements for animal-derived biological soil amendments that are not based on sound science
  • Water testing requirements for irrigation that are not based on sound science
  • Environmental impacts of rules that could encourage the reversal of conservation practices such as wildlife habitat and riparian buffers, practices which are beneficial not only to the watersheds that feed farms but to farm systems themselves
  • Coordination of efforts between state agricultural departments and federal agencies, including a clear line of authority
  • A climate of ‘fear of prosecution’ as opposed to one emphasizing assistance and training
  • Lack of clarity regarding due process resulting from withdrawal of qualified exemptions


We urge you to consider a second comment period after the above concerns have been addressed and thank you for your consideration.

Respectfully submitted,

Pennsylvania Farmers Union

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