Food Safety Modernization Act (FSMA) Proposed Rules (and Exemptions) For Farmers, an Easy to Understand Guide; And How to Comment on the Rules*The Food Safety Modernization Act (FSMA) is the federal food safety law that applies to farms growing fruits and vegetables that may be eaten raw. FSMA is intended to reduce the risk of microbial contamination of fresh produce. It will be administered by the federal Food & Drug Administration (FDA). The law was passed two years ago, but proposed regulations were released in January 2013 for public comment (due by September 16, 2013). The Following is an "easy to understand" guide to the proposed rules, regulations, and exemptions. It is presented here to help farmers understand what impact these rules could have on their farm business and share their comments with FDA (learn how to comment on the proposed rules). This guide presents a basic overview of the lengthy and complicated proposed FSMA rules presented by FDA and should not be considered a legal document or a substitute for official FDA rules. There are Two Parts to FSMA: 1) The Produce Safety Rule applies to “farms” or those who grow, harvest, pack or hold covered produce. The rules apply to produce generally eaten raw, i.e. greens, melons, tomatoes, apples, etc. (aka “covered produce” or raw agricultural commodities “RAC’s”). They do NOT apply to produce not eaten raw, i.e. sweet corn, potatoes, pumpkins, etc. Also NOT covered is produce grown for personal consumption, on farm consumption, or on another farm under the same ownership. 2) The Preventive Controls Rule applies to “facilities” that manufacture, process, pack or hold human food and to operations that buy and resell products grown on other farms. These facilities will need to register with the federal government and comply with regulations outlined in the preventive controls portion of the rule. Facilities are defined in the rules and cover operations that modify or process produce from its original state. There are Exemptions to the Act that May Apply to Farmers. (To Continue Reading this Guide Click "Read More")
Produce Rule Exemptions: 1) If you sell less than $25,000 of food per year averaged over three years, you are exempt, and therefore not covered under these rules. 2) If you sell more than $25,000 but less than $500,000 of food averaged over three years, AND more than half of your sales are directly to “qualified end users” (defined as consumers and restaurants or retailers either in-state or within 275 miles of your farm or facility), you will receive a qualified exemption. 3) If you sell more than $500,000 of food per year OR less than half of your sales are directly to “qualified end users” (defined as consumers and restaurants or retailers either in-state or within 275 miles of the farm or facility), you are not exempt, and therefore need to comply with these rules. 4) Be aware that your buyers may request that you meet stricter standards than what is required of you by law. 5) Also, if you are implicated in an outbreak of foodborne illness, your exemption can be taken away.
Preventive Controls Exemptions: 1) If you are a farm, and you only grow, wash and trim off outer leaves, and if you only sell products you grow, preventive controls does not apply to you. 2) If you peel, chop, combine ingredients or buy and resell products from another farm you are a facility or a farm mixed type facility and likely will be subject to some requirements under this law. 3) Additionally, food facilities must register with the Federal government.
Exemptions do apply based on type and size of the operation.
Requirements for the Produce Rule: Adhere to the science based minimum standards established by the FDA for the safe growing, harvesting, packing, and holding of produce on farms. The standards are for the following routes of microbial contamination of produce: agricultural water, biological soil amendments of animal origin, domesticated and wild animals, equipment, tools and buildings, and staff.
Requirements for Preventive Controls: Write a food safety plan that: a) identifies hazards, b) specifies the steps (preventive controls) that will be put in place to minimize or prevent those hazards, c) identifies monitoring procedures, d) records monitoring results and e) specifies what actions will be taken to correct problems that arise. Facilities would also need to comply with the updated FDA Good Manufacturing Practices (GMP).
To include your comments on the proposed rules, mail comments (deadline September 16, 2013) to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments must include:
1. Agency name and Docket No. FDA-2011-N-09212.
2. Regulatory Information Number RIN 0910-AG35
1. Agency name and Docket No. FDA-2011-N-0920
2. Regulatory Information Number RIN 0910-AG36
To Submit Comments Online:
For the Produce Rule – http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0028
For Preventive Controls – http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0013
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*This document was adapted with permission from a publication originally presented by NOFA-NH