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Food safety is at the forefront of consumers’ food concerns. The food recalls issued in recent years, along with pressure from consumer groups and constituents, caused Congress to take up legislation to ensure the safety of America’s food supply.
On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA). The Act amends the Federal Food, Drug, and Cosmetic Act with respect to safety of the food supply and is aimed at helping the U.S. Food and Drug Administration (FDA) prevent food safety problems by shifting the focus from response to contamination prevention. This amendment is the most significant reform to food safety law in 70 years. In addition to giving FDA new enforcement authorities and new tools for managing imported foods, the Act requires food facilities to identify potential food safety hazards, and to develop and implement preventive control plans. It also requires FDA to establish fruit and vegetable harvesting standards.
Read more about FSMA
FDA Releases Proposals for Two Key Rules Under FSMA
Two years later, FDA has released for public comment its proposed rule to establish science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. A proposed rule for preventive controls for human food was published at the same time. These are two of the proposed rules that are key to the preventive food safety approach established by FSMA.
View the home site for the new rules
View OTA’s summary presentation on the two new proposed rules
The Preventive Controls for Human Food Rule would require food companies—whether they manufacture, process, pack or store food—to put in place better controls to minimize and reduce the risk of contamination. The rule proposes each covered facility to prepare and implement a written food safety plan to to identify potential hazards, similar to Hazard Analysis and Critical Control Points (HACCP) systems that are required by FDA for juice and seafood.
View the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Proposed Rule.
View OTA’s Summary of the Preventative Controls for Human Food Rule
The Produce Safety Rule would require farms that grow, harvest, pack or hold fruits and vegetables to establish and follow science-based standards for the safe growing, harvesting, packing, and holding of produce in its raw or natural (unprocessed) state. FDA proposes to set standards associated with identified routes of microbial contamination of produce, including: (1) agricultural water; (2) biological soil amendments of animal origin; (3) health and hygiene; (4) animals in the growing area; and (5) equipment, tools and buildings. The proposed produce rule provides growers flexibility in their approach to on-farm food safety, so that food safety practices being taken by farmers can be appropriate for the scale of production and type of agricultural practices being used.
View the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Proposed Rule. Also referred to as the “Produce Safety Rule.”
View OTA’s Summary of the Produce Safety Rule
View OTA’s Summary of Who Would be Covered by the Rule
FDA is proposing that the requirements be effective 60 days after a final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, compliance dates would be phased in based on business size.
Comments on the proposed rule are due within 120 days of the rule’s publication in the Federal Register: May 16, 2013
How do I comment on the proposed rules?
These are proposed draft rules and not final regulation. Stakeholders are encouraged to comment on aspects of the rules they object to or do not understand. Comments must be submitted by May 16, 2013.
Electronic Submissions
Submit electronic comments in the following way:
- Federal eRulemaking Portal: http://www.regulations.gov/. Insert the docket number into the “search” box and follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
- Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
All submissions received must include the Agency name and Docket No. FDA-2011-N-0921 and Regulatory Information Number RIN 0910-AG35 for this rulemaking.
OTA Food Safety Task Force
In April 2009, OTA launched a Food Safety Legislation Task Force to track and analyze numerous pieces of pending U.S. food safety legislation for impact on the organic industry, and to recommend appropriate courses of action. During the drafting of FSMA, OTA successfully lobbied Congress to include language in the law that would prevent requirements from contradicting organic methods and materials.
In January 2013, OTA reconvened the Food Safety Task Force to analyze the two proposed rules in order to inform OTA's comments that will be submitted to FDA on behalf of membership. OTA invites members to take this opportunity to provide critical feedback on how the proposed food safety practices may impact your operations.
FDA Food Safety Public Meeting - OTA Oral Comments
Read more about OTA’s work on the food safety legislation
Where can I go for more detailed information?
FDA’s website is frequently updated with new information:
Produce Safety Rule: www.fda.gov/Food/FoodSafety/FSMA/ucm304045.htm
Preventative Control Rule: http://www.fda.gov/Food/FoodSafety/FSMA/ucm256826.htm
Please contact Gwendolyn Wyard, OTA’s Regulatory Director of Organic Standards and Food Safety, if you have any questions or if you would like to provide feedback on the proposed rules. | 
