FSMA: Proposed Produce Safety Standards and Exemptions
By Mark Zotti, Bureau of Regulation and Inspection
On February 28, 2013, the Food and Drug Administration
(FDA) issued a letter to the cantaloupe industry notifying them of
an increase in inspections and sampling in the upcoming year to enhance the safety of cantaloupes (see http://tinyurl.com/FDACantaloupeLetter). The FDA notification is in response to major foodborne illness outbreaks in 2011 and 2012 traced to microbial contamination of cantaloupes.
This comes less than two months after FDA released its proposed Produce Safety Rule, which encompasses a much broader spectrum of products and will affect all produce growers and handlers.
The proposed Produce Safety Rule, released on January 4, 2013, is only one part of the Food Safety and Modernization Act (FSMA) and is currently open for public comment. Farmers are encouraged to take advantage of this opportunity to provide input.
When finalized, the rule will implement science-based standards for the growing, harvesting, packing, and holding of produce for human consumption. These standards specifically address
Equipment, tools, and buildings
Biological soil amendments
Domesticated and wild animals
Worker training, health, and hygiene
This proposed rule will affect all operations that grow for sale designated crops—fruits, vegetables, nuts, mushrooms, herbs, or sprouts—that are not used for personal or on-farm consumption, or are not a raw agricultural commodity (identified below).
The level of compliance and applicable exemptions are based on the products, the end user, and the producer’s annual average income over the past three years.
According to Health and Human Services Secretary Kathleen Sebelius, FSMA is “a common sense law that shifts the food safety focus from reactive to preventive.” These required preventative measures take into account the size and diversity of produce growers and provide a specific timeline for implementation.
When the rule is finalized, it will extend labeling requirements for all fruits, vegetables, nuts, mushrooms, herbs, and sprouts that are not currently required by the Food, Drug, and Cosmetic Act.
The proposal identifies minimum requirements that include the complete name and address of the farm/business that grew the item. This information will need to be prominently displayed on a label or at the point of sale with a sign, poster, etc.
It appears that this requirement also will apply to produce sold at retail outlets such as farmers’ markets, farm stands, and CSAs. The proposed rule does not indicate any exemptions from this requirement. This proposal does exempt the following:
1. Produce that is rarely eaten raw.
FDA has identified arrowhead, arrowroot, artichokes, asparagus, beets, black-eyed peas, bok choy, brussels sprouts, chickpeas, collard greens, crabapples, cranberries, eggplant, figs, ginger root, kale, kidney beans, lentils, lima beans, okra, parsnips, peanuts, pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga, sugar beet, sweet corn, sweet potatoes, taro, turnips, water chestnuts, winter squash (acorn and butternut squash), and yams among this category of produce.
2. Produce that will be commercially processed with a documented “kill step” that reduces microorganisms in that product.
3. Farms/businesses whose annual food sales average for the past three years is less than $25,000.
4. Farms/businesses that sell more than 50 percent of their crop to “qualified end users”.
Qualified end users are identified as the consumer of the food or a restaurant or retail food establishment located in the same state or not more than 275 miles away from the farm.
Operations that do not meet any of the exemptions will be required to comply with the final rule in a specified amount of time that depends on the size of the operation. Business sizes are divided up into three categories, quantified by the average annual food sales over the past three years:
1. Operations with average annual food sales for the past three years that exceed $500,000 will have to comply with the final produce safety standards within two years of the effective date, and may have up to four years to comply with some of the water requirements.
2. Operations with average annual food sales for the past three years between $250,000 and $500,000 are considered small businesses. These businesses will have three years from the effective date to comply, and up to five years to comply with some of the water requirements.
3. Operations with average annual food sales for the past three years less than $250,000 are considered very small businesses. These businesses will have four years to comply from the effective date and may have up to six years to comply with some of the water requirements.
This proposed Produce Safety Rule does not mandate on-farm food safety audits (commonly referred to as GAP audits) or replace them. On-farm food safety audits may still be required by customers, and operations exempt from FSMA rules may still be required by customers to undergo third-party audits.
Many of the requirements found in on-farm food safety audits align with the requirements in FSMA, which may benefit producers and auditors by offering science-based standards for on-farm food safety measures.
Operations that have participated in on-farm food safety audits should continue to work with their customers to satisfy audit requests. The auditing firms and types of audits required will still be dependent on the customers.
FDA, in conjunction with USDA Agriculture Marketing Service and Cornell University, has developed the Produce Safety Alliance (PSA) (www.producesafetyalliance.cornell.edu). This group is charged with educating and training the produce industry with best practices, guidance, and regulatory requirements.
PSA has set up information sessions including webinars and conference calls, and created summaries of the proposal. These tools have made the task of reviewing the 500+ page proposal much easier, and can be used to better understand FDA’s proposal and—more importantly—to assess how it may affect your operation.
Many questions still need to be answered and will be, in time. All affected operations will have years to comply with FSMA requirements. It is anticipated that the largest challenges for the FDA will be enforcement of these proposed rules.
Many producers are concerned about the water requirements, worker training, record keeping, and overall cost of implementation. As dynamics of on-farm food safety continue to evolve, the full impact of this proposal will not be felt for years to come.
The FSMA’s proposed safety standards are NOT final. FDA is requesting public comment on this proposal and, based on those comments, will create a final rule. The importance of submitting comments cannot be stressed enough.
Comments are due by May 16, 2013. They can be made on a specific part or whole of the proposed rule. Be sure to include the docket number, FDA-2011-N-0921, and submit via any of the following methods:
Electronically at http://tinyurl.com/FSMASubmitComments
By fax to 301-827-6870
By mail to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852
Additional information about FSMA can be found at