July 26, 2013 UPDATE:
In July, FDA published two proposed rules under the Food Safety Modernization Act (FSMA). These are the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and Accreditation of Third-Party Auditors.
Under the foreign supplier verification program, importers are required to perform risk-based activities to verify that imported food had been produced with same food safety standards in the U.S. For more about the proposed rule, click here.
The third-party verification program aims to create a comprehensive and reliable program of audits and certification of foreign food facilities for food to be imported into the U.S. For more about the proposed program, click here.
The FDA also announced that the comment period for the pending preventative controls and produce safety rules are extended until Nov.13 Click here to comment on the produce rule.
March 6, 2013:
Editor’s note: The information used in this article is based on a series of webinars sponsored by the Produce Marketing Association (PMA), led by Dr. Bob Whitaker, chief science and technology officer for PMA. The webinar can be found here: www.pma.com/fsma_produce_rule_webinar. “FSMA: Ask the FDA about the Produce Rule” portion can be found at www.pma.com/ask_fda_fsma_produce_rule.
In January, FDA rolled out two new proposed rules for the Food Safety Modernization Act, specifically the preventive controls and produce rules. While preventive controls concern the manufacturing and processing portion of the produce industry, the produce rules focus in on compliance in the following categories: water; farm-worker hygiene; soil amendments; animals in growing area; equipment; tools and buildings; and sprouts.
Based on Whitaker’s webinar presentation, here are 10 questions — and answers — you need to know about the new rules.
1. What’s on the list, and what isn’t?
Under the new produce rule, most fruits and vegetables consumed raw will be covered. However, the end use of the produce will determine whether it falls under the produce rule or the preventive controls rule. Covered crops include apples, almonds, grapes, peaches, cherries, strawberries, plums, walnuts, blueberries, etc. Produce that is rarely consumed raw is mostly excluded from the rule.
Why this is important: “[When there is] some type of process in place that would reduce the risk of microbial contamination sufficient to prevent illness, that produce would also be excluded. For instance, nuts that would go through a validated roasting treatment, would be excluded because there would be a process in place to address the risk of pathogen contamination,” Whitaker said. “I guess one could also point out the exemption they gave to products that are cooked. In general, FDA has declined to go commodity by commodity and actually asked for comments on this area,” said Whitaker.
2. What size farm is covered under the produce rule?
Very small farms with revenue between $25,000 and $250,000 will have four years to comply with the rules and six years for some of the water standards. Small farms with revenue between $250,000 and $500,000 will have three years to comply and five years for some of the water standards. Farms with revenue greater than $500,000 will have two years for compliance and four years for some of the water standards. Very small farms with revenue below $25,000 are exempt.
Why this is important: Farm size will determine when a farm must be in compliance. Produce grown for on-farm consumption only is exempt. Farms with sales of less than $500,000 and half of those sales are to consumers, nearby restaurants, or retail, are also exempt from some or all of the provisions.
3. What type of records will I need to keep?
Areas of compliance that will need to be demonstrated are: soil amendments; water; worker training and health; domestic animals and animal intrusions; and building, equipment, and sanitation. Records must be kept for two years, and on-site for six months.
Growers are not required to have a written food safety plan. “Under the Produce Rule you are not required to have a written plan, however under the Preventive Controls Rule, a written plan is required,” said Whitaker. “FDA did not require an overarching written food safety plan for growers in order to minimize paperwork.”
Why this is important: Agriculture water, soil amendments, hygiene, equipment and facility sanitation, and animal pathogen vectors are key components of the produce rule. Documentation of training practices is another important part of the new rules.
“It’s an area where we are looking for more information about whether we’re targeting the right things,” said Samir Assar, Director of Produce Safety at FDA’s Center for Food Safety and Applied Nutrition. “I have seen some (GAP) programs that track our food safety rule pretty well. I would say there are some deviations, though … that’s why it’s important to first look at our proposed standards and eventually our final standards once they issue a final rule.”
4. What practices will need to be implemented in regard to health and hygiene?
Measures must be taken to prevent contamination of produce and food-contact surfaces from anyone with communicable illness, infection, etc. Employees will need to maintain personal cleanliness and will also have to avoid contact with animals, other than working animals. Produce grown that is covered under the produce rule must be kept separate from produce not covered under the rule.
Why this is important: The new rule outlines the steps to be taken and the necessary paperwork to ensure compliance.
5. What kind of training will I need?
Training will need to be conducted and documented for all personnel handling produce. This includes the principles of food hygiene and safety, the importance of personal hygiene, and FDA standards. Harvesters will need training on product inspection. This will include when not to harvest or proper corrective actions when a hazard is observed.
Why this is important: Visitors will need to be made aware of policies to prevent produce and contact surfaces from contamination.
6. What rules are therein regard to agriculture water?
Agriculture water is water that is likely to contact produce during growing, harvesting, and packing. Inspections need to be conducted on the water system, both the source and the distribution. The quality of the water must be tested and must have no detectable E. coli when it comes in direct contact with the produce during or after harvesting, and when it is used for hand washing.
Why this is important: Testing is a large part of the rules on water. Water must be tested and steps taken to prevent contamination. Surface water must be tested every seven days if it is subject to runoff, and every 30 days if it is not. Water must be tested at the beginning of the growing season and every three months after, unless it is from a public water system with certified testing.
7. What type of rules are there regarding soil amendments?
Treatment processes must be scientifically valid and must meet or exceed the proposed microbial standards. Soil amendments must be handled, stored, and transported in a way that prevents contamination with water sources, other soil amendments, and surfaces that food comes in contact with. Within this rule are specific application intervals based on how the soil amendment is applied and whether it is treated or untreated.
Why this is important: Records must be kept for application and harvest dates in relation to the application intervals. “It’s important to look at those specific areas of the rule and see where your particular operations intersect with these rules,” Whitaker said.
8. What rules are there regarding domestic and wild animals?
If domestic animals are allowed to graze or are used in the field where produce is grown, a waiting period must be established before harvesting. If there is a high probability that an animal intrusion may occur, monitor for evidence of animals, and prior to harvest, evaluate whether the produce can be harvested.
Why this is important: If there is evidence of an animal intrusion, take measures to ensure the product has not been compromised or if that is not possible, do not harvest that area.
9. What rules are there regarding equipment, tools, and buildings?
Growers must inspect, maintain, and clean equipment and tools and surfaces that are likely to come in contact with produce. In addition, regulate conditions to prevent the growth of contaminants. Buildings must be designed to allow for sanitary operations, proper storage of materials, and must allow for proper cleaning and draining. Waste must be disposed of properly and controls must allow for proper temperatures and sanitization.
Why this is important: Proper sanitization reduces the risk of contamination.
10. What’s next?
Keep in mind that these are still proposed rules, and that comments are being sought. FDA is seeking comments on feasibility, implementation, and clarification on some of the rules. To send comments, visit Regulations.gov, and check the box that says “open for comment” or visit http://1.usa.gov/VA6IgX. Once the rule is finalized, it will be 120 days before it goes into effect.
“We have a chance to make comments and interact and shape these rules,” added Whitaker. “What has been released right now is what FDA’s current thinking is on what will ultimately, of course, be legal requirements. So, we have a chance to inform and educate, construct comments, provide alternatives and … shape these rules.”
Let Your Voice Be Heard
Getting involved in the process and letting your voice be heard is essential during the comment portion as the Produce Safety Rule is being shaped. Here are some ways to get involved:
Stay informed. Read the proposed rules. There are summaries of the proposed rules through several organizations, but the complete text can be found at http://1.usa.gov/dMNspO. Food Safety Modernization Act resources are available through several associations and alliances, including the Produce Safety Alliance (http://bit.ly/kaBFOt) and Produce Marketing Association (www.pma.com/fsma).
Comment on the rules. FDA is looking for comments in many areas of the proposed rules in order to shape their final makeup. FDA dockets open for comment are found here: http://1.usa.gov/XnKV6J. The Produce Safety Alliance suggests “comments that are thoughtful and substantive, containing real examples and data that support your position, are encouraged and will likely have the most impact.”