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FDA releases records access final rule and guidance documents

FDA issued a final rule that affirms its regulations on record-keeping to be consistent with the expansion of FDA’s access to records as required by the Food Safety Modernization Act (FSMA). The amendments to the Food, Drug, and Cosmetic Act made by FSMA allow the FDA access to records beyond those relating to specific suspect food articles if the agency reasonably believes that other food articles are likely to be affected in a similar manner. In addition, the FSMA amendments permit FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals. The expanded records-access authority is designed to improve FDA’s ability to respond to and contain safety problems with the food supply for humans and animals. Click here for more.

The FDA is making available a guidance document “FDA Records Access Authority”, and a second guidance, “Why You Need to Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide.” Comments on both guidance documents are being accepted.

WHAT TO DO IN CASE OF A CRISIS

Food safety with any fresh or fresh-cut fruit or vegetable has been and will continue to be a high profile topic across our country, and our world, for many years. As a result, the NWA continues to work with the NWPB in support of the Crisis Management program that the NWPB is leading. If at any time there is an issue related or reported to be related to food safety with watermelon, the team will engage in the process. The NWA is part of that team, and will be diligent in our collective efforts if such an issue should arise.

OUTBREAKS AND RECALLS: ARE YOU PREPARED?

The unfortunate fact is that outbreaks and recalls seem to be part of our everyday lives. When we grow foods that we consume out in nature we face that possibility, ever so slight as it may be. It is estimated that there are well over one million servings of fresh fruits & vegetables consumed daily, with one in one million possibly causing illness. Nutritional experts have suggested that the nutritional values that our bodies derive from consuming fruits & vegetables far out-weigh the minimal risk of any illness. The odds are heavily in our favor.

However, federal rules, regulations and laws place requirements on our businesses to perform food safety and traceability procedures that will eventually be monitored by our government.

The Food Safety Modernization ACT (FSMA) is the most extensive revamp of our country’s food safety law ever, and includes a tsunami of rules and guidances that will take years to implement. The rules, once published in their final forms, will be implemented on schedule and set the floor for expectations in farming, packing, shipping and numerous other areas involving fresh fruits & vegetables.

The NWA has been heavily involved all along these multiple paths to represent you while helping to submit comments that will help FDA to create rules that are sensible while adhering to the law that Congress has charged them to implement.

However, in late 2013 the federal indictment and arrest of two farmers sent a ripple effect throughout the produce industry. As a result, the NWA held a grower-shipper seminar at the 2014 national convention to discuss outbreaks, recalls and readiness aspects with the attendees. We plan to hold more of these sessions in the future, and bringing in additional experts from farming and legal aspects.

The NWA is partnering with our friends at United Fresh Produce Association to offer their Recall Readiness Program to our members. The Ten Point Checklist can be reviewed by clicking here, and the Program Brochure and details can be accessed by clicking here.



Before an outbreak or recall should ever darken your business, ask yourself … Are we ready? None of us want to go through an outbreak or recall, but when one does occur, we must all be ready - - your business, your legal counsel, your communications experts, your association and marketing board, and your customers (one and all).

Remember the Boy Scout motto ……………………… BE PREPARED!

WATERMELON FOOD SAFETY GUIDANCE

“The 2nd edition of the Commodity Specific Food Safety Guidelines for the Fresh Watermelon Supply Chain is now available for your use. Please call the NWA, USDA, your State’s Department of Agriculture or any of the third party audit firms with your questions or needs.

It is up to each and everyone of us to make sure that our farms and sheds (including laborers) are following best practices to minimize the possibilities that could plague our crop industry. Please join us in this effort, and continue to help the Watermelon Industry to be safe, healthy and nutritious.

NWA releases second edition of a Watermelon-specific Food Safety program for Farmers and Packers, the “Commodity Specific Food Safety Guidelines for the Fresh Watermelon Supply Chain”
“Food safety has become a standard expectation of any produce industry to maintain and build consumer confidence. With the advent of produce outbreaks due to food safety issues, there has never been a more important time for our industry to build on our growing and handling practices to provide a safe, healthy watermelon supply. Although these guidelines are voluntary at this point in time, it is expected that they will become part of federal food safety legislation in the very near future. We look forward to supporting your efforts to implement these standards into your operation, to help you to protect our industry and your operation, to continue to provide a safe and healthy crop, and to continue to build consumer confidence. Together, we can make a difference.” Bob Morrissey, Executive Director National Watermelon Association, Inc.
Watermelon Food Safety Program Farm Self Audit Packer Self Audit Recordkeeping Documentation Logs Worker Hygiene and Training	Traceability HarvestMark Leger Case Study 2008 Frequently Asked Questions Supplemental Information and Detail Crisis Management

Watermelon is an important crop in North and Central America, and one of the healthiest and safest fruits available to consumers today. It is because of the multiple generations of Americans that have enjoyed watermelon, and the hard working people in the industry that produce and supply our crop, that we began an industry-wide initiative in the spring of 2010.

Labeled, “Watermelon is Not a Melon”, we began a process of submitting comments to help FDA obtain information about current practices and conditions for the production and packing of fresh watermelon. As an industry, we are concerned about food safety requirements and rules as they relate to our crop. While we agree with GAP and GHP standards of food safety, we believe that FDA needs to make significant changes to their previous direction as it relates to a commodity-specific and risk-based approach.

Finding consumer information about recalled food products grew a bit easier with the launch of a FDA website that compiles recall notices in a searchable table. Click here for more

2009 Melon Standards
- FDA 2009 Melon Guidance
- Guide to minimize Microbial Food Safety

Traceability Case Study on Watermelons:
Produce Traceability Initiative releases their final recommendations and action plan
- HarvestMark Leger Case Study

2005 Melon Standards:
- Melon Food Safety Guidelines (Spanish)
- Melon Guidance Document
- http://www.cfsan.fda..gov/~dms/prodgui4.html

Food Safety Guidelines:
- Voluntary Food Safety Guidelines for Watermelon
- Food Safety Questionnaire
- Self Assessment Sheets
- USDA Grading & Certification
- Introduction to Voluntary Guidelines for Control of Microbial Hazards
- Traceability Committee Lays Groundwork for Industry-wide Standards
- UFPA Traceability