FDA’s Definition of Natural and FDA’s Strategies for Gaining & Maintaining Industry Compliance with FSMA’s New Rules

Bess Ormond, Deputy Director, Florida District, U.S. Food & Drug Administration

FDA’s definition of natural isn’t actually a definition. It’s a policy,” Bess Ormond, deputy director of FDA’s Florida District told attendees of NAFFS 99th Annual Convention. “FDA has considered ‘natural’ to mean that nothing artificial or synthetic (including colors regardless of source) is included in or has been added to, the product that would not normally be expected to be there.”

The important thing to note about the policy is that it doesn’t attempt to address the issues that were brought up, noted Ormond. It has nothing to do with food production methods, like GMO, and it doesn’t have anything to do with safety. FDA is a science-based, risk-based organization and that’s how FDA tries to look at all of its definitions. “This is incredibly broad and new technologies were not there and, therefore, not considered when this became the law of the land,” she said.

FDA published in the Federal Register a notice of request for comments on Nov. 12, 2015 seeking input to define the term ‘natural’ in food labeling. Its 16 questions included:

● How production of a food, or processing of food can impact use of the term ‘natural’

● If foods or ingredients produced through genetic engineering can be considered natural

● About ingredients that can be used in a food labeled natural

The comments were due in February but FDA extended the comment period to May. Ormond said FDA received 7,600 comments. Consumers, Ormond said, let FDA know loudly whether they wanted or didn’t want a definition. Of the 7,600 comments received, roughly 100 are substantive. They either directly address some of the 16 questions that were posed or they provide useful data or information for the agency to review.

Of the non-substantive comments reviewed, only two percent are duplicates. “There were some interesting comments and some in ALL CAPS that indicated they were unhappy with FDA or the topic in general,” said Ormond. She said her favorite among the comments received read as follows: “Dudes – you should go and put a definition to the whole natural thing!”

Of the substantive comments reviewed to date, greater than 50 percent mention that the ‘natural’ claim should not apply to genetically engineered foods and more than 80 percent do want the FDA to define the term. “You can tell it’s a very emotional topic, especially in the consumer comments,” said Ormond. “We’ll review the remaining comments that were received and determine if there is a clear direction for a definition,” said Ormond.

Switching gears to the Food Safety Modernization Act, Ormond began to describe where FDA is on the regulations in terms of compliance. “So why do we have FSMA?” Ormond asked. “Congress decided there are still too many preventable food-borne illnesses in the U.S. so they gave the FDA this huge piece of legislation to address those issues. And they charged FDA with coming up with preventive strategies for industry to follow.” It requires FDA to work closely with its state partners on food safety; state health inspectors will receive the same FSMA training that FDA inspectors get.

Phase I was the standard-setting phase. All seven rules of the major FSMA rules are now in final status: Preventive Controls (Human Food), Preventive Controls (Animal Food), Produce Safety, Foreign Supplier Verification Program, Third Party Accreditation, Sanitary Transport and Intentional Adulteration.

Highlighting the keys areas of each rule, Ormond said the Preventive Control Rules updated the Current Good Manufacturing Practices (CGMP) for human food to look at some of industry’s processes. It also established CGMPs for animal food. The Preventive Control Rule also addressed Hazard Analysis and Risk-Based Preventive Controls which requires each facility to implement a written food safety plan that focuses on preventing hazards in foods/feeds. It also revised the definition of a ‘farm’.

In updating the Human Food Current Good Manufacturing Practices, FDA focused on cross-contact for allergens, inserted language such as “must” instead of “shall” and deleted some provisions while making others mandatory. Previously non-binding provisions such as education and training are now binding and GMPs for holding and distributing human food by-products for use as animal food are new.

Ormond reviewed the compliance dates for Preventive Controls. Businesses other than small or very small were required to comply by Sept. 19, 2016. Small businesses (business with fewer than 500 full-time equivalent employees) have until Sept. 18, 2017 and very small businesses (average less than $1M per year in sales of human food plus the value of such food manufactured, processed, packed or held without sale) have until Sept. 17, 2018. Ormond noted compliance dates for supply-chain program may differ.

Moving to Phase 2, FDA’s FSMA implementation program will align its inspectors (their boots on the ground) to specific commodities. In the past a consumer safety officer was a consumer safety officer – given a pad and sent out the door to do inspections, noted Ormond. But now the FDA will vertically align its inspectors to handle a specific commodity – food inspectors will handle food, biologics inspectors will handle biologics, drug inspectors will handle drug inspections, etc. “As a commodity inspector, I now only have to learn one program so it gives me the opportunity to learn it incredibly well,” said Ormond. “Everyone handling a specific area will help the compliance staff and allow FDA to implement clear consistent applied policy. And it will help industry too, because it won’t feel like you’re training someone every time you have to have an inspection. FDA staff has been given the message to educate before you regulate.”

FDA created seven workgroups and developed a framework along with a multi-year implementation plan for ensuring compliance with regulations through education, outreach and technical assistance for industry, Ormond explained. It is providing training and technical assistance for regulators both at the federal and state levels. The training workgroup includes the Office of Regulatory Affairs (ORA), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM) and the states. FDA is updating its IT and data collection methods and analysis as well as setting performance goals and metrics.

FDA’s key implementation principles include industry education, outreach and technical assistance. FDA plans to facilitate industry compliance with prevention-oriented standards through guidance, developing tools and resources for education, outreach and technical assistance.

The planned guidance documents for food facilities include:

● Hazard analysis and preventive controls

● Environmental monitoring

● Food allergen controls

● Validation of process controls

● Small entity compliance guide that explains the actions a small or very small business must take to comply with the rule

Ormond said FDA formed several alliances to help it educate industry. The Produce Safety Alliance is centered at Cornell University and has developed a curriculum to train the farming community. The Sprout Safety Alliance at the Illinois Institute of Technology has developed a curriculum to train sprout growers and the Food Safety Preventive Controls Alliance, also centered at the Illinois Institute of Technology, developed courses to teach the preventive control and foreign supplier verification rules. (NAFFS Executive Director Bob Bauer, in his role as president of the Association of Food Industries, served on the task force that helped develop the foreign supplier verification course.)

Ormond cited FDA’s FSMA Technical Assistance Network as a way for industry and regulators to get help. “If you have a question on how something in FSMA is supposed to work, you can send a question in to the TAN. The answers are interpretations to policy so give them time to answer.” There are two TANS working side by side. For Preventive Controls Scientific & Technical questions from industry, submit a web form at www.iit.edu/ifsh/alliance. For FSMA Regulation and Policy Interpretation questions, submit a web form at: www.fda.gov/fsma.

Phase 2 also includes an investment by FDA in regulatory training and continuing education. There will be ongoing training of regulators to promote consistent inspections and decision making. Regulators will take FSMA courses with industry. In addition, there will be regulator-specific training.

Ormond said inspections are not handled on a one-size-fits-all basis. “So when it comes to inspections, they will be much more risk-based,” said Ormond. Inspectors will look at where the controls should be. “The goal is not to spend as much time at companies that have a good track record and those that have their process under control so that FDA can spend more time at the ones that don’t.” She said FDA plans to be systems-based for foods, not observation focused. FDA will look at how a company’s receiving department works; how its processes work, its sanitation methods, etc. She said FDA wants inspections to be interactive and supports a two-way cooperative conversation. If a problem is discovered and the company representative can explain the process and how the problem can be corrected, it will help FDA determine any actions that might be needed, Ormond said.

FDA is working to develop and implement explicit inspection/enforcement strategies that facilitate consistent decision-making by regulators. Ormond said the agency recognizes that not all observations are the same relative to the risk and the potential for a public health impact. So FDA will re-evaluate how they write up the compliance reports so they will be more systems-based and more public-health based. They will be ranked according to public health outcome. She said FDA’s software will have an industry secure access portal where companies can access inspection reports, sampling results and corrective action submissions. There will also be a state access portal where the states can review inspection reports and sample results.

Ormond said FDA will develop meaningful public health/performance metrics to measure FSMA’s effectiveness. She said FDA also recognizes the role of the marketplace in influencing and expanding industry compliance with FSMA rules and will look at third-party audit systems and other things that can help industry with compliance. FDA, she said, will work closely with industry, government agencies, academia and other key stakeholders and partners.

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