FDA Briefs Stakeholders at FSMA Public Meeting

 

FDA officials discussed their “work in progress” toward implementing the Food Safety Modernization Act at a public meeting hosted by the agency in Washington, D.C. April 23-24, 2015.

The agency is currently considering some new inspection ideas, they explained. For example, they may introduce an inspection system that would separate violations into major and minor, depending on the public health impact. Requirements for major violations would be more stringent, such as shorter response times and increased inspection frequency. The agency is also considering a two-step approach to inspections, beginning with a data check at a company’s corporate offices in advance of an individual facility inspection, they said.

(see more details in Food Chemical News).

Effective training will be an essential component of any successful implementation of FSMA regulations and it is encouraging to see the agency moving forward with several training initiatives. It is working with the Institute for Food Safety and Health (IFSH) — which is led by former CFSAN Director Robert Brackett — on a training curriculum for the Foreign Supplier Verification Program (FSVP). This is still at an early development stage. IFSH, which manages the Food Safety Preventive Controls Alliance (FSPCA), is also developing training programs for preventive controls.

In another initiative, the agency is collaborating with the National Association of State Departments of Agriculture (NASDA) to create voluntary on-farm pre-assessments for use before the new FSMA produce rule is fully implemented.

“We appreciate FDA’s engagement with stakeholders by hosting today’s public meeting,” commented NASDA’s CEO Barbara Glenn. “While we fully support the development of a preventive food safety system, there is still more work needed to get this right,” she said.

“The successful implementation of these rules depends on active partner engagement and education of American farmers, prior to enforcement. We must strike a balance between enhancing public health and not driving American farmers away from growing the fruits and vegetables which are so vital to human health,” Glenn said.

It seems to me that a similar balance is needed for all seven proposed FSMA rules.

Stephen Sundlof, Senior Advisor for Animal and Human Food Safety

 

Dr. Margaret Hamburg, who retired as FDA Commissioner late last month, discussed the agency’s Food Safety Modernization Act (FSMA) budget in her final appearance before a House Appropriations Committee hearing on Capitol Hill, March 4.

Mindful of pressures on the federal budget, the administration focused its budget request for fiscal year 2016 on “the most urgent needs,” she told the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.

The agency’s budget request for FY 2016 seeks an increase of $301 million above the enacted level for FY 2015 for a total of $1.5 billion for food safety. This total includes a $109.5 million increase in budget authority and a $191.8 million increase in user fees. Almost all of the proposed budget authority increase will be dedicated to FSMA implementation, she said.

“With FDA under court order to issue many key FSMA regulations in 2015, FY 2016 is an absolutely crucial year for the investments needed to ensure timely, effective, and non-disruptive implementation,” she said.

As it implements FSMA, the agency will be taking a collaborative approach to inspection and enforcement, focusing on food safety outcomes and encouraging voluntary compliance. The largest single portion of the budget authority will go to states to better integrate, coordinate, and leverage federal and state food safety efforts, Hamburg said.

The agency’s FSMA philosophy of “educate before and while we regulate” calls for investing in guidance, education, and technical assistance for industry to support compliance efforts, especially by smaller scale farmers and manufacturers, she said.

Finally, she said, FDA must make investments in FY 2016 to implement the new import safety system, including the Foreign Supplier Verification Program (FSVP).

“The investments FDA can make with the FY 2016 budget authority request will enable the agency to maintain momentum toward timely and successful implementation of FSMA. Without these investments, implementation will be disrupted and delayed,” she said.

The FDA Center for Food Safety and Applied Nutrition is the only product center that does not receive a substantial portion of its budget from user fees charged to the regulated industries. Of the $4.9 billion requested by the Administration for FDA in 2016, $2.2 billion (45%) comes from user fees, yet the food safety program receives only 1% of its budget from user fees. In early House versions of the FSMA bills, user fees of $1,000 per registered facility were included. This was reduced to $500 per facility in subsequent versions, and eliminated altogether in the final version. With nearly 200,000 registered food facilities, user fees could have generated $200 million per year, increasing the food safety budget by 16%.

I believe the FDA food safety program will never be able to fulfill the promise of FSMA as long as its budget is limited to federal appropriations. Cost recovery user fees would go a long way toward closing the gap, but that opportunity was lost when registration fees were cut from FSMA.

With the first batch of FSMA-implementing regulations on the way this year, it would be prudent for food companies to look ahead and consider budgets for compliance with the new FSMA regulations.

Welcome to Europe!

You say color, I say colour. You say “dietary supplement”, we, legally, say “food supplement.” And of course, the French say “complément alimentaire,” the Danish say “Kosttilskud” and the Italians say “Supplemento Alimentare.” With 27 different Member States within Europe, there are many more ways to say “Food Supplement.”

Although the languages may not be harmonized, the good news is that there has been much progress in the past to harmonize controls on supplements in Europe.

The publication of the Food Supplements Directive in 2002 harmonized basic controls between EU Member States, such as definitions, the forms of vitamins and minerals that can be used and warning statements for use on labels. Together with other harmonized regulations, such as those on additives, novel foods, labeling and claims, it forms a good starting point for anyone looking to market food supplements in Europe.

However, Europe is made up of countries with long traditions and strong national identities so reaching agreements on new controls can be a challenge. The Food Supplements Directive made provision to harmonize other issues relevant to dietary supplements, such as maximum and minimum levels of vitamins and minerals permitted in a daily dose and controls on other nutritional substances used in supplements, but progress on these areas has stalled. On maximum levels that has been, in large part, due to a lack of agreement on how these levels should be derived relating back to national attitude towards food supplements. Typically, countries such as the UK, The Netherlands and Sweden have had a relaxed attitude, with no upper limits set other than for a minority of substances for which there is considered to be strong evidence of a risk to health. Other countries have a history of tight limits, such as 100% Recommended Daily Allowance (RDA) per daily dose of a vitamin or mineral supplement. With such diverse starting points, it is no wonder that the debate continues. Companies looking to sell food supplements in Europe therefore need to check the limits set by each Member State in which they wish to sell.

Beyond maximum and minimum levels, some Member States have created new laws to control the use of botanical substances in food supplements, with France the latest to publish new regulations in this area. Again, until such a time that harmonization is reached, companies need to work with a local market expert to ensure the formulation of their product is compliant with the requirements of each target Member State.

When it comes to labeling your dietary supplement, the majority of the requirements are harmonized and set out clearly in both the Food Supplement Directive and the Food Information Regulations. EU Member States may have minor additional requirements which need to be checked and incorporated before notification to the local market authority and commercialisation.

Launching into Europe will take time, patience – and often a little humor to help overcome cultural differences. A complete dossier of formula, detailed raw material specifications and the proposed label declarations will go a long way towards making the process faster and smoother.

Budgeting for FSMA Implementation

 

Dr. Margaret Hamburg, who retired as FDA Commissioner late last month, discussed the agency’s Food Safety Modernization Act (FSMA) budget in her final appearance before a House Appropriations Committee hearing on Capitol Hill, March 4.

Mindful of pressures on the federal budget, the administration focused its budget request for fiscal year 2016 on “the most urgent needs,” she told the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.

The agency’s budget request for FY 2016 seeks an increase of $301 million above the enacted level for FY 2015 for a total of $1.5 billion for food safety. This total includes a $109.5 million increase in budget authority and a $191.8 million increase in user fees. Almost all of the proposed budget authority increase will be dedicated to FSMA implementation, she said.

“With FDA under court order to issue many key FSMA regulations in 2015, FY 2016 is an absolutely crucial year for the investments needed to ensure timely, effective, and non-disruptive implementation,” she said.

As it implements FSMA, the agency will be taking a collaborative approach to inspection and enforcement, focusing on food safety outcomes and encouraging voluntary compliance. The largest single portion of the budget authority will go to states to better integrate, coordinate, and leverage federal and state food safety efforts, Hamburg said.

The agency’s FSMA philosophy of “educate before and while we regulate” calls for investing in guidance, education, and technical assistance for industry to support compliance efforts, especially by smaller scale farmers and manufacturers, she said.

Finally, she said, FDA must make investments in FY 2016 to implement the new import safety system, including the Foreign Supplier Verification Program (FSVP).

“The investments FDA can make with the FY 2016 budget authority request will enable the agency to maintain momentum toward timely and successful implementation of FSMA. Without these investments, implementation will be disrupted and delayed,” she said.

The FDA Center for Food Safety and Applied Nutrition is the only product center that does not receive a substantial portion of its budget from user fees charged to the regulated industries. Of the $4.9 billion requested by the Administration for FDA in 2016, $2.2 billion (45%) comes from user fees, yet the food safety program receives only 1% of its budget from user fees. In early House versions of the FSMA bills, user fees of $1,000 per registered facility were included. This was reduced to $500 per facility in subsequent versions, and eliminated altogether in the final version. With nearly 200,000 registered food facilities, user fees could have generated $200 million per year, increasing the food safety budget by 16%.

I believe the FDA food safety program will never be able to fulfill the promise of FSMA as long as its budget is limited to federal appropriations. Cost recovery user fees would go a long way toward closing the gap, but that opportunity was lost when registration fees were cut from FSMA.

With the first batch of FSMA-implementing regulations on the way this year, it would be prudent for food companies to look ahead and consider budgets for compliance with the new FSMA regulations.