The Food and Drug Administration Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of public meeting.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled “FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation.” The public meeting will provide importers and other interested persons an opportunity to discuss import safety regulations and programs, including final rules for foreign supplier verification programs (FSVPs) for importers of food for humans and animals (the FSVP final rule) and accreditation of third-party certification bodies (the third-party certification final rule). Participants will also be briefed on the status of FDA's Voluntary Qualified Importer Program (VQIP), which is still in development. Additionally, the public meeting will provide importers and other interested persons an opportunity to discuss FDA's comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act implementation relating to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance.

DATES:

See section III, “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meeting, closing dates for advance registration, and requesting special accommodations due to disability.

ADDRESSES:

See section III, “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

For questions about registering for the meeting, or to register by phone: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email: ctreece@planningprofessionals.com.

For general questions about the meeting or for special accommodations due to a disability: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email: Juanita.yates@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The FDA Food Safety Modernization Act (FSMA) (Pub. L.111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. Among other things, FSMA directs FDA to issue regulations requiring preventive controls for human food and animal food, setting standards for produce safety, and requiring importers to perform certain activities to help ensure that the food they bring into the United States is produced in a manner consistent with U.S. safety standards.

In the Federal Register of November 27, 2015, we published the FSVP final rule (80 FR 74225) and the third-party certification final rule (80 FR 74569).

The FSVP final rule requires importers of food to verify that their foreign suppliers use processes and procedures that provide the same level of public health protection as the preventive controls and produce safety regulations, where applicable, and also to verify that the food they import is not adulterated and is not misbranded with respect to food allergen labeling.

The third-party certification final rule adopts regulations to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign entities, including registered foreign food facilities, and to issue food and facility certifications under FSMA. Certification will be required to establish VQIP eligibility. To prevent potentially harmful food from reaching U.S. consumers, in specific circumstances FDA also may require a food offered for import to be accompanied by a certification.

On June 5, 2015, we published a notice of availability of a draft guidance for industry on VQIP for importers of human or animal food (80 FR 32136). The draft guidance describes and answers questions about VQIP. To ensure that we consider comments on the draft guidance before we complete a final version of the guidance, we invited electronic or written comments on the draft guidance by August 19, 2015.

The FSVP and third-party certification final rules and related fact sheets are available on FDA's FSMA Web page located at http://www.fda.gov/FSMA.

The FSVP and third-party certification final rules are two of several final rules that will establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in FSMA.

II. Purpose and Format of the Public Meeting

FDA is holding the public meeting on FSMA's prevention-oriented import system to brief participants on the key components of the FSVP and third-party certification final rules; brief participants on the status of the VQIP; discuss the plans for guidance documents related to import safety, as well as training, education, and technical assistance; provide an update on the development of a risk-based industry oversight framework that are at the core of FSMA; and answer questions about these import programs.

The public meeting is an opportunity for FDA to share its current thinking on implementation plans for programs related to import safety. We encourage interested persons to provide feedback during the meeting on any ideas that we present at the public meeting related to the operational aspects of FSMA implementation. The agenda and other documents will be accessible on our FSMA Web site at http://www.fda.gov/FSMA before the public meeting.

There will be an opportunity for stakeholders who are unable to participate in person to join the meeting via Webcast. (See section III for more information on the Webcast option.)

Following the public meeting, FDA plans to continue dialogue on implementation of these import safety programs with a series of regional meetings across the United States.

III. How To Participate in the Public Meeting

We are holding the public meeting on March 21, 2016, from 8:30 a.m. until 5 p.m., at FDA's Center for Food Safety and Applied Nutrition, Wiley Auditorium, 5100 Paint Branch Parkway, College Park, MD 20740. Due to limited space and time, we encourage all persons who wish to attend the meeting to register in advance. There is no fee to register for the public meeting, and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Onsite registration will be accepted, as space permits, after all preregistered attendees are seated.

Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting are asked to focus their remarks on the implementation or operational aspects of the import safety programs. To make such a presentation, please submit a request and provide the specific topic or issue to be addressed. Due to the anticipated high level of interest in presenting public comment and the limited time available, we are allocating 3 minutes to each speaker to make an oral presentation. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. We would like to maximize the number of individuals who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their opinions at the meeting.

We encourage persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, we will notify each participant before the meeting of the approximate time their presentation is scheduled to begin, and remind them of the presentation format (i.e., 3-minute oral presentation without visual media).

We encourage interested persons to provide feedback on any ideas that we present at the public meeting related to the operational aspects of FSMA implementation.

Table 1 provides information on participation in the public meeting.

IV. Transcripts and Recorded Video

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov and at FDA's FSMA Web site at: http://www.fda.gov/FSMA. You may also view the transcript at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on FDA's Web site at http://www.fda.gov. Additionally, we will be video recording the public meeting. Once the recorded video is available, it will be accessible at FDA's FSMA Web site at http://www.fda.gov/FSMA.