FDA Food Safety Modernization Act, Focus on Inspections and Compliance
This Notice document was issued by the Food and Drug Administration (FDA)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0366]
Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA) is announcing a public meeting entitled “FDA Food Safety Modernization Act: Focus on Inspections and Compliance.” The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of inspections and compliance under the recently enacted FDA Food Safety Modernization Act (FSMA). More specifically, the public will have an opportunity to provide information and share views that will inform FDA's FSMA implementation strategies relative to enforcement authorities; frequency and targeting of facility inspections; manner of inspection in a preventive controls environment; and improving the reportable food registry (RFR).
See table 1 in the SUPPLEMENTARY INFORMATION section of this document.
For Further Information Contact
Patricia M. Kuntze, Office of External Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5322, Silver Spring, MD 20993, 301-796-8641, .
FSMA (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation for a modernized, prevention-based food safety system. The legislation recognizes that inspection is an important means of assessing industry compliance with the law and holding industry accountable for their responsibility to produce a safe product. FDA will meet this expectation by:
Section 102 of FSMA, among other things, amends section 415 of the FD&C Act (21 U.S.C. 350d) for various purposes, including authorizing the Secretary of Health and Human Services to suspend registration of a facility if she determines that food manufactured, processed, packed, received, or held by the facility poses a reasonable probability of serious adverse health consequences or death and the facility either created, caused, or was otherwise responsible for that reasonable probability or knew of, or had reason to know of, such reasonable probability and packed, received, or held the food. A facility that is under suspension is prohibited from introducing food into commerce in the United States.
Section 201 of FSMA, among other things, creates a new section 421 of the FD&C Act (21 U.S.C. 350j) that establishes a mandated inspection frequency, based on risk, for food facilities that are required to register under section 415 of the FD&C Act and requires the frequency of inspection of such facilities to increase immediately. All high-risk domestic facilities must be inspected within 5 years of FSMA's enactment and no less than every 3 years thereafter. Non-high-risk domestic facilities must be inspected within 7 years of FSMA's enactment and no less than every 5 years thereafter. Within 1 year of FSMA's enactment, the law directs FDA to inspect at least 600 foreign facilities and to double those inspections every year for the next 5 years.
Section 206 of FSMA creates a new section 423 of the FD&C Act (21 U.S.C. 3501) to provide FDA with mandatory recall authority for foods other than infant formula. This authority applies when FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act (21 U.S.C. 342) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) and the use of or exposure to such article of food will cause serious adverse health consequences or death to humans or animals.
Section 207 of FSMA amends section 304(h)(1)(A) of the FD&C Act (21 U.S.C. 334(h)(1)(A)) to provide FDA with a more flexible standard for administratively detaining human and animal food products that are potentially in violation of the FD&C Act. Under the new law, FDA may administratively detain food if FDA has reason to believe that the food is adulterated or misbranded. Administrative detention is the procedure FDA uses to keep suspect food from being moved.
Section 211 of FSMA amends section 417 of the FD&C Act (21 U.S.C. 350f), among other things, to require FDA to publish, on the Web, an easily printable one page summary of certain consumer-oriented information regarding certain reportable foods, including information necessary to enable a consumer to accurately identify whether the consumer is in possession of the reportable food. Grocery stores that sold a reportable food that is the subject of a summary posting and that are part of a chain of establishments with 15 or more physical locations will be required to prominently display such summary or the information from such summary via at least one of the methods to be identified by FDA within 24 hours after FDA publishes the summary.
II. Purpose and Format of the Meeting
If you wish to attend and/or present at the meeting scheduled for June 6, 2011, please register by e-mail to by May 31, 2011. FDA is holding the public meeting to receive input from the public to inform FDA's implementation of the FSMA provisions identified previously in this document.
In general, the meeting format will include introductory presentations by FDA. Listening to our stakeholders is the primary purpose of this meeting. In order to meet this goal, FDA will provide multiple opportunities for individuals to actively express their views by making presentations at the meeting, participating in a total of three 75-minute breakout sessions on the provisions discussed at the meeting, and submitting written comments to the docket(s) within 30 days after this meeting. Participants can select up to three of the following four breakout sessions: Enforcement authorities, frequency and targeting of facility inspections, manner of inspection in a preventive controls environment, and improving the RFR.
FDA requests comment on the following questions in the break-out sessions:
1. Enforcement Authorities
2. Frequency and Targeting of Facility Inspections
3. Manner of Inspection in a Preventive Controls Environment
4. Improving the RFR
There will be an interactive Web cast; see section III of this document. If you would like to participate at the meeting via the Web cast, please register at . In order to provide Web cast participants with information before and after the meeting, we request attendees provide their name, their affiliation, and e-mail when registering. It is recommended that attendees via Web cast test their Internet connection to confirm access of the Web cast prior to the meeting. To test this connection, visit and click on “CDRH Television Tutorial and Firewall Test.”
III. How To Participate in the Meeting
Stakeholders will have an opportunity to provide oral comments. Due to limited space and time, FDA encourages all persons who wish to attend the meeting, either onsite or by Web cast, including those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting, to register in advance and to provide the specific topic or issue to be addressed and the approximate desired length of their presentation. Depending on the number of requests for such oral presentations, there may be a need to limit the time of each oral presentation (e.g., 3 minutes each). If time permits, individuals or organizations that did not register in advance may be granted the opportunity for such an oral presentation. FDA would like to maximize the number of stakeholders 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 views at the meeting. FDA anticipates that there will be several opportunities to speak in breakout sessions and an interactive Web cast will also be available for stakeholders who are not onsite.
FDA encourages persons and groups who have similar interests to consolidate their information for presentation through a single representative. After reviewing the presentation requests, FDA will notify each participant before the meeting of the amount of time available and the approximate time their presentation is scheduled to begin. 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 after all pre-registered attendees are seated. Table 1 of this document provides information on participating in the meeting and on submitting comments to the docket (see table 2 of this document for a list of docket numbers and corresponding sections of FSMA).
Regardless of attendance at the public meeting, interested persons may submit to the Division of Dockets Management (see table 1 of this document) either electronic or written comments for consideration at or after the meeting in addition to, or in place of, a request for an opportunity to make an oral presentation. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Please be advised that as soon as a transcript is available, it will be accessible at and . It may be viewed 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. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: May 20, 2011.
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13059 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P
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Date Posted: May 26, 2011
Federal Register Number: 2011-13059
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