UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
WASHINGTON, DC
FSIS DIRECTIVE 10,700.1, Revision 1 6/24/2003

Procedures for New Technology and Experimental Protocols for In-Plant Trials

  1. PURPOSE

The purpose of this directive is to inform inspection program personnel about the procedures that the Technology Program Development Staff (TPDS) will follow to notify the field about official meat and poultry establishments and egg products plants that will use new technologies or that will conduct in-plant trials of a new technology.

  1. CANCELLATION

10,700.1, dated 4/11/95

  1. REFERENCES

9 CFR Parts 317, 318, 381, 590.

  1. REASON FOR REISSUANCE

This directive has been revised in its entirety to inform inspection program personnel about the TPDS staff’s procedures for notifying the field about an establishment’s use of a new technology or the need for an in-plant trial.

  1. BACKGROUND

A.  FSIS published new procedures regarding new technology in a Federal Register notice, "FSIS Procedures for Notification of New Technology" (68 FR 6873; 2/18/03) (Attached). The new procedures state that all official establishments (meat, poultry, and egg products) and companies that manufacture and sell technology to official establishments, are to notify FSIS about the use of a new technology.

B.  FSIS defines "new technology" as "new, or new applications of, equipment, substances, methods, processes, or procedures affecting the slaughter of livestock and poultry or processing of meat, poultry, or egg products". This definition should not be interpreted to mean that all equipment used in official establishments now has to be approved. This definition does not include new equipment or new models of equipment that performs the same function in essentially the same manner as that routinely used in processing facilities. The definition does include new equipment or new models of equipment if it is used in a novel manner. This directive should not be applied to routine changes in HACCP procedures resulting from reassessment or in response to corrective actions. Additionally, the routine use of common sanitizers or chemicals covered by the Sanitation Performance Standards would not be considered as new technology.

C.  Establishments or companies interested in using or selling a new technology should submit documentation to TPDS describing the operation and purpose of the new technology. Within 60 calendar days, TPDS will make every effort to review the document and issue a letter to the establishment or company, with cc:’s to Technical Service Center (TSC) and the appropriate District Office (DO), Front-line Supervisor, and Inspector-in-Charge (IIC), stating either:

  1. TPDS does not object to the use of the new technology and the establishment or company may proceed to use or sell the new technology, or
  2. TPDS has determined that the use of the new technology could adversely affect product safety, interfere with FSIS inspection procedures, jeopardize the safety of inspection program personnel, or require a waiver of a regulation. In such cases, the letter will inform the establishment or company that a pre-use test is necessary, and that the establishment or company is to send TPDS a pre-use test protocol.

  1. FIELD NOTIFICATION BY TPDS

A.  TPDS will issue a weekly new technology report by e-mail to the DOs; Deputy Administrator and Associate Administrator for Field Operations (FO); TSC Director; Front-line Supervisors; Deputy Administrator for Program Evaluation, Enforcement, and Review; and other program employees that details the requests received and pending, the issued no objection letters, protocols required, and protocols approved.

B.  If in-plant test protocols are needed, TPDS sends correspondence approving the protocol to the establishment or company, with cc’s to the TSC and the appropriate DO, Front-line Supervisor, and IIC. TPDS also will send e-mails to the appropriate DO, Front-line Supervisor, and IIC advising them of the date of the trial two weeks before it is to begin. In the approval letter, TPDS informs the establishment that the protocol submitter will provide the affected inspection program personnel with training materials and conduct a pre-in-plant trial training session. Representatives from FO and the National Joint Council are to be invited to the pre-in-plant trial training session.

  1. INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES

As specified in FSIS Directive 5000.1, Revision 1, the Rules of Practice (9 CFR 500), and 9 CFR Part 590, inspection program personnel are to take appropriate action if the use of the new technology leads to insanitary conditions or to the adulteration of product.

Direct questions to the Technical Service Center.

 

 

/s/ Philip S. Derfler

Assistant Administrator
Office of Policy and Program Development

Attachment 1

DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; T/A Plant Mgt; TRA; ABB;TSC; Import Offices OPI: OPPD