• Provide a fair and uniform assessment process on new technologies for the meat, poultry, and egg industries.
• Provide a fair and uniform assessment process on new technologies for the meat, poultry, and egg industries
• Respond to questions regarding the use of new technologies.
• Encourage the development and utilization of new technologies, and
• Be cognizant of the need to reexamine current regulations.
  
  

• Section I. Definitions,
• Section II. Identifying New Technology,
• Section III. Notification, Section IV. Notification Process,
• Section V. Notification Review Process,
• Section VI. Protocols,
• Section VII. Protocol Submission Process,
• Section VIII. Protocol Review Process,
• Section IX. Verification Process,
• Section X. Evaluation Process,
• Section XI. Multi-plant Trials and Data Submission and,
• Section XII. Voluntary Information Checklist for Establishments Completing New Technology Protocols
  
  

• adversely affect the safety of the product,
• jeopardize the safety of the Federal inspection program personnel,
• interfere with the inspection procedures, or
• require a change to the Agency´s regulations.
  
  

1. Firms should submit a notification about technologies that affect product safety. Firms that recognize that the use of a technology will likely raise questions about its effects on product safety may elect to submit a protocol instead of first submitting a notification.
2. To avoid delay, firms should submit a protocol on technology that affects Agency regulations, inspection procedures, or the safety of Federal inspection personnel.
3. An establishment or plant that is unsure whether it should submit a protocol can first submit a notification, and the Agency will determine whether a protocol is necessary.

• Examples of New Technology for which Notification is likely all that will be necessary
  
  
  • New technologies that could affect product safety
    
    High pressure sterilization equipment
    Although FSIS approval of equipment is no longer required, high pressure sterilization equipment could affect product safety. Therefore, FSIS should be notified before an establishment begins to use the technology. High-pressure sterilization is used for the elimination of spores in various processed foods. While other government agencies have approved high-pressure sterilization for use, the use of this sterilization technique on processing meat and poultry products is new, and FSIS should be advised why the intended application would not adversely affect food safety and, therefore, not require an in-depth review by the Agency.
    
    Machine vision technology
    Machine vision technology used during slaughter and processing to detect abnormalities or foreign substances on product could affect product safety although there is no direct contact with the food product. For example, the technology could be misused to sort and treat product in a way that would mask disease conditions normally detected during FSIS inspection. FSIS should be notified before the technology is used so that the Agency can ensure that the intended use will not affect its inspection of the product for safety.
    
    Antimicrobial sprays that are processing aids
    An establishment may wish to use an antimicrobial spray that has been judged to be safe by the Food and Drug Administration on its products. (The use of lactic acid as an antimicrobial spray on beef carcasses is an example of a substance that falls into this category.) If the establishment wants, however, to not have to declare the use of the ingredient in its labeling (see 21 USC 101.100 (a)(3)). If there are questions as to whether the substance meets the processing aid definition, FSIS should be advised why the antimicrobial spray is a processing aid and, therefore, is not required to be declared. The establishment may be able to demonstrate why the substance is a processing aid based on data showing that very low levels and no continuing effects will result from its use, or it may be necessary to submit a protocol and conduct a short study to establish those results.
    
    
• Examples of New Technology for which a protocol will likely need to be filed
  
  
  • New technologies that affect the regulations
    New technologies for reprocessing of contaminated poultry carcasses on-line. A temporary waiver of FSIS´ regulation on contamination of carcasses (§381.91(b)(1)) is required to allow contaminated poultry carcasses to be reprocessed on the main processing line.
    
    SIS automated poultry eviscerator system equipment that requires 3 or more inspectors per main processing line. A temporary waiver of FSIS´ regulation on post-mortem inspection (§381.76(b)(3)(ii)(b)) is required to allow inspection to be performed by more than two inspectors per main processing line.
    
    
  • New technologies that affect inspection procedures
    Modified rail inspection in cattle slaughter, which changes the height of two rail inspection stations to a high inspection station and a low inspection station. The height of the inspection stations is not specified in the federal regulations, but variation affects the inspection procedure.
    
    Detection equipment to measure microbial load on the main processing line. The use of specific equipment is not in the federal regulations, but it affects how the program personnel perform their duties.
    
    
  • New technologies that affect the safety of inspection program personnel
    Use of ultraviolet wavelengths for anti-microbial purposes. Ultraviolet radiation can cause biological harm to program personnel. Even though the process has been approved for use, the system must be evaluated to ensure adequate safety precautions.
    
    Change in inspection program personnel workstations or facilities. Any change can affect the biomechanics of the program personnel´s duties. The change must be evaluated to ensure adequate safety precautions.
    
    

• How the new technology affects food safety?
  The definition of new technology that affects product safety includes new technology that has either a beneficial or adverse effect. Establishments should describe, in some detail, what the technology is intended to accomplish as well as the beneficial or adverse effects that the technology is expected to have on products.
• Why the new technology will not jeopardize the safety of Federal inspection program personnel?
  Provide the rationale that led the official establishment to conclude that the technology will not affect or jeopardize the safety of FSIS inspection personnel. This should include a description of safety measures taken to ensure their safety (e.g., installation of shields, ventilation, new construction to isolate the technology, protective equipment, etc.).
• Why the new technology will not require a waiver of any Agency regulation or inspection procedures?
  Cite any regulatory authority under which use of the technology is allowed or explain why the technology does not violate any existing regulatory requirements. If the new technology involves the use of a substance, state whether that substance´s use has been found to be safe by the Food and Drug Administration. State whether the substance´s use will be declared on the labeling of any resultant product. If not, explain why not declaring the substance is consistent with FSIS precedent.
• Any prior approvals, if applicable, by other Federal agencies, e.g., Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Association (OSHA), of the equipment, methods, processes, procedures, or substances.
  
  

• It sends written notice that the notification is inadequate and will need to be revised and resubmitted.
• It sends written notice that an in-plant trial is needed, and that a protocol must be submitted.
• It sends a written no objection response.
  
  

• A descriptive title and statement of purpose for the in-plant trial.
  The statement of purpose specifies the rationale, goals, and objectives of the proposed research or trial. If enhanced food safety is the purpose, the statement of purpose should identify the particular area of concern: e.g., pathogenic microorganisms in raw beef. In all cases, the practical outcome to be measured must be clearly defined.
  
  The statement of purpose should set forth the scope and any pertinent limitations of the study, such as species or production class.
  
  The statement of purpose should define the specific application to be measured and the standard of measure employed: e.g., a hot water wash at a certain temperature, pressure, and time to reduce quantities of certain pathogens.
  
  
• The name of the sponsor and the name and address of the facility at which the trial is to be conducted.
  Name the lead researcher for any submitted proposal who will act as principal spokesperson and contact with FSIS.
  
  
• A description of the experimental design, including the methods for control of bias.
  The general approach should be detailed: e.g., nature of the treatments, how they are to be applied, number and names of participating establishments, and time frame of the study.
  
  When the new technology is expected to be tested in more than one establishment or plant, see Section XI of this guidance document for additional information.
  
  
• Identification of the test subjects and control articles.
  Control and experimental groups and the number of independent replications of the experimental procedure should be clearly defined.
  
  
• The type and frequency of tests, analyses, and measurements to be made.
  Sample set characteristics should be described: e.g., sample size and adequacy for the question under investigation, random selection procedure, and effects of any rejected samples.
  
  Sample handling should be described: e.g., visual scoring or laboratory sample preparation, kind and number of laboratory analyses to be performed, and analytical methods to be used.
  
  In-plant trials where researchers artificially contaminate carcasses with fecal material that may contain human pathogens are not recommended. An alternative would be to treat product with a special sterile medium to which are added food-grade microorganisms that approximate the growth or spread of pathogens of interest. In such cases, trimming of treated areas followed by an antimirobial wash is required before product can move into commerce.
  
  Protocols involving research using such surrogate organisms and artificial contamination of product in commercial settings should be reviewed by FSIS before implementation.
  
  
• The records to be maintained.
  The protocol should describe the records that will be maintained during the in-plant trial. The records should document the performance of the technology throughout the trial and be adequate to verify that food products produced during the trial are not adulterated. When the new technology is expected to be tested in more than one establishment or plant, see Section XI of this guidance document for additional information.
  
  
• A statement of the proposed statistical methods to be used to analyze the data that are to be generated in the study.
  Data processing and analysis techniques should be fully described. Where appropriate, descriptions of analytical methods may be abbreviated if appropriate citations are provided.
  
  
• A time period for the in-plant trial.
  The protocol should state how long (i.e., the number of days, weeks, or months) the in-plant trial is expected to last. The duration of an in-plant trial should be based on judgment that considers factors such as:
  
  
  1. how long will it take to address the purpose that prompted the study
  2. how long it will take to obtain data that are representative of the conditions of use intended for the technology
  3. how long it will take to obtain the data needed to support a change in the regulations or inspection procedures
  4. how long it will take to obtain representative data if the data must reflect seasonal variations
  5. in-plant trials should be finished expeditiously so that food safety and public health improvements can be implemented
     
     
  The duration of studies should be sufficient to assess the sustainability of new technologies or procedures under commercial conditions. Studies should, however, last no longer than is necessary to assess the purpose that prompted the study.
  
  
• Any applicable research data.
  A literature review/bibliography should describe the current scientific status of the question addressed by the proposed research and highlight key previous work.
  
  A literature review/bibliography should be concise, representative, and balanced, with full and consistent citations. Data on pertinent preliminary experimentation should be included in this section.
  
  Any chemical reagents or other materials to be used in the project must have been approved by FDA, or the applicant must submit written FDA approval with the protocol. The proposed project must not violate any Federal law or regulation.
  
  
• Any prior approvals from other Federal Agencies.
  Ensuring the safety of inspection personnel is a key responsibility of FSIS. In order to safeguard its employees, FSIS will evaluate the protocol for impact on employee safety. Where pertinent, the protocol should contain written approval or appropriate regulatory citations from EPA or OSHA.
  
  Pertinent approvals from EPA, if necessary, will need to be in the protocol to demonstrate environmental safety.
  
  

Protocols will be reviewed by the lead FSIS project contact person for general acceptability and completeness. If complete, protocols will be assigned to a technical review team, with members drawn from pertinent disciplines and program areas, including Labor and Employee Relations Division (LERD).

FSIS will review the written protocol for the use of new technology to determine whether to waive provisions of the regulations for a limited period of time for the in-plant trial (9 CFR 303.1 (h), 381.3, and 590.10), whether inspection can be appropriately maintained, and whether the safety of inspection personnel will be affected. FSIS will also examine the protocol to determine whether it complies with the Agency´s humane slaughter regulations and is scientifically sound.

If the Agency rejects the written protocol to test use of the new technology under commercial operating conditions, the official establishment has the option to submit a revised written protocol to address any problem areas identified by FSIS. The Agency will then begin a new review of the revised protocol.

Protocols that are unapproved or still in the approval process will not be publicly available. Approved protocols will be available under the FOIA and will be on file in the Agency FOIA Reading Room. FSIS will ensure that FOIA protection for proprietary information will be maintained.

Section IX. Verification Process
FSIS will expect the submitter to provide data throughout the in-plant trial for the Agency to examine. Data may take several forms: laboratory results, weekly or monthly summary production reports, or the establishment´s evaluation reports. FSIS also may obtain data from its inspection program personnel, particularly for technology that involves inspection procedures. If at any time the Agency determines that the in-plant trial results in product being produced presents an increased risk to food safety or inspection program personnel safety, the trial will be suspended or ended.

If requested by FSIS, the submitter should provide an orientation session for each establishment and shift before the start of each in-plant trial. The Agency reserves the right to conduct on-site observations during the in-plant trial.

Section X. Evaluation Process
At the conclusion of the in-plant trial, the establishment or plant will be expected to submit a final report to the Agency. The Agency´s evaluation of the final report could result in a recommendation of additional in-plant trials or the issuance of a letter by FSIS either rejecting or accepting the use of the new technology in all FSIS-regulated establishments, or announcing the Agency´s intent to institute rulemaking to amend its regulation to provide for the new technology.

If applicable, the establishment or plant will need to submit a petition requesting rulemaking to change the pertinent provision(s) of the regulations. See Federal Register Notice, "FSIS Petition Submission and Review Procedures" (58 FR 63570) published December 2, 1993. The Agency may extend the in-plant trial period while the petition is pending if the Administrator determines that doing so will result in substantial benefit to public health.

Section XI. Multi-plant Trials and Data Submission
The meat, poultry, and egg products regulations (9 CFR; 303.1, 381.3, and 590.10) allow FSIS to waive regulatory requirements for a limited period for experimentation, so that new procedures, equipment, and processing techniques may be tested to facilitate improvements. This authority often is the basis for allowing in-plant trials to test new technologies under commercial conditions. Typically, in-plant trials conducted under this authority are to assess the efficacy and efficiency of new technology and to collect the additional data needed to support any desired change of FSIS regulations or procedures.

When the public health benefits that may be derived from validated technologies warrant allowing in-plant trials of new technologies that appear promising, firms that wish to test these technologies in official establishments should expect to maintain verification data that reflect the performance of the technology throughout the in-plant trials; and to provide appropriate and current data to support any necessary regulatory actions when the in-plant trials are finished. FSIS needs to see data from the first plant at which the technology is tested before it will authorize tests at additional plants.

• FSIS criteria for granting permission for multi-plant trials are described below for guidance in preparing protocols for in-plant trials.
  
  
  • Level I - Initially, FSIS will grant permission to conduct an in-plant trial at only one plant. Data from the trial must show that the expected improvement is obtained before permission will be granted to conduct trials at additional plants.
  • Level II - Permission to conduct tests in additional plants (maximum of three, two plus the initial plant) may be granted if the data show that the expected improvement is obtained at the initial plant. The protocol must provide for data that show that the desired action is warranted (for example, change the regulations or an inspection procedure). FSIS will work with the technology submitter at this point to ensure that the data collection aspects of the protocol are adequate. If not included in the original protocol, an addendum may be submitted to address the necessary data needs. Continued permission for the in-plant trials will be contingent upon submission of data to FSIS in accordance with an acceptable protocol.
  • Level III - FSIS will consider extending the trials to additional plants (i.e., more than three) if the data show that the expected improvement is achieved at Level II, and that it is reasonable to believe that the performance can be further replicated. FSIS will require that the trials be limited to the number of plants needed to acquire data representative of the plants that are expected to use the technology. Plants/manufacturers will need to determine the number, location, and characteristics that comprise such a universe and submit a proposal to FSIS for approval. At a minimum, factors to be considered in assembling a representative sampling of plants should include geographical location, production volume, and plant size. Plants/manufacturers should submit a proposed scheme to conduct in-plant trials at a representative sampling of plants and describe the rationale for concluding that the plants selected reflect an accurate representation. Continued permission for the in-plant trials will be contingent upon submission of data to FSIS for all plants included in the trial universe in accordance with an acceptable protocol.
  • Level IV – When amendment of the regulations is required, FSIS will consider interim general use (i.e., in-plant trials) at an unlimited number of plants only if the sponsor (1) provides data showing that the technology performance can be replicated in a universe that is statistically representative of the plants that can be expected to use it, (2) provides an acceptable data collection and submission scheme for monitoring the performance of the technology pending publication of an amended regulation, and (3) promptly submits a petition to the Agency for any needed amendment of the regulations.
    
    
• Following are FSIS data requirements for monitoring the performance of new technologies tested in multi-plant trials at Level IV above:
  
  
  • Plants/manufacturers must develop and receive FSIS approval for a data collection and submission scheme suitable for surveillance of the technology´s performance. All plants using the technology must submit surveillance sampling data to FSIS in accordance with the FSIS-approved data collection and submission scheme.
  • Continued permission to use the technology is contingent upon data showing that the technology continues to perform as expected. The data collection and submission scheme should include corrective actions (e.g., suspend use, determine the cause, increase sampling frequency, and modify the protocol or terminate the use of the technology) if the expected improvement is not achieved.

1. What processes in your plant are utilizing the new technology? [Examples: slaughter, cut up, further processing, packaging]
2. What are the anticipated costs of the new technology to your plant? Please identify the installation costs of the new technology and the annual operating costs.
3. What are the anticipated benefits of the new technology to your plant?
4. What are annual cost savings in terms of reduced labor, energy, water, or other production input?
5. What is the percentage increase in plant productivity, as measured by line speed? Are there other types of benefits anticipated at the plant, such as a new product or an increase in food safety? Please indicate.
6. What is the potential for either increase or decrease in costs per pound of final product associated with using this new technology? Please indicate in percentage of total final product cost.
7. How long (in minutes) did it take to fill out the initial new technology notification to FSIS?
8. How long (in minutes) did it take to put together the protocol for an in-plant trial of the new technology?