The Food Safety and Inspection Service (FSIS) is implementing new
procedures for meat and poultry establishments, egg product plants,
and companies that manufacture and sell technology to official
establishments. The Agency has moved away from the "pre-approval"
approach to one that facilitates the use of beneficial technologies
that can enhance food safety while holding establishments accountable
for ensuring that new technologies are introduced without compromising
(1) the Agency´s ability to ensure protection of the public health
or (2) the safety of FSIS inspectors. Although FSIS no longer approves
technologies, a new technology would be of regulatory interest
to FSIS if its use could affect product safety, inspection procedures,
inspection program personnel safety, or require changing existing
regulations.
Application of new technology can help protect product from physical,
chemical, or biological hazards, reduce or eliminate such hazards
on product, and improve product quality. Conversely, the use of
an inappropriate technology can result in a product that could
endanger public health. Establishments planning to use a new technology
must accept responsibility for ensuring the continued safety of
their workers, their products, and the environment, as well as
providing the information necessary for FSIS to examine the impact
of the new technology on inspection procedures and inspection program
personnel safety.
Under the new procedures official establishments notify FSIS in
writing of their intention to use a new technology. Notification
is necessary if FSIS is to effectively conduct its inspection activities.
In addition, notification will support FSIS activities designed
to:
-
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.
If FSIS determines that a new technology could affect product
safety, the safety of inspection program personnel, their inspection
activities, or affect existing regulations, it will advise the
official establishment that an in-depth pre-use review is necessary.
FSIS is aware that problems may arise when inspection program
personnel are not informed about a new technology that an official
establishment or plant is using or plans to use. Therefore, in
addition to establishing new, flexible procedures to actively
encourage the development and use of new technologies in meat,
poultry, and egg products establishments, FSIS is taking steps
to improve communications with inspection program personnel in
the field concerning new technologies. The new procedures provide
a central location in the Agency to review and evaluate new technology,
instead of having program inspection personnel address individual
instances and questions as they arise in official establishments.
These procedures are designed to eliminate unnecessary delays,
to keep inspection personnel informed of the use of new technologies,
and to establish uniform acceptance criteria to facilitate the
application of new technology.
The Agency has revised
FSIS Directive 10,700.1, "Guidelines For Preparing Experimental
Protocols for In-plant Trials of New Technologies and Procedures,"
to include provisions to inform inspection program personnel
about the new procedures that will be used to notify them about
new technologies that may be used in official establishments.
Reports on the status of new technology notification and protocols
received by the New Technology Staff (NTS) will be sent to inspection
program personnel on a regular basis. One of the benefits of
the new procedures is that inspection program personnel will
know the status of new technologies that official establishments
are using or planning to use.
The guidance provided in this document is intended to assist
establishments to determine whether they need to notify FSIS
of new technologies that they propose to use in meat, poultry,
or egg product establishments and when to submit protocols for
in-plant testing of new technologies.
The guide consists of twelve sections:
-
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
This material will be continually updated and made available through
the FSIS Internet web page located at
https://webarchive.library.unt.edu/eot2008/20080916221503/http://www.fsis.usda.gov.
Copies of this guidance are available from the Office of Policy, Program
and Employee Development (OPPED), New Technology Staff. Comments
regarding this document should be directed to NTS.
Send Notifications/Protocols to:
USDA, FSIS, OPPED, NTS
1400 Independence Ave., SW
Room 2932 South Building
Washington, DC 20250-3700
Phone: 202-205-0675
Fax: 202-205-0080
Email:
FSISTechnology@fsis.usda.gov
Section I. Definitions
For the purpose of FSIS, new technology is
defined 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.
New technology that affects product safety is
defined as one that might have a beneficial or adverse effect on
the safety of the food product. A notification
is defined as a document written to inform the Food Safety and
Inspection Service that a new technology is going to be tested
or used in an establishment.
A protocol is defined as a detailed plan of a
scientific experiment, treatment, or procedure that is submitted
to the Food Safety and Inspection Service if the scientific experiment,
treatment, or procedure affects inspection procedures, the safety
of Federal inspection program personnel, or requires a change to
the Agency's regulations.
Section II. Identifying New
Technology
Official establishments that are interested in introducing new
technology into their operations should pursue the introduction
in an appropriate manner. Failure to do so is likely to create
delays in the introduction of the new technology and interruption
in establishment or plant operations.
Firms should first decide whether the definition of new technology
covers the technology that they intend to use or sell to determine
if the new procedures apply. For example, the definition of new
technology includes new antimicrobials and new uses of antimicrobials.
Therefore, the new technology procedures apply to the use of
a new antimicrobial or a new application of an antimicrobial
that has been in use.
Firms that are interested in using or selling a new technology
should submit documentation to the FSIS New Technology Staff
(see address on page 3), describing the
operation and purpose of the new technology. The document should
explain why the new technology will not:
-
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.
If the intended new technology will have an effect on any of
the four areas of regulatory interest to FSIS, then the establishment
or plant will need to notify the Agency either by notification
or by protocol.
If the intended new technology will have an effect on any of the
four areas of regulatory interest to FSIS, then the establishment
or plant will need to notify the Agency either by notification
or by protocol.
-
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.
-
To avoid delay, firms should submit a protocol on technology
that affects Agency regulations, inspection procedures, or
the safety of Federal inspection personnel.
-
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.
The following examples are provided as a guide to distinguish when
a technology would be considered new, when notification is necessary,
or when a protocol will be required.
-
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.
Section III. Notification
New technology that has a direct effect on meat, poultry, or egg products
during slaughter and processing could affect their safety as human foods. The
FSIS Notice
published in the Federal Register on February 11, 2003, informed
firms that written notification should be sent to FSIS whenever an official
establishment plans to introduce a new technology (for examples see
Section II) into meat, poultry, or egg product
establishments.
Section IV. Notification Process
The written notification should describe the operation and purpose of the new
technology and contain the following information:
-
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.
Section V. Notification Review Process
The petitioner will be notified of the date on which its submission was
received by FSIS.
After reviewing a notification, FSIS will respond, usually within 60 days of
receipt, either that the Agency has concerns that need to be addressed before
use of the technology begins or has no objection to the use of the new
technology. FSIS´s review may be considered to be complete when either of
the following occurs:
- 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.
If FSIS sends a written no objection response, an establishment may proceed to use the new technology. If the establishment or plant proceeds with the use of a new technology before receiving a written no objection response from FSIS, it risks enforcement action affecting products produced using the new technology.
If FSIS determines that the new technology does affect the regulations, inspection procedures, or Federal inspection personnel safety, even after it sends a "no objection response," FSIS will act to halt the use of the new technology until appropriate use of the technology can be established, e.g., after receipt of a protocol.
Section VI. Protocols
An official establishment should submit a protocol to FSIS (see
page 3 for address) for any new technology (see
Section II for examples) intended for use in the slaughter or processing of
meat, poultry, or egg products if use of the new technology is expected to
affect inspection procedures or the safety of Federal inspection program
personnel, requires a change to the Agency´s regulations, or poses a need to
confirm, under commercial conditions, that use of the new technology will not
adversely affect the safety of the product.
Before conducting an in-plant trial of the new technology, the establishment
or plant should have a written protocol that has been reviewed by FSIS and that
clearly states the objectives and methods for conducting the in-plant trial and
when the trial will be completed.
FSIS regulations (specifically 9 CFR 303.1 (h), 381.3 (b), and 590.10) make provision for the administrator to waive for limited periods any provisions of the regulations to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements. No waiver can be granted if the new technology conflicts with the provisions of the Meat and Poultry Inspection Act (21 U.S.C. 601, et seq.), the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031, et seq.).
The duration of an in-plant trial should be limited to the time needed to validate the performance of the technology under commercial conditions. The data needed for such validation and the time needed to obtain it will vary. However, FSIS wishes to see in-plant trials completed as expeditiously as possible so that technologies that can improve food safety and public health are available and used as quickly as possible. FSIS expects that most in-plant trials should be completed within 6 – 12 months after the Agency grants authorization. Some may be able to be completed in a very short time. FSIS will review the progress of authorized in-plant trials that have not been completed within 12 months to see whether it should continue the authorizations. Continued authorization will be granted based on evidence of a timely start, adherence to the schedule in the protocol, and appropriate progress towards the purpose stated in the protocol. Firms will be notified in writing of FSIS´ intent to end authorization for an in-plant trial and will have the opportunity to show why the trial should not be terminated.
Section VII. Protocol Submission Process
The written protocol should contain, as applicable, the following information:
- 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:
-
how long will it take to address the purpose
that prompted the study
-
how long it will take to obtain data that are
representative of the conditions of use intended for the technology
-
how long it will take to obtain the data
needed to support a change in the regulations or inspection procedures
-
how long it will take to obtain representative data if the data must
reflect seasonal variations
-
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.
All changes in, or revisions of, an approved protocol must be approved by FSIS and maintained with the protocol.
Section VIII. Protocol Review Process
FSIS will designate a lead project contact person who will coordinate and
facilitate FSIS/industry activities.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.
Section XII. Voluntary Information Checklist for
Establishments Completing New Technology Protocols When the use of new technology requires a change in the Agency´s regulations, answering the following questions will assist FSIS in conducting regulatory analyses which are required for rulemaking. Answers provided to the last two questions on the checklist will help FSIS determine the extent of the paperwork burden imposed on industry by the new technology notification procedures.
-
What processes in your plant are utilizing the new
technology? [Examples: slaughter, cut up, further
processing, packaging]
-
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.
-
What are the anticipated benefits of the new technology to
your plant?
-
What are annual cost savings in terms of reduced labor,
energy, water, or other production input?
-
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.
-
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.
-
How long (in minutes) did it take to fill out the initial
new technology notification to FSIS?
-
How long (in minutes) did it take to put together the
protocol for an in-plant trial of the new technology?
Send to:
USDA, FSIS, OPPD, NTS
1400 Independence Ave., SW
Room 2932 South Building
Washington, DC 20250-3700
Revised Feb 2004
|