[Federal Register: February 11, 2003 (Volume 68, Number 28)]
[Notices]               
[Page 6873-6875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe03-25]                         




[[Page 6873]]


-----------------------------------------------------------------------


DEPARTMENT OF AGRICULTURE


Food Safety and Inspection Service


[Docket No. 00-011N]


 
FSIS Procedures for Notification of New Technology


AGENCY: Food Safety and Inspection Service, USDA.


ACTION: Notice.


-----------------------------------------------------------------------


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
new procedures for meat and poultry official establishments, egg 
products official plants, and companies that manufacture and sell 
technology to official establishments and plants, to notify the Agency 
of any new technology intended for use in official establishments and 
plants, so that the Agency has an opportunity to decide whether the new 
technology requires a pre-use review. If a new technology could affect 
product safety, FSIS regulations, inspection procedures, or the safety 
of Federal inspection program personnel, FSIS will advise the firm that 
a pre-use review is necessary. The Agency will cancel FSIS Directive 
10,700.1, ``Guidelines For Preparing and Submitting Experimental 
Protocols for In-Plant Trials of New Technologies and Procedures.'' 
''Guidelines For Preparing Experimental Protocols for In-plant Trials 
of New Technologies and Procedures,'' and issue a revised directive. 
FSIS is requesting comments on these new procedures. The Agency 
believes that facilitation of the use of new technology represents an 
important means of improving the safety of meat, poultry, and egg 
products.


DATES: This notice is effective February 11, 2003. The Agency must 
receive comments by April 14, 2003.


ADDRESSES: Submit one original and two copies of written comments 
within the scope of the rulemaking to the FSIS Docket Room, Docket 
00-011N, U.S. Department of Agriculture, Food Safety and 
Inspection Service, Room 102, Cotton Annex, 300 12th Street, SW., 
Washington, DC 20250-3700. All comments submitted in response to this 
proposal will be available for public inspection in the Docket Room 
Office between 8 a.m. and 4:30 p.m., Monday through Friday, except 
Federal holidays. Guidance material for completing protocols will be 
available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.usda.gov and in the Docket 
Room.


FOR FURTHER INFORMATION: For further information contact Charles 
Edwards, Director, Technology Program Development Staff, Office of 
Policy, Program Development, and Evaluation, FSIS, U.S. Department of 
Agriculture, Room 112, Cotton Annex Building, 300 12th Street, SW., 
Washington, DC 20250-3700; telephone (202) 205-0675, fax (202) 205-
0080.


SUPPLEMENTARY INFORMATION:


Background


    On May 25, 1995, FSIS published a notice in the Federal Register, 
``Guidelines for Preparing and Submitting Experimental Protocols for 
In-Plant Trials of New Technologies and Procedures'' (60 FR 27714). 
This notice stated that the Agency is encouraging industry 
technological innovation in the meat and poultry industry. At the same 
time, FSIS established a single entry point for in-plant research 
protocols.
    With the issuance of the Pathogen Reduction/Hazard Analysis 
Critical Control Point (HACCP) System final rule (61 FR 38806) on July 
25, 1996, the Agency shifted away from a command and control approach 
to one that gives industry greater flexibility to innovate in order to 
meet food safety requirements.
    On October 20, 1999, FSIS published the Sanitation Requirements 
final rule (64 FR 56400), which was intended to make sanitation 
requirements less prescriptive and to allow for more innovation on the 
part of industry.
    New technologies have resulted in significant improvements in the 
safety of meat and poultry in recent years. Steam vacuums, steam 
pasteurization, and antimicrobials are all examples of advances in food 
safety technology that have occurred in recent years. The Agency is 
desirous of seeing these kinds of advances continue.
    Therefore, in the spirit of providing an opportunity for further 
technological advances and innovations, FSIS is establishing new, 
flexible procedures to actively encourage the development and use of 
new technologies in meat and poultry establishments and egg products 
plants. These new procedures provide for a central location in the 
Agency to handle new technology, instead of having program inspection 
personnel address individual instances and questions as they arise in 
establishments and plants. In addition, these procedures are designed 
to eliminate unnecessary delays and to establish uniform acceptance 
criteria to facilitate the application of new technology. By screening 
the initial notifications of new technology, FSIS will eliminate 
unnecessary submissions of protocols for pre-use review. Consequently, 
the Agency is announcing its procedures for submitting notifications of 
new technologies by the meat, poultry, and egg products industries. 
FSIS will also cancel FSIS Directive 10,700.1, ``Guidelines For 
Preparing Experimental Protocols for In-plant Trials of New 
Technologies and Procedures,'' and issue a revised directive to explain 
these new procedures to inspection program personnel.
    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. The Agency has a regulatory interest in a new technology 
if the new technology could affect product safety, inspection 
procedures, or inspection program personnel safety, or if it would 
require a waiver of a regulation. Substances used as new technology 
must also meet the requirements for safety and suitability under the 
Agency's food ingredient approval process. While FDA has the 
responsibility for determining the safety of food ingredients and 
additives, as well as prescribing safe conditions of use, FSIS has the 
authority to determine that new ingredients and new uses of ingredients 
are suitable for use in meat and poultry products.


Notification


    It is important that establishments and plants that are interested 
in introducing new technology into their operations 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. Consequently, firms 
that are interested in using or selling a new technology should submit 
documentation to the FSIS Technology Program Development Staff (see 
address above), describing the operation and purpose of the new 
technology. The document should explain whether why the new technology 
will not:
    [sbull] adversely affect the safety of the product,
    [sbull] jeopardize the safety of Federal inspection program 
personnel, or
    [sbull] interfere with inspection procedures.
    The notification also should state whether the technology will 
require a waiver of any Agency regulation and, if it will, identify the 
regulation and explain why a waiver would be appropriate.
    FSIS will make every effort to review the document and notify the 
firm within 60 calendar days as to whether the Agency needs to review 
the new technology, or whether the establishment, plant, or company may 
proceed to use or sell it. If FSIS


[[Page 6874]]


determines that the new technology will not have any of the effects 
listed above, the Agency will issue a letter of no objection to the use 
of the new technology to the firm.
    If the establishment or plant proceeds with the use of the new 
technology before the 60 day period has expired or without receiving a 
no objection notice from FSIS, then the Agency will take appropriate 
action the product processed using the new technology could be deemed 
to be adulterated (see, e.g., 21 U.S.C. 453(g)(4); 601(m)(4); and 
1033(a)(4)).
    If FSIS determines that the proposed 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, then the Agency will so inform the 
firm. Following are two examples of new technologies that could 
adversely affect product safety, inspection procedures, inspection 
program personnel safety, or Agency regulations: A new technology that 
changed the line speeds for poultry would require a waiver to the 
regulations for a limited time to test the new technology (see 9 CFR 
381.67 and 381.68). Devices capable of detecting and sorting 
contaminated carcasses might also alter the method of carcass 
presentation to inspection program personnel and thus probably require 
changes to current inspection procedures.
    FSIS will advise the establishment, plant, or company of the 
information that it needs for full pre-use review of the new 
technology, including whether a pre-use review of the new technology, 
including an in-plant trial of the new technology is necessary. An in-
plant trial is necessary when the Agency needs data to perform a more 
informed review of the new technology. If an in-plant trial is 
necessary, FSIS will request that the firm submit a protocol that is 
designed to collect relevant data to support the use of the new 
technology.
    Firms that recognize that the use of their new technologyy will 
likely raise questions about its effects on could affect product 
safety, the safety of inspection program personnel, or inspection 
procedures, or that recognize that their new technology is not 
consistent with FSIS the regulations, may simply contact FSIS about 
developing information that the Agency will need to make an informed 
judgment on the new technology a protocol instead of first submitting a 
notification.


Pre-Use Review and Protocol


    The protocol should contain , as applicable, the following 
information:
    [sbull] A descriptive title and statement of purpose for the in-
plant trial.
    [sbull] The name of the sponsor and the name and address of the 
facility at which the trial is to be conducted.
    [sbull] A description of the experimental design, including the 
methods for control of bias.
    [sbull] Identification of the test subjects and control articles.
    [sbull] The type and frequency of tests, analyses, and measurements 
to be made.
    [sbull] The records to be maintained.
    [sbull] A statement of the proposed statistical methods to be used 
to analyze the data that are to be generated in the study.
    [sbull] A time period for the in-plant trial.
    [sbull] Any applicable research data.
    [sbull] Any prior approvals from other Federal agencies.
    All changes in, or revisions of, an approved protocol must be 
approved by FSIS and be documented and maintained with the protocol.
    If the in-plant trial requires a waiver of any provision of FSIS'' 
regulations, the submitter must request and obtain the waiver receive 
written permission from the Agency before proceeding. FSIS regulations 
(specifically 9 CFR 303.1(h), 381.3(b), and 590.10) authorize 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 Federal Meat 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.).
    If, based on the in-plant trial, the submitter plans to petition 
FSIS for a change in the Agency's regulations to permit the use of the 
new technology, then the submitter should collect information that will 
assist the Agency in performing rulemaking analyses required by law and 
executive orders, such as Executive Order 12866 and the Regulatory 
Flexibility Act.
    FSIS will expect the submitter to provide data throughout the 
duration of the in-plant trial for the Agency to examine. Data may take 
several forms: laboratory results, weekly or monthly summary production 
reports, and or evaluations from inspection program personnel. If, at 
any time, the Agency determines that the in-plant trial results in 
product being produced that presents an increased risk to food safety 
or to the safety of inspection program personnel safety, the trial will 
be suspended or ended.
    If requested by FSIS, the submitter should provide an orientation 
session for employees of the establishment on each shift before the 
start of each in-plant trial. The Agency reserves the right to review 
all data collected and to conduct on-site observations during an in-
plant trial.
    At the conclusion of the in-plant trial, the establishment or plant 
will is expected to submit a final report to the Agency and, if 
applicable, a petition requesting rulemaking to change the pertinent 
provisions of the regulations. See FSIS Notice, ``FSIS Petition 
Submission and Review Procedures'' (58 FR 63570), published December 2, 
1993. The Agency may extend the in-plant trial period pending action on 
the petition.
    FSIS will review the final report on the in-plant trial. The 
Agency's evaluation of the final report could result in a decision to 
initiate rulemaking in response to a petition, a recommendation of 
additional in-plant trials, or either acceptance or rejection by FSIS 
of the use of the new technology.
    If the Agency rejects the use of the new technology, the 
establishment or plant would have the option to submit a revised 
protocol to address any problems areas identified by FSIS. The Agency 
will then begin a new review of the revised protocol.
    FSIS is requesting comment on these procedures.


Paperwork Analysis


    Abstract: FSIS has reviewed the paperwork and recordkeeping 
requirements in this notice in accordance with the Paperwork Reduction 
Act and submitted an information collection request to the Office of 
Management Budget for emergency clearance. FSIS is publishing 
procedures for meat and poultry official establishments, egg products 
plants, and companies that manufacture and sell technology to official 
establishments to notify the Agency of new technology that they propose 
to use in meat and poultry establishments or egg products plants.
    If the new technology could affect FSIS regulations, product 
safety, inspection procedures, or the safety of Federal inspection 
program personnel, then the establishment or plant would need to submit 
a written protocol to the Agency. As part of this process, the 
submitter will have be expected to conduct in-plant trials of the new


[[Page 6875]]


technology. The submitter will need to provide data to FSIS throughout 
the duration of the in-plant trial for the Agency to examine. Data may 
take several forms: laboratory results, weekly or monthly summary 
production reports, and evaluations from inspection program personnel.
    Estimate of Burden: FSIS estimates that it will take 8 hours for 
establishments to answer all of FSIS'' questions for the notification 
of intent to use new technologies. If the notification involves the 
submission of a protocol for FSIS approval, FSIS estimates that this 
will take an additional 80 hours for the submitter to develop. For in-
plant trials, FSIS estimates that the data collection and recordkeeping 
involved will take establishments 10 hours per week over an average of 
an 8-week (2-month) period.
    Respondents: Meat, Poultry and Egg Products establishments, 
equipment manufacturers.
    Estimated Number of Respondents: 250 requests for new technologies. 
40 requests for new technologies that require a protocol.
    Estimated Number of Responses per Respondent: 1.
    Estimated Total Annual Burden on Respondents: 5,440.
    Copies of this information collection assessment can be obtained 
from John O'Connell, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, Room 109 Cotton Annex, Washington, DC 20250-3700.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information will have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information including the validity of the method 
and the assumptions used; (c) ways to enhance the quality, utility, and 
clarity of the information to be collected; (d) ways to minimize the 
burden of the collection of information on those who are to respond; 
including through use of appropriate automated, electronic, mechanical, 
or other technological collection techniques or other forms of 
information technology. Comments may be sent to John O'Connell, see the 
address above, and to the Desk Officer for Agriculture, Office of 
Information and Regulatory Affairs, Office of Management and Budget 
(OMB) Washington, DC 20253.


Additional Public Notification


    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it and make copies of this Federal Register 
publication available through the FSIS Constituent Update. FSIS 
provides a weekly Constituent Update, which is communicated via 
Listserv, a free e-mail subscription service. In addition, the update 
is available on-line through the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov. 
The update is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, recalls, and any other types of information that could affect 
or would be of interest to our constituents/stakeholders. The 
constituent Listserv consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through the Listserv and web page, FSIS is able to provide 
information to a much broader, more diverse audience.
    For more information contact the Congressional and Public Affairs 
Office, at (202) 720-9113. To be added to the free e-mail subscription 
service (Listserv) go to the ``Constituent Update'' page on the 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/ oa/update/update.htm. Click on 
the ``Subscribe to the Constituent Update Listserv'' link, then fill 
out and submit the form.


    Done at Washington, DC, on: February 6, 2003.
Garry L. McKee,
Administrator.
[FR Doc. 03-3373 Filed 2-10-03; 8:45 am]