• Embed Doc
  • Copy Link
  • Readcast
  • Collections
  • CommentGo Back
Download
 
Federal Register
/ Vol. 68, No. 28 / Tuesday, February 11, 2003 / Notices
6873
DEPARTMENT OF AGRICULTUREFood Safety and Inspection Service
[Docket No. 00
 –
011N]
FSIS Procedures for Notification ofNew Technology
AGENCY
:
Food Safety and InspectionService, USDA.
ACTION
:
Notice.
SUMMARY
:
The Food Safety andInspection Service (FSIS) is announcingnew procedures for meat and poultryofficial establishments, egg productsofficial plants, and companies thatmanufacture and sell technology toofficial establishments and plants, tonotify the Agency of any newtechnology intended for use in officialestablishments and plants, so that theAgency has an opportunity to decidewhether the new technology requires apre-use review. If a new technologycould affect product safety, FSISregulations, inspection procedures, orthe safety of Federal inspection programpersonnel, FSIS will advise the firm thata pre-use review is necessary. TheAgency will cancel FSIS Directive10,700.1,
‘‘
Guidelines For Preparing andSubmitting Experimental Protocols forIn-Plant Trials of New Technologies andProcedures.
’’ ’’
Guidelines For PreparingExperimental Protocols for In-plantTrials of New Technologies andProcedures,
’’
and issue a reviseddirective. FSIS is requesting commentson these new procedures. The Agency believes that facilitation of the use of new technology represents an importantmeans of improving the safety of meat,poultry, and egg products.
DATES
:
This notice is effective February11, 2003. The Agency must receivecomments by April 14, 2003.
ADDRESSES
:
Submit one original andtwo copies of written comments withinthe scope of the rulemaking to the FSISDocket Room, Docket #00
–
011N, U.S.Department of Agriculture, Food Safetyand Inspection Service, Room 102,Cotton Annex, 300 12th Street, SW.,Washington, DC 20250
–
3700. Allcomments submitted in response to thisproposal will be available for publicinspection in the Docket Room Office between 8 a.m. and 4:30 p.m., Mondaythrough Friday, except Federal holidays.Guidance material for completingprotocols will be available on theInternet at
http://www.usda.gov 
and inthe Docket Room.
FOR FURTHER INFORMATION
:
For furtherinformation contact Charles Edwards,Director, Technology ProgramDevelopment Staff, Office of Policy,Program Development, and Evaluation,FSIS, U.S. Department of Agriculture,Room 112, Cotton Annex Building, 30012th Street, SW., Washington, DC20250
–
3700; telephone (202) 205
–
0675,fax (202) 205
–
0080.
SUPPLEMENTARY INFORMATION
:
Background
On May 25, 1995, FSIS published anotice in the
Federal Register
,
‘‘
Guidelines for Preparing andSubmitting Experimental Protocols forIn-Plant Trials of New Technologies andProcedures
’’
(60 FR 27714). This noticestated that the Agency is encouragingindustry technological innovation in themeat and poultry industry. At the sametime, FSIS established a single entrypoint for in-plant research protocols.With the issuance of the PathogenReduction/Hazard Analysis CriticalControl Point (HACCP) System finalrule (61 FR 38806) on July 25, 1996, theAgency shifted away from a commandand control approach to one that givesindustry greater flexibility to innovatein order to meet food safetyrequirements.On October 20, 1999, FSIS publishedthe Sanitation Requirements final rule(64 FR 56400), which was intended tomake sanitation requirements lessprescriptive and to allow for moreinnovation on the part of industry.New technologies have resulted insignificant improvements in the safetyof meat and poultry in recent years.Steam vacuums, steam pasteurization,and antimicrobials are all examples of advances in food safety technology thathave occurred in recent years. TheAgency is desirous of seeing these kindsof advances continue.Therefore, in the spirit of providingan opportunity for further technologicaladvances and innovations, FSIS isestablishing new, flexible procedures toactively encourage the development anduse of new technologies in meat andpoultry establishments and egg productsplants. These new procedures providefor a central location in the Agency tohandle new technology, instead of having program inspection personneladdress individual instances andquestions as they arise in establishmentsand plants. In addition, theseprocedures are designed to eliminateunnecessary delays and to establishuniform acceptance criteria to facilitatethe application of new technology. Byscreening the initial notifications of newtechnology, FSIS will eliminateunnecessary submissions of protocolsfor pre-use review. Consequently, theAgency is announcing its procedures forsubmitting notifications of newtechnologies by the meat, poultry, andegg products industries. FSIS will alsocancel FSIS Directive 10,700.1,
‘‘
Guidelines For Preparing ExperimentalProtocols for In-plant Trials of NewTechnologies and Procedures,
’’
andissue a revised directive to explain thesenew procedures to inspection programpersonnel.FSIS defines
‘‘
new technology
’’
asnew, or new applications of, equipment,substances, methods, processes, orprocedures affecting the slaughter of livestock and poultry or processing of meat, poultry, or egg products. TheAgency has a regulatory interest in anew technology if the new technologycould affect product safety, inspectionprocedures, or inspection programpersonnel safety, or if it would requirea waiver of a regulation. Substancesused as new technology must also meetthe requirements for safety andsuitability under the Agency
’
s foodingredient approval process. While FDAhas the responsibility for determiningthe safety of food ingredients andadditives, as well as prescribing safeconditions of use, FSIS has the authorityto determine that new ingredients andnew uses of ingredients are suitable foruse in meat and poultry products.
Notification
It is important that establishmentsand plants that are interested inintroducing new technology into theiroperations pursue the introduction in anappropriate manner. Failure to do so islikely to create delays in theintroduction of the new technology andinterruption in establishment or plantoperations. Consequently, firms that areinterested in using or selling a newtechnology should submitdocumentation to the FSIS TechnologyProgram Development Staff (see addressabove), describing the operation andpurpose of the new technology. Thedocument should explain whether whythe new technology will not:
•
adversely affect the safety of theproduct,
•
jeopardize the safety of Federalinspection program personnel, or
•
interfere with inspectionprocedures.The notification also should statewhether the technology will require awaiver of any Agency regulation and, if it will, identify the regulation andexplain why a waiver would beappropriate.FSIS will make every effort to reviewthe document and notify the firm within60 calendar days as to whether theAgency needs to review the newtechnology, or whether theestablishment, plant, or company mayproceed to use or sell it. If FSIS
 
6874
Federal Register
/ Vol. 68, No. 28 / Tuesday, February 11, 2003 / Notices
determines that the new technology willnot have any of the effects listed above,the Agency will issue a letter of noobjection to the use of the newtechnology to the firm.If the establishment or plant proceedswith the use of the new technology before the 60 day period has expired orwithout receiving a no objection noticefrom FSIS, then the Agency will takeappropriate action the productprocessed using the new technologycould be deemed to be adulterated (
see,e.g.
, 21 U.S.C. 453(g)(4); 601(m)(4); and1033(a)(4)).If FSIS determines that the proposeduse of the new technology couldadversely affect product safety, interferewith FSIS inspection procedures,jeopardize the safety of inspectionprogram personnel, or require a waiverof a regulation, then the Agency will soinform the firm. Following are twoexamples of new technologies thatcould adversely affect product safety,inspection procedures, inspectionprogram personnel safety, or Agencyregulations: A new technology thatchanged the line speeds for poultrywould require a waiver to theregulations for a limited time to test thenew technology (
see
9 CFR 381.67 and381.68). Devices capable of detectingand sorting contaminated carcassesmight also alter the method of carcasspresentation to inspection programpersonnel and thus probably requirechanges to current inspectionprocedures.FSIS will advise the establishment,plant, or company of the informationthat it needs for full pre-use review of the new technology, including whethera pre-use review of the new technology,including an in-plant trial of the newtechnology is necessary. An in-planttrial is necessary when the Agencyneeds data to perform a more informedreview of the new technology. If an in-plant trial is necessary, FSIS willrequest that the firm submit a protocolthat is designed to collect relevant datato support the use of the newtechnology.Firms that recognize that the use of their new technologyy will likely raisequestions about its effects on couldaffect product safety, the safety of inspection program personnel, orinspection procedures, or that recognizethat their new technology is notconsistent with FSIS the regulations,may simply contact FSIS aboutdeveloping information that the Agencywill need to make an informedjudgment on the new technology aprotocol instead of first submitting anotification.
Pre-Use Review and Protocol
The protocol should contain , asapplicable, the following information:
•
A descriptive title and statement of purpose for the in-plant trial.
•
The name of the sponsor and thename and address of the facility atwhich the trial is to be conducted.
•
A description of the experimentaldesign, including the methods forcontrol of bias.
•
Identification of the test subjectsand control articles.
•
The type and frequency of tests,analyses, and measurements to be made.
•
The records to be maintained.
•
A statement of the proposedstatistical methods to be used to analyzethe data that are to be generated in thestudy.
•
A time period for the in-plant trial.
•
Any applicable research data.
•
Any prior approvals from otherFederal agencies.All changes in, or revisions of, anapproved protocol must be approved byFSIS and be documented andmaintained with the protocol.If the in-plant trial requires a waiverof any provision of FSIS
’’
regulations,the submitter must request and obtainthe waiver receive written permissionfrom the Agency before proceeding.FSIS regulations (specifically 9 CFR303.1(h), 381.3(b), and 590.10) authorizethe Administrator to waive for limitedperiods any provisions of theregulations to permit experimentationso that new procedures, equipment, andprocessing techniques may be tested tofacilitate definite improvements. Nowaiver can be granted if the newtechnology conflicts with the provisionsof the Federal Meat Inspection Act (21U.S.C. 601,
et seq.
), the Poultry ProductsInspection Act (21 U.S.C. 451,
et seq.
),or the Egg Products Inspection Act (21U.S.C. 1031,
et seq.
).If, based on the in-plant trial, thesubmitter plans to petition FSIS for achange in the Agency
’
s regulations topermit the use of the new technology,then the submitter should collectinformation that will assist the Agencyin performing rulemaking analysesrequired by law and executive orders,such as Executive Order 12866 and theRegulatory Flexibility Act.FSIS will expect the submitter toprovide data throughout the duration of the in-plant trial for the Agency toexamine. Data may take several forms:laboratory results, weekly or monthlysummary production reports, and orevaluations from inspection programpersonnel. If, at any time, the Agencydetermines that the in-plant trial resultsin product being produced that presentsan increased risk to food safety or to thesafety of inspection program personnelsafety, the trial will be suspended orended.If requested by FSIS, the submittershould provide an orientation sessionfor employees of the establishment oneach shift before the start of each in-plant trial. The Agency reserves theright to review all data collected and toconduct on-site observations during anin-plant trial.At the conclusion of the in-plant trial,the establishment or plant will isexpected to submit a final report to theAgency and, if applicable, a petitionrequesting rulemaking to change thepertinent provisions of the regulations.See FSIS Notice,
‘‘
FSIS PetitionSubmission and Review Procedures
’’
(58 FR 63570), published December 2,1993. The Agency may extend the in-plant trial period pending action on thepetition.FSIS will review the final report onthe in-plant trial. The Agency
’
sevaluation of the final report couldresult in a decision to initiaterulemaking in response to a petition, arecommendation of additional in-planttrials, or either acceptance or rejection by FSIS of the use of the newtechnology.If the Agency rejects the use of thenew technology, the establishment orplant would have the option to submita revised protocol to address anyproblems areas identified by FSIS. TheAgency will then begin a new review of the revised protocol.FSIS is requesting comment on theseprocedures.
Paperwork Analysis
Abstract:
FSIS has reviewed thepaperwork and recordkeepingrequirements in this notice inaccordance with the PaperworkReduction Act and submitted aninformation collection request to theOffice of Management Budget foremergency clearance. FSIS is publishingprocedures for meat and poultry officialestablishments, egg products plants, andcompanies that manufacture and selltechnology to official establishments tonotify the Agency of new technologythat they propose to use in meat andpoultry establishments or egg productsplants.If the new technology could affectFSIS regulations, product safety,inspection procedures, or the safety of Federal inspection program personnel,then the establishment or plant wouldneed to submit a written protocol to theAgency. As part of this process, thesubmitter will have be expected toconduct in-plant trials of the new
of 00

Leave a Comment

You must be to leave a comment.
Submit
Characters: ...
You must be to leave a comment.
Submit
Characters: ...