96-14586. Import and Private Laboratory Communities: Public Meetings  

  • [Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
    [Notices]
    [Pages 29416-29418]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-14586]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    
    
    Import and Private Laboratory Communities: Public Meetings
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice of public meetings.
    
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    SUMMARY: The Food and Drug Administration's (FDA's) Office of 
    Regulatory Affairs (ORA) is announcing a series of Grassroots Meetings 
    to be held with the import and private laboratory communities. These 
    meetings will follow a prescribed format similar to what was used 
    recently in the Grassroots Regulatory Partnership Meetings held as part 
    of the National Performance Review and will be conducted by key agency 
    officials including ORA's Division of Field Science, the Division of 
    Import Operations and Policy, and other representatives from the field 
    and headquarters.
        The purpose of the meetings is to establish a dialogue with the 
    import, domestic, and private laboratory communities, trade 
    associations, and other interested persons. The intent of the dialogue 
    is to explore ways the agency might improve current policy and 
    procedures related to the use of private laboratories to establish 
    product compliance with FDA regulations. After the meetings a report 
    will be prepared outlining a strategy for making positive changes in 
    policy and/or procedures related to the agency's use of analytical data 
    from private laboratories.
    DATES: The public meetings are scheduled as follows:
    1.  Tuesday, June 25, 1996, 9 a.m. to 4:30 p.m., Brooklyn, NY.
    2.  Friday, June 28, 1996, 9 a.m. to 4:30 p.m., Orlando, FL.
    3.  Tuesday, July 9, 1996, 9 a.m. to 4:30 p.m., Houston, TX.
    4.  Thursday, July 11, 1996, 9 a.m. to 4:30 p.m., Oakland, CA.
    ADDRESSES: The public meetings will be held at the following locations:
    1. Brooklyn--Fort Hamilton Community Club, 101st St. and Fort Hamilton 
    Pkwy., Bldg. 207, Brooklyn, NY.
    2. Orlando--Sheraton Plaza Hotel, 1500 Sand Lake Rd., Orlando, FL.
    3. Houston--Houston Plaza Hilton, 6633 Travis St., Houston, TX.
    4. Oakland--Oakland Federal Bldg., Edward Royball Auditorium, 1301 Clay 
    St., Oakland, CA.
    FOR FURTHER INFORMATION CONTACT: 
        Regarding attendance at the Brooklyn, NY public meeting: George 
    Walden, Small Business Representative Northeast Region, 850 Third Ave., 
    Brooklyn, NY 11232, 718-965-5300, ext. 5528 or FAX 718-965-5759.
        Regarding attendance at the Orlando, FL public meeting: Barbara 
    Ward-Groves, Small Business Representative Southeast Region, 60 Eighth 
    St. NE., Atlanta, GA 30309, 404-347-4001, ext. 5256 or FAX 404-347-
    4349.
        Regarding attendance at the Houston, TX public meeting: Marie T. 
    Falcone, Small Business Representative Southwest Region, 7920 Elmbrook 
    Dr., suite 102, Dallas, TX 75247-4982, 214-655-8100, ext. 128 or FAX 
    214-655-8130.
        Regarding attendance at the Oakland, CA public meeting: Mark S. 
    Roh, Small Business Representative Pacific Region, Oakland Federal 
    Bldg., 1301 Clay St., suite 1180-N, Oakland, CA 94612-5217, 510-637-
    3980 or FAX 510-637-3977.
        In addition to this public notice of the meetings, invitations will 
    be sent directly to interested persons representing private 
    laboratories, importers, brokers, independent samplers, scientific and 
    trade associations, accreditation bodies, and domestic users of private 
    laboratories. -
        Interested persons who have not received an invitation to attend 
    one of these meetings by June 7, 1996, may contact the Small Business 
    Representatives specified above for registration forms.
        Persons who are unable to attend, or who cannot be accommodated due 
    to space limitations are invited to provide written comments. Written 
    comments may be submitted to Liza Lehman, Division of Field Science 
    (HFC-140), 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857. Issues 
    submitted in writing will be included for discussion at the meetings 
    and will appear in the final report.
        Questions related to these meetings should be directed to Richard 
    A. Baldwin or Liza Lehman (address above) or by calling 301-443-7103 
    between 8 a.m. and 4:30 p.m.
    SUPPLEMENTARY INFORMATION: The following background information is 
    provided for meeting participants. The term ``private laboratory'' 
    refers to those private sector laboratories that conduct analysis on 
    freely marketed, FDA regulated products whose analytical data is 
    submitted to the agency in order to demonstrate a product's compliance 
    with laws and regulations administered by FDA.
    Meeting Objectives
        (1) To establish a dialogue with the import, domestic, and private 
    laboratory communities; trade associations; and other interested 
    persons on ways the agency might improve current policy and procedures 
    related to the use of private laboratories to establish product 
    compliance with FDA laws and regulations.
        (2) To obtain information and views from interested persons on ways 
    the agency might enhance its use of private laboratories to facilitate 
    getting products that comply with applicable laws and regulations to 
    the consumer while removing non-compliant products from the 
    marketplace.
        The following workshops will be offered at each meeting:
    
    Workshop I
    
        Workshop I will focus on the following issues:
        (1) What practices, procedures, or policies should be changed so 
    that private sector testing expedites the removal of products that do 
    not comply with FDA laws and regulations and the distribution of 
    products that are fully compliant?
        (2) What is FDA's experience with how the current process works?
        (3) What needs to be changed about the current process?
        (4) Why and how?
    
    [[Page 29417]]
    
        (5) To what extent are training and education involved?
        (6) What are the training needs of private laboratories? -
        (7) How can FDA, industry, and private laboratories work together 
    to meet these training needs?
    Background for Workshop I
        FDA has long recognized the role of private laboratories in 
    evaluating the quality and safety of FDA regulated commodities produced 
    both domestically and abroad. Certificates of analysis (or analytical 
    data) issued (or generated) by private laboratories are sometimes used 
    by FDA to assist it in making regulatory decisions. This most often 
    occurs when Certificates of Analysis are received for products offered 
    for import to this country that have been detained without FDA 
    examination due to previous violations or when FDA is concerned about a 
    potential public health problem. FDA may also make compliance decisions 
    with the help of private laboratory results for domestic products that 
    have undergone reconditioning under the terms of a consent decree of 
    condemnation, or to comply with the terms of a consent decree of 
    permanent injunction, so that the firm may lawfully resume operations.
        FDA needs to ensure that private laboratories submitting analytical 
    results are capable of performing the analyses and that the results 
    submitted were obtained using reliable and appropriate methods. The 
    current guidance for the review of private laboratory results submitted 
    in support of regulated products is outlined in chapter 21 of the 
    Laboratory Procedures Manual (LPM). The stated purpose of this guidance 
    is to establish a uniform, systematic, and effective approach to ensure 
    that private laboratories conducting analyses on FDA regulated products 
    submit appropriate and reliable data to the agency. Based on LPM 
    chapter 21, the existing mechanism for FDA's acceptance of private 
    laboratory data involves the review of analytical data for scientific 
    validity along with the evaluation of a laboratory's capabilities 
    through assessment visits and audit sampling.
        In recent meetings with the private laboratory community, an issue 
    has been raised concerning the lack of uniformity among the FDA 
    District Offices (the Districts) in evaluating private laboratory 
    submissions. FDA is committed to attaining a uniform application of 
    policy and program guidelines among all Districts in the handling of 
    private laboratory submissions. Possible solutions FDA may consider 
    implementing to improve uniformity include: (1) The establishment of a 
    national data base on private laboratories to be used as a mechanism 
    for sharing information among the Districts (see Attachment); (2) 
    providing better coordination of assessment and review efforts through 
    training and strengthening the guidance provided to the Districts; and 
    (3) identifying other ways to foster communications among interested 
    parties involved in private laboratory issues.
        Another topic of discussion concerned the training needs of private 
    laboratories. FDA is often asked to answer questions related to sample 
    collection, analytical methodology, and the documentation needed to 
    demonstrate product compliance with FDA laws and regulations. As a 
    result of these inquiries, training seminars have been conducted for 
    private laboratories (and importers) on a variety of topics. Some of 
    these seminars have included training on the use of sample collection 
    and analysis techniques employed by FDA.
        FDA would like to better identify the training needs of private 
    laboratories. We would also like to explore mechanisms for effectively 
    providing any necessary training to private laboratories.
    
    Workshop II
    
        Workshop II will focus on the following issues:
        (1) How should FDA ensure the competency and proficiency of private 
    laboratories?
        (2) What should be FDA's guiding principles in ensuring the 
    competency and proficiency of private laboratories?
        (3) What criteria should FDA use to assess integrity and quality of 
    private sector sampling and analysis data?
        (4) Under what circumstances should FDA base public health 
    protection decisions on private sector sampling and analysis of 
    regulated products?
        (5) What are the barriers or hurdles to what FDA proposes? -
        (6) How do private laboratories demonstrate their competency to 
    their customers?
        (7) Is this mechanism appropriate for FDA to use?
    Background for Workshop II
        There are several mechanisms the agency could use to ensure the 
    proficiency and integrity of private sector sampling and analysis of 
    regulated products. They include options such as maintaining the 
    current program, adjusting the current program to focus on assuring a 
    more consistent agency approach, adding components to the current 
    program such as an independent sampling and direct reporting 
    requirement, seeking regulatory authority to inspect and impose Good 
    Laboratory Practices regulations on private laboratories, and formally 
    accrediting or recognizing third party accreditations of private 
    laboratories.
        FDA currently has serious concerns about the effectiveness of our 
    current program. We presently are unable to ensure the integrity of the 
    sample collection process because we do not require that all samples be 
    collected independently or by qualified sample collection agents. When 
    the sample is collected improperly, or is not truly representative of 
    the lot to be tested, then even the most reliable and effective 
    analytical testing procedures will be invalid. An additional concern 
    regarding our current procedures is that the analytical results 
    obtained by a private laboratory are not required to be submitted 
    directly to the agency for review. Because FDA does not require that an 
    initial or subsequent violative result be submitted directly from the 
    private laboratory, a violative product can be retested until results 
    are obtained that will remove the appearance of a violation. The 
    validity of this laboratory result is, of course, questionable based on 
    previous results, but FDA does not have the information concerning 
    earlier testing on which to base the appropriate consumer protection 
    decision. FDA is considering incorporating these two concepts of 
    mandatory independent sampling, and direct reporting of analytical 
    results by private laboratories to FDA into our current program.
    
    Workshop III
    
        Workshop III will focus on the following issues:
        (1) How can FDA best enhance its use of private laboratories to 
    test regulated products?
        (2) What is meeting participants' comfort level with shared 
    consumer protection authority and liability?
        (3) What are FDA and private sector common interests and how can we 
    capitalize on them?
        (4) What are our mutual responsibilities and to whom?
        (5) On what basis can FDA and the private sector collaborate?
    Background for Workshop
        FDA would like to enhance its use of the private sector in 
    monitoring imported foods and possibly other regulated products as 
    well. Several initiatives along this line have already been 
    implemented. For example, the
    
    [[Page 29418]]
    
    New York District recently completed a pilot program in which importers 
    of seafood products were allowed to choose between having their 
    products sampled and tested by FDA or by a private laboratory at their 
    own expense. A similar pilot program was conducted in Boston District. 
    The New York and Boston pilot programs are currently being evaluated to 
    see if further pilot studies can be developed to make better use of 
    non-FDA laboratories for monitoring imported products.
        Our intention is to improve our current policy and program 
    regarding the use of data from private laboratories. The existing 
    mechanism for the assessment of private laboratories and review of 
    analytical packages may be adequate for our current needs as we move to 
    enhance our use of the private sector for analytical testing, however, 
    we will likely find the need for a more streamlined and effective 
    approach to assessing the competency of a private laboratory and the 
    validity of its test results.
        Enhancing FDA's use of private laboratories may also be dependent 
    on the private sector's ability to comply with international standards. 
    As a result, another potential issue for discussion includes the 
    standards for analytical laboratories being developed by the joint Food 
    and Agriculture Organization of the United Nations and World Health 
    Organization's Codex Alimentarius Commission. At the 20th Session of 
    the Codex Committee on Methods of Analysis and Sampling (the 
    Committee), the Committee agreed that certain criteria for quality 
    assurance be adopted by laboratories involved in the official import 
    and export control of foods. The Committee recommendations include 
    compliance with the general criteria for testing laboratories laid down 
    in ISO/IEC Guide 25:1990, ``General Requirements for the Competence of 
    Calibration and Testing Laboratories,'' participation in appropriate 
    proficiency testing schemes, the use validated analytical methods, and 
    the application of internal quality control procedures. These criteria 
    have been referred to the Codex Committee on Food Import and Export 
    Inspection and Certification Systems for consideration and review to be 
    used for the development of objective criteria for assessing the 
    competency of laboratories involved in the testing of foods at the 
    international level. FDA is committed to using international standards 
    whenever appropriate, and to working with international standards 
    organizations like Codex to develop and adopt international standards 
    that provide adequate health protection.
        Because of the agency's commitment to international harmonization 
    efforts, the fact that the Committee has made these recommendations is 
    significant to FDA. Successful application of these criteria may be 
    viewed as providing a sound basis for judging the level of quality of 
    both public and private laboratories. Discussion of how (and if) FDA 
    should implement these criteria in evaluating the competency of private 
    laboratories may be included during this workshop.
    
    Attachment--Proposal for the Development of a National Data base on 
    Private Laboratories
    
        An internal FDA-wide private laboratory inventory will be 
    established. This data base is envisioned as being a repository of 
    basic information on private laboratories that routinely submit 
    analytical packages to the agency. The data base will be simple in 
    design serving mainly to foster communication between the Districts.
        The following guidance will be issued related to the use of the 
    private laboratory inventory (PLI):
        This data base contains information on certain private 
    laboratories that submit analytical results for review to the 
    agency. Private laboratories that do not routinely submit analytical 
    packages to the agency do not appear on this list, since creating a 
    directory of all private laboratories capable of analyzing regulated 
    products, including those laboratories that are associated with 
    regulated industry, or laboratories that have not submitted 
    analytical data for agency review, is not our intention.
        The information provided in the PLI is to be used only as a tool 
    to help District personnel make appropriate individual product 
    compliance decisions. The information is not intended to be used as 
    a final evaluation of the acceptability of results for the noted 
    types of analyses from a given private laboratory. As always, 
    Districts should make individual product compliance decisions based 
    on all information available regarding whether or not private 
    laboratory analyses are sufficient to demonstrate product 
    compliance.
    This data base may not be treated as an all inclusive listing of 
    private laboratories that are capable of submitting high quality 
    data or analytical results on regulated products to the agency.
        The following information will be included in the data base:
    Private Laboratory Data
    Private Laboratory Name
    Private Laboratory Contact/Phone
    Complete Mailing Address
    Home District Contact/Phone
    
    Submission Data
    Type(s) of analytical packages submitted (Chemistry, Micro, Filth, 
    etc)
    Date and type of analytical package submission (Date, product, 
    analysis type)
    Analysis results
    Audit sample results
    Narrative describing the audit sample results
    Analytical package review (Accepted, accepted with Comment, 
    Unacceptable)
    Analytical package review comments
    
    Private Laboratory Assessment Data
    Status of initial assessment records on file per analysis type 
    (complete, in process)
    Date of most recent on-site assessment visit per analysis type 
    (month/year)
    Narrative results of assessment visit(s) per analysis type.
    
        Dated: May 30, 1996.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 96-14586 Filed 6-7-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Published:
06/10/1996
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of public meetings.
Document Number:
96-14586
Dates:
The public meetings are scheduled as follows: 1. Tuesday, June 25, 1996, 9 a.m. to 4:30 p.m., Brooklyn, NY. 2. Friday, June 28, 1996, 9 a.m. to 4:30 p.m., Orlando, FL. 3. Tuesday, July 9, 1996, 9 a.m. to 4:30 p.m., Houston, TX. 4. Thursday, July 11, 1996, 9 a.m. to 4:30 p.m., Oakland, CA.
Pages:
29416-29418 (3 pages)
PDF File:
96-14586.pdf