[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