[Code of Federal Regulations]

[Title 19, Volume 2]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 19CFR151.12]



[Page 172-181]

 

                        TITLE 19--CUSTOMS DUTIES

 

   CHAPTER I--BUREAU OF CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF 

        HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED)

 

PART 151_EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE--Table of 

Contents

 

                            Subpart A_General

 

Sec.  151.12  Accreditation of commercial laboratories.



    This section sets forth the requirements for commercial laboratories 

to obtain accreditation by Customs for the testing of certain 

commodities, and explains the operation of such accredited laboratories. 

This section also provides for the imposition of accreditation and 

reaccreditation fees, sets forth grounds for the suspension and 

revocation of accreditation, and provides for the imposition of a 

monetary penalty for an accredited commercial laboratory that fails to 

adhere to the provisions of this section.

    (a) Definitions. For purposes of this section, the following words 

and phrases have the meanings indicated:

    Analysis record. An ``analysis record'' is a compilation of all 

documents which have been generated during the course of analysis of a 

particular sample which, under normal circumstances, may include, both 

in paper and electronic-form, such documents as work sheets, notes, 

associated spectra (both spectra of the actual product and any standard 

spectra used for comparison), photographs and microphotographs, and the 

laboratory report.

    Assistant Commissioner. In Sec. Sec.  151.12 and 151.13, references 

to the ``Assistant Commissioner'' mean the Assistant Commissioner, 

Office of Field Operations, located in Washington, D.C.

    Check samples. ``Check samples'' are samples which have been 

distributed by Customs to accredited laboratories to test their 

proficiency in a certain area of accreditation.

    Commodity Group Brochure. A ``Commodity Group Brochure'' is a 

booklet which contains a listing of laboratory methods which commercial 

laboratories are required to have the capability to perform to qualify 

for Customs-accreditation in a particular commodity group. The brochures 

and the U.S. Customs Laboratory Methods Manual will specify the 

particular laboratory testing methods required for particular commodity 

groups, unless written permission from the Executive Director is given 

to use an alternate method. Procedures required by the Executive 

Director may reference applicable general industry testing standards, 

published by such organizations as the American Society for Testing and 

Materials (ASTM) and the American Petroleum Institute (API). Commodity 

Group Brochures and a listing of the methods found in the U.S. Customs 

Laboratory Methods Manual are available from the U.S. Customs Service, 

Attention: Executive Director, Laboratories and Scientific Services, 

Washington, D.C. 20229 and can also be found on the Customs Internet Web 

Site: www.customs.gov.

    Executive Director. In Sec. Sec.  151.12 and 151.13, references to 

the ``Executive Director'' mean the Executive Director, Laboratories and 

Scientific Services, located in Washington, D.C.

    (b) What is a ``Customs-accredited laboratory''? ``Commercial 

laboratories'' are individuals and commercial organizations that analyze 

merchandise, i.e.,



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determine its composition and/or characteristics, through laboratory 

analysis. A ``Customs-accredited laboratory'' is a commercial 

laboratory, within the United States, that has demonstrated, to the 

satisfaction of the Executive Director, pursuant to this section, the 

capability to perform analysis of certain commodities to determine 

elements relating to the admissibility, quantity, composition, or 

characteristics of imported merchandise. Customs accreditation extends 

only to the performance of such functions as are vested in, or delegated 

to, Customs.

    (c) What are the obligations of a Customs-accredited laboratory? A 

commercial laboratory accredited by Customs agrees to the following 

conditions and requirements:

    (1) To comply with the requirements of part 151, Customs Regulations 

(19 CFR part 151), and to conduct professional services in conformance 

with approved standards and procedures, including procedures which may 

be required by the Commissioner of Customs or the Executive Director;

    (2) To have no interest in or other connection with any business or 

other activity which might affect the unbiased performance of duties as 

a Customs-accredited laboratory. It is understood that this does not 

prohibit acceptance of the usual fees for professional services;

    (3) To maintain the ability, i.e., the instrumentation, equipment, 

qualified staff, facilities, etc., to perform the services for which the 

laboratory is accredited, and allow the Executive Director to evaluate 

that ability on a periodic basis by such means as on-site inspections, 

demonstrations of analysis procedures, reviews of submitted records, and 

proficiency testing through check samples;

    (4) To retain those laboratory records beyond the five-year record-

retention period and samples (see paragraph (j)(1) of this section) 

specified by Customs as necessary to address matters concerned in 

pending litigation, and, if laboratory operations or accreditation 

cease, to contact Customs immediately regarding the disposition of 

records/samples retained;

    (5) To promptly investigate any circumstance which might affect the 

accuracy of work performed as an accredited laboratory, to correct the 

situation immediately, and to notify both the port director and the 

Executive Director of such matters, their consequences, and any 

corrective action taken or that needs to be taken; and

    (6) To immediately notify both the port director and the Executive 

Director of any attempt to impede, influence, or coerce laboratory 

personnel in the performance of their duties, or of any decision to 

terminate laboratory operations or accredited status. Further, within 5 

days of any changes involving legal name, address, ownership, parent-

subsidiary relationships, bond, other offices or sites, or approved 

signatories to notify the Executive Director by certified mail.

    (d) What are the commodity groups for which accreditation may be 

sought? (1) Commercial laboratories may apply for accreditation to 

perform tests for any of the commodity groups listed in paragraph (d)(2) 

of this section. Applicable test procedures are listed in Commodity 

Group Brochures and the U.S. Customs Laboratory Methods Manual. 

Application may be made for accreditation in more than one commodity 

group. At the discretion of the Executive Director accreditation may be 

granted for subgroups of tests within a commodity group or for commodity 

groups not specifically enumerated. Once accredited, a Customs-

accredited laboratory may apply at any time to expand its accreditation, 

to add new testing sites, or increase the number of commodity groups or 

subgroups accredited.

    (2) The commodity groups for which accreditation may be sought 

without special permission from the Executive Director are:

    (i) Dairy and Chocolate Products entered under Chapters 4, 18, and 

21 of the Harmonized Tariff Schedule of the United States (HTSUS);

    (ii) Food and Food Products entered under Chapters 7-12, 15, 16, and 

19-21, HTSUS;

    (iii) Botanical Identification--materials and products entered under 

Chapters 14 and 44-46, HTSUS;



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    (iv) Sugar, Sugar Syrups, and Confectionery products entered under 

Chapter 17, HTSUS;

    (v) Spirituous Beverages entered under Chapter 22, HTSUS;

    (vi) Building Stone, Ceramics, Glassware, and Other Mineral 

Substances entered under Chapters 25 and 68-70, HTSUS;

    (vii) Inorganic Materials, including Inorganic Compounds and Ores, 

entered under Chapters 26, 28, 31, and 36-38, HTSUS;

    (viii) Petroleum and Petroleum Products entered under Chapters 27 

and 29, HTSUS;

    (ix) Organic Materials, including Intermediates and Pharmaceuticals, 

entered under Chapters 29, 30, 34, 35, and 38, HTSUS;

    (x) Rubber, Plastics, Polymers, Pigments and Paints entered under 

Chapters 32, 39, and 40, HTSUS;

    (xi) Essential Oils and Perfumes entered under Chapter 33, HTSUS;

    (xii) Leather and Articles of Leather entered under Chapters 41 and 

42, HTSUS;

    (xiii) Paper and Paper Products entered under Chapters 47-49, HTSUS;

    (xiv) Textiles and Related Products, including footwear and hats, 

entered under Chapters 50-67, HTSUS; and,

    (xv) Metals and Alloys entered under Chapters 72-83, HTSUS.

    (e) What are the approved methods of analysis? Customs-accredited 

laboratories must follow the general or specific testing methods set 

forth in Commodity Group Brochures and the U.S. Customs Laboratory 

Methods Manual in the testing of designated commodities, unless the 

Executive Director gives written permission to use an alternate method. 

Alternative methods will be considered and approved on a case-by-case 

basis.

    (f) How would a commercial laboratory become a Customs-accredited 

laboratory?--(1) What should an application contain? An application for 

Customs accreditation must contain the following information:

    (i) The applicant's legal name and the address of its principal 

place of business and any other facility out of which it will work;

    (ii) Detailed statements of ownership and any partnerships, parent-

subsidiary relationships, or affiliations with any other domestic or 

foreign organizations, including, but not limited to, importers, other 

commercial laboratories, producers, refiners, Customs brokers, or 

carriers;

    (iii) A statement of financial condition;

    (iv) If a corporation, a copy of the articles of incorporation and 

the names of all officers and directors;

    (v) The names, titles, and qualifications of each person who will be 

authorized to sign or approve analysis reports on behalf of the 

commercial laboratory;

    (vi) A complete description of the applicant's facilities, 

instruments, and equipment;

    (vii) An express agreement that if notified by Customs of pending 

accreditation to execute a bond in accordance with part 113, Customs 

Regulations (19 CFR part 113), and submit it to the Customs port nearest 

to the applicant's main office. (The limits of liability on the bond 

will be established by the Customs port in consultation with the 

Executive Director. In order to retain Customs accreditation, the 

laboratory must maintain an adequate bond, as determined by the port 

director);

    (viii) A listing of each commodity group for which accreditation is 

being sought and, if methods are being submitted for approval which are 

not specifically provided for in a Commodity Group Brochure and the U.S. 

Customs Laboratory Methods Manual, a listing of such methods;

    (ix) A listing by commodity group of each method according to its 

Customs Laboratory Method Number for which the laboratory is seeking 

accreditation;

    (x) An express agreement to be bound by the obligations contained in 

paragraph (c) of this section; and,

    (xi) A nonrefundable pre-payment equal to 50 percent of the fixed 

accreditation fee, as published in the Federal Register and Customs 

Bulletin, to cover preliminary processing costs. Further, the applicant 

agrees to pay Customs within 30 days of notification of preliminary 

accreditation the associated charges assessed for accreditation, i.e., 

those charges for actual travel and background investigation costs,



[[Page 175]]



and the balance of the fixed accreditation fee.

    (2) Where should an application be sent? A commercial laboratory 

seeking accreditation or an extension of an existing accreditation must 

send a letter of application to the U.S. Customs Service, Attention: 

Executive Director, Laboratories & Scientific Services, 1300 

Pennsylvania Ave., NW, Washington, D.C. 20229.

    (3) How will an application be reviewed?--(i) Physical plant and 

management system. The facility of the applicant will be inspected to 

ensure that it is properly equipped to perform the necessary tests and 

that staff personnel are capable of performing required tests. Customs 

evaluation of an applicant's professional abilities will be in 

accordance with the general criteria contained in either the American 

Society for Testing and Materials (ASTM) E548 (Standard Guide for 

General Criteria Used for Evaluating Laboratory Competence) or the ISO/

IEC Guide 25 (General Requirements for the Competence of Calibration and 

Testing Laboratories). This review will ascertain the laboratory's 

ability to manage and control the acquisition of technical data. The 

review will be performed at the time of initial application and upon 

reaccreditation at three-year intervals.

    (ii) Ability to perform tests on specified commodity groups. For 

each commodity group applied for, the applicant will undergo a separate 

review of testing capabilities. The specific accreditation will be based 

on the laboratory's ability to perform the tests required for that 

commodity group. This will include the qualifications of the technical 

personnel in this field and the instrument availability required by the 

test methods. Maintenance of accreditation will be ongoing and may 

require the submission of test results on periodic check samples. The 

criteria for acceptance will be based on the laboratory's ability to 

produce a work product that assists in the proper classification and 

entry of imported merchandise.

    (iii) Determination of competence. The Executive Director will 

determine the applicant's overall competence, independence, and 

character by conducting on-site inspections, which may include 

demonstrations by the applicant of analysis procedures and a review of 

analysis records submitted, and background investigations. The Executive 

Director may also conduct proficiency testing through check samples.

    (iv) Evaluation of technical and operational requirements. Customs 

will determine whether the following technical and operational 

requirements are met:

    (A) Equipment. The laboratory must be equipped with all of the 

instruments and equipment needed to conduct the tests for which it is 

accredited. The laboratory must ensure that all instruments and 

equipment are properly calibrated, checked, and maintained.

    (B) Facilities. The laboratory must have, at a minimum, adequate 

space, lighting, and environmental controls to ensure compliance with 

the conditions prescribed for appropriate test procedures.

    (C) Personnel. The laboratory must be staffed with persons having 

the necessary education, training, knowledge, and experience for their 

assigned functions (e.g., maintaining equipment, calibrating 

instruments, performing laboratory analyses, evaluating analytical 

results, and signing analysis reports on behalf of the laboratory). In 

general, each technical staff member should hold, at a minimum, a 

bachelor's degree in science or have two years related experience in an 

analytical laboratory.

    (g) How will an applicant be notified concerning accreditation?--(1) 

Notice of accreditation or nonselection. When Customs evaluation of a 

laboratory's credentials is completed, the Executive Director will 

notify the laboratory in writing of its preliminary accreditation or 

nonselection. (Final accreditation determinations will not be made until 

the applicant has satisfied all bond requirements and made payment on 

all assessed charges and the balance of the applicable accreditation 

fee). All final notices of accreditation, reaccreditation, or extension 

of existing Customs accreditation will be published in the Federal 

Register and Customs Bulletin.

    (2) Grounds for nonselection. The Executive Director may deny a 

laboratory's



[[Page 176]]



application for any of the following reasons:

    (i) The application contains false or misleading information 

concerning a material fact;

    (ii) The laboratory, a principal of the laboratory, or a person the 

Executive Director determines is exercising substantial ownership or 

control over the laboratory operation is indicted for, convicted of, or 

has committed acts which would:

    (A) Under United States federal or state law, constitute a felony or 

misdemeanor involving misstatements, fraud, or a theft-related offense; 

or

    (B) Reflect adversely on the business integrity of the applicant;

    (iii) A determination is made that the laboratory-applicant does not 

possess the technical capability, have adequate facilities, or 

management to perform the approved methods of analysis for Customs 

purposes;

    (iv) A determination is made that the laboratory has submitted false 

reports or statements concerning the sampling of merchandise, or that 

the applicant was subject to sanctions by state, local, or professional 

administrative bodies for such conduct;

    (v) Nonpayment of assessed charges and the balance of the fixed 

accreditation fee; or

    (vi) Failure to execute a bond in accordance with part 113 of this 

chapter.

    (3) Adverse accreditation decisions; appeal procedures--(i) 

Preliminary notice. A laboratory which is not selected for accreditation 

will be sent a preliminary notice of nonselection. The preliminary 

notice of nonselection will state the specific grounds for the proposed 

nonselection decision and advise the laboratory that it may file a 

response addressing the grounds for the action proposed with the 

Executive Director within 30 calendar days of the date the preliminary 

notice of nonselection was received by the laboratory.

    (ii) Final notice--(A) Based on nonresponse. If the laboratory does 

not respond to the preliminary notice, the Executive Director will issue 

a final notice of nonselection within 60 calendar days of the date the 

preliminary notice of nonselection was received by the laboratory 

applicant. The final notice of nonselection will state the specific 

grounds for the nonselection and advise the laboratory that it may 

choose to pursue one of the following two options:

    (1) Submit a new application for accreditation, in accordance with 

the provisions of paragraph (f)(1) of this section, 180 days after the 

date of the final notice of nonselection; or

    (2) Administratively appeal the final notice of nonselection to the 

Assistant Commissioner within 30 calendar days of the date of the final 

notice of nonselection.

    (B) Based on response. If the laboratory files a timely response, 

the Executive Director will issue a final determination regarding the 

laboratory's accreditation within 30 calendar days of the date the 

applicant's response is received by the Executive Director. If this 

final determination is adverse to the laboratory, then the final notice 

of nonselection will state the specific grounds for nonselection and 

advise the laboratory that it may choose to pursue one of the two 

options provided at paragraphs (g)(3)(ii)(A)(1) and (2) of this section.

    (iii) Appeal decision. The Assistant Commissioner will issue a 

decision on the appeal within 30 calendar days of the date the appeal is 

received. If the appeal decision is adverse to the laboratory, then the 

decision notice will advise the laboratory that it may choose to pursue 

one of the following two options:

    (A) Submit a new application for accreditation, in accordance with 

the provisions of paragraph (f)(1) of this section, 120 days after the 

date of the appeal decision; or

    (B) File an action with the Court of International Trade, pursuant 

to chapter 169 of title 28, United States Code, within 60 days of the 

date of the appeal decision.

    (h) What are the accreditation/reaccreditation fee requirements?--

(1) In general. A fixed fee, representing Customs administrative 

overhead expense, will be assessed for each application for 

accreditation or reaccreditation. In addition, associated assessments, 

representing the actual costs associated with travel and per diem of 

Customs



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employees related to verification of application criteria and background 

investigations will be charged. The combination of the fixed fee and 

associated assessments represent reimbursement to Customs for costs 

related to accreditation and reaccreditation. The fixed fee will be 

published in the Customs Bulletin and the Federal Register. Based on a 

review of the actual costs associated with the program, the fixed fee 

may be adjusted periodically; any changes will be published in the 

Customs Bulletin and the Federal Register.

    (i) Accreditation fees. A nonrefundable pre-payment equal to 50 

percent of the fixed accreditation fee to cover preliminary processing 

costs must accompany each application for accreditation. Before a 

laboratory will be accredited, it must remit to Customs, at the address 

specified in the billing, within the 30 day billing period, the 

associated charges assessed for the accreditation and the balance of the 

fixed accreditation fee.

    (ii) Reaccreditation fees. Before a laboratory will be reaccredited, 

it must submit to Customs, at the billing address specified, within the 

30 day billing period the fixed reaccreditation fee.

    (2) Disputes. In the event a laboratory disputes the charges 

assessed for travel and per diem costs associated with scheduled 

inspection visits, it may file an appeal within 30 calendar days of the 

date of the assessment with the Executive Director. The appeal letter 

must specify which charges are in dispute and provide such supporting 

documentation as may be available for each allegation. The Executive 

Director will make findings of fact concerning the merits of an appeal 

and communicate the agency decision to the laboratory in writing within 

30 calendar days of the date of the appeal.

    (i) Can existing Customs-accredited laboratories continue to 

operate? Commercial laboratories accredited by the Executive Director 

prior to December 8, 1993, will retain that accreditation under these 

regulations provided they conduct their business in a manner consistent 

with the administrative portions of this section. This paragraph does 

not pertain to any laboratory which has had its accreditation suspended 

or revoked. Laboratories which have had their accreditations continued 

under this section will have their status reevaluated on their next 

triennial inspection date which is no earlier than three years after the 

effective date of this regulation. At the time of reaccreditation, these 

laboratories must meet the requirements of this section and remit to 

Customs, at the address specified in the billing, within the 30 day 

billing period, the fixed reaccreditation fee. Failure to meet these 

requirements will result in revocation or suspension of the 

accreditation.

    (j) How will Customs-accredited laboratories operate?--(1) Samples 

for testing. Upon request by the importer of record of merchandise, the 

port director will release a representative sample of the merchandise 

for testing by a Customs-accredited laboratory at the expense of the 

importer. Under Customs supervision, the sample will be split into two 

essentially equal parts and given to the Customs-accredited laboratory. 

One portion of the sample may be used by the Customs-accredited 

laboratory for its testing. The other portion must be retained by the 

laboratory, under appropriate storage conditions, for Customs use, as 

necessary, unless Customs requires other specific procedures. Upon 

request, the sample portion reserved for Customs purposes must be 

surrendered to Customs.

    (i) Retention of non-perishable samples. Non-perishable samples 

reserved for Customs and sample remnants from any testing must be 

retained by the accredited laboratory for a period of four months from 

the date of the laboratory's final analysis report, unless other 

instructions are issued in writing by Customs. At the end of this 

retention time period, the accredited laboratory may dispose of the 

retained samples and sample remnants in a manner consistent with 

federal, state, and local statutes.

    (ii) Retention of perishable samples. Perishable samples reserved 

for Customs and sample remnants from any testing can be disposed of more 

expeditiously than provided for at paragraph (j)(1)(i) of this section, 

if done in accordance with acceptable laboratory



[[Page 178]]



procedures, unless other instructions are issued in writing by Customs.

    (2) Reports.--(i) Contents of reports. Testing data must be obtained 

using methods approved by the Executive Director. The testing results 

from a Customs-accredited laboratory that are submitted by an importer 

of record with respect to merchandise in an entry, in the absence of 

testing conducted by Customs laboratories, will be accepted by Customs, 

provided that the importer of record certifies that the sample tested 

was taken from the merchandise in the entry and the report establishes 

elements relating to the admissibility, quantity, composition, or 

characteristics of the merchandise entered, as required by law.

    (ii) Status of commercial reports where Customs also tests 

merchandise. Nothing in these regulations will preclude Customs from 

sampling and testing merchandise from a shipment which has been sampled 

and tested by a Customs-accredited laboratory at the request of an 

importer. In cases where a shipment has been analyzed by both Customs 

and a Customs-accredited laboratory, all Customs actions will be based 

upon the analysis provided by the Customs laboratory, unless the 

Executive Director advises otherwise. If Customs tests merchandise, it 

will release the results of its test to the importer of record or its 

agent upon request unless the testing information is proprietary to the 

holder of a copyright or patent, or developed by Customs for enforcement 

purposes.

    (3) Recordkeeping requirements. Customs-accredited laboratories must 

maintain records of the type normally kept in the ordinary course of 

business in accordance with the provisions of this chapter and any other 

applicable provision of law, and make them available during normal 

business hours for Customs inspection. In addition, these laboratories 

must maintain all records necessary to permit the evaluation and 

verification of all Customs-related work, including, as appropriate, 

those described below. All records must be maintained for five years, 

unless the laboratory is notified in writing by Customs that a longer 

retention time is necessary for particular records. Electronic data 

storage and transmission may be approved by Customs.

    (i) Sample records. Records for each sample tested for Customs 

purposes must be readily accessible and contain the following 

information:

    (A) A unique identifying number;

    (B) The date when the sample was received or taken;

    (C) The identity of the commodity (e.g., crude oil);

    (D) The name of the client;

    (E) The source of the sample (e.g., name of vessel, flight number of 

airline, name of individual taking the sample); and

    (F) If available, the Customs entry date, entry number, and port of 

entry and the names of the importer, exporter, manufacturer, and 

country-of-origin.

    (ii) Major equipment records. Records for each major piece of 

equipment or instrument (including analytical balances) used in Customs-

related work must identify the name and type of instrument, the 

manufacturer's name, the instrument's model and any serial numbers, and 

the occurrence of all servicing performed on the equipment or 

instrument, to include recalibration and any repair work, identifying 

who performed the service and when.

    (iii) Records of analytical procedures. The Customs-accredited 

laboratory must maintain complete and up-to-date copies of all approved 

analytical procedures, calibration methods, etc., and must document the 

procedures each staff member is authorized to perform. These procedures 

must be readily available to appropriate staff.

    (iv) Laboratory analysis records. The Customs-accredited laboratory 

must identify each analysis by sample record number (see paragraph 

(j)(3)(i) of this section) and must maintain all information or data 

(such as sample weights, temperatures, references to filed spectra, 

etc.) associated with each Customs-related laboratory analysis. Each 

analysis record must be dated and initialed or signed by the staff 

member(s) who did the work.

    (v) Laboratory analysis reports. Each laboratory analysis report 

submitted to Customs must include:

    (A) The name and address of the Customs-accredited laboratory;



[[Page 179]]



    (B) A description and identification of the sample, including its 

unique identifying number;

    (C) The designations of each analysis procedure used;

    (D) The analysis report itself (i.e., the pertinent characteristics 

of the sample);

    (E) The date of the report; and

    (F) The typed name and signature of the person accepting technical 

responsibility for the analysis report (i.e., an approved signatory).

    (4) Representation of Customs-accredited status. Commercial 

laboratories accredited by Customs must limit statements or wording 

regarding their accreditation to an accurate description of the tests 

for the commodity group(s) for which accreditation has been obtained. 

Use of terms other than those appearing in the notice of accreditation 

(see paragraph (g) of this section) is prohibited.

    (5) Subcontracting prohibited. Customs-accredited laboratories must 

not subcontract Customs-related analysis work to non Customs-accredited 

laboratories or non Customs-approved gaugers, but may subcontract to 

other facilities that are Customs-accredited/approved and in good 

standing.

    (k) How can a laboratory have its accreditation suspended or revoked 

or be required to pay a monetary penalty?--(1) Grounds for suspension, 

revocation, or assessment of a monetary penalty.--(i) In general. The 

Executive Director may immediately suspend or revoke a laboratory's 

accreditation only in cases where the laboratory's actions are 

intentional violations of any Customs law or when required by public 

health or safety. In other situations where the Executive Director has 

cause, the Executive Director will propose the suspension or revocation 

of a laboratory's accreditation or propose a monetary penalty and 

provide the laboratory with the opportunity to respond to the notice of 

proposed action.

    (ii) Specific grounds. A laboratory's accreditation may be suspended 

or revoked, or a monetary penalty may be assessed because:

    (A) The selection was obtained through fraud or the misstatement of 

a material fact by the laboratory;

    (B) The laboratory, a principal of the laboratory, or a person the 

port director determines is exercising substantial ownership or control 

over the laboratory operation is indicted for, convicted of, or has 

committed acts which would: under United States federal or state law, 

constitute a felony or misdemeanor involving misstatements, fraud, or a 

theft-related offense; or reflect adversely on the business integrity of 

the applicant. In the absence of an indictment, conviction, or other 

legal process, the port director must have probable cause to believe the 

proscribed acts occurred;

    (C) Staff laboratory personnel refuse or otherwise fail to follow 

any proper order of a Customs officer or any Customs order, rule, or 

regulation;

    (D) The laboratory fails to operate in accordance with the 

obligations of paragraph (c) of this section;

    (E) A determination is made that the laboratory is no longer 

technically or operationally proficient at performing the approved 

methods of analysis for Customs purposes;

    (F) The laboratory fails to remit to Customs, at the billing address 

specified, within the 30 day billing period the associated charges 

assessed for the accreditation and the balance of the fixed 

accreditation fee;

    (G) The laboratory fails to maintain its bond;

    (H) The laboratory fails to remit to Customs, at the billing address 

specified, within the 30 day billing period, the fixed reaccreditation 

fee; or

    (I) The laboratory fails to remit any monetary penalty assessed 

under this section.

    (iii) Assessment of monetary penalties. The assessment of a monetary 

penalty under this section, may be in lieu of, or in addition to, a 

suspension or revocation of accreditation under this section. The 

monetary penalty may not exceed $100,000 per violation and will be 

assessed and administered pursuant to published guidelines. Any monetary 

penalty under this section can be in addition to the recovery of:

    (A) Any loss of revenue, in cases where the laboratory intentionally 

falsified the analysis report in collusion with the importer, pursuant 

to 19 U.S.C. 1499(b)(1)(B)(i); or



[[Page 180]]



    (B) Liquidated damages assessed under the laboratory's Customs bond.

    (2) Notice of adverse action. When a decision to suspend or revoke 

accreditation, and/or assess a monetary penalty is made, the Executive 

Director will immediately notify the laboratory in writing, indicating 

whether the action is effective immediately or is proposed.

    (i) Immediate suspension or revocation. Where the suspension or 

revocation of accreditation is immediate, the Executive Director will 

issue a final notice of adverse determination. The final notice of 

adverse determination will state the specific grounds for the immediate 

suspension or revocation, direct the laboratory to cease performing any 

Customs-accredited functions, and advise the laboratory that it may 

choose to pursue one of the following two options:

    (A) Submit a new application for accreditation, in accordance with 

the provisions of paragraph (f)(1) of this section, 180 days after the 

date of the final notice of adverse determination; or

    (B) Administratively appeal the final notice of adverse 

determination to the Assistant Commissioner within 30 calendar days of 

the date of the final notice of adverse determination.

    (ii) Proposed suspension, revocation, or assessment of monetary 

penalty--(A) Preliminary notice. Where the suspension or revocation of 

accreditation, and/or the assessment of a monetary penalty is proposed, 

the Executive Director will issue a preliminary notice of proposed 

action. The preliminary notice of proposed action will state the 

specific grounds for the proposed action, inform the laboratory that it 

may continue to perform those functions requiring Customs-accreditation 

until the Executive Director's final notice is issued, and advise the 

laboratory that it may file a response addressing the grounds for the 

action proposed with the Executive Director within 30 calendar days of 

the date the preliminary notice of proposed action was received by the 

laboratory. The laboratory may respond by accepting responsibility, 

explaining extenuating circumstances, and/or providing rebuttal 

evidence. The laboratory also may ask for a meeting with the Executive 

Director or his designee to discuss the proposed action.

    (B) Final notice--(1) Based on nonresponse. If the laboratory does 

not respond to the preliminary notice of proposed action, the Executive 

Director will issue a final notice of adverse determination within 60 

calendar days of the date the preliminary notice of proposed action was 

received by the laboratory. The final notice of adverse determination 

will state the specific grounds for the adverse determination, direct 

the laboratory to cease performing any Customs-accredited functions, and 

advise the laboratory that it may choose to pursue one of the two 

options provided at paragraphs (k)(2)(i)(A) and (B) of this section.

    (2) Based on response. If the laboratory files a timely response, 

the Executive Director will issue a final determination regarding the 

status of the laboratory's accreditation within 30 calendar days of the 

date the laboratory's response is received by the Executive Director. If 

this final determination is adverse to the laboratory, then the final 

notice of adverse determination will state the specific grounds for the 

adverse action, advise the laboratory to cease performing any functions 

requiring Customs accreditation, and advise the laboratory that it may 

choose to pursue one of the two options provided at paragraphs 

(k)(2)(i)(A) and (B) of this section.

    (3) Publication of final notices of adverse determination. Any final 

notices of adverse determination issued by the Executive Director 

resulting in a laboratory being directed to cease performing Customs-

accredited functions will be published in the Federal Register and 

Customs Bulletin and the notice published will include the effective 

date, duration, and scope of the determination.

    (4) Appeal decision. The Assistant Commissioner will issue a 

decision on the appeal within 30 calendar days of the date the appeal is 

received. If the appeal decision is adverse to the laboratory, then the 

decision notice will advise the laboratory that it may choose to pursue 

one of the following two options:

    (i) Submit a new application for accreditation, in accordance with 

the



[[Page 181]]



provisions of paragraph (f)(1) of this section, 120 days after the date 

of the appeal decision; or

    (ii) File an action with the Court of International Trade, pursuant 

to chapter 169 of title 28, United States Code, within 60 days of the 

date of the appeal decision.



[T.D. 99-67, 64 FR 48534, Sept.7, 1999; T.D. 99-67, 65 FR 10009, 10010, 

Feb. 25, 2000]