Supporting Law/Reg

§ 151.12

19 CFR Ch. I (4–1–02 Edition)

the importer a written request, on Customs Form 28, Request for Information, or other appropriate form, to submit the necessary samples or packages.
If the request is not promptly complied
with, the port director may make a demand under the bond for the return of
the necessary merchandise to Customs
custody in accordance with § 141.113 of
this chapter.
[T.D. 73–175, 38 FR 17470, July 2, 1973, as
amended by T.D. 75–152, 40 FR 27444, June 30,
1975; T.D. 84–213, 49 FR 41186, Oct. 19, 1984]

§ 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 §§ 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 labora-

tories 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 §§ 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.,
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

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United States Customs Service, Treasury
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)

§ 151.12
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;
(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;

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§ 151.12

19 CFR Ch. I (4–1–02 Edition)

(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,
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

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United States Customs Service, Treasury
(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

§ 151.12
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
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;

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§ 151.12

19 CFR Ch. I (4–1–02 Edition)

(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 deter-

mination 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
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

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United States Customs Service, Treasury
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.

§ 151.12
(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 Customsaccredited 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
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

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§ 151.12

19 CFR Ch. I (4–1–02 Edition)

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 Customsaccredited 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-oforigin.
(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-todate 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;
(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

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United States Customs Service, Treasury
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

§ 151.12
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
(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

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§ 151.12

19 CFR Ch. I (4–1–02 Edition)

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 Customsaccredited functions, and advise the
laboratory that it may choose to pur-

sue 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
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]

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