[Federal Register Volume 69, Number 83 (Thursday, April 29, 2004)]
[Proposed Rules]
[Pages 23460-23473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 59
[Docket No. 2002N-0085]
RIN 0910-AB96
Requirements Pertaining to Sampling Services and Private
Laboratories Used in Connection With Imported Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing new
regulations for persons who use sampling services (services that
collect samples for another party) and private laboratories used in
connection with imported food. The proposal would require samples to be
properly identified, collected, and maintained. Additionally, the
proposal would require laboratories to use validated or recognized
analytical methods, and to submit analytical results directly to FDA.
The proposal is intended to help assure the integrity and scientific
validity of data and results submitted to FDA.
DATES: Submit written or electronic comments by July 28, 2004. Submit
written or electronic comments on the information collection provisions
by June 1, 2004. See section VIII of this document for the proposed
effective date of any final rule that may publish based on this
proposal.
ADDRESSES: You may submit comments, identified by Docket No. 2002N-
0085, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the
agency Web site.
E-mail: [email protected]. Include Docket
No. 2002N-0085 and RIN number 0910-AB96 in the subject line of your e-
mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or
CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name and
Docket No. or Regulatory Information Number (RIN) for this rulemaking.
All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, including any personal information
provided. For detailed instructions on submitting comments and
additional information on the rulemaking process, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
The Office of Management and Budget (OMB) is still experiencing
significant delays in the regular mail, including first class and
express mail, and messenger deliveries are not being accepted. To
ensure that comments on the information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Introduction
Persons who import food products into the United States often use
private laboratories to test their food imports and submit the results
of such tests to FDA. For example, FDA may refuse admission of an
imported food into the United States if the food appears to be
adulterated or misbranded in violation of the Federal Food, Drug, and
Cosmetic Act (the act). Pending a decision to refuse admission, the
owner or consignee of the imported article may wish to present evidence
to show that
[[Page 23461]]
the product does not violate the act or may wish to apply for
authorization to recondition the imported food to bring it into
compliance with the act. The owner or consignee may hire a sampling
service to collect statistically representative samples for testing and
hire a private laboratory to test the food. The private laboratory can
then run tests designed to show whether the imported food complies with
the act. The private laboratory would report the test results either to
the owner or consignee or to FDA directly. FDA, in turn, would evaluate
the analytical data to determine whether the imported food complies
with the act and can be released into the United States.
Thus, private laboratories can play an important role in
demonstrating that imported food products comply with laws and
regulations administered by FDA. In doing so, the private laboratories
help ensure that imported food products reaching consumers meet FDA
requirements and help prevent noncompliant or violative products from
entering the market. Additionally, when firms use private laboratories
that produce reliable test results, FDA's laboratory resources can be
devoted to other regulatory matters.
FDA estimates that importers have used over 100 separate private
laboratories to generate analytical data for submission to FDA. These
submissions go to FDA offices throughout the United States, and
questions have arisen regarding the coordination of FDA and private
laboratory services. In 1996, FDA held several ``grassroots'' meetings
in Brooklyn, NY, Orlando, FL, Houston, TX, and Oakland, CA, to discuss
how FDA might improve its policies and procedures relating to the use
of private laboratories and establish a uniform, systematic, and
effective approach to assure that private laboratories conducting tests
on FDA-regulated products submit scientifically sound data (see Food
and Drug Administration, ``Private Laboratory Grassroots Meetings
1996'' (available on the Internet at http://www.fda.gov, in the ``ORA''
section, ``Scientific References'' directory)). The grassroots meetings
resulted in an action plan which suggested, among other things, that
FDA:
1. Establish consistent, and objective national standards for the
format and content of analytical data that private laboratories submit
to FDA;
2. Require independent sampling so that FDA may be assured that
samples collected and tested by private laboratories are truly
representative of a lot or shipment and are collected properly to
ensure the integrity of any samples that were collected for testing;
and
3. Require private laboratories to report analytical results
directly to FDA to assure that the results are reported fairly. Even
though some participants supported reporting results to FDA directly,
other participants stated that sampling results should be sent to the
private laboratory's ``client'' first or that direct reporting to FDA
would not provide any assurance regarding the private laboratory's
competency.
The agency also indicated that it would consider how laboratory
accreditation might affect its relationship with private laboratories.
Participants at several meetings supported an accreditation concept,
but did not agree on the accreditation body. Some participants
suggested that FDA or other entities should establish an accreditation
process that complies with the International Organization for
Standardization (ISO)/International Electrochemical Commissioner (IEC)
Guide 58 (``Calibration and Testing Laboratory Accreditation Systems--
General Requirements for Operation and Recognition'') procedures.
Others suggested laboratories be accredited using ISO/IEC Guide 25
(``General Requirements for the Competence of Calibration and Testing
Laboratories''), which has since been replaced by ISO/IEC 17025,
``General Requirements for the Competence of Testing and Calibration
Laboratories''. FDA is aware of other ISO/IEC guides, such as ISO/IEC
Guide 61 (``General Requirements for the Assessment and Accreditation
of Certification/Registration Bodies'') that might be used. Other
participants mentioned using the National Environmental Laboratory
Accreditation Conference, using validation programs from the
Association of Official Analytical Chemists (AOAC), or having FDA set
up a separate accrediting system.
Additionally, in 1998, the Senate Governmental Affairs Committee's
Permanent Investigations Subcommittee held hearings on the safety of
food imports. The committee heard testimony about various methods used
to avoid food safety inspections and to introduce adulterated food into
the United States. These methods included substituting clean food
samples for the adulterated food import and testing multiple food
samples until a sample meets FDA's approval (see ``The Safety of Food
Imports: Fraud & Deception in the Food Import Process; Hearings Before
the Senate Committee on Governmental Affairs, Permanent Subcommittee on
Investigations,'' September 10, 1998 (statement of ``Former Customs
Broker''); see also ``The Safety of Food Imports; Hearings Before the
Senate Committee on Governmental Affairs, Permanent Subcommittee on
Investigations,'' May 14, 1998 (statement of Reggie Jang)).
On July 3, 1999, then-President Clinton issued a memorandum on the
safety of imported foods. The memorandum identified food safety as a
high priority and directed the Secretary of Health and Human Services
and the Secretary of the Treasury, among other things, to take all
actions available to ``set standards for private laboratories for the
collection and analysis of samples of imported food for the purpose of
gaining entry into the United States.'' Subsequently, FDA and the U.S.
Customs Service (Customs Service) held two public meetings on imported
food safety. These meetings, during which interested persons could
comment on the issues identified by FDA, including the private
laboratories initiative, were held on February 10, 2000, in Los
Angeles, CA, and on February 17, 2000, in Washington, DC. FDA addresses
comments from those meetings later in this document.
More recently, President Bush strongly supported efforts at FDA and
other health agencies to respond to and treat potential bioterrorism
attacks. The administration identified improving food safety,
particularly in relation to imported food, as a key goal.
In March 2003, the administration launched Operation Liberty
Shield, a comprehensive national plan designed to increase protections
for American citizens and infrastructure while maintaining the free
flow of goods and people across the nation's border with minimal
disruption to the economy and American way of life. One component of
Operation Liberty Shield involves increased food security, including
enhanced inspection of imported food. This proposed rule complements
efforts to enhance inspection of imported food by helping assure the
integrity and scientific validity of data and results submitted to FDA
concerning imported food. Furthermore, Homeland Security Presidential
Directive HSPD-9 directs Federal agencies to ``develop nationwide
laboratory networks for food, veterinary, plant health, and water
quality that integrate existing Federal and State laboratory resources,
are interconnected, and utilize standardized diagnostic protocols and
procedures.'' In developing the final rule, FDA will coordinate with
other Federal agencies to ensure that the protocols and procedures
required for private
[[Page 23462]]
laboratories fit appropriately within this framework.
This proposed rule would codify the requirements for sampling
services and private laboratories used in connection with imported
food. By doing so, the proposed rule would help deter the importation
of unsafe food.
II. Description of the Proposed Rule
The proposal would add in title 21 CFR a new part 59 entitled
``Requirements Pertaining to Sampling Services and Private Laboratories
Used in Connection With Imported Food.'' The proposal would create four
subparts. Subpart A of proposed part 59 would contain general
information, such as scope and definitions. Subpart B of proposed part
59 would describe the obligations of persons who use private
laboratories to submit data to FDA. Subpart C of proposed part 59 would
establish requirements for sampling services. Subpart D of proposed
part 59 would establish requirements for private laboratories.
A. Proposed Subpart A--General Information
1. Who Is Subject to This Part? (Proposed Sec. 59.1)
Proposed subpart A of part 59 would consist of two provisions.
Proposed Sec. 59.1 would describe the rule's scope and state that
proposed part 59 applies if you:
Use a sampling service to collect samples of an
imported food in connection with an FDA enforcement action; or
Use a private laboratory to collect, analyze, or
test samples of an imported food in connection with an FDA enforcement
action.
The proposal would explain that FDA enforcement actions would include,
but not be limited to, product seizure, refusal of imports, or the
issuance of an injunction.
You would also be subject to part 59 if you are a sampling service
or a private laboratory and you have been hired or retained to collect,
test, and/or analyze an imported food in connection with an FDA
enforcement action. For example, if you are a private laboratory, and
an importer wants you to test an imported food and to use your test
results to ask FDA to allow the imported food into the United States,
you would be subject to part 59. In contrast, if an importer wants you
to test an imported food to determine whether a food meets other
Federal requirements (i.e., requirements not administered by FDA or
standards that are not involved in an FDA enforcement action), part 59
would not apply to you because no FDA enforcement action is involved.
You should also note that, if you are a private laboratory that
collects its own samples in connection with an FDA enforcement action,
you would be subject to the requirements for sampling services, in
addition to the requirements for private laboratory analysis.
2. What Definitions Apply? (Proposed Sec. 59.3)
Proposed Sec. 59.3 would define three terms.
Proposed Sec. 59.3(a) would define FDA as the U.S. Food and Drug
Administration.
Proposed Sec. 59.3(b) would define ``private laboratory'' as an
independent person who analyzes or tests samples of imported food.
Please note that section 201(e) of the act (21 U.S.C. 321), in turn,
defines ``person'' as including individuals, partnerships,
corporations, and associations.
Proposed Sec. 59.3(c) would define a ``sampling service'' as an
independent person who collects samples of an imported food. The
definition would explain that sample collection may include collecting
samples from lots of imported food in conformance with FDA-recommended
sampling procedures and schedules (see, e.g., Food and Drug
Administration, Investigations Operations Manual, ch. 4--Sampling
(January 1999)).
As stated earlier, you should note that a private laboratory may
also be a ``sampling service'' if the private laboratory collects its
own samples for testing or analysis in connection with an FDA
enforcement action. In other words, a private laboratory that acts as a
sampling service would be subject to the requirements for sampling
services in addition to the requirements for private laboratories.
B. Proposed Subpart B--Requirements for Persons Using Private
Laboratories and Sampling Services in Connection With Imported Food
Proposed subpart B of part 59 would describe the requirements for
persons who use private laboratories and sampling services in
connection with imported food.
1. What Requirements Apply if You Use Sampling Services? (Proposed
Sec. 59.101)
Under proposed Sec. 59.101, if you intend to use a sampling
service to collect samples of an imported food in connection with an
FDA enforcement action, you must:
Notify the FDA district office that is reviewing
the entry of the imported food of your intent to use a sampling
service. Your notification must include the name and address for each
sampling service you intend to use, each sampling service's
qualifications and knowledge of sampling procedures, a primary contact
(name and phone number) for each sampling service, the address where
the sampling records will be maintained, and the reason(s) why the food
is being sampled;
Give to each sampling service the Customs
Service entry number, FDA entry line number (if applicable or
available), the location of the lot that will be sampled, sufficient
information to identify the lot to be sampled, and the name and address
of the private laboratory that will test the sample;
Not influence or interfere with the manner and
process in which samples are collected. For example, you should not
prevent the sampling service from collecting the samples itself,
dictate how samples are collected, or restrict the sampling service's
ability to obtain a representative sample from the imported food; and
Maintain control of the lot from which the
sample was taken until FDA notifies you that you can release the lot or
take other action on the lot.
2. What Requirements Apply if You Use Private Laboratories? (Proposed
Sec. 59.103)
Under proposed Sec. 59.103, if you use a private laboratory to
test or analyze samples of an imported food in connection with an FDA
enforcement action, you must:
Notify the FDA district office that is reviewing
the entry of the imported food of your intent to use a private
laboratory and to have the private laboratory submit the results and
supporting data to FDA. Your notification must include the private
laboratory's name and address, its qualifications, a primary contact
(name and phone number), the address where the test will be conducted
(if different from the private laboratory's address), and the reason(s)
why the product is being tested or analyzed;
If the private laboratory will obtain the sample
for testing, give to the private laboratory the Customs Service entry
number and FDA entry line number (if applicable or available);
Not influence or interfere with the manner and
process in which samples are tested and/or analyzed. For example, you
should not tell the private laboratory how it should test the samples
or which piece of equipment to use;
Maintain control of the lot from which the
sample was taken until FDA
[[Page 23463]]
notifies you that you can release the lot or take other action on the
lot; and
If more than one private laboratory is or will
be conducting tests, notify all private laboratories involved and FDA.
The notice must state how many private laboratories are conducting or
will conduct tests or analyses and describe those tests or analyses.
Proposed Sec. Sec. 59.101 and 59.103 are intended to notify FDA
about any sampling service or private laboratory that will be used in
connection with an imported food and to enable those parties to perform
their tasks effectively and independently. They are also intended to
deter manipulation, alteration, or substitution of the samples that a
private laboratory will test or selective reporting of a private
laboratory's results. A 1998 Senate hearing on the safety of food
imports noted these types of abuse when a former customs broker
testified that some unscrupulous importers attempt to deceive FDA by
selecting samples that may not be from the correct shipment or by
submitting multiple samples to a private laboratory for testing until
they obtain a sample that will comply with the act and reporting only
the successful test (see ``The Safety of Food Imports: Fraud &
Deception in the Food Import Process; Hearings Before the Senate
Committee on Governmental Affairs, Permanent Subcommittee on
Investigations,'' September 10, 1998 (statement of ``Former Customs
Broker'')).
FDA considered whether to require all importers who analyze their
products to use independent sampling services. Such a requirement could
help ensure that samples are not manipulated, altered, or substituted
during the sampling process, but could be unfair to those importers who
sample their own imported food in a legitimate manner. FDA, therefore,
invites comment on whether this rule should require the use of
independent sampling services.
3. What Requirements Apply if You Collect Your Own Samples? (Proposed
Sec. 59.105)
Proposed Sec. 59.105 would apply if you collect samples of your
own imported food and intend to have them tested or analyzed in
connection with an FDA enforcement action. In brief, the proposal would
require you to adhere to the same requirements that a sampling service
must observe. The requirements for sampling services, which are
described in more detail in the following discussion of proposed Sec.
59.201, are intended to ensure that samples are correctly identified,
collected, and maintained. These requirements also should help deter
unscrupulous food importers from attempting to manipulate samples or to
substitute foods that are known to be in compliance with the act for a
possibly adulterated or misbranded imported food.
C. Proposed Subpart C--Requirements for Sampling Services
What Are the Requirements for Collecting, Identifying, and Maintaining
Samples? (Proposed Sec. 59.201)
Proposed subpart C of part 59 would describe the requirements for
sampling services. In brief, if you are a sampling service who is
subject to the rule, proposed Sec. 59.201(a) would require you to
perform the following operations independently:
Verify the location, identity, and size of the
lot to be sampled;
Collect samples following established procedures
that ensure the sample's integrity, accuracy, and representational
nature;
Ensure the integrity of the sample after the
sample is collected. You can do this by including proper identification
to avoid mixups between samples, avoiding contamination of the sample
and the lot to be sampled, maintaining sterility or appropriate
temperatures, or taking other measures to protect the sample's
integrity;
Identify all containers from which samples are
collected. You can do this by placing the FDA entry line number or
Customs Service entry number on the sample container that is to be
shipped to the private laboratory and also by identifying the container
from which the sample was collected;
Complete a sample collection report for each
sample collected. The proposal would require that the sample collection
report, at a minimum, document sample collection methods and sample
preparation techniques; and
Prepare and ship the sample, using precautions
where necessary to prevent contamination, to maintain the sample's
integrity, or to maintain sterility or appropriate temperatures, and
ship the original sample collection report directly to the private
laboratory.
These provisions are intended to ensure that you properly collect,
identify, and maintain samples from the time you collect the sample
until the time you deliver the sample to a private laboratory.
Additionally, by using the word ``independently,'' the proposed rule
would have you perform these sampling operations without interference
from or assistance by the person who retained your services. If you are
collecting samples and are employed by the person who owns or imported
the food (as allowed by proposed Sec. 59.105), the word
``independently'' indicates that you should perform the sampling
operations free from coercion or undue interference from your employer.
For example, you should determine how samples are to be collected, the
methods to be employed, and the quantity to be collected; your employer
should not dictate how you will collect samples or provide the samples
to you.
If you are a sampling service who is subject to the rule, proposed
Sec. 59.201(b) would require you to retain records documenting your
compliance with proposed Sec. 59.201(a). These records would include
documents showing how you identified, collected, and maintained the
sample. You may choose either to follow an FDA procedure for sampling,
for example, those published in FDA's investigations operations manual,
or any other applicable procedure that ensures the integrity, accuracy,
and representational nature of the sample. If you collect samples under
an established, non-FDA procedure, the proposal would require you to
retain records concerning that procedure. You could do this either by
retaining the procedure itself or records referring to the specific
procedure if the procedure is publicly available. If you collect
samples under an FDA sampling procedure, you can omit the FDA sampling
procedure from your records, but you should keep notes to show which
FDA sampling procedure you used. The proposal would require you to
retain these records for 3 years after you have sent the sample
collection report to the private laboratory and to make the records
available to FDA, upon request, for inspection and copying.
D. Proposed Subpart D--Requirements for Private Laboratories
Proposed subpart D of part 59 would pertain to private laboratories
and would consist of two provisions.
In drafting this proposed rule, FDA carefully considered whether to
require private laboratories subject to proposed part 59 to be
accredited. Accreditation would show that the private laboratory is
competent to perform specific tasks, but would not, by itself,
guarantee that a private laboratory's test or analytical results are
correct or that it performed the tests or analyses correctly.
Nevertheless, accreditation could increase confidence in the private
laboratory's results.
The agency also considered whether the accreditation would have to
operate in conformance with ISO/IEC 17025 or
[[Page 23464]]
with any other specific standard. Both FDA and the Customs Service
heard comments at the public meetings that supported requiring
accreditation of private laboratories, but some comments wanted less
FDA oversight or fewer FDA inspections in exchange for accreditation.
FDA also examined accreditation costs and the time required to go
through an accreditation process.
Given these considerations, FDA decided to omit a laboratory
accreditation requirement from the proposed rule. While the agency
strongly encourages laboratories to become accredited, questions about
the accreditation standard to be used, how FDA would ensure that the
accrediting body is a recognized or competent accrediting body, and
other issues suggest that it would be premature for FDA to propose
requiring private laboratories to be accredited. The agency invites
comment on this subject.
1. What Requirements Pertain to Analyzing Samples, Preparing Analytical
Reports, and Maintaining Records? (Proposed Sec. 59.301)
If you are a private laboratory subject to the rule, proposed Sec.
59.301 would require you to observe certain requirements when handling
or testing samples, preparing analytical reports, or maintaining
records. In brief, proposed Sec. 59.301(a) would require you to:
Verify that the sample received corresponds to
the sample described on the sample collection report. You can do this
by identifying the sample by the Customs Service entry number and FDA
entry line number (if applicable or available) or other appropriate
identifying information in the sample collection report, and by
documenting the conditions under which the sample was received (e.g.,
measures taken to prevent contamination, to maintain the integrity of
the sample, or to maintain sterility or appropriate temperatures);
Confirm the reasons for analyzing the sample;
Use appropriately validated or recognized
analytical procedures to analyze the sample, including the creation and
maintenance of a reserve portion of a composite sample; and
Prepare an analytical report for submission with
the original sample collection report and complete analytical package.
The proposal would require the analytical package to: (1) Describe the
analytical methods used, (2) include an original compilation of all
data and corresponding quality control results supporting the test, (3)
include reagent blank and spike recovery data, (4) describe
instrumental conditions and parameters, (5) include the analysts'
signatures, and (6) include calculations. The proposal would also
require the analytical report to contain a certificate of analysis.
Proposed Sec. 59.301(b) would require you to provide, as part of
your analytical package, an affidavit stating that:
The analytical package pertains to the only
test(s) done on the lot or product and that you are not aware of any
other tests being performed on the lot; or
If you are aware of other tests being performed
by other persons, the name and address of the person conducting the
other tests. FDA is not proposing to require you to investigate whether
other persons are conducting tests; you would only provide this
information if you are aware of other tests being performed by other
persons.
Proposed Sec. 59.301(c) would require you to submit the analytical
package and the original sample collection report to the FDA district
office that is reviewing the entry of the imported food. Additionally,
it would require you to maintain records relating to proposed Sec.
59.301 for 3 years after you submitted the analytical package and
original sample collection report to FDA, and, upon request, to make
records available to FDA for inspection and copying.
These provisions are intended to ensure that, if you submit
analytical packages to FDA, you have analyzed the correct sample, used
appropriate analytical or testing methods, and acted independently.
Furthermore, by requiring you to send the analytical package and sample
collection report directly to FDA, the proposal would increase the
agency's confidence that the analytical package accurately represents
the private laboratory's findings. FDA notes that the proposal would
not preclude you from sending a duplicate copy of the analytical
package to the person who retained your services. FDA is leaving these
arrangements up to you and those who retain your services.
2. What Are the Requirements for Private Laboratories Collecting
Samples? (Proposed Sec. 59.303)
FDA recognizes that many private laboratories may prefer to collect
samples themselves. Thus, to ensure that these private laboratories
observe the same requirements that would be placed on sampling
services, proposed Sec. 59.303 would state that, if you are a private
laboratory who collects samples of imported food in connection with an
FDA enforcement action, you must comply with the sampling service
requirements contained in proposed subpart C (``Requirements for
Sampling Services'').
III. Public Meeting Comments and Responses
As stated earlier, FDA and the Customs Service held two public
meetings on February 10, 2000, in Los Angeles, CA, and on February 17,
2000, in Washington, DC, to discuss issues related to the safety of
imported food. Several comments focused on the private laboratories
issue. Those comments and FDA's responses are addressed in this
section. To make it easier to identify comments and FDA's responses to
the comments, the word ``Comment'' will appear before the description
of the comment, and the word ``Response'' will appear before FDA's
response. FDA also has numbered each comment to make it easier to
identify a particular comment. The numerical value assigned to each
comment is purely for organizational purposes and does not signify the
comment's value or importance or the order in which it was submitted.
(Comment 1) Some comments said that FDA should expand the rule to
cover all private laboratories dealing with any FDA-regulated product
instead of limiting the rule to private laboratories involved with
imported food.
(Response) While the concepts and principles expressed in the
proposed rule may be relevant to private laboratories dealing with FDA-
regulated products other than imported food products, FDA has elected
to focus on private laboratories involved with imported food. This
focus corresponds to concerns regarding the safety of imported food.
Additionally, FDA is not aware of any significant problems associated
with private laboratories that test or analyze other FDA-regulated
products other than imported food products.
(Comment 2) Several comments stated that, if FDA intends to
regulate private laboratories and to require laboratory accreditation,
FDA should accept the results from those laboratories and either reduce
(if not eliminate) its oversight of private laboratories or let those
private laboratories act in FDA's place. Some comments argued that
private laboratories are able to conduct tests more quickly than FDA's
laboratories and reach results that are as good as, if not superior to,
FDA's laboratory results.
(Response) The proposed rule does not require laboratories to be
accredited. FDA also declines to draft the rule to allow private
laboratories to act in FDA's place. Under section 801 of the
[[Page 23465]]
act (21 U.S.C. 381), FDA, rather than the importer or a private
laboratory retained by the importer, has the responsibility for
deciding whether an imported article complies with the act.
(Comment 3) One comment urged FDA to accredit private laboratories
itself. The comment stated that only FDA has the necessary experience
to judge the adequacy of private laboratory facilities and the
competency of their analysts. The comment asked FDA to publish
accreditation requirements and create an appeals process, but also said
that FDA must absorb accreditation costs itself in order to avoid any
burden on small businesses. The comment said a ``user fee'' on all FDA-
regulated imports could defray FDA's accreditation costs.
(Response) FDA lacks explicit statutory authority to impose ``user
fees'' for this purpose and also lacks the resources that would be
necessary to implement and operate an accreditation program for private
laboratories. Consequently, FDA declines to adopt the comment's
suggestions.
(Comment 4) Some comments asked FDA to ``accredit,'' ``approve,''
or license sampling services. The comments explained that private
laboratories should not be held accountable for samples collected by
other parties and that the reliability of a private laboratory's
results depends largely on the sample being tested. A few comments said
that FDA should charge sampling services as part of any accreditation,
approval, or licensing program. Other comments suggested that some
entity (not necessarily FDA) accredit sampling services.
(Response) FDA recognizes the value in ensuring that sampling
services are capable of performing their tasks in a competent manner.
However, FDA is unaware of any accreditation system for sampling
services, and resource limitations prevent FDA from ``approving'' or
licensing sampling services itself or establishing an accreditation,
approval, or licensing system for private laboratories.
(Comment 5) One comment sought a governmentwide certification
process so that laboratory results would be accepted by all Federal
Government agencies. The comment noted that other Federal agencies have
certification programs and receive fees for such certifications.
(Response) The proposed rule focuses on importers, sampling
services, and private laboratories involved with imported food. A
broader initiative would require input across a broad range of
agencies. A need for the broader initiative has not yet been
demonstrated. The issue of a governmentwide certification program is
outside the scope of this proposed rule.
(Comment 6) One comment argued that requiring importers to notify
FDA if they intend to use a sampling service or a private laboratory
has no benefit. Another comment mistakenly construed the notice as
requiring FDA approval before a sampling service or private laboratory
began work.
(Response) The notices to FDA in proposed Sec. Sec. 59.101 and
59.103 are supposed to alert FDA that an importer intends to use a
sampling service or a private laboratory in connection with an imported
food. It would also enable FDA to check whether the sampling services
and private laboratories identified in the notices are, in fact, the
same sampling services and private laboratories that collect or test
the samples. For example, if an importer notifies FDA that it intends
to use private laboratories A, B, and C, but private laboratory X
submits the analytical package to FDA, FDA may decide to look into the
reasons why the importer used a different laboratory.
No prior FDA approval is necessary before the sampling service or
private laboratory may begin work. The agency does not have the
resources that would be needed for such an approval system and related
matters (such as resolving disputes if the agency decided to not
approve a particular sampling service or private laboratory).
(Comment 7) Several comments urged FDA to treat perishable goods
differently from other food products. The comments said that delays in
admitting perishable goods into the United States reduced their value
or their potential value if FDA ultimately refuses admission. Another
comment added that some goods have seasonal values so that their value
rises or falls over time.
(Response) The proposed rule has no direct bearing on how quickly
perishable or seasonal goods are sampled or analyzed or how they are
admitted or refused admission into the United States. Consequently, the
proposal treats all imported foods alike.
IV. Legal Authority
Several provisions of the act provide the legal authority for the
proposed rule. In brief, section 402 of the act (21 U.S.C. 342) defines
when a food is deemed adulterated, and section 403 of the act (21
U.S.C. 343) defines when a food is deemed misbranded. The act prohibits
a number of actions concerning adulterated or misbranded food,
including the introduction or delivery for introduction into interstate
commerce of any adulterated or misbranded food. (See section 301 of the
act (21 U.S.C. 331).) The act does, however, allow owners or consignees
of imported products to seek FDA's permission to take actions to bring
an otherwise violative imported food into compliance with the act. (See
section 801(b) of the act (21 U.S.C. 381(b).)
The act also authorizes FDA to take various enforcement actions
such as injunctions (see section 302 of the act (21 U.S.C. 332)), and
seizures (see section 304 of the act (21 U.S.C. 334)).
To enforce these and other provisions of the act, the act
authorizes FDA to conduct examinations and investigations (see section
702 of the act (21 U.S.C. 372)), to conduct factory inspections (see
sections 704 and 706 of the act (21 U.S.C. 374 and 376)), and to
examine and, where appropriate, to refuse admission to imported
products (see section 801 of the act). The agency may also take samples
for analysis, and, in the case of food samples, may impose ``reasonable
exceptions'' and ``reasonable terms and conditions'' relating to the
sample collection (see sections 702(b) and 801(a) of the act). Section
701(a) of the act further authorizes the agency to issue regulations
for the efficient enforcement of the act, while section 701(b) of the
act authorizes FDA and the Department of the Treasury to jointly
prescribe regulations for the efficient enforcement of section 801 of
the act.
Additionally, section 361 of the Public Health Service Act (the PHS
Act) authorizes the agency to issue regulations to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries (see 42 U.S.C. 264).
The proposed rule would apply where a person uses a sampling
service and/or a private laboratory for an imported food when the
sample is to be tested or analyzed in connection with an FDA
enforcement action. The sampling service or the private laboratory will
provide evidence that may help the agency determine whether the
imported food is adulterated, misbranded, or otherwise violates the act
or the PHS Act and whether FDA should permit the product to enter
interstate commerce. Consequently, FDA must have some confidence and
assurance that the sampling service and private laboratory are
performing their tasks accurately and reliably. The proposed rule
would, therefore, establish uniform requirements for sampling services
and private laboratories. In doing so, the proposed rule would further
promote the efficient enforcement of the act's
[[Page 23466]]
adulteration, misbranding, and prohibited acts provisions, as well as
the act's provisions on imports, and inspections and examinations. The
proposed rule would also be consistent with the PHS Act's provisions
regarding protection against the spread of communicable disease because
contaminated food products can spread certain communicable diseases.
V. Environmental Impact
FDA has determined under 21 CFR 25.30(a) and (h) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). A description of these provisions is
given below with an estimate of the annual reporting and recordkeeping
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on these topics: (1) Whether the collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Reporting and Recordkeeping Requirements Pertaining to
Sampling Services and Private Laboratories Used in Connection With
Imported Food
Description: The proposed rule would, in part, require persons who
use sampling services and private laboratories in connection with
imported food to notify FDA, to prepare sample collection reports, to
keep records regarding sample collection, to prepare and submit
analytical reports to FDA, and to prepare and sign an affidavit.
Description of Respondents: Businesses and individuals.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Frequency of Total Annual Hours per
21 CFR Section No. of Respondents Responses Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
59.101 1,739 4.8 8,329 1 8,329
59.103 1,739 5.0 8,767 1 8,767
59.201(a)(4) 200 44 8,767 1 8,767
59.201(a)(5) 200 44 8,767 1 8,767
59.301(a)(4) 200 44 8,767 2 17,534
59.301(b) 200 44 8,767 0.5 4,384
Total .................... .................. .................. ............... 56,548
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Frequency of Total Annual Hours per
21 CFR Section No. of Respondents Responses Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
59.201(b) 200 44 8,767 1 8,767
59.301(c) 200 44 8,767 0.5 4,384
Total .................... .................. .................. ............... 13,151
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA based its estimates on the number of food importers (as
identified in a database) and the numbers of sampling services and
private laboratories that currently submit information to the agency
regarding imported food. In fiscal year (FY) 1999, there were 1,739
food importers, and approximately 100 private laboratories submitted
analytical data concerning imported food products to FDA. The agency is
unable to predict whether the proposed rule will lead to any changes in
the number of private laboratories submitting data to FDA, but, for
purposes of estimating the information collection burden for this
proposal, will assume that 200 private laboratories (twice the number
of private laboratories currently submitting data on imported food to
FDA) will be affected.
As for sampling services, FDA notes that most private laboratories
conduct their own sample collection operations and that there are few
(perhaps 10) sampling services. However, because the proposed rule
would require private laboratories that collect samples to adhere to
the same requirements as sampling services, for those provisions
involving a collection of information from sampling services, FDA has
decided to count 95 percent of the private laboratories (190 private
laboratories) as adhering to the sampling service requirements in
addition to the 10 known sampling services, thus resulting in 200
sampling services.
To determine the information collection burden for proposed Sec.
59.101, FDA assumed that all 1,739 food importers would be affected.
FDA data for FY 1999 indicates that approximately 11,690 food imports
were detained for safety reasons. If 75 percent of these shipments are
sampled, this would lead to 8,767 samples. However, FDA's experience
suggests that sampling rates vary; in some areas, importers do very
little sampling themselves and, instead, use sampling services. As
described in section VII of this document, and for purposes of this
information collection estimate, FDA will assume that importers will
perform
[[Page 23467]]
only 5 to 20 percent of the sample collection themselves, so that, at
most, 8,329 shipments (95 percent of 8,767 shipments) would be sampled
by sampling services. This, in turn, would result in a response
frequency of approximately 4.8 shipments per importer (8,329 shipments/
1,739 food importers = 4.789 shipments/importer, rounded up to 4.8) and
8,329 sampling service notifications to FDA under proposed Sec.
59.101. Given the minimal nature of the information sought, FDA
estimates that only 1 hour would be needed to complete each
notification.
For proposed Sec. 59.103, FDA notes that not all food samples lead
to laboratory analyses. In fiscal year 1999, FDA received 8,767
laboratory tests or analyses on imported food. Thus, for proposed Sec.
59.103, the agency assumes that all 1,739 food importers may be
affected and that 8,767 private laboratory notifications may result.
The frequency of responses per importer, therefore, would be
approximately 4.6 (8,767 notifications/1,739 importers = 5.04
notifications per importer). Again, given the minimal nature of the
information sought, FDA estimates that only 1 hour would be needed to
complete the notification.
For proposed Sec. 59.201(a)(4), (a)(5), and (b), the agency, as
explained earlier, estimates that 200 sampling services would be
affected. Although sampling services have submitted reports to FDA as
part of an analytical package for a submission from a private
laboratory previous to this proposed rule, these submissions are not
considered a ``usual and customary business practice.'' Usual and
customary business practices are not included in the burden calculated
in the Paperwork Reduction Act Analysis. However, because the sampling
reports are in response to government requirements, they are not
considered usual and customary. Because proposed Sec. 59.201 would, in
essence, pertain to sample collection reports that are sent forward to
private laboratories (as opposed to reports of all samples) and because
FDA receives approximately 8,767 laboratory tests or analyses on
imported food annually, the agency estimates that the proposal would
result in 8,767 sample collection reports and records each year, at a
frequency of 44 sample collection reports per sampling service (8,767
tests/200 sampling services = 43.8 tests per sampling service, and each
test should result in a sample collection report). While sample
collection reports would be prepared and records would be kept
regardless of the regulation (because the sampling service would
document its procedures for the importer's or private laboratory's
use), FDA cannot determine whether the proposal would require sampling
services to devote additional time to such reports and records.
Consequently, FDA has assigned 1 burden hour per identification of the
containers from which samples are collected, 1 burden hour per sample
collection report for reporting purposes, and 1 burden hour per sample
collection report for recordkeeping purposes.
FDA estimates that 200 private laboratories would be subject to the
information collection requirements in proposed Sec. 59.301(a)(4),
(b), and (c). Because FDA currently receives approximately 8,767
laboratory reports annually, the agency estimates that the proposal
would result in preparation, submission, and recordkeeping of 8,767
analytical packages and affidavits each year, at a frequency of
approximately 44 packages and affidavits per private laboratory (8,767
laboratory reports/200 private laboratories = 43.8 laboratory reports
per private laboratory, with each report resulting in an analytical
package and affidavit). The analytical packages submitted by private
laboratories are also not considered usual and customary business
practices, because they are in response to government requirements.
They are also included in the estimate of paperwork burden. The
analytical packages described in the proposed rule are similar to
analytical packages currently submitted to FDA, so the agency has
assigned only 1 burden hour for the preparation of each analytical
package (proposed Sec. 59.301(a)(4)) and another burden hour for
recordkeeping purposes (proposed Sec. 59.301(c)). As for the affidavit
described in proposed Sec. 59.301(b), the information sought in the
affidavit does not require a person to conduct any investigations,
research, or examinations in order to complete the affidavit, so FDA
has assigned 30 minutes for each affidavit.
In compliance with the PRA (44 U.S.C. 3507(d)), the agency has
submitted the information collection provisions of this proposed rule
to OMB for review. Interested persons are requested to submit comments
regarding information collection to OMB (see ADDRESSES and DATES).
VII. Analysis of Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the proposed
rule is a significant regulatory action as defined by the Executive
order and so is subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because most food importers are small businesses,
the proposal could have a significant economic impact on a substantial
number of small entities. The agency's Regulatory Flexibility Act
analysis appears later in section VII.F of this document.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement of anticipated costs and
benefits before proposing any rule that may result in an expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million in any one year (adjusted annually for
inflation). As discussed later in section VII.G of this document, FDA
has determined that this proposed rule does not constitute a
significant rule under the Unfunded Mandates Reform Act.
B. Need for the Regulation
Current policies for sampling services and private laboratories do
not create sufficient safeguards to prevent importers testing into
compliance, which is testing multiple samples from a shipment and
submitting only those results that will allow the shipment to enter the
United States, or banking samples, which is retaining samples from a
previous, acceptable shipment and submitting these samples instead of
samples from the shipment that should be tested. Both of these
activities permit importers to market adulterated or misbranded foods
in the United States, representing a health hazard for American
consumers.
Also, there is a lack of consistency in standards for sampling
services and private laboratories across districts. Currently, ch. 21
entitled ``Guidance on the Review of Analytical Data,'' FDA Laboratory
Procedures Manual lays out guidance for importers and their agents.
[[Page 23468]]
Although this guidance provides important information for importers,
it is not sufficiently specific and may have contributed to a lack of
consistency between districts. This lack of consistency creates
barriers to entry for new private laboratories, inhibiting the
competitiveness of the industry.
C. Regulatory Options
1. No New Regulatory Action
FDA can take no new regulatory action and rely on current guidance
with enhanced enforcement to improve the quality of test submissions
for food imports on detention without physical exam (DWPE). However,
the current standards for sample collection do not provide safeguards
against fraudulent sample collection. The lack of these safeguards
makes ensuring appropriate sample collections difficult. Additionally,
this will not correct the lack of consistency between districts in
laboratory submission requirements.
2. Require the Use of Independent Sampling Services
One goal of the proposed rule is to aid in ensuring that
representative samples from questionable shipments are tested
correctly. Sampling by the importer creates the possibility that
importers will control the composition of samples from their shipments.
Requiring the use of an independent sampling service, which may be a
third party or the private laboratory doing the testing, would decrease
the opportunity for importers to cheat. Because FDA does not know how
many importers deliberately take nonrepresentative samples, it is
difficult to quantify the benefits, but the rule, if finalized, should
reduce the number of violative shipments that enter the United States.
Requiring the use of an independent sampling service would only be
costly for those importers who have not previously used independent
sampling services. Therefore, the cost of this alternative depends on
the number of importers not using independent sampling services.
Currently, the number of importers that use independent sampling
services varies between districts. Many districts, including Baltimore,
Los Angeles, San Francisco, and Dallas, strongly encourage the use of
an independent sampling service. In these districts, less than 1
percent of shipments are sampled by the importer. In other ports, such
as New York, as much as 27 percent of shipments are sampled by the
importer. The percentage of importers using a sampling service is
clearly more than 1 percent, but probably less than 27 percent. A
reasonable estimate of the percentage of all shipments that are sampled
by the importer is between 5 percent and 20 percent.
In FY 1999, approximately 11,690 food shipments were detained
without physical exam for reasons that may have led to a laboratory
analysis. If 75 percent of the shipments were sampled, 8,767 shipments
would have required the taking of a sample by the importer or an
independent sampling service. The additional number of shipments that
would be independently sampled would be between 438 (5 percent sampled
by the importer) and 1,753 (20 percent sampled by the importer) in FY
1999.
The time required to sample a shipment depends on the reason for
detention. Using the Office of Regulatory Affairs' workplan and the
expertise of former field personnel, FDA estimated the time to sample
shipments for different violations. Estimates of sampling time ranged
from 3 hours to sample seafood for decomposition to 30 minutes to
sample for filth. The weighted average of the sampling times for all
shipments that were detained without physical examination was 1.25
hours in FY 1999. A typical laboratory charges $65 an hour for
sampling. However, an importer sampling his or her own goods would
still have to pay a worker. The Bureau of Labor Statistics reports the
average cost to the employer to hire a blue-collar worker in
transportation and material moving is $17 an hour. The difference
between $65 and $17 an hour would be the incremental hourly cost to the
importer for independent sampling. At an average sampling time of 1.25
hours, the average shipment would cost $60 (1.25 x $48) more to be
sampled by an independent sampling service. This additional cost would
be borne by 438 to 1,753 shipments, giving a total annual cost between
$26,280 (438 x $60) and $105,180 (1,753 x $60).
3. Require Lab Accreditation
Requiring lab accreditation would provide assurance that the
private laboratories testing imported food have the appropriate
equipment, personnel, and procedures to conduct their analyses.
Improved performance by private laboratories should reduce the number
of test results that falsely approve violative shipments. However, this
benefit is mitigated by FDA's careful review of results submitted by
private laboratories. During this review, FDA analysts are able to
identify most incorrectly done analyses.
Requiring accreditation is currently subject to a number of
difficulties. First, there are very few accrediting bodies qualified to
accredit laboratories. Since a small percentage of private laboratories
that submit results to FDA are currently accredited (10 to 15 percent
of more than 100 private laboratories), the infrastructure to accredit
unaccredited private laboratories does not currently exist. Second, the
preferred accreditation standard is being changed from ISO/IEC Guide 25
to ISO/IEC Standard 17025. Laboratories and accreditors are in the
process of adopting the new requirements, creating additional strain on
the accreditation process. Third, accreditation is costly. The fees to
an accrediting body would be at least $6,900 for the first year per
private laboratory. This fee does not include the costs to the
laboratory of actions needed to meet accreditation standards: Hiring
additional personnel, training, proficiency testing, and quality
assurance procedures. The additional costs would typically be much
larger than the accreditation fees. These costs may be particularly
prohibitive for very small labs (33 percent of private labs have fewer
than five employees).
4. The Proposed Rule
The proposed rule would require food importers to prenotify FDA of
their use of a sampling service or a private laboratory. It would also
create requirements for sampling services collecting imported food
samples and create requirements for private laboratories testing
imported food samples and submitting laboratory reports to FDA.
D. Benefits of the Proposed Rule
1. Shortened Review Time
Review of a typical private laboratory test package requires, at
most, 3 days by FDA (although most reviews occur within 1 to 2 days).
If the package is found to be unacceptable, FDA contacts the laboratory
or importer and attempts to reach a consensus about the test results,
whether the problem is inappropriate or inaccurate analytical reports
or dubious test results. This dialogue with the lab and importer can
greatly increase the amount of time the imported food is held at the
port. Creating more consistent requirements for laboratories will
reduce the number and length of delays in reviewing analytical
packages. Since shipments lose value while the analytical package is
being reviewed, a benefit of this rule would be the gain in value of
shipments due to the shortened review time. This benefit is difficult
to quantify in dollar terms, due to variation in shipment value,
perishability, and review times.
[[Page 23469]]
For some shipments, such as fresh produce, there is a considerable
deterioration of shipment value associated with delay, so the benefits
of shortened review will be considerable.
2. Reduced Potential Fraud by Importers
Fraudulent activities by food importers have been alleged in the
General Accounting Office (GAO) Report ``Food Safety: Federal Efforts
to Ensure the Safety of Imported Foods are Inconsistent and
Unreliable'' (GAO/RCED-98-103) and ``The Safety of Food Imports: Fraud
& Deception in the Food Import Process; Hearings Before the Senate
Committee on Governmental Affairs, Permanent Subcommittee on
Investigations,'' September 10, 1998 (statement of ``Former Customs
Broker''). These fraudulent activities include banking samples and
testing into compliance. Both of these inappropriate activities would
be more difficult for importers with required prenotification of
private laboratory use and direct reporting of results to FDA.
Requiring importers to notify FDA of the private laboratory being
used for testing before submission of the analytical package will
discourage importers from using multiple laboratories to test samples
and choosing the results most beneficial to their businesses. If the
importer is required to notify FDA of the laboratory used before
submitting samples to the laboratory, the importer is committed to
using results from that laboratory. A secondary benefit of
prenotification is improved communication between the private
laboratory, the importer, and FDA, which may reduce review times.
Requiring the direct reporting of results from the lab to FDA would
prevent importers from submitting multiple samples to a lab then
choosing among the results for submission to FDA. It would also prevent
importers from choosing not to submit results from violative shipments,
ensuring that violative shipments will not be tested into compliance
and admitted into the United States.
A secondary benefit to direct reporting would be improved
enforcement of disposal of hazardous shipments and better tracking of
shipments for removal from DWPE. Because FDA may recommend destruction
of a shipment that poses a health hazard, the importer may not choose
to report results showing that the shipment is a health hazard and
instead take the shipment to another port. Also, the decision to remove
an importer from DWPE is often affected by several (five or more)
consecutive nonviolative shipments. If direct reporting is not
required, the importer can choose not to submit results from any
shipments that would disrupt the count of consecutive nonviolative
shipments.
3. Health Benefits Resulting From a Reduction in Violative Food
Entering the United States
It is difficult to determine how many violative shipments are
admitted to the United States. Without knowing how many of these
shipments are illegally admitted into the United States by importers
banking samples or testing into compliance, FDA cannot quantify how
much the proposed rule would reduce shipments of violative food
admitted into the United States. However, the agency can quantify the
costs of some of the illnesses that typically arise from consumption of
violative imported foods.
Filth was the most common reason for detention in FY 1999. While
filth itself may not pose a danger, it indicates that the food has been
held in unsanitary conditions and so is at a higher risk for microbial
contamination. Microbial contaminants such as Salmonella spp. and
Escherichia coli O157:H7 can cause acute gastrointestinal illnesses, as
well as chronic sequelae. Other risks associated with filth include
dental injury, and aflatoxicosis (Ref. 11). Contamination with
Salmonella and Listeria were also common reasons for detention (2,322
and 809 shipments, respectively). Listeria monocytogenes infection in a
pregnant woman may result in spontaneous abortions or encephalitis in
the newborn. For immuno-compromised persons, exposure to Listeria can
result in septicemia or meningitis.
Illegal food additives (741 shipments) have been linked to
gastroenteritis and disruptions of the nervous system (Ref. 11). Color
additives (1,008 shipments), yellow no. 5 (46 shipments), and excess
sulfites (47 shipments) were also common reasons for detention. These
additives can cause allergic reactions with some sensitive individuals,
ranging from mild contact dermatitis to a severe allergy attack (Ref.
11). Pesticide contamination (1,529 shipments) may also pose long-term
risks of cancer, as well as kidney, liver, or central nervous system
changes (Ref. 11). Foreign objects in food (381 shipments) may pose a
hazard ranging from simple dental injury to esophageal perforation
(Ref. 11).
Table 3 of this document shows some of the possible illnesses and
injuries that can result from violative foods and includes their
symptoms and an average cost per case. The quality-adjusted life days
(QALD) (Ref. 10) column represents the lost utility per day to a
consumer from an illness. It is essentially the loss to the consumer
due to symptoms and problems associated with the illness. The QALDs are
valued in dollars by multiplying the number of lost days by the value
of a statistical day, $630 (64 FR 36516 at 36523, July 6, 1999). This
value of a statistical life day is drawn from the economic literature
(Ref. 12). The medical cost column is the direct, medical cost of
illness, which includes hospitalization and doctor visits. Most
illnesses arising from E. coli O157:H7 or Salmonella are self-limiting
and short in duration. However, both Salmonella and E. coli O157:H7 can
be serious. E. coli in some cases can result in kidney damage or death.
Salmonella can sometimes trigger chronic arthritis and, in a small
percentage of cases, can result in death.
Table 3.--Cost of Some Illnesses Potentially Averted by the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dollar Value of
Potential Harm Symptoms QALD Loss Lost QALDs Medical Costs Total Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allergens\1\ Contact dermatitis Reddening, swelling, itching 2.10 $1,325 $125 $1,450
of skin
Allergic reaction Difficulty breathing, asthma, 1.03 $646 $550 $1,196
rash, possible shock
--------------------------------------------------------------------------------------------------------------------------------------------------------
Listeria contamination\2\ Moderate and severe Fever, nausea, diarrhea, may 1,754 $1,104,979 $9,548 $1,114,527
listeriosis result in stillbirths, coma,
death
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 23470]]
Objects in food\3\ Simple dental injury Toothache, headache 0.23 $145 $0 $145
Complex dental injury Simple, plus infection 3.47 $2,187 $3,540 $5,727
Oral emergency Sharp pain in mouth, face, 4.27 $2,687 $3,540 $6,227
neck, bleeding, plus possible
metastatic or local infection
Tracheo-esophageal Choking, difficulty breathing, 0.48 $304 $0 $304
obstruction cyanosis, hypertension
Esophageal perforation Pain in chest, bleeding 13.93 $8,776 $14,160 $22,936
aspiration pneumonia,
requires surgery
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salmonella contamination\4\ Salmonellosis Vomiting, nausea, possible 24.37 $15,357 $2,289 $17,646
arthritis, low probability of
death
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli contamination\5\ Gastroenteritis Hemolytic Vomiting, nausea, bloody 10.79 $6,797 $4,829 $11,626
Uremic Syndrome stools, possible kidney
damage, low probability of
death
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1, 2, 3\ Mauskopf et al., 1988.
\4, 5\ 63 FR 24254.
4. Other Consumer Benefits
Although problems such as insects or filth in food may not
necessarily represent a direct health threat, they show that the food
was not held in sanitary conditions. Moreover, consumers who purchase
food expect it to be clean and sanitary. The Food Marketing Institute
found 89 percent of consumers surveyed ranked a clean, neat store as a
very important factor in selecting their primary supermarket. If
consumers pay a premium, believing their food is sanitary and the food
is not, this payment represents a social loss. However, FDA cannot
quantify the economic benefit from avoiding this social loss because
the agency does not know what percentage of the price of food is a
``cleanliness premium.''
E. Costs of the Proposed Rule
The costs of this proposed rule arise from the new activities
required over and above those already in existence. ``The Laboratory
Procedures Manual,'' chapter 21 entitled ``Guidance on the Review of
Analytical Data Generated by Private Laboratories'' lists the
information that should be included in analytical packages for sample
collections and analyses conducted by private laboratories that conduct
analyses on FDA-regulated commodities imported into the United States
submitted to FDA (Ref. 13). This is guidance for FDA field personnel
who receive analytical packages from private laboratories on how to
review these packages. This guideline replaces and is very similar to
that in the ``Regulatory Procedures Manual,'' part 9, chapter 52
entitled ``Private Laboratories,'' revised January 1988 (Ref. 14). It
specifies that submissions should include information on how the sample
was collected, including identification of the sample, what sample
collection procedures were used, and how the samples were prepared. For
the analyses, the submissions should contain a description of the
analytical methods used, raw data and results, instrumental conditions
and parameters, analysts' signatures, and statements from the
laboratory director and the importer that the report contains all
analyses related to the sample.
To verify that the national guidance is followed, we communicated
with field personnel in four districts: Los Angeles, San Francisco,
Baltimore, and Southwest. Field personnel in all districts confirmed
that they follow the national guidance or district guidance that has
the same elements as the national guidance (Refs. 15 and 16). Since
importers were not previously required to prenotify FDA of their
intention to use a private laboratory, this requirement is a cost of
the rule. Notification would likely require 30 to 60 minutes of a
secretary's time at a cost of $17 per hour (Bureau of Labor
Statistics). For 8,767 shipments each year, this cost would range from
$74,519 to $149,039. Importers are also required to prenotify FDA of
their intention to use a sampling service. Eighty to 95 percent of
importers use sampling services, so this will require between 7,014 and
8,329 additional notifications. This additional cost will range between
$59,619 and $141,593; this gives a total cost of $134,138 to $290,626
per year.
F. Regulatory Flexibility Analysis
FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities. The primary impact of this rule will be on food
importers. The small business definition for food importers is 100
employees or fewer; this definition applies to more than 95 percent of
food importers. A search of companies in the Duns Market Identifiers
database found 1,739 food importers that would potentially be affected
by this rule. Of the 1,739 potentially affected food importers, 1,700
had fewer than 100 employees (Ref. 4). FDA finds that this proposed
rule may have a significant economic impact on a substantial number of
small entities, particularly if the notifications required by the rule
are distributed unequally across firms.
FDA considered additional flexibility for small businesses by
waiving the notification requirements. However,
[[Page 23471]]
since the vast majority of importers are small, this would reduce the
benefits of the rule significantly. Also, the overall effect of the
rule will be beneficial to small business, due to the clearer
guidelines for gathering and handling samples and submission of
analytical packages.
G. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement of costs
and benefits before proposing any rule that may result in an
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100 million in any one year (adjusted
annually for inflation). FDA has determined that this rule is not a
significant action as defined in the Unfunded Mandates Reform Act and
will not have an effect on the economy that exceeds $100 million
adjusted for inflation in any one year. The current inflation-adjusted
statutory threshold is $110 million.
VIII. Submission of Comments and Proposed Effective Date
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written comments regarding this proposal. Sumit written
comments regarding information collection to OMB (see ADDRESSES). Two
paper copies of any comments are to be submitted, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA
proposes that any final rule that may issue based on this proposal
become effective 30 days after its date of publication in the Federal
Register.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register.)
1. Aureli, P. et al, ``An Outbreak of Febrile Gastroenteritis
Associated With Corn Contamination by Listeria Monocytogenes,'' New
England Journal of Medicine, pp. 1236-1241, April 27, 2000.
2. Bureau of Labor Statistics, Employer Costs for Employee
Compensation Summary, http://stats.bls.gov/news.release/ecec.nws.htm, 1999.
3. Congressional Hearing, ``The Safety of Food Imports: Fraud
and Deception in the Food Import Process; Hearing Before the Senate
Committee on Governmental Affairs, Permanent Subcommittee on
Investigations,'' September 10, 1998.
4. Dialog Classic, Search of Wholesalers Who Import With SIC
Codes Between 5141 to 5149 That Are Importers, February 29, 2000.
5. Dalton, C. B. et al, ``An Outbreak of Gastroenteritis and
Fever Due to Listeria Monocytogenes in Milk,'' New England Journal
of Medicine, pp. 100-105, January 9, 1997.
6. Food and Drug Administration, ``Food Labeling: Warning and
Notice Statement: Labeling of Juice Products; Final Rule,'' (63 FR
37029 at 37037, July 8, 1998).
7. Food and Drug Administration, ``Preliminary Regulatory Impact
Analysis and Initial Regulatory Flexibility Analysis of the Proposed
Rule to Require Refrigeration of Shell Eggs at Retail and Safe
Handling Labels,'' (64 FR 36516, July 6, 1999).
8. Food Marketing Institute, Consumer Attitudes and the
Supermarket, Research International USA, 1999.
9. GAO Report, ``Food Safety: Federal Efforts to Ensure the
Safety of Imported Foods Are Inconsistent and Unreliable'' (GAO/
RCED-98-103).
10. Kaplan, R. M., J. P. Anderson, and T. G. Ganiats, ``The
Quality of Well-Being Scale: Rationale for a Single Quality of Life
Index,'' edited by Walker, S. R. and Rosser, R. M., Quality of Life
Assessment: Key Issues in the 1990s, The Netherlands: Kluwer
Academic Publishers, 1993.
11. Mauskopf, J. A., M. T. French, A. S. Ross, et al.,
``Estimating the Value of Consumers' Loss From Foods Violating the
Federal Food, Drug, and Cosmetic Act,'' Research Triangle Report to
the Center for Food Safety and Applied Nutrition, U.S. Food and Drug
Administration, September 1988.
12. Viscusi, W. K., ``The Value of Risks to Life and Health,''
Journal of Economic Literature, vol. 31, pp. 1912-1946, December
1993.
13. U.S. Food and Drug Administration, ``Laboratory Procedures
Manual,'' chapter 21, available at http://www.fda.gov/ora/science_ref/lpm/lpchtr21.html, accessed on 3/17/2003.
14. U.S. Food and Drug Administration, ``Regulatory Procedures
Manual,'' chapter 9-52, ``Import Procedures, Private Laboratories,''
revised 1988.
15. U.S. Food and Drug Administration, Baltimore District SOP
Manual, S.O.P. 609 Private Laboratories.
16. U.S. Food and Drug Administration, Pacific Region Private
Laboratory Guidelines, Private Laboratory Analytical Collection
Report, revised April 1995.
List of Subjects in 21 CFR Part 59
Foods, Imports, Laboratories, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I be amended as follows:
1. Part 59 is added to read as follows:
PART 59--REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD
Subpart A--General Information
Sec.
59.11 Who is subject to this part?
59.3 What definitions apply?
Subpart B--Requirements for Persons Using Private Laboratories and
Sampling Services in Connection With Imported Food
59.101 What requirements apply if you use sampling services?
59.103 What requirements apply if you use private laboratories?
59.105 59.105 What requirements apply if you collect your own
samples?
Subpart C--Requirements for Sampling Services
59.201 What are the requirements for collecting, identifying, and
maintaining samples?
Subpart D--Requirements for Private Laboratories
59.301 What requirements pertain to analyzing samples, preparing
analytical reports, and maintaining records?
59.303 What are the requirements for private laboratories collecting
samples?
Authority: 21 U.S.C. 331, 332, 333, 334, 341, 342, 343, 344,
348, 371, 372, 374, 376, 381, 393; 42 U.S.C., 264.
Subpart A--General Information
Sec. 59.1 Who is subject to this part?
(a) The requirements in this part apply to you if you:
(1) Use a sampling service to collect samples of an imported food
in connection with an FDA enforcement action; or
(2) Use a private laboratory to collect, analyze, or test samples
of an imported food in connection with an FDA enforcement action.
(b) This part also applies to you if you are a sampling service or
a private laboratory and you have been hired or retained to collect,
analyze, or test an imported food in connection with an FDA enforcement
action.
(c) Enforcement actions include, but are not limited to, product
seizure, refusal of imports, or the issuance of an injunction. This
part does not apply if you collect, analyze, or test imported food
samples for purposes not related to an FDA enforcement action.
Sec. 59.3 What definitions apply?
(a) FDA means the U.S. Food and Drug Administration.
[[Page 23472]]
(b) Private laboratory means an independent person who analyzes or
tests samples of imported food.
(c) Sampling service means an independent person who collects
samples of an imported food. Sample collection may include collecting
samples from lots of FDA-regulated products in conformance with FDA-
recommended sampling procedures and schedules.
Subpart B--Requirements for Persons Using Private Laboratories and
Sampling Services in Connection With Imported Food
Sec. 59.101 What requirements apply if you use sampling services?
(a) If you intend to use a sampling service to collect samples of
an imported food in connection with an FDA enforcement action, you must
notify the FDA district office that is reviewing the entry of the
imported food. Your notification must inform the FDA district office
that you intend to use such services and include:
(1) The name and address for each sampling service you intend to
use,
(2) Each sampling service's qualifications and knowledge of
sampling procedures,
(3) A primary contact (name and phone number) for each sampling
service,
(4) The address or addresses where the sampling records will be
maintained, and
(5) The reason(s) why the product is being sampled.
(b) You must also:
(1) Give to each sampling service the U.S. Customs Service entry
number, FDA entry line number (if applicable or available), the
location of the lot that will be sampled, sufficient information to
identify the lot to be sampled, and the name and address of the private
laboratory that will test the sample;
(2) Not influence or interfere with the manner and process in which
samples are collected; and
(3) Maintain control of the lot from which the sample was taken
until FDA notifies you that you can release the lot or take other
action on the lot.
Sec. 59.103 What requirements apply if you use private laboratories?
(a) If you use a private laboratory to test or analyze samples of
an imported food in connection with an FDA enforcement action, you must
notify the FDA district office that is reviewing the entry of the
imported food. Your notification must state that you intend to use a
private laboratory and to have the private laboratory submit the
results and supporting data to FDA. Your notification must also
include:
(1) The private laboratory's name and address,
(2) The private laboratory's qualifications,
(3) A primary contact (name and phone number) for the private
laboratory,
(4) The address where the test will be conducted (if different from
the private laboratory's address), and
(5) The reason(s) why the product is being tested or analyzed.
(b) You must also:
(1) Give to the private laboratory the U.S. Customs Service entry
number (if the product is imported or offered for import into the
United States), and FDA entry line number (if applicable or available);
(2) Not influence or interfere with the manner and process in which
samples are tested and/or analyzed;
(3) Maintain control of the lot from which the sample was taken
until FDA notifies you that you can release the lot or take other
action on the lot; and
(4) If you will use or are using more than one private laboratory
to conduct tests, notify all private laboratories involved and FDA.
Your notice must state how many private laboratories are conducting or
will conduct tests or analyses and describe those tests or analyses.
Sec. 59.105 What requirements apply if you collect your own samples?
If you collect your own imported food samples and intend to have
the samples tested or analyzed and used in connection with an FDA
enforcement action, you must comply with subpart C of this part.
Subpart C--Requirements for Sampling Services
Sec. 59.201 What are the requirements for collecting, identifying,
and maintaining samples?
(a) If you collect samples of an imported food in connection with
an FDA enforcement action, you must perform the following operations
independently:
(1) Verify the location, identity, and size of the lot to be
sampled;
(2) Collect samples following established procedures that ensure
the sample's integrity, accuracy, and representational nature;
(3) Ensure the integrity of the sample after collection by
including proper identification to avoid mixups between samples,
avoiding contamination, maintaining sterility or appropriate
temperatures, or taking other measures to protect the sample's
integrity;
(4) Identify all containers from which samples are collected;
(5) Complete a sample collection report for each sample collected.
The sample collection report must, at a minimum, document sample
collection procedures and sample preparation techniques; and
(6) Prepare and ship the sample, using precautions where necessary
to prevent contamination, to maintain the integrity of the sample, or
to maintain sterility or temperatures, and ship the original sample
collection report directly to the private laboratory.
(b) You must maintain records demonstrating your compliance with
paragraph (a) of this section for 3 years after you have sent the
sample collection report to the private laboratory. These records
should include documents showing how you identified, collected, and
maintained the sample. You must also make these records available to
FDA upon request for inspection and copying. If you collect samples
under an established, non-FDA procedure, you must retain records
concerning that procedure. However, if you collect samples under an FDA
sampling procedure, you can omit the FDA sampling procedure from your
records, but you should keep notes to show which FDA sampling procedure
you used.
Subpart D--Requirements for Private Laboratories
Sec. 59.301 What requirements pertain to analyzing samples, preparing
analytical reports, and maintaining records?
(a) If you are a private laboratory conducting tests or analyses on
an imported food, and the results and supporting data of those tests or
analyses will be used in connection with an FDA enforcement action or
submitted directly to FDA, you must:
(1) Verify that the sample received corresponds to the sample
described on the sample collection report;
(2) Confirm the reasons for analyzing the sample;
(3) Use appropriately validated or recognized analytical procedures
to analyze the sample, including the creation and maintenance of a
reserve portion of a composite sample; and
(4) Prepare an analytical report for submission with the original
sample collection report and complete analytical package. The
analytical package must:
(i) Describe the analytical methods used;
(ii) Include an original compilation of all data and corresponding
quality control results and supporting data supporting the test;
[[Page 23473]]
(iii) Include reagent blank and spike recovery data;
(iv) Describe instrumental conditions and parameters;
(v) Include the analysts' signatures;
(vi) Include the analysts' calculations; and
(vii) Contain a certificate of analysis.
(b) You must provide, as part of your analytical package, an
affidavit stating that:
(1) The analytical package pertains to the only test(s) done on the
lot or product and that you are not aware of any other tests being
performed; or
(2) If you are aware of other tests that are being or have been
performed by other persons, the name and address of the person who is
conducting or who has conducted the other tests.
(c) You must submit the analytical package and the original sample
collection report to the FDA district office that processed the entry
of the imported food. Additionally, you must:
(1) Maintain records relating to the requirements under paragraphs
(a) and (b) of this section for 3 years after you submitted the
analytical package and original sample collection report to FDA, and
(2) Upon request, make records available to FDA for inspection and
copying.
Sec. 59.303 What are the requirements for private laboratories
collecting samples?
If you are a private laboratory and collect samples of an imported
food in connection with an FDA enforcement action, you must comply with
subpart C of this part.
Dated: April 22, 2004.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 04-9699 Filed 4-26-04; 11:58 am]
BILLING CODE 4160-01-S