FDA Authority to Oversee Private Laboratories that Analyze Imported FDA-Regulated Food

^Pr^ep^ar^{ed f}^o^r^M^e^m^b^ers^an^d^Com^mⁱ^t^t^ees^of^C^ong^r^e^ss

Backgr ound ..................................................................................................................................... 1
The FDA and Private Laboratories..................................................................................................1
Agency and Bush Administration Proposals...................................................................................3
Legislative Proposals from the 110^th Congress...............................................................................4
The Food and Drug Administration Globalization Act (Dingell Draft)....................................4
Ending Agricultural Threats: Safeguarding America’s Food Supply for Everyone
(EAT SAFE) Act of 2007 (S. 2418).......................................................................................5
Safe Food Enforcement, Assessment, Standards, and Targeting (FEAST) Act of 2008
(H.R. 5904)............................................................................................................................5
Keeping America’s Food Safe Act of 2008 (H.R. 5827)...........................................................5
Author Contact Information............................................................................................................6
Acknowledgments ........................................................................................................................... 6

Industry observers have raised concerns about perceived gaps in food import safety over the past
few years. One particular area of concern focuses on imported goods that are released into the
United States market after the Food and Drug Administration (FDA) detains them under an
import alert. Generally, these goods may be released into the market after an importer “provides ¹
evidence that the entry is in compliance with federal laws and regulations.” The proof can be
provided by private laboratories that have tested samples of the detained imported goods, and
importers can present results indicating that the goods are FDA-compliant. Currently, the FDA
does not have express statutory authority to regulate the private laboratories that sample or test
these imported goods, although the FDA regulates the importer and imported products. This
report focuses on proposals for FDA regulation of the private laboratories that analyze imported,
FDA-regulated goods. It will provide background to the relationship between the FDA and the
private laboratories, as well as information about agency and Bush Administration proposals and ^th
legislative responses in the 110 Congress (particularly the Dingell Draft, S. 2418, H.R. 5904,
and H.R. 5827) to the current lack of regulation.

Administrative responsibility for regulation of certain types of imported food is delegated to the ²
FDA under Chapter VIII of the Federal Food, Drug and Cosmetic Act (FFDCA). Generally, the
FFDCA provides that an article must be refused admission into the United States, with some
exceptions, on the following bases:
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^s^ectⁱ^oⁿ^505.
Under the FFDCA, the FDA can automatically detain a product without physically examining it.⁴
Automatic detention occurs as a result of the issuance of import alerts, which “identify problem
commodities and/or shippers and/or importers and provide guidance for import coverage,” such ⁵
as if “those products or shippers ... have met the criteria for automatic detention.” Importers
¹
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whose products have been detained because of import alerts can petition for the release of their
products by presenting testimony from private, or third-party, laboratories that shows that their ⁶
products are compliant. In order to do this, they submit either their products or samples of their
products for testing to the private laboratories. For the products to be released, the private
laboratories must then present test results that indicate that the products do not violate the FDA’s
entry standards. The test results can be returned to the importer, who will give it to the FDA, or
the lab can turn in the results directly to the FDA. The FDA may then use this data “to determine
whether the imported food complies with the [FFDCA] and can be released into the United ⁷
States.”
The FDA has recognized these private laboratories as an integral part of food import safety.⁸
According to the FDA, the third-party labs help ensure that the food reaching the market complies
with agency standards and allow agency laboratory resources to be devoted to other regulatory ⁹
matters. However, there has been criticism regarding the autonomy given to the importers and
private laboratories. Such criticism varies from the manner in which the samples are collected for
testing to the reporting of test results by the importers to the FDA. For example, at a 1998 hearing
before a Senate Governmental Affairs subcommittee, a former customs broker testified regarding
the abuses of the private laboratory system in relation to the product samples given to the private
laboratory. He recounted how some importers selected samples for testing that were from
shipments that had not been detained or they submitted multiple samples for testing until a ¹⁰
sample was found to be compliant. As the FDA has noted, “[b]oth of these activities permit
importers to market adulterated or misbranded foods in the United States, representing a health ¹¹
hazard.”
Another example occurred early in 2008, when the chairman of a private laboratory that samples
and tests FDA-regulated goods testified at a House Energy and Commerce subcommittee hearing.
His testimony concerned encounters with importers who deleted information from test results that
evidenced FDA violations and then submitted the altered results to the FDA, as well as
suggestions for improving the FDA’s regulation of imported foods via the use of laboratories and ¹²
existing FDA programs. Additionally, he stated that the FDA should be able to visit and audit
laboratories at their physical location at any time. Currently, the FDA may conduct voluntary, on-¹³
site assessments of such laboratories. Recent agency, administration, and legislative proposals
address various ways to curb the potential for such abuses by monitoring private laboratories.
⁶
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The FDA Office of Regulatory Affairs publishes a Laboratory Manual with a section on Private ¹⁴
Laboratory Guidance. The Guidance “seeks to establish a uniform, systematic, and effective
approach to ensuring that private labs performing analyses on FDA-regulated imported ¹⁵
commodities submit scientifically sound data.” To that end, the Guidance provides
recommendations on sampling techniques, information regarding the training and experience of
private lab analysts, considerations for reviewing the analytical packages, and suggested criteria ¹⁶
for collecting audit samples. In general, a guidance document is a type of policy statement,
“issued by an agency to advise the public prospectively of the manner in which the agency ¹⁷
proposes to exercise a discretionary power.” General statements of policy do not “impose any ¹⁸
rights and obligations,” nor do they “establish a ‘binding norm’ ” because they are “not finally ¹⁹
determinative of the issues or rights to which [they are] addressed.”
In April 2004, the FDA proposed a rule to regulate imported food product sampling services and ²⁰²¹
private laboratories. It was withdrawn without comment on August 5, 2005. Some of the ²²
recommendations from the FDA’s Laboratory Guidance were put forth in the proposed rule. The
proposed rule would have required “samples to be properly identified, collected and ²³
maintained.” The proposed sampling requirements outlined specific provisions for
identification, collection, and documentation from the time the sample was collected to the time
the sample was delivered to a private laboratory. Particularly, the proposed rule placed an
emphasis on an “independent” execution of the sampling, to ensure that the sampling and the tests

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are conducted without the importer’s influence. It went further to require “laboratories to use ²⁴
validated or recognized analytical methods, and to submit analytical results directly to FDA.” It ²⁵
purposefully omitted a laboratory accreditation requirement.
In November 2007, the FDA prepared a report entitled, the Food Protection Plan.²⁶ The FDA’s
plan is integrated with a separate plan prepared for President Bush by the Interagency Working ²⁷
Group on Import Safety called an Action Plan for Import Safety. Both reports highlight how the
Bush Administration would like to improve food import safety. The Food Protection Plan ²⁸
recommends legislation that would give the FDA the authority to accredit private laboratories.
The Action Plan for Import Safety notes that the FDA plans to issue guidance “that would set
standards for the sampling and testing of imported products, including the use of accredited
private laboratories submitting data to FDA to assist in evaluating whether an appearance of a ²⁹
violation may be resolved.”

Several bills introduced in the 110^th Congress addressed the issue of private laboratory regulation.
One common theme among these legislative proposals is the accreditation or certification of
private laboratories.
Representative Dingell of the House Committee on Energy and Commerce began circulating a ³⁰
bill in draft form in April 2008. The draft sought to alter the FFDCA in a variety of ways,
including by requiring new sampling and testing protocols for food shipments. The Dingell draft
would have added a new section to the FFDCA dedicated to the testing of food shipments. The
new section would have addressed three areas of food shipment testing: (1) testing in facilities
that manufacture, process, pack, or hold food that would not have been certified under the
provisions that the bill would have established (in which case accredited laboratories would
conduct sampling and testing of each shipment and simultaneously submit the sampling results
electronically to the Health and Human Services (HHS) Secretary and the facility owner); (2)
testing in like facilities that would have been certified under the bill’s provisions (accredited
laboratories would conduct sampling and testing of shipments “on a periodic basis specified by
the Secretary” and submit the sampling results electronically to the HHS Secretary and the
facility owner); and (3) accreditation of laboratories by the HHS Secretary “for the purpose of
²⁴
^Id^.
²⁵^Id^{. a}^t²³⁴⁶^4.
²⁶^D^e^pa^r^t^m^e^{nt of}^H^e^a^{lth a}^{nd H}^u^m^a^{n Se}^r^v^ic^e^s^{, Foo}^d^aⁿ^{d D}^r^ug^A^d^mⁱ^nis^t^r^a^tio^{n: F}^o^o^d^P^r^ote^c^tioⁿ^Plaⁿ¹⁽²⁰⁰⁷⁾
^[he^r^eⁱ^na^f^t^e^r^Food^P^r^ote^c^tⁱ^oⁿ^]^,^ht^t^p^://w^w^w^.^f^da^.g^ov^/oc^/initia^tiv^e^s^/a^dv^aⁿ^c^e^/^f^ood/p^l^aⁿ^.^h^tm^l.
²⁷^Id^{. a}^t^{3; I}ⁿ^te^r^a^g^e^ncy^W^o^r^k^ing^G^r^oup^oⁿ^I^m^por^{t Sa}^f^e^t^y^{: A}^c^tion^P^l^aⁿ^f^o^r^I^m^por^{t Sa}^f^e^t^y⁽²⁰⁰⁷⁾^[^h^e^r^eⁱ^na^f^t^e^r^I^m^por^t
^Sa^f^e^t^y^]^,^http:^//www^.i^m^portsa^f^e^t^y^.^g^o^v^/^re^port/a^c^tion^p^laⁿ^.^p^d^f^.
²⁸^Fo^od^Pr^ote^c^tio^n,^s^upr^aⁿ^o^te²⁶^{, a}^t^3.
²⁹^I^m^por^{t Sa}^f^e^t^y^,^s^upr^a^no^t^e²⁷^,^at⁵⁰^.
³⁰^FD^A^Le^gⁱ^s^l^a^{tion, htt}^p^://e^ne^rg^y^c^o^m^m^e^rce^.^hous^e^.^g^o^v^/^FD^A^G^loba^lA^c^t^-08/i^nde^x^.^s^h^tm^l.

conducting sampling and testing.”³¹ The section would have required the Secretary to establish a
standard for accreditation and mandated that all certified and non-certified facilities submit all
their samples to accredited labs only. The accredited labs would then return the results
simultaneously to the FDA and to the importer.
The EAT SAFE Act was introduced by Senator Casey in December 2007. The bill would have
required private laboratories that conduct tests on FDA-regulated imports to be certified by the
agency under a fee-funded certification and audit process developed by the FDA. Laboratories
would have had to submit to the agency the results of all tests conducted.
The Safe FEAST Act was introduced in April 2008 by Representative Costa. In particular, it
would have allowed the HHS Secretary to recognize “qualified” laboratories to test imported
foods, once the laboratories have established, to the recognizing agency’s satisfaction, that they
maintain internal quality systems and meet other criteria. The Secretary would also have been ³²
required to establish a registry of such laboratories. Alternative laboratories would have been
allowed to test samples as well, but additional requirements, such as the submission of evidence
to the Secretary to establish the laboratory’s qualifications and the submission to the FDA of all
testing results and data, would have been imposed on such laboratories.
This bill was introduced by Representative Roskam in April 2008. Among other things, the bill
would have required the addition of a section to the FFDCA that would have required the HHS
Secretary to certify all private laboratories and sampling services that test imported FDA-³³
regulated goods. Laboratories would have had to allow audits and submit all test results directly
to the FDA. In addition, importers, laboratories, and sampling services would have faced civil
penalties for knowingly falsifying test results.
³¹
^FD^A^Le^gⁱ^s^l^a^{tion, §}¹⁰^7,^htt^p^://eⁿ^e^rgy^c^om^m^e^rce^.^hous^e^.^g^o^v^/^FD^A^G^l^oba^lA^c^t^-08/^Dⁱ^ng^e^l^_60A^X^M^L^.^pdf^(e^m^pha^sⁱ^s
^a^dde^d)^.
³²^H^.^R^.⁵⁹⁰⁴^,^§^{8: R}^e^c^o^gⁿ^iti^on^of^Q^u^a^lif^ie^{d L}^a^bor^a^t^or^ie^s^f^o^r^Aⁿ^a^l^y^s^es^of^I^m^por^te^{d Foo}^d^s^.
³³^H^.^R^.⁵⁸²⁷^,^§^{2: C}^e^r^tif^ic^a^tion^of^Pr^iv^a^t^e^La^bor^a^t^or^ie^s^aⁿ^d^Sa^m^p^ling^Se^r^v^ic^e^s^.

^Van^e^s^s^{a K. B}^u^rro^w^s
^L^e^gⁱ^s^l^at^iv^{e A}^t^torn^e^y
^v^b^u^rro^w^s^@^c^rs^.l^oc.g^ov^{, 7-}⁰⁸³¹

^Saden^a^T^h^ev^araj^ah^{, L}^a^w^C^l^erk