![](media/image1.jpeg){width="1.1708333333333334in" height="0.58125in"}

January 6, 2003

Dockets Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

> Re: Comments On Regulatory Procedures Manual; Chapter 9, Imports --
> Guidance Concerning Recommending Customs' Seizure and Destruction of
> Imported Human and Animal Food [That Has Not Been Reconditioned
> \[Docket No. 02D-0137\]]{.underline}

Dear Sir or Madam:

The Association of Food Industries is pleased to submit comments on the
agency's draft Guidance Concerning Recommending Customs' Seizure And
Destruction Of Imported Human And Animal Food That Has Not Been
Reconditioned. AFI is an association of 300+ U.S. companies in the
international food trade. The association has represented U.S. importers
since 1906. AFI has grave doubts concerning the legality of the Draft
Customs Guidance. Specifically, it appears that FDA is using the Draft
Customs Guidance to circumvent the requirements of § 801(a) and § 304 of
the Food, Drug and Cosmetic Act ("FD&C Act"), 21 U.S.C. § 381(a), § 334.

**The Draft Guidance Is Contrary To Statutory Authority**

The Draft Customs Guidance makes no reference whatsoever to provisions
of the FD&C Act that specifically govern the importation of food that
appears to be or is violative. The two-track option which allows the
agency to proceed under either § 334 or § 381 has existed since Pure
Food And Drugs Act of 1906. Congress modeled § 334 and § 381 of the FD&C
Act on sections 10 and 11 of the 1906 Act, and did so "without
substantial change." The draft guidance proposes a method for FDA to
circumvent this governing statutory scheme of obligations and remedies
that has existed nearly 100 years. The draft guidance guts the
importer's right to re-export, while freeing FDA of the burdens the
agency must bear in a § 334 proceeding.

If the agency believes the risk to health is so severe that it must
foreclose the possibility of re-importation, the FD&C Act and Congress
have required FDA to bear the burden of demonstrating the adulteration,
by a preponderance of evidence, before FDA is permitted to destroy the
article. The Draft Customs Guidance allows FDA to foreclose the
importer's re-export right and to do so on much weaker evidentiary
grounds. Under the provisions of the Draft Customs Guidance, FDA can
recommend Customs seize and destroy product simply on the grounds that
the product "may" be adulterated and has a "reasonable probability" of
harm. Why would FDA ever again go through the cumbersome litigation
burdens of § 334, when it can resort to the Draft Customs Guidance
instead? The Draft Customs Guidance effectively writes the requirements
of § 334 right out of the FD&C Act.

#### FDA is Overstepping its Bounds

If Congress wished to limit the flexibility of § 381 and § 334, it has
had ample opportunity to amend the statute and eliminate the right to
re-export. As recently as in the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, Congress, again looked at the
treatment of articles refused admission into the United States. In this
broad legislation, Congress amended § 381, among other things, to
increase inspections at ports, improve coordination among agencies,
develop rapid testing methodologies, provide prior notice of
importations and require marking of goods that have been refused
admission into the United States. However, Congress did not alter the
right of the owner or consignee to re-export refused articles within 90
days under § 381.

The stated purpose of the guidance is "to ensure that imported food that
poses a significant risk to public health is not distributed or exported
or subsequently re-imported into the U.S." The assumption this practice
exists comes from a General Accounting Office report, with testimony
made as part of a plea bargain. Neither the GAO nor FDA has demonstrated
that "port shopping" exists apart from the actions admitted to by the
convicted criminal. FDA's assertion that port shopping goes on to any
significant degree is implausible for the simple reason that importers
have no economic incentive to engage in the practice, a fact which the
GAO and FDA have apparently failed to even consider. There is little or
no cost to the importer in the event merchandise is refused admission
and must be re-exported because sales contracts almost universally
provide that the goods must meet U.S. government standards. In the event
the merchandise is refused entry by the U.S. government, the seller
agrees to either take back the rejected goods or permit the buyer to
sell them to another overseas market and to reimburse the buyer for any
payment made against such goods, plus freight, insurance, labor,
cartage, storage, interest and other expenses incurred by the buyer in
re-exporting the goods.

Not only has FDA failed to present any convincing proof that importers
are, as it charges, bringing unsafe food back into the United States
through port shopping, it has also failed to present any epidemiological
evidence showing that public health has been jeopardized by the
introduction of these re-imported foods. FDA and other federal agencies
(e.g., The Centers for Disease Control and Prevention) keep and release
detailed information regarding outbreaks of foodborne illness caused by
imported foods and domestically produced foods alike. The failure of FDA
to cite from this extensive collection of pertinent data to even a
single instance of a food borne outbreak caused by a refused food that
was subsequently re-imported attests to the fact that the Draft Customs
Guidance will do little or nothing to improve public health and safety.

**The Draft Guidance Violates Customs Law and the Administrative
Procedures Act**

Not only does FDA not have the statutory authority under the FD&C Act to
implement the Draft Customs Guidance, the guidance does not comport with
Customs law either. Section 1595a(c)(2) only permits seizure on health
or safety grounds if the article "[is not in]{.underline} compliance
with the applicable rule, regulation or statute." If implemented, the
Draft Customs Guidance would permit FDA to recommend seizure and
destruction if the product "may" be adulterated and has a "reasonable
probability" of harm. Thus, the Draft Customs Guidance does not comport
with the plain language of § 1595a.

Agency actions are unlawful and will be set aside if, pursuant to the
Administrative Procedure Act, they are "in excess of statutory
jurisdiction, authority, or limitations, or short of statutory right."
The Draft Customs Guidance circumvents the plain language and intent of
the FD&C Act. It eliminates by guidance rights of importers that
Congress and Courts have repeatedly affirmed. Adoption of the Draft
Customs Guidance would not withstand a legal challenge under the APA.

For the reasons stated above, AFI is opposed to the Draft Customs
Guidance. The two-track statutory scheme of § 334 and § 381 not only
grants FDA enforcement powers, it also places limits on the agency's
authority. Litigation has repeatedly upheld these limits and Congress
has repeatedly reaffirmed them. AFI urges FDA to reconsider and then
withdraw the Draft Customs Guidance.

Respectfully submitted,

![](media/image2.png){width="1.8375in" height="0.7006944444444444in"}

Robert Bauer

President