NATIONAL CUSTOMS BROKERS AND

FORWARDERS ASSOCIATION OF AMERICA, INC.

**Office of General Counsel Phone: (212) 944-6611**

**One Astor Plaza Facsimile: (212) 944-9779**

**1515 Broadway - 43rd Floor e-mail: hisaacs@tdllp.com**

**New York, N.Y. 10036**

July 8, 2003

**[Via Fedex]{.underline}**

Food and Drug Administration

Dockets Management Branch (HFA -- 305)

5630 Fishers Lane

Room 1061

Rockville, Maryland 20852

> **Re: Comments on Proposed Notices of Rulemaking:**
>
> **[Docket Number 02N--0277]{.underline}**

Dear Sirs:

The following is submitted by the National Customs Brokers & Forwarders
Association of America, Inc. ("NCBFAA"), in connection with the Notice
of Proposed Rulemaking, ("NPRM") published in the Federal Register of
May 9, 2003, (68 F.R. 25187) relating to proposed amendments to 21
C.F.R. Parts 1 and 11, and implementing the relevant provisions of the
P.L. 107-188, the "Public Health Security and Bioterrorism Preparedness
and Response Act of 2002" (hereinafter referred to as the "Bioterrorism
Act" or the "Act").

The NCBFAA is a national organization with regular membership consisting
of licensed customs brokers, international freight forwarders,
non-vessel operating common carriers, and international air cargo
agents. Our member customs brokers prepare and file entries on behalf of
persons importing merchandise into the United States.

At the outset, we wish to express wholehearted support for the intended
aim of the proposed regulations --- the protection of the integrity of
the U.S. food supply, and consequently, of the American public. However,
because section 1.326 applies the proposed regulations to, *inter alia,*
persons that "import" food, it could be interpreted to include customs
brokers, who act only as agents for the actual importer. This would
result in placing a redundant and burdensome recordkeeping
requirements[^1] on customs brokers. For the following reasons, we
believe that the regulations should make it clear that customs brokers
are exempted from these requirements.

As set forth in the notice, the proposed rules will amend FDA
regulations to require the establishment and maintenance of records, by
a person who "*owns* food or who *holds*, *processes*, *packs*,
*imports*, *receives*, or *distributes* food for purposes other than
transportation." Customs brokers perform none of the enumerated
functions. At most, they aid in obtaining customs release of the goods
by filing an entry on behalf of the actual importer. Certainly, they
possess only the information having to do with the customs entry of the
food. Those records are immediately available under existing customs
regulations.

Pursuant to 19 U.S.C. §1508(a) and 19 C.F.R. 163.2, customs brokers are
required by the Bureau of Customs and Border Protection ("CBP") to
establish, maintain, and produce documents for examination and
inspection.[^2] These requirements are applicable to a customs broker
irrespective of whether the broker or the actual importer appears as the
importer of record on the entry. In addition to maintaining records
relating to importations, 19 C.F.R. §111.25 requires that customs
brokers make those records readily available to the government and
§111.26 prohibits a broker from interfering in their inspection. Thus,
any recordkeeping requirement imposed upon customs brokers by these
regulations would be unnecessarily redundant.

In addition, in a related context, we note that under 21 C.F.R. §1.90,
dealing with imports and exports, employs the term "owner or consignee"
as the party to receive notice. Similarly, in the context of the instant
regulations, "imports" should not be used. Rather, that term should be
deleted and the following inserted, ". . . is the actual consignee of
the imports . . . ." That will clearly exempt customs brokers from the
regulations.

We thank you for the opportunity to submit these comments.

Sincerely,

Federico C. Zuniga,

President

> Harvey A. Isaacs
>
> General Counsel

[^1]: The recordkeeping requirements vary according to whether the
    person is a "Transporter" or a "Non-transporter," etc.

[^2]: 19 U.S.C. §1508(a) and 19 C.F.R. 163.2 require the following
    parties to maintain and produce records relating to the entry of
    merchandise to Customs for examination and inspection, upon
    reasonable demand, whether or not Customs required the presentation
    of such documents at the time of entry:

    \(1\) Any owner, importer, consignee, importer of record, *entry
    filer* or other party who

    imports merchandise into the customs territory of the United States,
    files a drawback claim, or transports or stores merchandise carried
    or held under bond; or

    knowingly causes the importation or transportation or storage of
    merchandise carried or held under bond into or from the customs
    territory of the United States;

    \(2\) *Any agent* of any party described above; or

    Any person whose activities require the filing or a declaration or
    entry, or both.

    > (Emphasis supplied.)