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Imported Meat, Poultry & Egg Products Remain Under USDA
Jurisdiction
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Issue
The U.S. Department of Agriculture’s (USDA) Food Safety and
Inspection Service (FSIS) is reemphasizing the current requirements
and procedures for companies importing meat, poultry and egg products
into the United States. This document is meant to clarify the situation
for meat, poultry and egg products given that the U.S. Health and Human
Services (HHS) &150; Food and Drug Administration’s (FDA) two
interim final regulations of the Bioterrorism Act will take effect
on December 12, 2003. The Bioterrorism Act regulations include (1)
the registration of food facilities exporting to the United States
and (2) the prior notice of imported food shipments.
The USDA-FSIS import requirements remain the same. It is crucial that
importers, brokers, exporting countries and others understand that
the new Bioterrorism Act does not supersede the import provisions of
the Federal Meat Inspection Act, the Poultry Products Inspection Act,
the Egg Products Inspection Act, or the regulations adopted under
these Acts.
In the United States, USDA-FSIS regulates meat, poultry and egg products.
The remaining foods are regulated by HHS-FDA. As a result, imported
meat, poultry and egg products are not covered by the Bioterrorism Act
and are not subject to the HHS-FDA’s prior notice requirements
(unless they are being imported for use in animal feed). Products
that have in the past been presented to USDA-FSIS for port-of-entry
reinspection will continue to be presented to USDA-FSIS in the future
and no prior notice will be required.
Facts
In summary, the following conditions outline how countries exporting
meat, poultry and egg products are affected by HHS-FDA’s two new
rules:
- Facilities producing, handling or transporting only
meat, poultry or egg products for human consumption are regulated
exclusively by the USDA-FSIS and therefore do not need
to be registered with HHS-FDA under the Bioterrorism Act or give
prior notice of shipment.
- If facilities handle HHS-FDA regulated food products as well as
USDA-FSIS regulated products then they must comply with HHS-FDA’s
two new rules only for the HHS-FDA regulated products. The meat, poultry and egg products do not need prior registration or prior notice even if the company exports other food products.
- The only meat, poultry and egg products that do not fall under USDA-FSIS oversight are products that contain 3% or less raw meat; less than 2% cooked meat; or less than 2% cooked poultry meat. Facilities producing products in these categories should comply with HHS-FDA regulations.
FSIS’ Requirements
FSIS does have a registration and record keeping requirement of its
own that has been in effect since 1970. All meat brokers, poultry
products brokers, official establishments and carriers and importers
of poultry or livestock carcasses are required to keep business records
and make them available to USDA-FSIS employees upon request.
On June 25, 2003, USDA-FSIS announced in the Federal Register that a new
registration form had been developed, which contains certain information
that was not required on the previous form. All parties that are required to register, including those that are currently registered, must complete the new form and submit it to USDA-FSIS by March 22, 2004.
Background
On October 10, 2003, HHS-FDA published two interim final regulations to
implement its portion of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act). These
become effective on December 12, 2003.
The first regulation requires that food facilities (other than facilities
that produce meat, poultry, or egg products for human consumption)
exporting to the United States register with HHS-FDA by December 12,
2003. The second regulation is the prior notice rule. Under this
rule’s provisions, if an HHS-FDA regulated food product is shipped
to the United States then there must be a two-hour notice for shipments
arriving by road; a four-hour notice for shipments arriving by air or
by rail; and an eight-hour notice for shipments arriving by water.
On November 20, 2003, HHS-FDA issued guidance to industry on the
implementation of this new prior notice requirement. This guidance
focused on U.S. Bureau of Customs and Border Protection’s (CBP)
Harmonized Tariff Schedule (HTS) codes, which are used to identify
imported products in their import data base. HHS-FDA has identified
certain HTS codes as requiring prior notice under the Bioterrorism
Act. Two tag codes have been assigned by HHS-FDA: FD4, which
indicates to CBP that the imported food will
require prior notice, and FD3, which indicates to CBP that the
imported food might require prior notice.
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Tag Codes Which Indicate Whether or Not Imported Food Will
Require Prior Notice |
| FD3
&150; Might Require Prior Notice |
FD4
&150; Requires Prior Notice |
| Imported
foods with a tag code of FD3 would include products such
as: meat, poultry, and egg products, food with 3% or less
raw meat; less than 2% cooked meat; or less than 2% cooked
poultry and tallow oil. |
Imported
foods with a tag code of FD4 would include products such
as: dairy, cheeses, seafood, pasta, fruits, vegetables
and shell eggs. |
Frequently Asked Questions
Q: In HHS-FDA’s November 20, 2003, guidance to
industry on prior notices of imported foods, many Harmonized Tariff
Schedule (HTS) codes were flagged with prior notice indicator FD3.
Some of these FD3 products clearly appear to be meat or poultry for
human consumption. Does that mean exporting countries and U.S.
importers or brokers must provide prior notice of these meat or
poultry imports to the HHS-FDA?
A: No. Imported meat and poultry products for human
consumption continue to be regulated by USDA-FSIS, not HHS-FDA, and will
continue to be presented to USDA-FSIS for reinspection. The FD3 coding
simply means the product might or might not require prior notice to
HHS-FDA. The classification was applied to some HTS codes in recognition
of the fact that USDA-FSIS does not regulate certain products that
contain only a small percentage of meat or poultry that traditionally
have not been considered meat or poultry products, or products that
are intended for use in animal feed. Products not regulated by
USDA-FSIS inspection are subject to HHS-FDA inspection and thus
are bound to all applicable requirements of the Bioterrorism Act,
including prior notice requirements.
Q: Which products that contain meat or poultry
ingredients are not regulated by USDA-FSIS and these would be
regulated under HHS-FDA’s inspection and prior notice requirements?
A: Any products that contain 3% or less raw meat;
less than 2% cooked meat; or less than 2% cooked poultry meat for human
consumption, unless they are regulated as a meat or poultry product.
Q: So does that mean if my product contains more meat
or poultry than the threshold described above then it will not be
regulated by HHS-FDA and will not be subject to prior notice
requirements?
A: Yes. Products containing more than the relatively
small amounts of meat or poultry described above are not covered by
the Bioterrorism Act, are not subject to HHS-FDA’s prior notice
requirements and will continue to be presented to USDA-FSIS for
port-of entry reinspection as has always been the case.
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