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Four provisions in Title III, Subtitle A, of the Act
require the Secretary of Health and Human Services, through FDA, to
propose and issue final food regulations. These four provisions are:
Unless exempted, these provisions apply to all types
of food products regulated by FDA, including dietary supplements
and animal feed.
The Bioterrorism Act establishes ambitious deadlines
for most of the provisions that require proposed and final regulations.
FDA is committed to meet these deadlines. The Agency's goal is to
publish proposed regulations by the end of the 2002 calendar year,
and to offer an adequate comment period. During the comment period,
we plan to hold several public meetings at various locations across
the country to explain the proposed regulatory requirements and receive
additional comments.
Before issuing these proposed rules, FDA sought to identify
stakeholders' concerns and potential options for addressing them.
Between July 29 and August 16, 2002, the Agency held meetings to brief
constituents on the Act and began hearing concerns and suggestions.
We have opened public dockets for each food regulation
and are ready to receive your comments now. Comments will be most
helpful if you not only identify any concerns you may have, but also
provide your recommended solution and any supporting data, if applicable.
These comments will be included with other comments received in response
to the proposed regulation.
For a list of FDA contacts for each regulation, see
FDA's stakeholder
letter.
Docket No. 02N-0275 Section
303 (Detention)
Section 303 (Administrative Detention) authorizes the Secretary of
Health and Human Services, through FDA, to order the detention of
food if an officer or qualified employee has credible evidence or
information indicating an article of food presents a threat of serious
adverse health consequences or death to humans or animals. The Act
requires the Secretary, through FDA, to issue final regulations to
expedite enforcement actions on perishable foods. No time frame is
specified.
View
comments submitted to this docket.
Submit written comments in duplicate [individuals may
submit one copy] to:
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
ATTN: Docket No. 02N-0275
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Docket No. 02N-0276, Section
305 (Registration)
Section 305 (Registration of Food Facilities) requires the owner,
operator, or agent in charge of a domestic or foreign facility to
register with FDA no later than Dec. 12, 2003. Facilities are defined
as any factory, warehouse, or establishment, including importers.
While FDA expects to issue regulations by this date, food facilities
must register by this date even if regulations have not been issued.
View
comments submitted to this docket.
Submit written comments in duplicate [individuals may
submit one copy] to:
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
ATTN: Docket No. 02N-0276
[top]
Docket No. 02N-0277 Section
306 (Recordkeeping)
Section 306 (Establishment and Maintenance of Records) requires the
Secretary of Health and Human Services to establish requirements by
Dec. 12, 2003 for the creation and maintenance of records needed to
determine the immediate previous sources and the immediate subsequent
recipients of food, (i.e., one up, one down). Such records are to
allow FDA to address credible threats of serious adverse health consequences
or death to humans or animals. Entities subject to these provisions
are those that manufacture, process, pack, transport, distribute,
receive, hold or import food. Farms and restaurants are exempt from
these requirements.
View
comments submitted to this docket.
Submit written comments in duplicate [individuals may
submit one copy] to:
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
ATTN: Docket No. 02N-0277
[top]
Docket No. 02N-0278 Section
307 (Prior Notice)
Section 307 (Prior Notice of Imported Food Shipments) requires that
prior notice of imported food shipments be given to FDA. The notice
must include a description of the article, the manufacturer and shipper,
the grower (if known), the country of origin, the country from which
the article is shipped, and the anticipated port of entry. The Secretary
of Health and Human Services, through FDA, must issue final regulations
by Dec. 12, 2003. While FDA fully expects regulations to be issued
by this date, if such regulations are not issued, the statute still
requires importers to provide no less than 8 hours and no more than
5 days notice to FDA until the regulation takes effect.
View
comments submitted to this docket.
Submit written comments in duplicate [individuals may
submit one copy] to:
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
ATTN: Docket No. 02N-0278
[top]
Additional References:
Informal
Summary of the Provisions of Title III, Subtitle A & Pertinent
Sections of Subtitle B
Good
Guidance Practice Regulations (21 CFR 10.115)
Stakeholder Letter
to the FDA Foods Community (July 17, 2002)
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