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New FDA Food Facility Registration & Recording Keeping Requirements Will Affect the Bottled Water Industry
As a result of the events of Sept. 11, 2001, Congress passed
and President Bush signed the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. The U.S. Food and Drug Administration (FDA)
is responsible for carrying out certain provisions of the Bioterrorism Act
including Title III, Subtitle A (Protection of Food Supply). Because bottled
water is regulated as a food by the FDA, the bottled water industry will be
required to comply with these new regulations. 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
303: administrative detention,
305: the registration of food and animal feed facilities,
306: the establishment and maintenance of records, and
307: prior notice of imported food shipments.
While all the sections have impact on the bottled water
industry, discussion in this article will be limited to the Registration
(Section 305) and Records Maintenance (Section 306) proposed rules. This
article includes discussion of the broad industry impact of these regulations
as a whole, an overview of key aspects from each rule and a timetable of
anticipated important dates.
Before delving into the details of each of these proposed
rules, it is important to put their potential widespread impact into
perspective. These regulations apply to anyone who manufactures, processes,
packs or holds food for human or animal consumption in the United States
whether engaged in interstate or intrastate commerce. In drafting these
regulations FDA has chosen to apply the broad definition of "food"
from Section 201(F) of the Federal Food Drug and Cosmetic Act. The use of this
definition includes food contact substances, ingredients, raw agricultural
commodities and alcoholic beverages. Therefore, compliance with these
regulations could be required by each facility that manufactures, processes,
packs or holds food in addition to each facility that manufactures, process,
packs or holds an item used as an ingredient and/or packaging material for a
food product. Many industries have submitted comments requesting FDA to clarify
and narrow the scope of "facilities" required to comply with these
regulations. FDA’s decision regarding these comments will not be known
until issuance of these final rules, which will occur between October and
December of this year.
On Jan. 29, 2003, the FDA announced its proposed regulations
for the Registration of Food Facilities. The proposed regulation would require
domestic and foreign food facilities that manufacture, process, pack or hold
food for human or animal consumption in the United States to register with the
agency between Oct. 12 and Dec. 12, 2003. (The FDA defines facility as any
factory, warehouse or establishment of an importer that manufactures,
processes, packs, or holds food for human or animal consumption.) Except for
specific exemptions, the new regulations would apply to all facilities for all
foods and animal feed products regulated by FDA including dietary supplements,
infant formula, beverages (including alcoholic beverages) and food additives.
Each facility as defined in the rule would be required to
register with FDA either online or via mail and provide the following
name, full address, phone number, fax number and e-mail address of the
name and address of the parent company, if the facility is a subsidiary of the
contact information including an individual’s name, title, office phone,
home phone, cell phone (if available) and e-mail address (if available).
trade names the facility uses.
categories as identified in 21 CFR Part 170.3.
a foreign facility, the name, address, phone number, fax number (if available)
and e-mail address (if available) of its U.S. agent.
statement certifying that the information submitted is true and accurate and
that the person submitting the registration is authorized by the facility to
register on its behalf. The statement requires the name of the person
registering the facility. This statement also requires the phone number, e-mail
address (if available) and fax number (if available) of the person submitting
Failure to register by Dec. 12, 2003, would result in civil
actions and criminal prosecutions. Imported foods from non-registered
facilities would be held at port and/or moved to a secure location at the
private parties expense.
A few types of facilities are proposed to be exempt from the
registration requirement. These include farms, retail food operations,
restaurants, nonprofit operations that prepare food for or serve food directly
to consumers, fishing vessels not engaged in processing, facilities regulated
exclusively throughout the entire facility by the U.S. Department of
Agriculture and some ingredient food processors not shipping directly to the United
Final rules are anticipated to be issued by Oct. 12, 2003.
These rules are to include details on how to register. If FDA should be unable
to finalize these regulations, however, food facilities still are required to
provide required information to FDA by the Dec. 12, 2003, deadline per the
Bioterrorism Act regulations passed by Congress.
On May 6, 2003, the FDA announced proposed regulations for
the Establishment and Maintenance of Records. The record-keeping proposal is
designed to help FDA track foods implicated in future emergencies such as
terrorism-related contamination. As proposed, the rules would require
facilities that manufacturer, process, pack, distribute, receive, hold or
import food destined for consumption in the United States to keep records
identifying the immediate source from which they received the food as well as
the immediate subsequent recipient to whom they sent it. This regulation
requires records to be kept on files for up to two years and would apply to
most foreign and domestic food sources and recipients of food destined for
consumption in the United States.
A few types of facilities are proposed to be exempt from the
registration requirement. These include farms, restaurants, non-profit
operations that prepare food for or serve food directly to consumers, fishing
vessels not engaged in processing and facilities regulated exclusively by the
U.S. Department of Agriculture. The proposed rule would require all
businesses--with the exception of small and very small businesses--to comply
with the final rule six months from publication. Small businesses (fewer than
500 but more than 10 full-time equivalent employees) would have to comply
within 12 months from publication of the final rule. Very small businesses (10
or fewer full-time equivalent employees) would have to comply within 18 months
from publication of the final rule. Final rules are expected to be published by
Dec. 12, 2003.
While subject to change based on final rules and publication
dates, the timeline on the previous page provides a rough timeline of the
important dates associated with these two rules.
For more information regarding these two rules as well as
the other sections of the Bioterrorism Act Title III, Subtitle A go to the FDA
website at www.fda.gov/oc/bioterrorism/bioact.html.
Keeping up with government regulations is a necessity, but
it is not always an easy process. Companies must be diligent in this regard or
maintain business relationships with reliable sources of regulatory information
in order to avoid noncompliance.
Note: If the
final rule for the Establishment and Maintenance of Records is published before
or after Dec. 12, 2003, the record-keeping deadline dates would need to be