[Federal Register Volume 68, Number 197 (Friday, October 10, 2003)]
[Rules and Regulations]
[Pages 58894-58974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25849]
[[Page 58893]]
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Part VI
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 1 and 20
Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002; Interim Rule
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002; Interim Rule
Risk Assessment for Food Terrorism and Other Food Safety Concerns;
Availability; Notice
Federal Register / Vol. 68, No. 197 / Friday, October 10, 2003 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1 and 20
[Docket No. 02N-0276]
RIN 0910-AC40
Registration of Food Facilities Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim
final regulation that requires domestic and foreign facilities that
manufacture/process, pack, or hold food for human or animal consumption
in the United States to register with FDA by December 12, 2003. The
interim final rule implements the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act), which requires domestic and foreign facilities to register with
FDA by December 12, 2003, even in the absence of a final regulation.
Registration is one of several tools that will enable FDA to act
quickly in responding to a threatened or actual terrorist attack on the
U.S. food supply by giving FDA information about facilities that
manufacture/process, pack, or hold food for consumption in the United
States. In the event of an outbreak of foodborne illness, such
information will help FDA and other authorities determine the source
and cause of the event. In addition, the registration information will
enable FDA to notify quickly the facilities that might be affected by
the outbreak.
DATES: This interim final rule is effective December 12, 2003. Submit
written or electronic comments by December 24, 2003.
FOR FURTHER INFORMATION CONTACT: Leslye M. Fraser, Center for Food
Safety and Applied Nutrition (HFS-4), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2378.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background and Legal Authority
II. Highlights of the Interim Final Rule and Summary of the
Significant Changes Made to the Proposed Rule
III. Comments on the Proposed Rule
A. General Comments
B. Foreign Trade Issues
C. Comments on ``Who Must Register Under This Subpart?''
(Proposed Sec. 1.225)
D. Comments on ``Who is Exempt from This Subpart?'' (Proposed
Sec. 1.226)
E. Comments on ``What Definitions Apply to This Subpart?''
(Proposed Sec. 1.227)
F. Comments on ``When Must You Register?'' (Proposed Sec.
1.230)
G. Comments on ``How and Where Do You Register?'' (Proposed
Sec. 1.231)
H. Comments on ``What Information is Required in the
Registration?'' (Proposed Sec. 1.232)
I. Comments on ``What Optional Items are Included in the
Registration Form?'' (Proposed Sec. 1.233)
J. Comments on ``How and When Do You Update Your Registration
Information?'' (Proposed Sec. 1.234)
K. Comments on ``What Other Registration Requirements Apply?''
(Proposed Sec. 1.240)
L. Comments on ``What Happens if You Fail to Register?''
(Proposed Sec. 1.241)
M. Comments on ``What Does Assignment of a Registration Number
Mean?'' (Proposed Sec. 1.242)
N. Comments on ``Is Food Registration Information Available to
the Public?'' (Proposed Sec. 1.243)
IV. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
V. Final Regulatory Flexibility Analysis
VI. Unfunded Mandates
VII. Small Business Regulatory Enforcement Fairness Act (SBREFA)
Major Rule
VIII. Paperwork Reduction Act of 1995
IX. Request for Comments
X. Analysis of Environmental Impact
XI. Federalism
XII. References
I. Background and Legal Authority
On February 3, 2003 (68 FR 5378), FDA and the Department of the
Treasury jointly issued a proposed rule requiring certain food
facilities to register with FDA. The events of September 11, 2001, had
highlighted the need to enhance the security of the infrastructure of
the United States, including the food supply. Congress had responded by
enacting the Bioterrorism Act (Pub. L. 107-188), which was signed into
law on June 12, 2002. The Bioterrorism Act includes a provision in
title III (Protecting Safety and Security of Food and Drug Supply),
Subtitle A--Protection of Food Supply, section 305, which requires the
Secretary of Health and Human Services (the Secretary) to develop a
regulation to require domestic and foreign facilities that manufacture,
process, pack, or hold food for consumption in the United States to
register with FDA by December 12, 2003. The provision creates section
415 and amends sections 301 and 801 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 331 and 381). The Bioterrorism
Act also requires FDA to issue regulations mandating prior notice of
imported food shipments (section 307), directs FDA to issue regulations
regarding the maintenance of certain records (section 306), and grants
FDA the authority to administratively detain food (section 303). FDA
and the Department of the Treasury have jointly published proposed
rules implementing section 307 (68 FR 5428, February 3, 2003), and FDA
has published proposed rules implementing section 303 (68 FR 25242, May
9, 2003), and section 306 (68 FR 25188, May 9, 2003). The prior notice
interim final rule appears elsewhere in this issue of the Federal
Register.
The major components of section 305 of the Bioterrorism Act are as
follows:
[sbull] The owner, operator, or agent in charge of a facility is
responsible for the submission of a registration to FDA;
[sbull] Each facility must be separately registered and the
registration must include the name and address of the facility, and all
trade names under which the registrant conducts business from that
facility. The registration for foreign facilities also must include the
name of the U.S. agent for the facility;
[sbull] FDA also may require each registration to include the
general food category (as identified under Sec. 170.3 (21 CFR 170.3))
of the food manufactured, processed, packed, or held at the facility,
if FDA determines through guidance that this submission is necessary.
FDA issued guidance on July 17, 2003 (68 FR 42415), available at http://www.fda.gov/oc/bioterrorism/bioact.html, that concluded that
information about food product categories is necessary for a quick,
accurate, and focused response to an actual or potential bioterrorist
incident or other food-related emergency;
[sbull] Foreign facilities that manufacture/process, pack, or hold
food that is exported for consumption in the United States are required
to register unless the food undergoes further processing or packaging
at another facility outside the United States;
[sbull] Establishments excluded from the registration requirement
are farms, restaurants and other retail food establishments, nonprofit
food establishments, and fishing vessels (except those engaged in
processing as defined in Sec. 123.3(k) (21 CFR 123.3(k));
[sbull] FDA shall notify the registrant when it has received the
registration
[[Page 58895]]
and assign a unique registration number to each registered facility;
[sbull] FDA may encourage electronic registration;
[sbull] Registered facilities must notify FDA in a timely manner of
changes to their registration information;
[sbull] FDA is required to compile and maintain an up-to-date list
of registered facilities; and
[sbull] FDA's list of facilities and registration documents are not
subject to public disclosure under 5 U.S.C. 552 (the Freedom of
Information Act). Information derived from this list or these documents
is also not subject to such disclosure to the extent that it discloses
the identity or location of a specific registered facility.
In addition to section 305 of the Bioterrorism Act, FDA is relying
on section 701(a) and (b) of the FD&C Act (21 U.S.C. 371(a) and (b)) in
issuing this interim final rule. Section 701(a) authorizes the agency
to issue regulations for the efficient enforcement of the act, while
section 701(b) of the FD&C Act authorizes FDA and the Department of
Treasury jointly to prescribe regulations for the efficient enforcement
of section 801 of the FD&C Act (21 U.S.C. 381).
This interim final rule implements the food facility registration
requirements in section 305 of the Bioterrorism Act. Elsewhere in this
issue of the Federal Register, FDA is issuing an interim final rule
implementing section 307 (prior notice of imported food). The two
interim final rules published in this issue of the Federal Register, as
well as the regulations FDA will issue to implement section 306
(recordkeeping/records access) and section 303 (administrative
detention) of the Bioterrorism Act, will help FDA act quickly in
responding to a threatened or actual bioterrorist attack on the U.S.
food supply or to other food-related emergencies. Registration will
provide FDA with information about facilities that manufacture/process,
pack, or hold food for consumption in the United States. In the event
of an outbreak of foodborne illness, such information will help FDA and
other authorities determine the source and cause of the event. In
addition, the registration information will enable FDA to notify more
quickly the facilities that might be affected by the outbreak. In
developing this interim final rule, FDA has complied with its
international trade obligations, including the applicable World Trade
Organization (WTO) agreements and the North American Free Trade
Agreement (NAFTA).
II. Highlights of the Interim Final Rule and Summary of the Significant
Changes Made to the Proposed Rule
A. The Highlights of This Interim Final Rule Are Described Briefly
Below and Are Discussed in More Detail Later in the Preamble
The highlights of this interim final rule are as follows:
[sbull] The owner, operator, or agent in charge of a facility
engaged in manufacturing/processing, packing, or holding food for
consumption in the United States by humans or animals is responsible
for registering the facility with FDA;
[sbull] The owner, operator, or agent in charge of a facility that
is required to register may authorize an individual to submit the
facility's registration to FDA;
[sbull] Facilities covered under this rule must be registered by
December 12, 2003;
[sbull] A foreign facility is exempt from registering if food from
the facility undergoes further processing or packaging by another
facility outside the United States. The facility is not exempt from
registration if the processing or packaging activities of the
subsequent facility are limited to affixing a label to a package or
other de minimis activity. The facility that conducts the de minimis
activity also must register;
[sbull] The following domestic and foreign facilities are also
exempt from registration: Farms; restaurants and other retail food
establishments; nonprofit food facilities that prepare or serve food
directly to the consumer or otherwise provide food or meals for
consumption by humans or animals in the United States; fishing vessels
not engaged in processing as defined in Sec. 123.3(k); and facilities
regulated exclusively, throughout the entire facility, by the U.S.
Department of Agriculture (USDA) under the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.);
[sbull] Registrants must use Form 3537 to register. This form is
available either on the Internet (see address below) or via mail or
phone request. FDA will begin processing paper registrations on October
16, 2003. Registrants must use Form 3537a to cancel their registration;
[sbull] FDA strongly encourages electronic registration, which will
be quicker and more convenient for both facilities and FDA than
registration by mail or CD-ROM;
[sbull] To register electronically, beginning on October 16, 2003,
a registrant may visit http://www.fda.gov/furls, which is available for
registration 24 hours a day, 7 days a week. This Web site is available
from wherever the Internet is accessible, including libraries, copy
centers, schools, and Internet cafes, as well as through a foreign
facility's U.S. agent or other authorized individual if the facility
makes such arrangements;
[sbull] Regardless of the mode of submission (electronic, paper, or
CD-ROM), each registration must include the name and contact
information for the facility and its parent company (if applicable);
all trade names the facility uses; applicable food product categories
as identified in Sec. 170.3 of this chapter; a 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; and if a foreign facility, the name of and contact
information for the facility's U.S. agent. A domestic facility must
provide emergency contact information;
[sbull] No registration fee is required;
[sbull] Updates to registration information or cancellation of
registration must be submitted within 60 calendar days of any change to
any of the required information previously submitted;
[sbull] Failure of a domestic or foreign facility to register,
update, or cancel its registration in accordance with this regulation
is a prohibited act under section 301(dd) of the FD&C Act;
[sbull] The disposition of food imported or offered for import from
an unregistered foreign facility will be governed by the procedures set
out in subpart I of this part 1 (21 CFR part 1) (Prior Notice of
Imported Food); and
[sbull] Assignment of a registration number to a facility means
that the facility is registered with FDA. Assignment of a registration
number does not in any way convey FDA's approval or endorsement of a
facility or its products.
B. Significant Changes Made to the Proposed Rule
The significant changes FDA made to the proposed rule are as
follows:
[sbull] The interim final rule provides that private residences of
individuals and nonbottled water drinking water collection and
distribution establishments and structures are not facilities and,
therefore, are not required to register;
[sbull] The interim final rule clarifies that transport vehicles
are not facilities if they hold food only in the usual course of
business as carriers;
[sbull] The definition of farm now states that washing, trimming of
outer leaves, and cooling produce are part of harvesting;
[[Page 58896]]
[sbull] The definition of farm now includes facilities that pack or
hold food, provided that all food used in such activities is grown,
raised, or consumed on that farm or another farm under the same
ownership;
[sbull] The definition of food for purposes of the Bioterrorism Act
excludes food contact substances as defined in section 409(h)(6) of the
FD&C Act (21 U.S.C. 348(h)(6)) and pesticides as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136(u);
[sbull] Packaging (when used as a verb) has been defined and means
``placing food into the container that directly contacts the food and
that the consumer receives;''
[sbull] The definition of ``retail food establishment'' has been
revised to
an establishment that sells food products directly to consumers as
its primary function. A retail establishment may manufacture/
process, pack, or hold food if the establishment's primary function
is to sell from that establishment food that it manufactures/
processes, packs, or holds directly to consumers. A retail food
establishment's primary function is to sell food directly to
consumers if the annual monetary value of sales of food products
directly to the consumers exceeds the annual monetary value of sales
of food products to all other buyers. The term `consumers' does not
include businesses. A `retail food establishment' includes grocery
stores, convenience stores, and vending machine locations.
[sbull] FDA has added a definition for ``trade name'' as ``the name
or names under which the facility conducts business, or additional
names by which the facility is known. A trade name is associated with a
facility, and a brand name is associated with a product;''
[sbull] FDA has determined that it will contact the foreign
facility's U.S. agent when an emergency occurs, unless the registration
specifies another emergency contact under Sec. 1.233(b);
[sbull] FDA is clarifying that having a single U.S. agent for FDA
registration purposes does not preclude facilities from having multiple
agents (such as foreign suppliers) for other business purposes. A
firm's commercial business in the United States need not be conducted
through the U.S. agent designated for purposes of registration;
[sbull] FDA is allowing registrants to submit their registrations
by fax or CD-ROM, which FDA will enter into its registration system,
along with the mailed submissions, as soon as practicable, in the order
received;
[sbull] FDA has changed the timeframe in which registrants must
update their registrations from 30 days to within 60 days of any change
in the required information;
[sbull] FDA has deleted the requirement to update optional
information previously submitted, but encourages facilities to do so
voluntarily; and
[sbull] FDA has clarified that if a facility has a new owner, the
former owner must submit a cancellation within 60 calendar days of the
change and the new owner must re-register the facility.
[sbull] FDA now provides that the failure of an owner, operator, or
agent in charge of a facility governed by this interim final rule to
register such facility, update required elements of its registration,
or cancel its registration, is a prohibited act under section 301(dd)
of the FD&C Act (21 U.S.C. 331(dd)).
III. Comments on the Proposed Rule
FDA received approximately 350 submissions in response to the
proposed rule, which raised almost 200 major issues. To make it easier
to identify comments and FDA's responses to the comments, the word
``Comment'' will appear in parentheses before the description of the
comment, and the word ``Response'' will appear in parentheses before
FDA's response. FDA has also numbered each comment to make it easier to
identify a particular comment. The number assigned to each comment is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which it was submitted.
A. General Comments
(Comment 1) Most commenters state that they generally support
protection of the U.S. food supply under the Bioterrorism Act. Although
some commenters assert that the proposed rule should be amended to
reflect more accurately industry practices, other commenters believe
the regulation should be strengthened to ensure that FDA has all the
information required to identify foods that may pose a health or
security threat. Other commenters question how the interim final rule
would enhance FDA's ability to improve food safety and whether the
benefits outweigh the costs.
Some commenters argue that the proposed regulation should either be
reproposed or not implemented at all. These commenters claim that the
proposed rule is seriously flawed, unduly burdensome, and will
unnecessarily interfere with trade. Some of these commenters also argue
that FDA already has complete information to allow for identification
of, and quick communication with, affected facilities before a shipment
is introduced into U.S. commerce.
(Response) In response to the comments regarding reproposing or not
implementing the rule, these options are not available to FDA under the
Bioterrorism Act, because that act requires FDA to ``promulgate
proposed and final regulations for the requirement of registration'' by
December 12, 2003. The Bioterrorism Act further states that the
registration requirement takes effect on December 12, 2003, even if FDA
does not have a final regulation in effect by the deadline. FDA
believes that both the proposed rule and this interim final rule
properly implement section 305 of the Bioterrorism Act, and thus, there
is no need to repropose the regulation. Further, based on the many
comments supporting the proposed regulation as well as those comments
suggesting limited changes to the rule as proposed, FDA disagrees that
the proposed regulation is so flawed that reproposal is required.
FDA is aware that the registration regulation may alter industry
practices to some extent. In enacting the Bioterrorism Act, Congress
determined that registration with FDA was necessary to respond to
bioterrorism and other food-related emergencies. Registration will give
FDA information it does not currently have about facilities that
manufacture/process, pack, or hold food for consumption in the United
States, and current contact information for all of these facilities.
FDA will be able to use this information to target its contacts to both
domestic and foreign facilities in the event of a bioterrorist threat
or other food-related emergency. Information about food product
categories will permit FDA to screen food imports more carefully
because the agency will be able to match a registrant's food product
category with the product code and common or usual or market name
submitted as part of a prior notice (21 CFR part 1, subpart I).
Registration will also give FDA information that we can use to focus
and better utilize the agency's limited inspection resources.
Registering with FDA creates an information trail, which would,
even if the information in the registration were falsified, provide
evidence that could link the registration to the registrant. By
creating this paper trail, persons in the food supply chain who might
intentionally contaminate food may be deterred by the creation of
additional evidence that might be used against them. Persons who might
intentionally contaminate the food supply but refuse to register would
be subject to criminal and civil sanctions and would risk having their
product, if imported, held at the port.
[[Page 58897]]
To alleviate some of the burden registration may impose on
industry, FDA has modified some of the elements of registration,
including emergency contact information; the definitions for ``farm,''
``facility,'' and ``retail food establishment,'' and the timing for
submitting updates to FDA when required elements in a registration
change. These changes will be discussed in the appropriate sections
later in this document.
FDA also believes that its electronic registration system will make
registration an efficient and straightforward process. FDA has received
positive comments from stakeholders who attended FDA's preliminary
demonstrations of the electronic prototype registration system.
(Comment 2) Some commenters request that FDA include a provision in
the interim final rule that permits the agency to amend the system
quickly to respond to flaws in the rule discovered through practice.
Some of these commenters state that this arrangement would be
especially helpful for countries that are able to reach a more
efficient or effective registration arrangement with FDA that reflects
actual reductions in risks through such arrangements.
(Response) FDA always has the option to amend its regulations if
the agency believes that improvements would serve the public interest,
and interested persons may request such modification by following the
procedures in 21 CFR 10.30, regarding citizen petitions. The process
for any amendment to an existing FDA regulation must conform to the
requirements of the Administrative Procedure Act (APA) (5 U.S.C. 551-
559). Notably, section 553 of the APA provides a process for issuing a
final rule in an expedited timeframe if certain conditions are met.
Importantly, however, FDA can only amend the interim final registration
rule consistent with the requirements in the Bioterrorism Act.
(Comment 3) FDA received several comments about the need for
outreach efforts regarding the registration requirement. Some
commenters encourage FDA to facilitate education regarding the new rule
and to provide foreign facilities with information necessary to
maintain the flow of trade to the United States. Other commenters
encourage FDA to develop clear, definitive statements that outline
registration requirements in a simple manner. Some commenters ask about
the role of States in the outreach strategy. One commenter recommends
that FDA reach out to State agencies and the relevant media to ensure
that all affected industries are aware of the registration requirement.
Finally, some commenters request that FDA establish consultation
services staffed with both English and foreign language speakers to
answer questions about the registration system and requirements and to
give technical assistance to help foreign facilities meet the
requirements of the regulation.
(Response) FDA conducted extensive outreach on the proposed
registration rule, including having relevant FDA staff attend 6
international meetings and over 100 domestic meetings to ensure that
affected parties were aware of the Bioterrorism Act registration
requirement. On January 29, 2003, FDA held a public meeting (via
satellite downlink) to discuss the registration and prior notice
proposed rules. (See 68 FR 1568, January 13, 2003, or http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.) Nearly 1,000
participants in North and South America and the Caribbean viewed that
live broadcast. The meeting was later rebroadcast to Europe, Asia,
Africa, and the Pacific (areas in different time zones). FDA has also
provided transcripts of the broadcast in English, French, and Spanish
(the three official WTO languages) on the agency's Web site. In
addition to this outreach to the affected industry, FDA has conducted
outreach on the proposed rule to States.
FDA plans similar outreach directed to both domestic and
international stakeholders following publication of the interim final
rules implementing the registration and prior notice provisions of the
Bioterrorism Act. Our outreach will include:
[sbull] Dissemination of materials to guide affected domestic and
international food facilities through the new processes established to
implement the registration and prior notice requirements of the
Bioterrorism Act;
[sbull] A satellite downlink video broadcast and a series of
videoconferences to various regions of the world;
[sbull] Materials and events for the media;
[sbull] Domestic outreach meetings to States and industry;
[sbull] International outreach to U.S. trading partners;
[sbull] Online assistance to registrants;
[sbull] Presentations by FDA officials and exhibits at professional
and trade conferences and meetings to inform industry and State and
local government representatives of the new regulations and their
requirements; and
[sbull] Cooperative arrangements with Customs and Border Protection
(CBP) and other Federal agencies to ensure that information on the
final regulations and their requirements is disseminated to affected
companies and individuals.
More specifics regarding each of these will be included on FDA's
Web site at http://www.fda.gov/oc/bioterrorism/bioact.html.
FDA will notify the WTO of these regulations. In addition, shortly
after publication of this interim final rule, FDA will begin
disseminating at the U.S. ports of entry flyers and posters summarizing
the new requirements and informing representatives of affected
facilities how to register and provide prior notice to FDA.
(Comment 4) One commenter suggests that FDA should utilize State
resources to cross-reference with its registration database. This
commenter suggests that FDA supply States with copies of registration
forms that the State inspectors can give to local facilities during
routine inspections, but cautions that FDA should supply the forms so
as not to deplete State funds.
(Response) FDA agrees with the commenter's suggestion that FDA
should use State resources to cross-reference registrations, and will
work with States to do so. FDA believes working in cooperation with our
State partners will enhance our collective ability to protect the
safety of the U.S. food supply, and our ability to work with facilities
in the event of an actual or potential threat against a facility or
food product. FDA acknowledges the suggestion that the agency should
supply States with copies of the FDA registration form for distribution
to potential registrants. However, because FDA is trying to encourage
as many registrants as possible to register electronically, FDA intends
to make paper forms available only through the methods described in
this rule. FDA intends to work with States to disseminate information
about the Federal registration requirements.
B. Foreign Trade Issues
(Comment 5) Some commenters questioned the consistency of the
proposed regulation with U.S. obligations under the NAFTA and various
WTO agreements.
(Response) FDA is aware of the international trade obligations of
the United States and has considered these obligations throughout the
rulemaking process for this regulation. As noted below, FDA believes
that these regulations are consistent with these international trade
obligations.
(Comment 6) Some commenters asserted that the proposed regulation
is burdensome, costly, discriminatory, and will have a negative impact
on foreign trade.
[[Page 58898]]
(Response) In drafting the interim final rule, FDA structured the
rule to be consistent with the statutory mandates of the Bioterrorism
Act and, at the same time, to reduce the costs associated with
compliance. As discussed in more detail later in the preamble, FDA
carefully considered comments received regarding the burden imposed by
the proposed rule, including its impact on international trade. The
agency has made a number of changes in the interim final rule that are
both consistent with FDA's statutory mandate and that will make it
easier and less costly for covered facilities (foreign or domestic) to
register. In addition, the interim final rule exempts certain
establishments from the registration requirement that, under the rule
as proposed, would have been required to register. For example:
[sbull] FDA has changed the definition of ``food'' for purposes of
the Bioterrorism Act to exclude food contact substances as defined in
section 409(h)(6) of the FD&C Act and pesticides as defined in FIFRA (7
U.S.C. 136(u)).
[sbull] FDA has broadened the definition of ``farm'' to include the
activities of harvesting, and the rule considers washing, trimming of
outer leaves, and cooling of crops on a farm to be harvesting. Also, in
the interim final rule, ``farm'' includes facilities that pack or hold
food, provided that all food used in such activities is grown, raised,
or consumed on that farm or another farm under the same ownership.
[sbull] FDA is clarifying that having a single U.S. agent for FDA
registration purposes does not preclude facilities from having multiple
agents (such as foreign suppliers) for other business purposes.
[sbull] The interim final rule allows registrants to submit their
registrations by fax or CD-ROM, which FDA will enter into its
registration system, along with the mailed submissions, as soon as
practicable, in the order received.
[sbull] FDA has extended the timeframe in which registrants must
update their registrations from 30 to 60 days of any change in the
required information.
[sbull] FDA has deleted the requirement to update optional
information previously submitted.
C. Comments on Who Must Register Under This Subpart? (Proposed Sec.
1.225)
(Comment 7) Some commenters disputed the statement in the proposed
rule that [i]ndividual homes are not subject to the regulation if the
food that is manufactured/processed, packed, or held in the home does
not enter commerce.'' (68 FR 5378). These commenters argue that under
this limited exclusion for homes, individuals, such as Girl Scout and
Boy Scout volunteer parents, individuals who prepare food in their
homes for functions such as church bake sales, and individuals who
temporarily store food in their homes as sales samples or small
inventories of product for delivery to rural retailers would be
required to register because they often hold in their homes food
products destined for further movement through commerce. The commenters
argue that the Bioterrorism Act does not mention individual residences
in the scope of facilities that manufacture, process, pack, or hold
food and asserts that Congress did not intend that the registration
requirements compel ordinary citizens to register their residences, and
that including residences would not give FDA any useful or actionable
information. This commenter concludes that FDA should explicitly exempt
individual residences under all circumstances.
(Response) FDA has concluded that private individual residences are
not ``facilities'' for purposes of the registration provision of the
Bioterrorism Act. Under the Bioterrorism Act, the term ``facility''
includes ``any factory, warehouse, or establishment.'' Congress did not
specify any definition for these terms. Under their common meanings,
the terms can include private residences. For example, according to
Webster's II New Riverside University Dictionary (1994), the most
relevant definition of ``establishment'' is ``a business firm, club,
institution, or residence, including its possessions and employees.''
However, ``[i]n determining whether Congress has specifically addressed
the question at issue, the court should not confine itself to examining
a particular statutory provision in isolation * * *. It is a
'fundamental canon of statutory construction that the words of a
statute must be read in their context and with a view to their place in
the overall statutory scheme.''' FDA v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 121 (2000). Other parts of the registration
provisions in section 415 of the FD&C Act indicate that Congress only
intended businesses to register, and raise a question as to whether
Congress intended that private individual residences, even though food
is manufactured/processed, packed, or held at such residences, be
considered facilities. For instance, a registrant is required to submit
``the name and address of each facility at which, and all trade names
under which, the registrant conducts business * * * `` (21 U.S.C.
350d(a)(2)). Thus it is unclear whether Congress intended all
individual private residences at which food is manufactured/processed,
packed, or held to be included in the term ``facility.'' Furthermore,
the requirement that a facility submit its ``name'' as well as its
``trade names'' raises a question as to whether Congress intended
``facility'' to include private individual residences since it is
unlikely that a home would have a name or a trade name. Where the words
of the statute are ambiguous, an agency may make a reasonable
interpretation of the statute. Chevron, USA, Inc. v. NRDC, Inc., 467
U.S. 837, 842-843 (1984); Brown & Williamson, supra, at 132.
Consistent with the language of section 415(a)(2) discussed
previously, the agency concludes that interpreting the term
``facility'' to exclude private individual residences is a reasonable
construction for purposes of registration. This interpretation,
however, does not necessarily preclude a reasonable construction of
other provisions of the FD&C Act to include such residences.
Therefore, in response to these comments, we have revised the
interim final rule at 1.227(b) to provide that the definition of
facility does not include private residences of individuals.
Accordingly, homes that store Girl Scout cookies for distribution,
homes in which food is prepared for church bake sales, and homes where
individuals temporarily store sales samples or small inventories of
products for delivery to rural retailers are not facilities, and
therefore, are not subject to registration.
(Comment 8) One commenter requests that FDA clarify whether trans-
shippers, who ship products through the United States en route to other
countries, are required to register. Another commenter wants FDA to
clarify whether it will require registration of foreign facilities that
export food to locations outside the mainland United States, such as
Hawaii and the Northern Mariana Islands.
(Response) Because the registration requirement only applies to
facilities that manufacture/process, pack, or hold food for consumption
``in the United States,'' facilities that manufacture/process, pack, or
hold food that is for consumption only in other countries are not
required to register. Therefore, manufacturers/processors, packers, or
holders of food that is trans-shipped through the United States to
other countries for consumption are not required to register.
Facilities that export food for consumption in locations that are part
of the United States are required to register. Locations are part of
the United States if they are
[[Page 58899]]
in any State or Territory of the United States, the District of
Columbia, or the Commonwealth of Puerto Rico because section 415(b)(2)
of the Bioterrorism Act (21 U.S.C. 350d(b)(2)) defines the term
``domestic facility'' to mean a facility in any of the States or
Territories. Facilities that manufacture/process, pack, or hold food
for consumption in Hawaii and the Northern Mariana Islands are thus
required to register because these locations are respectively a State
and a Territory of the United States.
(Comment 9) Several commenters responded to FDA's request for
comments on whether it has authority to exempt domestic facilities
engaged only in intrastate commerce from the registration requirement
and if so, whether the agency should use that authority. The commenters
agree with FDA's decision in the proposed rule to require facilities
engaged in intrastate commerce to register. One commenter states that
intrastate facilities should not be excluded because individuals
wanting to contaminate the food supply could choose key States from
which to launch an attack. This commenter also points out that foreign
facilities are not exempt, even if they only import food into one
State. Several commenters argue that requiring these foreign facilities
to register, while exempting facilities engaged in intrastate commerce,
is discrimination against foreign facilities.
(Response) In the preamble to the proposed rule, FDA tentatively
concluded that the Bioterrorism Act requires all domestic facilities to
register, whether or not they engage in interstate commerce.
Accordingly, proposed Sec. 1.225(b) stated that a domestic facility
must register (unless otherwise exempt) ``whether or not the food from
the facility enters interstate commerce.''
FDA sought comment on whether the agency has authority to exempt
domestic facilities engaged only in intrastate commerce from the
registration requirement and, if so, whether FDA should use that
authority. FDA also asked for comment on the number of so-called
``intrastate'' facilities that would not be covered by one of the
exemptions from registration. No one asserted that Congress could not
require such facilities to register. Similarly, no one identified
intrastate facilities that would not already be covered by one of the
exemptions. As noted in the preamble to the proposed rule, FDA believes
that most facilities that do not engage directly in interstate commerce
would be covered by an exemption in the interim final rule (e.g.,
residences of private individuals, farms, restaurants, retail food
establishments.)
The comments received agreed with FDA's decision in proposed Sec.
1.225 to require all nonexempt facilities to register even if food from
the facility does not enter interstate commerce. They agreed with FDA's
position that having a central database including all facilities that
manufacture/process, pack, or hold food would help achieve the goals of
the Bioterrorism Act. Moreover, the commenters gave additional reasons
why excluding so-called ``intrastate'' facilities from the registration
requirement could be detrimental or inappropriate. Importantly, no
comments presented any reason for excluding facilities from the
registration requirement solely on the basis of whether the food from
the facility enters interstate commerce.
FDA is mindful that its interpretation of the Bioterrorism Act
should not cast doubt on the constitutionality of the statute. (See
Solid Waste Agency of Northern Cook County v. U.S., 531 U.S. 159
(2001)). The agency has considered the relevant provisions of the
Bioterrorism Act, the comments submitted on this issue, FDA's
responsibilities in implementing the Bioterrorism Act, and the law
interpreting the commerce clause of the Constitution (Article I,
section 8). Based on these considerations, FDA is retaining Sec.
1.225(b) as proposed, with the result that all facilities that
manufacture/process, pack, or hold food (unless otherwise exempt) must
register even if food from the facility does not enter interstate
commerce.
Significantly, the plain language of new section 415 of the FD&C
Act does not exclude a facility from registration because food from
such facility does not enter interstate commerce. Notably, sections 301
and 304 of the FD&C Act (21 U.S.C 334) demonstrate that Congress has
included a specific interstate commerce nexus in the provisions of the
FD&C Act when that is its intent. Accordingly, it is reasonable to
interpret the Bioterrorism Act as not limiting registration only to
those facilities with a direct connection to interstate commerce.
Congress's power to legislate under the commerce clause is very broad.
However, such power is not without limits, see United States v. Lopez,
514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S. 598, 618 (2000),
and these limits have been construed in light of relevant and enduring
precedents.
In particular, in Lopez, supra, the Supreme Court acknowledged the
continuing vitality of Wickard v. Filburn, 317 U.S. 111 (1942), noting
that ``although Filburn's own contribution to the demand for wheat may
have been trivial by itself, that was not `enough to remove him from
the scope of federal regulation where, as here, his contribution, taken
together with that of many others similarly situated, is far from
trivial.' '' (514 U.S. at 556.) This principle applies squarely to the
registration provision of the Bioterrorism Act. Accordingly, given the
collective impact on commerce of so-called ``intrastate'' facilities
that manufacture/process, pack, or hold food, FDA has concluded that
each such facility should be required to register regardless of whether
food from that facility enters interstate commerce. Thus, FDA is
retaining Sec. 1.225(b) as proposed.
This outcome is consistent with section 709 of the FD&C Act (21
U.S.C 379a), which states that in any action to enforce the act's
requirements respecting foods, drugs, devices, and cosmetics, any
necessary connection with interstate commerce is presumed. Likewise,
this outcome is consistent with Congress's goal in enacting the
Bioterrorism Act because the potential harm from bioterrorist attacks
or other food emergencies can be great, whether or not the food moves
from one state to another. The usefulness of the registration database
can also be significant in food emergencies where interstate shipment
has not occurred. Finally, as noted, FDA received no comments
identifying so-called ``intrastate'' facilities that would not
otherwise be exempt from registration. Thus, this outcome, as a
practical matter, should have little if any impact on which facilities
must register. Accordingly, FDA concludes that it is appropriate to
require facilities that do not fall within an exemption to register
regardless of whether the food from the facility enters interstate
commerce.
(Comment 10) One commenter states that the proposed rule requires
all foreign and domestic facilities with operations that have an effect
or impact on food to register unless subject to specific exemptions.
The commenter believes that this is vague and not specific for imported
shipments, especially fresh produce, and would require all parties
having any contact with the produce to register. This commenter also
argues that the party registering with FDA for produce shipments should
be the exporter.
(Response) The commenter misunderstands the proposed rule. First,
the statement that the rule would require registration by all
facilities that ``have an effect on food'' is not accurate. As stated
previously, both the
[[Page 58900]]
Bioterrorism Act and this interim final rule (which is consistent with
the proposed rule) provide that a facility must be registered if it is
engaged in manufacturing/processing, packing, or holding food for
consumption in the United States. Second, both the Bioterrorism Act and
the interim final rule (as did the proposal) provide that foreign
facilities are exempt from registration if food from these facilities
undergoes further manufacturing/processing (including packaging) by
another foreign facility outside the United States. Finally, because
the registration requirement is facility-based, an exporter is required
to register only if it is the owner, operator, or agent in charge of a
facility that manufactures/processes, packs, or holds food for
consumption in the United States, and the facility is not subject to
any of the listed exemptions. This is consistent with the specific
language in the Bioterrorism Act.
(Comment 11) One commenter asks FDA to clarify whether registration
applies to ``bulk grain handling facilities which exist for the purpose
of export and domestic shipments.''
(Response) It is not clear from the comment what activities the
bulk grain handling facility conducts. If ``bulk grain handling'' means
storing grain in bulk, the facility is required to register with FDA if
the grain will be consumed by humans or animals in the United States,
because the facility is engaged in ``holding'' food. Similarly, if
``bulk grain handling'' is synonymous with the activities of a
feedmill, the facility is required to register with FDA because feed
mills manufacture/process, pack, and hold feed for animal consumption.
The discussion under the definition of ``retail food establishment''
provides further clarification.
(Comment 12) One commenter has several questions related to who is
required to register: Is the registration requirement limited strictly
to commercial shipments? How does registration affect United States
travelers who bring varying quantities of goods into the United States?
(Response) The registration requirement applies to facilities that
manufacture/process, pack, or hold food for consumption in the United
States. Thus the requirement is tied to: (1) Facilities, and (2) food
that will be consumed in the United States. The Bioterrorism Act,
therefore, does not limit the registration requirement to commercial
shipments. However, travelers who bring foods into the United States on
their person or in their baggage are not facilities under this rule,
and thus, they are not required to register. FDA notes that travelers
may nevertheless be subject to prior notice if they are carrying or
otherwise are accompanied by food that is not for personal use (i.e.,
for consumption by themselves, family, or friends, and not for sale to
anyone.)
(Comment 13) A commenter asks what is the responsibility of foreign
governments owning facilities that hold food? Also, what is the
responsibility of a country through whom goods of concern may be trans-
shipped?
(Response) The registration requirement applies to facilities that
manufacture/process, pack, or hold food for consumption in the United
States. Thus the requirement is tied to: (1) Facilities, and (2) food
that will be consumed in the United States. There is no exemption in
the Bioterrorism Act or this interim final rule for facilities that
manufacture/process, pack, or hold food that happen to be government-
owned. Accordingly, such government-owned facilities are required to
register if they meet the other requirements of registration.
A country through which foods may be trans-shipped on their way to
the United States has no responsibility regarding registration, as the
registration requirement applies to facilities that manufacture/
process, pack, or hold food. Under the Bioterrorism Act, the
responsibility to register is on the owner, operator, or agent in
charge of a facility that manufactures/processes, packs, or holds food
for consumption by humans or animals in the United States.
(Comment 14) A commenter primarily engaged in exporting products
from the United States asks FDA to clarify whether such an exporter is
required to register if the foreign country or foreign buyer rejects
food being exported from the United States, and the food is returned to
the United States.
(Response) Where food exported from the United States is rejected
and returned to this country, the owner, operator, or agent of any
facility that manufactures/processes, packs, or holds the food is
required to register if the food will be consumed in the United States.
FDA is assuming in comment 14 that no foreign facility other than the
exporting facility manufactures/processes, packs, or holds the food
before it is returned to the United States.
(Comment 15) One commenter asks FDA to clarify whether domestic
grain handling, and feed manufacturing facilities engaged solely in
exporting bulk or processed agricultural commodities to other countries
are exempt from the registration requirement.
(Response) A facility is only required to register with FDA if the
food manufactured/processed, packed, or held in the facility is for
consumption or is actually consumed in the United States by humans or
animals.
(Comment 16) One commenter asks ``[w]hat happens if [an] exporter
cannot get [the foreign] manufacturer to register, and does not have
all of the necessary information to do it himself?'' The commenter asks
whether the exporter ``will not be permitted to send the shipment
resulting in lost sales to his company.''
(Response) The response to comment 17 addresses which foreign
facilities are required to register with FDA. If the manufacturer/
processor in the above scenario (or a packer or holder) is required to
register but fails to do so, the Bioterrorism Act provides that food
shall be held at the U.S. port of arrival or in a secure facility until
the facility registers (21 U.S.C. 381(l)). However, the provisions of
the prior notice interim final rule (which is published elsewhere in
this issue of the Federal Register) that address product under hold
provide for export of such products.
FDA has made some editorial changes in this section for the purpose
of clarity.
D. Comments on ``Who is Exempt From This Subpart?'' (Proposed Sec.
1.226)
In the interim final rule, the title of this section has been
changed to ``Who does not have to register under this subpart?''
1. Foreign Facilities
(Comment 17) A commenter asks which foreign facilities would be
required to register in the case of raw agricultural commodities, such
as cocoa beans, which may be dried, (in some cases) fermented, blended
with beans from other farms, packed into bags, fumigated, weighed,
graded, and stored in one or more warehouses before being exported to
the United States.
(Response) The Bioterrorism Act states that a foreign facility must
register if food from such a facility is exported to the United States
for consumption in this country ``without further processing or
packaging outside the U.S.'' Therefore, a foreign facility is only
required to register if it manufactures/processes the food without
further manufacturing/processing of the food by another foreign
facility prior to export to the United States. The foreign facility is
required to register even if there is a subsequent facility that
further manufactures/processes the food if the activities of the
subsequent facility are merely of a de minimis nature. A foreign
facility must also register if, prior to
[[Page 58901]]
export to the United States, it packs or holds food after the last
foreign manufacturer/processor of the food. Under these provisions, the
last facility that manufactures/processes the cocoa beans, and every
facility that subsequently engages in packing or holding the beans, as
well as any facility that subsequently engages in de minimis
manufacturing/processing (such as labeling) of the cocoa beans, is
required to register.
(Comment 18) Several commenters argue that registration of foreign
facilities should be limited to the last holder of the goods, since it
would be difficult for many facilities further up the distribution
chain to find a U.S. agent.
(Response) FDA is denying this request due to the registration
requirement provided in the Bioterrorism Act for foreign facilities
that manufacture/process, pack, or hold food. See the response to
comment 17 for these specific requirements.
(Comment 19) A commenter requests clarification on whether
registration applies to foreign port facilities such as warehouses or
storage and inspection facilities belonging to private companies.
Another commenter asks whether brokers, warehousers, or traders who
take possession of food before it is exported to the United States need
to register.
(Response) As noted, the registration requirement of the
Bioterrorism Act is facility-based and has no exemption from
registration for port storage and inspection facilities if these
facilities are used to hold food. Therefore, foreign port storage and
inspection facilities must be registered with FDA if they manufacture/
process, pack, or hold food for consumption in the United States.
Similarly, a broker, warehouser, or trader who takes possession of food
before it is exported to the United States is required to register if
the broker, warehouser, or trader is the owner, operator, or agent in
charge of a facility that manufactures/processes, packs, or holds food
for consumption in the United States.
(Comment 20) One commenter states that all foreign processors,
holders, and manufacturers throughout the foreign distribution chain
should be required to register.
(Response) FDA is denying this request due to the registration
requirement provided in the Bioterrorism Act for foreign facilities
that manufacture/process, pack, or hold food. See the response to
comment 17 for these specific requirements.
(Comment 21) One commenter states that, in its application to
foreign facilities, FDA should revise its definition of ``holding'' to
``provid[ing] storage of food products and neither engag[ing] in the
manufacturing nor processing of the food products, except for
incidental services that do not involve unsealing of the primary food
container.''
(Response) FDA declines to change ``holding'' to include
``incidental services that do not involve unsealing of the primary food
container.'' This change would blur the distinction between
manufacturing/processing and holding because activities that do not
involve unsealing of a food container could be considered de minimis
processing, as opposed to holding. See the response to comment 17 for
specific registration requirements for foreign facilities.
(Comment 22) Some commenters involved in the production of food
that either has a long shelf life or long production phase ask whether
they are required to register with FDA if they do not know the eventual
export destination at the time of production. For example, for vintage
wine, the eventual destination of the wine (i.e., whether the wine is
for consumption in the United States) is generally not known at the
time of production. Other commenters state that for similar reasons,
registration should not be required of foreign ``collection points,''
which receive products from a large number of suppliers, then
distribute or sell them at auctions.
(Response) Under this interim final rule, an owner, operator, or
agent in charge must register its facility only if the food
manufactured/processed, packed, or held at the facility is for
consumption in the United States. In the response to comment 17, FDA
has clarified the registration requirements for foreign facilities that
manufacture/process, pack, and hold food. That discussion is also
relevant to this comment. Although the destination of some food
produced abroad is not known at the time of its production, FDA
believes that producers and distributors of these products are likely
to have an idea of the eventual destination, based on prior sales and
promotional activities. Because the Bioterrorism Act generally
prohibits food from an unregistered foreign facility from being
delivered for distribution in the United States until the facility is
registered, FDA recommends that the owners, operators, or agents in
charge of facilities producing these types of food register their
facilities if they reasonably believe their foods may be consumed in
the United States.
(Comment 23) One commenter states that, for commercial
confidentiality reasons, foreign traders may not wish to reveal the
identity of the packer or producer to the importer, and that the
registration requirement would interfere with this confidentiality.
(Response) FDA acknowledges that for some entities, the
registration requirements may result in some alterations of their past
business practices. However, the Bioterrorism Act imposes certain
requirements on the importation of food for consumption in the United
States, including registration of foreign and domestic food facilities.
It is incumbent on these facilities to make the necessary arrangements
to comply with the Bioterrorism Act if they wish to continue to import
food into the United States.
(Comment 24) Some commenters request that foreign facilities should
be exempt if they export food solely to their own subsidiaries in the
United States. These commenters state that these foreign facilities
send finished or semifinished goods or raw materials to their
subsidiaries in the United States for further processing. The
commenters argue that, under these circumstances, the foreign parent
company should not have to register; however, under the proposed rule,
not only the final processor, but also all of its suppliers, would be
required to register.
(Response) FDA is denying this request because the Bioterrorism Act
does not authorize an exemption from registration for facilities that
export solely to their subsidiaries in the United States. Moreover, it
appears that the commenter misunderstands the requirements that apply
to foreign facilities. Under both the proposed rule and this interim
final rule, suppliers of food need not register if another foreign
facility subsequently manufactures/processes the food before it is
exported to the United States, unless the subsequent facility is
conducting de minimis activities, such as labeling. In the latter
situation, both facilities would have to register.
(Comment 25) Several commenters request further clarification
regarding the ``de minimis'' provision. Some commenters request that
FDA exempt foreign facilities engaging in de minimis activity. In fact,
one commenter mistakenly states that the proposed rule exempts foreign
facilities if a facility subsequent to them conducts de minimis
activity.
(Response) Please see the response to comment 17 regarding the
registration requirements as applied to foreign manufacturers/
processors. An exemption for foreign facilities engaged
[[Page 58902]]
in de minimis manufacturing/processing would be inconsistent with the
Bioterrorism Act language quoted in the response to comment 17.
(Comment 26) One commenter requests that FDA provide either a
definition of ``de minimis'' or more examples of what constitutes de
minimis activity, such as blending, sieving, particle size
distribution, drying crops, and repackaging.
(Response) FDA has concluded that de minimis manufacturing/
processing does not involve direct manipulation of food. Therefore,
most of the activities included in the comment (blending, sieving,
particle size distribution, and drying crops) are not de minimis
because they manipulate food. Regarding ``re-packaging,'' it is not
clear whether this activity would contact the food itself or merely
involve contact with outer materials that do not contact the food. If
the re-packaging involves contact with the food itself, it would not be
considered de minimis.
2. Farms
FDA did not receive any comments on ``farm'' as an exemption.
Please see section III.E.6 of this document for changes FDA made to the
definition of ``farm.'' FDA also addresses the comments we received on
farms in section III.E.6 of this document.
3. Retail Facilities
FDA did not receive any comments on ``retail facilities'' as an
exemption. In this interim final rule, we have changed the term
``retail facility'' to ``retail food establishment'' to be consistent
with the statutory term. Please see section III.E.14 of this document
for changes FDA made to the definition of ``retail food
establishment.'' FDA also addresses the comments we received on retail
food establishments in III.E.14 of this document.
4. Restaurants
Please see the definitions section III.E.13 of this document for
changes FDA made to the definition of ``restaurant.'' FDA also
addresses all but one of the comments we received on the ``restaurant''
exemption in section III.E.13 of this document.
(Comment 27) FDA did receive one comment specifically addressing
the restaurant exemption. This comment states that although the
proposed rule provides that restaurants are exempt from registration,
it ``continues to define when it is necessary for food facilities to
register and provides an opportunity for the foreign facilities to
designate a U.S. agent for registration. This language alone
contradicts the exemption in many circumstances within the restaurant
industry. The intention of Congress was to exempt restaurants * * *
language must be incorporated to state that foreign facilities should
not have the ability to designate a U.S. agent for registration.'' This
commenter also urges FDA to incorporate language in the interim final
rule clearly stating that foreign facilities may designate a restaurant
as a U.S. agent, while emphasizing that this designation does not
remove the restaurant exemption from all restaurants.
(Response) FDA is not certain it understands this comment. This
commenter appears to be concerned that the restaurant exemption would
conflict with the U.S. agent requirement, if a foreign facility were to
choose a domestic restaurant as its U.S. agent. FDA agrees that even if
a foreign facility designates a domestic restaurant as its U.S. agent,
the restaurant is still exempt from registration itself. In such
circumstances, the restaurant can also be authorized by the owner,
operator, or agent in charge of the foreign facility to register that
facility. Regarding incorporation of language specifying that
restaurants can be U.S. agents in the interim final rule, FDA believes
that this change is not necessary because the interim final rule states
that a U.S. agent is ``a person (as defined in section 201(e) of the
act (21 U.S.C. 321(e))).'' This definition includes a restaurant.
5. Nonprofit Food Facilities
In this interim final rule, FDA has changed the term ``nonprofit
food facility'' to ``nonprofit food establishment'' to be consistent
with the statutory term.
(Comment 28) One commenter asks FDA to confirm that the commenter's
affiliates and their agencies are exempt as nonprofit food facilities.
This commenter states that all of its food banks, food rescue
organizations, and local agencies of its affiliates are required to be
incorporated as nonprofit organizations that are exempt from paying
income tax as defined by the U.S. Internal Revenue Code Section
501(c)(3) or ``the equivalent.'' The commenter states that its
certified affiliate food banks and food rescue organizations provide
food to the public through direct distributions and through
distributions to local nonprofit section 501(c)(3), or equivalent
nonprofit, agencies.
(Response) The interim final rule defines a ``nonprofit food
establishment'' as ``a charitable entity that prepares or serves food
directly to the consumer or otherwise provides food or meals for
consumption by humans or animals in the U.S.'' The interim final rule
includes central food banks, soup kitchens, and nonprofit food delivery
services as examples of nonprofit food establishments. In response to
the comment, FDA is clarifying that to be considered a nonprofit food
establishment, the establishment must meet the terms of section
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)). If
the commenter's establishments meet all aspects of the definition of
nonprofit food establishment in this interim final rule, they would be
exempt from registration.
Please see section III.E.10 of this document for changes FDA made
to the definition of ``nonprofit food establishment.''
6. Fishing Vessels
(Comment 29) One commenter states that the fishing vessel exemption
will not achieve its intended purpose, due to the Bioterrorism Act's
reference to Sec. 123.3(k), which FDA includes in the fishing vessel
exemption. The commenter argues that incorporating the reference to
Sec. 123.3(k) into the proposed rule invalidates nearly the entire
exemption, because harvested fish must be removed from the harvest
vessel for any further processing. The exemption, therefore, would only
exempt those fishing vessels that transfer harvested fish by brailing
or pumping to offshore processing vessels. The exemption would not
apply to fishing vessels that enter port and offload fish dockside. As
a result of these restrictions on the exemption, the commenter requests
that FDA ``acknowledge the irony of this exemption'' and consider
requesting a technical amendment to the Bioterrorism Act to broaden the
exemption.
(Response) The Bioterrorism Act (21 U.S.C. 350d(b)(1)) expressly
references the Seafood Hazard Analysis Critical Control Point (Seafood
HACCP) regulations (Sec. 123.3(k)) as part of the fishing vessel
exemption. Accordingly, to the extent that the exemption for fishing
vessels is limited, it is limited by Congress. Importantly, however,
FDA notes that ``dockside unloading'' is included in the definition of
``processing'' (Sec. 123.3(k)) to cover waterfront facilities that
unload vessels and pack the catch for shipment to buyers, not the
vessels from which the catch is unloaded. (See 60 FR 65096, 65114 to
65115, December 18, 1995.) Thus, the comment is not correct that the
only vessels that would be exempt are those that transfer fish by
brailing or pumping to offshore processing vessels. Generally, vessels
covered by the
[[Page 58903]]
Seafood HACCP regulations are required to register with FDA.
FDA is using the term ``fish'' to describe the cargo of fishing
vessels in order to be consistent with the use of the term in 21 CFR
Part 123. ``Fish'' is defined in Sec. 123.3(d) as ``fresh or saltwater
finfish, crustaceans, other forms of aquatic animal life (including,
but not limited, to alligator, frog, aquatic turtle, jellyfish, sea
cucumber, and sea urchin and the roe of such animals) other than birds
or mammals, and all mollusks, where such animal life is intended for
human consumption.''
(Comment 30) A commenter asks FDA to clarify whether any facilities
would be required to register in the following scenario: Company A
purchases fish from a Mexican fisherman, loads it onto refrigerated
trucks, and transports it to Company B, which is located in the United
States.
(Response) Under the interim final rule, fishing vessels are exempt
from registration unless processing is done on board the ship. For
purposes of this exemption, ``processing `` is defined in Sec.
123.3(k)(1) as ``[h]andling, storing, preparing, heading, eviscerating,
shucking, freezing, changing into different market forms,
manufacturing, preserving, packing, labeling, dockside unloading, or
holding.'' Importantly, however, according to Sec. 123.3(k)(2),
harvesting and transport vessels that engage in ``[h]arvesting or
transporting fish or fishery products, without otherwise engaging in
processing,'' or ``[p]ractices such as heading, eviscerating, or
freezing, intended solely to prepare a fish for holding on board a
harvest vessel,'' are exempt from registration under 21 CFR 1.126(f).
Under the scenario described in the comment, the Mexican fisherman
would have to register the vessel if he catches fish and processes it
aboard the vessel under Sec. 123.3(k). If the fisherman does not
process the fish (other than heading, eviscerating, or freezing the
fish to prepare it for holding on board his vessel), the vessel would
not need to register. Whether Company A or Company B would be required
to register depends upon their activities. If either company engages in
manufacturing/processing, packing, or holding the fish, all facilities
at which such activities occur must be registered (unless a facility
qualifies for one of the exemptions from registration, e.g., a
restaurant). A transportation vehicle is not a facility and would not
need to register if it holds the fish only in its usual course of
business as a carrier (Sec. 1.226(f).)
7. Facilities Regulated Exclusively, Throughout the Entire Facility, by
USDA
(Comment 31) Several commenters ask FDA to clarify which facilities
are regulated exclusively by USDA, as USDA versus FDA jurisdiction is
not clear to foreign facilities.
(Response) Whether a facility is regulated exclusively by USDA (and
thus, is exempt from registration, 21 CFR 1.226(g)) depends upon the
products manufactured/processed, packed, or held at the facility. Any
facility that manufactures/processes, packs, or holds some foods
subject to FDA jurisdiction does not satisfy the exclusivity part of
the exemption in Sec. 1.226(g) and thus, must register with FDA.
More specifically, under the Meat Inspection Act (MIA) (21 U.S.C.
601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C.
451 et seq.), USDA inspects facilities that slaughter poultry, cattle,
sheep, swine, equines, or goats and facilities that process ``poultry
products'' or ``meat food products'' as defined under the MIA and the
PPIA (21 U.S.C. 453(f), 455, 601(j), 603). Any USDA-inspected facility
that slaughters only poultry, cattle, sheep, swine, equines, or goats
is solely under USDA jurisdiction and is exempt from registration.
Facilities that slaughter these animals, but that also slaughter other
animals, such as deer or elk, are under both USDA and FDA jurisdiction
and must register. Facilities that manufacture/process only ``poultry
products'' or ``meat food products,'' as defined by USDA, are exempt
from registration. Facilities that manufacture/process ``meat food
products,'' such as pizzas with meat topping, and other products, such
as cheese pizzas, are under both FDA and USDA jurisdiction and must
therefore register with FDA.
Under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.),
USDA inspects facilities that process ``egg products,'' which are ``any
dried, frozen, or liquid eggs, with or without added ingredients,
excepting products which contain eggs only in a relatively small
proportion or historically have not been * * * considered by consumers
as products of the egg food industry * * * '' (21 U.S.C. 1033(ff)). A
facility is regulated exclusively by USDA if it manufactures/processes
only ``egg products.'' If a facility manufactures/processes other food
in addition to, or instead of, egg products, the facility is not
regulated exclusively, throughout the entire facility, by USDA and it
must be registered. Thus, a facility is regulated exclusively,
throughout the entire facility, by USDA if it manufactures/processes,
packs, or holds only ``meat food products,'' ``poultry products,'' or
``egg products'' as defined above. If a facility manufactures/
processes, packs, or holds other food in addition to meat food
products, poultry products, or egg products, the facility is not
regulated exclusively, throughout the entire facility, by USDA and
thus, would not be exempt from registration.
(Comment 32) One commenter requests FDA to expand this exemption by
including all facilities that are subject to USDA jurisdiction, even if
they are also subject to FDA jurisdiction. Another commenter asks why,
under this exemption, FDA exempts such a considerable part of the
production chain from the registration requirements, while also
establishing strict requirements for other facilities.
(Response) The Bioterrorism Act requires that, unless exempt, all
facilities that manufacture, process, pack, or hold food for
consumption in the United States must register (21 U.S.C. 350d(a)).
However, section 315 of the Bioterrorism Act states that no part of
Title III should be construed to alter the jurisdiction between USDA
and FDA. Under current practice, FDA may have jurisdiction over a food
facility, USDA's Food Safety and Inspection Service may have
jurisdiction over a food facility, or the two agencies may have joint
jurisdiction over a food facility. Under section 315, the Bioterrorism
Act does not change this structure. Accordingly, only those facilities
that manufacture/process, pack, or hold food that is regulated
exclusively by USDA is exempt from registration under section 315. In
response to the comment asking why FDA exempts such a considerable part
of the production chain from registration under this exemption, the
authority in the Bioterrorism Act only extends to facilities
manufacturing/processing, packing, or holding food under FDA's
jurisdiction. Congress did not extend these requirements to facilities
under USDA's exclusive jurisdiction. (USDA has other existing authority
over facilities under their jurisdiction.) Moreover, even though a
facility is exempt from registration with FDA this does not mean that
it is exempt from all statutes and regulations that protect the safety
and security of food consumed in the United States.
(Comment 33) Several commenters urge FDA to exempt from the
registration requirement other facilities in addition to those
exclusively regulated by USDA, such as USDA-approved, federally
licensed grain storage silos and elevators, low acid
[[Page 58904]]
canned food, aquatic products, and fruit exporting enterprises. One of
these commenters states that under the Warehouse Act, USDA performs
regular, unscheduled inspections of these grain storage facilities;
therefore, USDA, not FDA, is the most appropriate federal agency to
respond to threats affecting these facilities. The other commenter
states that fruit exporters have already registered with USDA.
(Response) FDA believes that this interim final rule implements the
intent of Congress as expressed in the Bioterrorism Act. The statute
does not include exemptions from the registration requirement for the
types of facilities listed in the comment, and the comment identifies
no other basis for the exemptions proposed.
E. Comments on ``What Definitions Apply to This Subpart?'' (Proposed
Sec. 1.227)
1. The Act
There were no comments on this issue.
2. Calendar Day
There were no comments on this issue.
3. Facility
(Comment 34) Several commenters recommend exempting temporary
storage units, public storage facilities, and bulk storage facilities
from the definitions of ``facility'' and ``holding,'' because many of
these storage facilities are not staffed, so it would be very difficult
for FDA to get in touch with these facilities in the event of a
bioterrorist attack or other food-related emergency. In addition, the
commenters state that many of these holding facilities only hold goods
for several hours; therefore, the contents of the facility are
continually changing and would require constant updates.
(Response) The interim final rule maintains the definition of
facility as proposed although FDA has clarified that ``facility'' does
not include a transporter that holds food only in the usual course of
its business as a carrier, private residences of individuals, and
nonbottled drinking water collection and distribution establishments
and their structures. The Bioterrorism Act does not exempt facilities
based on the period of time during which they hold food. In terms of
contacting facilities that are not staffed, the interim final rule
requires facilities to provide an emergency contact who is accessible
24 hours/day, 7 days/week. (For foreign facilities, FDA will consider
the U.S. agent the emergency contact, unless the facility designates
someone else, as provided in Sec. 1.227(b)(13) and Sec. 1.233(e).)
This person does not have to be located at the facility, but does need
to be accessible to FDA in case of an emergency.
(Comment 35) One commenter cites case law to argue that FDA has
authority to provide for an additional de minimis exemption because the
burdens of regulating very small facilities will yield trivial or no
value. The commenters suggest that FDA change the definition of
facility to exempt these storage buildings.
(Response) The Bioterrorism Act does not exempt facilities based on
their size. Furthermore, many storage facilities, including temporary
storage facilities, may be a target of terrorist attack. Therefore,
having the registration information for these facilities can facilitate
FDA's response to such an attack.
(Comment 36) Several commenters state that the proposed rule is not
clear as to whether transport vehicles hauling food are ``mobile
facilities.'' These commenters argue that vehicles used to hold food
such as rail cars, tanker trucks, river barges, refrigerated/freezer
spaces on ships, truck terminals, marine terminals, and freight
forwarders should be exempt from registration. One commenter asserted
that the intent of the ``holding'' definition is to ``capture those
facilities which hold large quantities of food items for extended
periods of time, pending some other action such as movement to a
subsequent facility for processing,'' and states that products being
held are ``deliberately held under physical control, i.e., restrained
from movement.'' In contrast, ``transportation of food items means
deliberate movement of those items, under specific arrangements as
defined in a bill of lading covering the movement, which would
delineate the shipper, consignee, date of movement, details of the
shipment, liability for freight charges, and many other elements of
transportation.'' The commenter asserts that based on this distinction,
transportation providers who are engaged in the movement of goods from
a shipper to a consignee, should be exempt from registration.
(Response) FDA has clarified in Sec. 1.227(b)(2) of the interim
final rule that a ``mobile facility'' means a mobile manufacturer/
processor, packer, or holder. In addition, the interim final rule
provides that a vehicle used to transport food is exempt from
registration unless it manufactures/processes, packs, or holds the food
beyond the usual course of its business as a carrier. This is
consistent with the legislative history of the Bioterrorism Act, which
states that ``facility'' does not include trucks or other motor
carriers, by reason of their receipt, carriage, holding, or delivery of
food in the usual course of business as carriers (H.R. Conf. Rep. No.
481, 107th Cong., 2d Sess., 134 (2002)). However, stationary facilities
that serve to assist transporters, such as truck or marine terminals or
freight forwarders, are required to register because they hold food. If
a railcar is used as a grain storage bin for a manufacturing plant, it
would be akin to a silo, and as such, the railcar would be ``holding''
food, not transporting it. Thus, the railcar would be a facility that
must be registered. As indicated in comment 36, the Bioterrorism Act
does not exempt facilities based on how long they hold food.
(Comment 37) One commenter asks whether trucker-dealers, who
purchase and take title to grain from producers, and hold the grain in
a transportation conveyance until it can be sold to another processor,
storage facility, or end user, are mobile facilities.
(Response) Based on the comment, FDA believes that trucker-dealers
are mobile facilities, because they are holding grain in a
transportation conveyance beyond the usual course of business as
carriers.
(Comment 38) Several commenters state that requiring registration
of mobile facilities that manufacture/process food is impractical for
fishing vessels that process fish. These commenters state that these
vessels have a home port designation but no fixed or permanent address;
therefore, they would be required to continually update their
registrations based on where the vessel was located in the ocean.
(Response) Registration requires a facility to provide sufficient
information to enable FDA to contact the facility if FDA receives
information about a bioterrorist threat or other food-related
emergency, as well as for routine communications. FDA understands that
a mobile facility does not have a fixed address. However, the
Bioterrorism Act provides that the owner, operator, or agent in charge
of a facility must register the facility; therefore, for mobile
facilities such as vessels, the owner or operator of the facility
usually has a fixed address and may include that fixed address on the
registration.
(Comment 39) Several commenters request that FDA change the
proposed definition of facility from being in ``one physical location''
to allow registration to be by firm, instead of by facility.
[[Page 58905]]
(Response) The Bioterrorism Act (21 U.S.C. 350d(a)(1)) requires
that each domestic and foreign facility be registered. ``Facility'' is
defined as ``any factory, warehouse, or establishment (including a
factory, warehouse, or establishment of an importer) that manufactures,
processes, packs, or holds food'' (21 U.S.C. 350d(b)(1)). Thus, the
plain language of the Bioterrorism Act requires registration to be by
individual facility, not by firm. As noted below, FDA will allow a
parent company to register all of its facilities; however, each
facility must be registered separately and each will receive a separate
registration number.
(Comment 40) Some commenters state that FDA should provide a more
flexible definition of facility, thereby allowing companies to decide
how many buildings to consider a single facility. Some of these
commenters question whether two structures under single ownership with
different addresses that are physically next to each other, across the
street from each other, or around the block from each other, are
considered one or two facilities. Other commenters argue that a company
may conduct business at more than one address, but may consider all of
the locations as part of one operation. For example, an operation could
include offsite storage buildings, water pipelines from one area to
another, pump-houses, and bulk processing in one location, with
finished processing or packaging at another address.
(Response) The Bioterrorism Act (21 U.S.C. 350d(a)(4)) requires
that FDA compile and maintain an up-to-date list of registered
facilities; this list will serve two purposes. One purpose of the
registration database is to provide FDA with information that will
permit FDA to respond promptly to a bioterrorist event or other food
safety emergency. A second purpose is to provide the agency with a list
of facilities for inspection. Because both the agency's emergency
response and its inspections are facility specific, it is important for
FDA to have particular information about facility location. This need
will not be met if a business with multiple locations is registered as
a single facility. FDA suggests that one factor for determining whether
a business is one or two facilities is through real estate records,
because a property line could demonstrate that several buildings are on
the same lot, and therefore, are the same facility.
4. Domestic Facility
FDA received no comments on this definition.
5. Foreign Facility
FDA received no comments on this definition.
6. Farm
(Comment 41) Some commenters state that the proposed definition of
farm is unduly narrow because it does not exempt farms that engage in
activities traditionally performed on farms for nearly all commodities,
including farms that cut, trim, wash, grade, mill, wax, size, cool,
apply inventory control items (e.g., universal product codes), treat
against pests, transport from the fields, transport to storage or
processing facilities, mist, treat with water/ice during storage,
package, mill, grind, box/wrap for the sole purpose of transport off
the farm, and transport from the farm. Some commenters also ask FDA to
clarify whether placing produce into netting or bags for retail sale
before placing them in cartons is considered ``packing.''
(Response) In response to these comments and to ensure that FDA is
fulfilling Congress's intent to exempt ``farms,'' FDA has revised the
definition of farm in the interim final rule (21 CFR 1.227(c)(3)) to
state that a farm is a facility in one general location that is devoted
to the growing and harvesting of crops, the raising of animals
(including seafood), or both, and that washing, trimming outer leaves,
and cooling of food are considered part of harvesting. FDA considers
several of the activities identified in the comment to be ``packing or
holding,'' including sorting, grading, wrapping, or boxing harvested
food for the sole purpose of transporting this food off the farm. A
farm that performs these activities will not necessarily cease to be a
farm and exempt from registration because the definition of farm
includes facilities that pack or hold food, provided all food used in
such activities is grown, raised, or consumed on that farm or another
farm under the same ownership (21 CFR 1.227(c)(3)(i)). Similarly, FDA
considers several of the activities identified in the comment (waxing,
milling, grinding, and treating against pests) to be manufacturing/
processing. A farm that performs these activities will not necessarily
cease to be a farm and exempt from registration because the definition
of farm includes facilities that manufacture/process food, provided
that all food used in these activities is consumed on that farm or
another farm under the same ownership (21 CFR 1.227(c)(3)(ii)).
Finally, a farm that transports its products does not cease to be a
``farm'' within the meaning of 21 CFR 1.227(c)(3) because, as noted
earlier in this document, a transport vehicle is not a ``facility'' for
purposes of this rule if it holds food only in the usual course of its
business as a carrier and thus, is not required to register.
(Comment 42) Some commenters request that FDA extend the farm
definition to public lands used by harvesters or collectors of wild
products, including botanicals. The commenters state that these
collectors do not manufacture/process or pack foods, and they hold
foods similar to many farms.
(Response) FDA does not believe that this comment requires a change
in the farm definition. When wild botanicals are grown and harvested on
public land, FDA would consider that location to meet the definition of
``farm.'' However, if those harvesting on public land engage in any
activity that takes them outside the ``farm'' definition, they must
register the facilities where they conduct these activities.
(Comment 43) Some commenters note that some farming operations are
spread out over several locations within several miles or more of each
other and all of these locations are under the same ownership and
management. Accordingly, these commenters request that FDA change the
farm definition to cover several different locations. Another commenter
asks whether two facilities separated by fencing, a wooded area, a body
of water, or a road are one or two farms. Other commenters request that
FDA amend the farm definition to include the term ``contiguous,'' which
appears in the preamble to the proposed rule but not the definition
itself.
(Response) FDA does not believe that these comments require a
modification of the definition of farm. Each of these establishments,
whether considered one farm or many farms, is exempt if it meets the
definition of farm. Additionally, the interim final rule provides that
establishments that pack or hold food fall within the farm definition
if all food used in such activities is grown, raised, or consumed on
that farm or another farm under the same ownership. The interim final
rule also considers establishments that manufacture/process food as
farms if all food used in such activities is consumed on that farm or
another farm under the same ownership.
(Comment 44) Some commenters ask FDA to clarify whether packing and
other facilities owned by more than one farm on a partnership or
cooperative basis fit within the farm definition.
(Response) The farm definition extends to only those packing or
holding facilities that are located on a farm or another farm under the
same
[[Page 58906]]
ownership and the facilities are exclusively used to pack or hold food
grown or raised on such farm or another farm under the same ownership.
A packing shed that packs food grown or raised on several farms under
different ownership is not covered by the farm definition and thus, is
required to register.
(Comment 45) Some commenters argue that the farm definition should
address whether a farm that engages in agriculture on several different
properties under separate ownership will be considered a single farm
for purposes of registration.
(Response) The definition of a farm provides that a farm must be in
one general physical location and under the same ownership. In the
situation described by the comment, different properties under separate
ownership, if they otherwise meet the definition of farm, would be
exempt from registering.
(Comment 46) Some commenters argue that a farmer who owns more than
one field or piece of property and is required to register with FDA
should be required to register only once, identifying on the
registration form the physical location of all areas under that
farmer's cultivation.
(Response) Generally, a farm is exempt from registration unless it
is a mixed-type facility. A mixed-type facility performs activities of
a facility that is both ordinarily required to register and ordinarily
exempt. An example of a farm that is a mixed-type facility is a farm
that grows oranges and processes them into orange juice for sale to a
distributor at the same physical location. However, if the farmer
manufactures/processes the oranges into orange juice in a different
physical location, the location where the oranges are grown is exempt
as a farm and the facility where manufacturing/processing occurs must
register. Because registration is by individual facility, the farmer
must, if required to register, register each facility separately and
obtain a separate registration number for each facility. The effort to
register in this situation will be reduced if the farmer registers
electronically, because he can register each facility in succession,
``auto-filling'' each section of the form that repeats the information
contained in the previous registration.
(Comment 47) One commenter asks FDA to clarify that the definition
of farm applies to foreign, as well as domestic, farms.
(Response) The commenter is correct; the farm definition applies to
both domestic and foreign farms. Therefore, foreign farms that satisfy
the farm definition are not required to register, even if they export
food directly to the United States. However, if such a foreign farm
harvests food and manufactures/processes it before exporting it to the
United States, this would be a mixed-type facility that ordinarily must
register. However, the foreign facility exemption may apply to this
mixed type facility if further manufacturing/processing that is not of
a de minimis nature occurs after the food leaves the mixed-type
facility and before it is exported to the United States.
(Comment 48) One commenter states that the definition of ``farm''
is circular in Sec. 1.227(c)(3)(ii). The term ``farm'' includes: * * *
(ii) Facilities that manufacture/process food, provided that all food
used in such activities is consumed on that farm or another farm under
the same ownership.
(Response) In the previous excerpt from the ``farm'' definition,
FDA's intent is to describe a certain activity (manufacturing/
processing) in which a farm may engage without losing its exemption as
a farm, so long as all food manufactured/processed by the farm is
consumed on that farm or another farm under the same ownership.
(Comment 49) Several commenters state that FDA's definition of
``farm'' should be size-neutral, and apply equally to integrated
livestock and poultry facilities as long as the activities at such
locations are limited to ``growing or raising'' farm animals for human
food, but do not extend to further processing of food-producing animals
into meat, milk, or eggs (which occurs at food processing and packing
plants and rendering facilities) for subsequent commercial sale for
consumption by humans or animals.
(Response) The proposed rule's definition of ``farm'' had no size
limitation, and neither does the interim final rule's definition. FDA
agrees that integrated livestock and poultry operations are ``farms,''
as long as these operations are devoted to raising animals for food,
the growing of crops, or both, and otherwise engage in only those
activities included in the farm definition. FDA considers milking cows
and collecting eggs from chickens to be ``harvesting'' when applied to
animals, because these activities are akin to harvesting crops.
(Comment 50) Several commenters ask FDA to clarify whether packing
sheds, warehouses, and low temperature storage facilities located on
farms are considered part of the farm.
(Response) The interim final rule clarifies the definition of
``farm'' and provides that an operation that includes on-farm packing
and holding of food grown, raised, or consumed on the farm or on
another farm under the same ownership is still a ``farm'' under Sec.
1.227(c)(3). The rule also provides that an operation that includes on-
farm manufacturing/processing of food, where all food is consumed on
that farm or another farm under the same ownership, is still a
``farm.''
(Comment 51) One commenter requests that FDA clarify that
greenhouse facilities devoted to growing fruits and vegetables are
considered ``farms'' for purposes of the farm definition. The commenter
states that it appears that greenhouse facilities would easily fit
within the proposed definition of farm as ``[facilities] in one general
physical location devoted to the growing of crops * * *``, however, FDA
does not explicitly state in the proposed rule or preamble to the
proposal that greenhouses would be considered farms.
(Response) FDA agrees with the commenter that a greenhouse devoted
to the growing of crops is a ``farm'' under Sec. 1.227(c)(3).
(Comment 52) One commenter, quoting the proposed definition of farm
as including ``facilities that manufacture/process food, if all food
used in such activities is consumed on that farm or another farm under
the same ownership,'' asks FDA to clarify whether on-farm facilities
that manufacture/process food sold to a third party would be required
to register with FDA.
(Response) An on-farm operation engaging in manufacturing/
processing food that is subsequently sold to an off-farm third party is
a facility that is required to register with FDA, unless the facility
qualifies under another exemption, such as the retail food
establishment exemption.
(Comment 53) One commenter asks FDA to clarify whether a farm is
required to register if several companies are involved in the farming
operation. For example, some farms may perform their own harvesting or
employ another company to provide harvesting services.
(Response) Because registration is by facility, a farm operation is
not required to register, provided all of the on-farm activities are
covered in the farm definition and the farm is under the same
ownership. It therefore makes no difference for purposes of
registration if different companies perform different services at a
facility. The determinative question is whether the facility is
manufacturing/processing, packing, or holding food for consumption in
the United States and is not subject to an exemption.
(Comment 54) One commenter asks FDA to clarify: (1) Whether a
grower of
[[Page 58907]]
grapes is covered under the farm definition unless the grower processes
these grapes into wine and bottles or packages the wine itself; and (2)
whether the grower would be required to register if the grower grows
grapes, sends them to a third party who makes wine from them and
bottles or packages the wine, and returns the bottled wine to the
grower, who then labels the bottles.
(Response) This comment describes an example of a mixed-type
facility. In the first example, the grower of the grapes who does not
itself process the grapes into wine, would not be required to register
its establishment because it is ``farm'' and is exempt from
registration. If the grower's establishment manufactures/processes the
grapes into wine and/or bottles or packages it, the establishment is a
facility that must register. In the second example, the grower of the
grapes would be exempt as a farm; however, labeling the wine after
receiving it back from a third party is considered manufacturing/
processing. Thus, both the grape grower's labeling facility and the
third party's manufacturing/processing facility must register.
(Comment 55) One commenter asks whether cattle feed yards
manufacturing feed that is fed onsite to the cattle are required to
register.
(Response) The ``farm'' definition states that ``farm'' includes
``facilities that manufacture/process food, if all of the food used in
such activities is consumed on that farm or another farm under the same
ownership.'' Therefore, a cattle feed yard that manufactures/processes
feed that is fed only at that feed yard or another farm or feed yard
under the same ownership is a ``farm'' that is exempt from
registration. Conversely, a cattle feed yard that manufactures/
processes feed that is fed to cattle at another location that is under
different ownership would be required to register as a manufacturing/
processing facility.
(Comment 56) One commenter quotes FDA's proposed provision for
contract facilities, which states:
[t]he definition of farm does not include facilities that contract
with multiple farmers to grow crops or raise animals. These
facilities may manufacture/process feed and distribute it to the
contract farmers for feeding to animals being raised on the farm.
FDA is proposing that the facilities that manufacture/process feed
for the contract farmers would be required to register. The farms
that grow the crops or raise the animals would be exempt from the
registration requirement.
The commenter states:
[d]espite FDA's clarifications on its definition of farm, it does
not specify what happens if these same products are later sold
outside the farm or if these products are grown, harvested, held,
and sold for consumption of any kind outside the farm, thus going to
a second owner and facility to serve other purposes (international
commerce).
(Response) This comment is not clear regarding ``what happens'' if
products are ``later sold outside the farm'' or ``are grown, harvested,
held, and sold for consumption of any kind outside the farm.'' The
``farm'' definition covers a facility that grows crops or raises
animals for food. If an establishment sells animal feed obtained from a
contract facility to a third person, that establishment would be
required to register unless it was exempt as a retail food
establishment. If the establishment sells the animal feed to, for
example, a distributor or another business, it would not fall within
the retail exemption and thus, it would be required to register.
(Comment 57) One commenter states that FDA is proposing to exempt
farms from registration even if they conduct packing/holding/processing
on their premises, as long as they only handle food grown on that farm
or another farm under the same ownership, or if they mix feed from
outside sources for exclusive use on that farm. However, the commenter
asserts that most farmers that pack or process the crops that they grow
may sell or pay for the discarded materials, such as sorted-out
produce, hulls, etc., to be used as feed. The commenter asks:
[i]s it FDA's intent to include all incidental by-products from
processing that go to feed as feed production, therefore triggering
the registration requirement? Would the by-products sold/disposed of
as feed need to be listed among the items produced by a facility
that is registering for other reasons?
(Response) This comment raises several questions regarding the
status of farms that produce animal feed or animal feed components. The
farm definition in the interim final rule includes farms packing or
holding food, if all of the food used in animal feed production
activities is grown or raised on that farm or consumed on that farm.
Similarly, a farm that manufactures/processes animal feed is not
required to register, if all of the food used in such activities is
consumed on that farm or another farm under the same ownership. Thus,
if a farm manufactures/processes food grown on the farm and feeds by-
products of these crops to the farm's own animals, the farm does not
need to register. However, if the facility sells the by-products to
another entity, it must register, unless it is otherwise exempt.
Any registered facility that is producing such by-products may
identify such products in section 11b of the registration form (Form
3537). Because the categories listed in section 11b of the form are not
included in Sec. 170.3, they are optional.
7. Food
(Comment 58) The agency received a number of comments regarding the
proposed definition of ``food'' provided in Sec. 1.227(c)(4). Most of
these commenters asserted that the definition was too broad and, for a
number of reasons, recommended that certain items covered by the
proposed definition be excluded from the rule's coverage. In
particular, the commenters requested that food packaging and components
of food packaging, other food contact articles (such as food processing
equipment and components of such equipment, glassware, dishware,
cutlery, kitchen appliances), and so-called indirect additives
(including those applied to food contact surfaces) be excluded from the
interim final rule's definition of ``food.''
In support of these proposed exclusions, many commenters cited the
language in section 415(a)(1) of the FD&C Act requiring registration of
facilities that manufacture, process, pack, or hold ``food for
consumption in the United States,'' claiming that such language
indicates that Congress intended the registration provision to apply
only to facilities that manufacture, process, pack or hold ``edible
food,'' ``traditionally understood as food,'' or articles that are
``intended for consumption.'' In addition, one commenter cited the
reference in section 415(a)(2) of the FD&C Act to the general
categories of food provided in Sec. 170.3, which does not include
listings for food packaging or other food-contact materials or their
components. Several commenters argued that extending registration to
facilities that produce food-contact materials was not consistent with
the purpose of the Bioterrorism Act and that there was no historical
evidence associating foodborne illness with packaging or other food
contact material. Finally, some commenters argued that an overly broad
definition of ``food'' would have the effect of diluting the
government's resources and thereby hampering the government's
opportunity to achieve the protective goals of the Bioterrorism Act.
Other commenters argued that additional items or facilities should
be excluded from the registration requirement; those comments are
addressed in section III.D of this document.
[[Page 58908]]
Several commenters favor inclusion of packaging and its components.
Some commenters point out that food packaging and components are
``food'' under section 201(f) of the FD&C Act. Some of these commenters
suggest that FDA should require facilities currently manufacturing
substances subject to approval under section 409 of the act to
register, and FDA should clarify the definition at Sec. 1.227(c)(4),
and consider outer packaging food.
(Response) Relying on the act's definition of ``food'' in section
201(f), the proposed rule defined ``food'' as follows:
Food has the meaning given in section 201(f) of the act.
Examples of food include, but are not limited to, fruits,
vegetables, fish, dairy products, eggs, raw agricultural commodities
for use as food or components of food, animal feed, including pet
food, food and feed ingredients and additives, including substances
that migrate into food from food packaging and other articles that
contact food, dietary supplements and dietary ingredients; infant
formula, beverages, including alcoholic beverages and bottled water,
live food animals, bakery goods, snack foods, candy, and canned
foods (emphasis added).
Thus, food packaging and other food contact materials were
expressly included as examples of ``food'' in the proposed definition,
with the result that, under the rule as proposed, facilities that
manufacture/process, pack, or hold food packaging, food-contact
materials, or their components would have been required to register.
(See 68 FR 5378 at 5382). The breadth of the proposed definition of
``food'' was based on both the statutory definition in section
201(f)(3) of the FD&C Act, which defines articles used as components of
food as ``food,'' and the case law interpreting the definition,
including Natick Paperboard v. Weinberger, 525 F.2d 1103 (1st Circuit
1975) (paperboard containing PCBs intended for food use is adulterated
food); U.S. v. Articles of food * * * 688 Cases * * * of Pottery (Cathy
Rose), 370 F. Supp. 371 (E.D. Mi. 1974) (ceramic pottery that leaches
lead is adulterated food).
The comments on food-contact substances raise the question of what
Congress intended ``food'' to mean in terms of registration of
facilities that manufacture, process, pack, or hold ``food.'' In
construing the registration provision of the Bioterrorism Act , FDA is
confronted with two questions. First, has Congress directly spoken to
the precise question presented? (``Chevron step one''). Chevron,
U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984). To find no
ambiguity, Congress must have clearly manifested its intention with
respect to the particular issue. Young v. Community Nutrition
Institute, 476 U.S. 974, 980 (1986). If Congress has spoken directly
and plainly, the agency must implement Congress's unambiguously
expressed intent. Chevron, 467 U.S. at 842-843. If, however, the
Bioterrorism Act is silent or ambiguous as to the meaning of ``food,''
FDA may define ``food'' in a reasonable fashion (``Chevron step two'').
Chevron, 467 U.S. at 842-843; FDA v. Brown & Williamson Tobacco Corp.,
529 U.S. 120, 132 (2000).
The agency has determined that, in enacting section 415, Congress
did not speak directly and precisely to the meaning of ``food.'' As
noted, the FD&C Act has a definition of ``food'' at section 201(f). It
may be a reasonable assumption that, when the term ``food'' is used in
the FD&C Act, section 201(f) applies. However, although there may be
``a natural presumption that identical words used in different parts of
the same act are intended to have the same meaning [citation omitted],
* * * the presumption is not rigid * * *'' Atlantic Cleaners & Dyers,
Inc. v. U.S., 286 U.S. 427, 433 (1932). Accord: U.S. v. Cleveland
Indians Baseball Co., 532 U.S. 200, 213 (2000). Thus, the same word may
be given different meanings, even in the same statute, if Congress
intended different interpretations or if different interpretations are
reasonable (at ``Chevron Step two.''). Atlantic Cleaners & Dryers,
Inc., supra.
Even before the Bioterrorism Act amendments, the term ``food'' was
not given an identical meaning throughout the FD&C Act. For example, in
construing the parenthetical ``(other than food)'' in section
201(g)(1)(C), the seventh circuit noted that Congress meant to exclude
only ``articles used by people in the ordinary way that most people use
food-primarily for taste, aroma, or nutritive value'' and not all
substances defined as food by section 201(f) (Nutrilab, Inc. v.
Schweiker, 713 F.2d 335, 338 (7th Cir. 1983)). Similarly, section
409(h)(6) of the FD&C Act defines a food-contact substance as ``any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food
(emphasis added).'' This definition makes sense only if ``food'' in
this context excludes materials that contact food because components of
food contact materials are plainly intended to have a technical effect
in such materials.\1\
---------------------------------------------------------------------------
\1\ FDA's long-standing interpretation of the FD&C Act's
definition of color additive, section 201(t), is an additional
example of where ``food'' is used more narrowly than as defined in
section 201(f). A color additive is defined in section 201(t) as a
substance that ``when applied to a food * * * is capable * * * of
imparting color thereto.'' The agency's food additive regulations
distinguish between color additives and ``colorants,'' the latter
being used to impart color to a food-contact material (21 CFR
178.3297(a)). (See also 21 CFR 70.3 (f)). Thus, ``food'' as it
appears in the statutory definition of color additive, necessarily
excludes food-contact materials.
---------------------------------------------------------------------------
Thus, in this larger statutory context, FDA has evaluated section
415 to determine whether the meaning of the word ``food'' is ambiguous.
In conducting this Chevron step one analysis, all of the traditional
tools of statutory interpretation are available to determine whether
the language Congress used is ambiguous. Pharmaceutical Research &
Manufacturers of America v. Thompson, 251 F. 3d 219, 224 (D.C. Cir.
2001). Beginning with the language of the statute, in section
415(a)(1), ``food'' is used to describe who must register: ``The
Secretary shall by regulation require that any facility engaged in
manufacturing, processing, packing, or holding food for consumption in
the United States to be registered with the Secretary (emphasis
added).'' The Bioterrorism Act is silent as to the meaning of ``food.''
Furthermore, the prepositional phrase ``for consumption in the United
States'' creates an ambiguity because it could be read to suggest that
``food'' within the context of the section 415 registration requirement
only refers to food that is ordinarily thought of as ``consumed.'' By
modifying the term ``food'' by the prepositional phrase ``for
consumption in the United States,'' Congress apparently intended to
limit the term ``food'' to something less than the broad definition in
section 201(f). Although ``consume'' has multiple meanings, most
relevant in this context is ``to eat or drink up; ingest.'' Webster's
II New Riverside University Dictionary (1994). Emphasizing the word
``consumption'' could appear to limit ``food'' to those items commonly
eaten primarily for taste, aroma, or nutritive value. Nutrilab v.
Schweiker, supra at 338.
Where, as here, the statutory language on its face does not clearly
establish Congress's intent, it is appropriate to consider not only the
particular statutory language at issue, but also the language and
design of the statute as a whole. Martini v. Federal Nat'l Mortgage
Association, 178 F. 3d 1336, 1345 (D.C. Cir. 1999), citing K Mart Corp.
v. Cartier, Inc., 486 U.S. 281 (1988). Indeed, the analysis should not
be confined to the specific provision in isolation because the meaning
or ambiguity of a term may
[[Page 58909]]
be evident only when considered in a larger context. FDA v. Brown &
Williamson Tobacco Corp., supra at 132 (2000).
Consistent with this instruction, FDA has considered other parts of
the registration provision in assessing whether the meaning of ``food''
in section 415(a)(1) ambiguous. In particular, FDA has considered
section 415(b)(1). In defining ``facility'' for purposes of section
415, Congress expressly exempted ``farms; restaurants; other retail
food establishments; nonprofit food establishments in which food is
prepared for or served directly to the consumer * * *'' These
exemptions do not make clear whether Congress intended them to cover
only food that is ordinarily eaten at some point by consumers primarily
for taste, aroma, or nutritive value or whether, for example, a retail
food establishment could include retailers of food contact materials,
such as retail cookware stores.
The legislative history of section 415 also supports the conclusion
that Congress did not speak directly to the meaning of ``food'' in that
Bioterrorism Act provision. Such history is appropriately consulted at
Chevron step one. Atherton v. FDIC, 519 U.S. 213, 228-29 (1997). In
particular, the Conference Report to H.R. 3448, which became the
Bioterrorism Act, explains what Congress intended by ``retail food
establishments,'' which is used to create an exemption from
registration:
The Managers intend that, for the purposes of this section, the
term ``retail food establishments'' includes establishments that
store, prepare, package, serve, or otherwise provide articles of
food directly to the retail consumer for human consumption, such as
grocery stores, convenience stores, cafeterias, lunch rooms, food
stands, saloons, taverns, bars, lounges, catering or vending
facilities, or other similar establishments that provide food
directly to a retail consumer.
H.R. Conf. Rep. No. 481, 107th Cong., 2d Sess., 133 (2002).
Similarly, the Conference Report notes that the term ``non-profit
food establishments'' includes not-for-profit establishments in which
food is prepared for, or served directly to the consumer, such as food
banks, soup kitchens, homebound food delivery services, or other
similar charitable organizations that provide food or meals for human
consumption.'' (Id. at 133-34.) Notably, the examples provided by
Congress for both types of exempt food establishments are not those
that generally sell or distribute food contact materials. Accordingly,
the legislative history of section 415 creates additional ambiguity as
to the meaning of ``food.''
Finally, a review of section 307 of the Bioterrorism Act (the prior
notice of food imports provision) and its legislative history confirms
that the meaning of the word ``food'' when used in the Bioterrorism
Act, including section 415, is ambiguous. The Bioterrorism Act's
registration provision is one piece of several enacted by Congress to
enhance the safety of the U.S. food supply. Registration works in
concert with prior notice (section 307 of the Bioterrorism Act). This
is reflected in section 305(c) of the Bioterrorism Act, which requires
that food from an unregistered facility be held at the port when
offered for import. Thus, this provision and its legislative history
are of particular relevance in determining whether ``food'' is
ambiguous in the registration provision. The legislative history of
section 307 of the Bioterrorism Act supports the ambiguity of the term
``food'' in the Bioterrorism Act. For example, the Conference Report
states that the prior notice provision is to be construed not to apply
to ``packaging materials if, at the time of importation, such materials
will not be used for or in contact with food * * *'' (See H.R. Conf.
Rep. No. 481, 107th Cong., 2d Sess., 136 (2002).) This statement could
be read to mean that the term ``food'' does not include packaging or
other materials that contact food.
Having concluded that the meaning of ``food'' in section 415(a)(1)
is ambiguous, FDA has considered how to define the term so as to
achieve a ``permissible construction'' of the registration provision.
Chevron, USA, Inc. v. NRDC, Inc., supra at 843. In conducting this
Chevron step two analysis, the agency has considered the same
information evaluated at step one of the analysis. Bell Atlantic
Telephone Co. v. FCC, 131 F. 3d 1044, 1049 (D.C. Cir. 1997); Chevron
U.S.A., Inc. v. FERC, 193 F. Supp. 2d 54, 68 (D.D.C. 2002). FDA has
determined that it is permissible, for purposes of the registration
provision, to exclude food contact materials from the definition of
``food.''
Excluding food-contact materials (including food packaging) is
consistent with the statutory phrase, ``food for consumption'', section
415(a)(1), in that foods that are ``consumed'' are generally those
intentionally eaten for their taste, aroma, or nutritive value. In
addition, excluding food contact materials from ``food'' in this
regulation is consistent with the exemptions in section 415(b)(1), as
well as the legislative history of section 415, in that the
establishments exempted by statute and the entities used as examples of
retail and nonprofit food establishments are those that sell,
distribute, or otherwise provide what is considered food in the
conventional sense and, generally speaking, are not purveyors of food
contact articles. Finally, restricting ``food'' to substances other
than food-contact materials is consistent with the legislative history
of the prior notice provision of the Bioterrorism Act, a provision
linked to the registration provision.
As discussed in responses to comments 64 and 65, FDA has also
interpreted ``food'' for purposes of section 415 to exclude pesticides
as defined in FIFRA (7 U.S.C. 136(u)). Accordingly, for the reasons
discussed in response to this comment and comments 64 and 65, FDA has
determined that a reasonable interpretation of ``food'' for purposes of
section 415 is as follows. Section 1.227(b)(4) of this interim final
rule has been revised to provide:
Food has the meaning given in section 201(f) of the act, (i)
except for purposes of this subpart, it does not include: (A) food
contact substances as defined in section 49(h)(6) of the act (21
U.S.C. 348 (h)(6)); or (B) pesticides as defined in 7 U.S.C 136(u).
(ii) Examples of food include fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or as
components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and
dietary ingredients, infant formula, beverages (including alcoholic
beverages and bottled water), live food animals, bakery goods, snack
foods, candy, and canned foods.
(Comment 59) One commenter asks FDA to address the foreign facility
exemption as it applies to ``products that migrate into food from food
packaging and other articles that contact food.''
(Response) Because the interim final rule excludes food contact
substances from the definition of ``food,'' establishments that
manufacture/process, pack, or hold food contact materials or components
of such materials are not required to register, unless these
establishments also manufacture/process, pack, or hold ``food'' as
defined in Sec. 1.227(b)(4).
(Comment 60) A commenter asks whether water collection and
distribution facilities are required to register as food facilities if
the owner or operator of such facility knows that the water is to be
used as a food ingredient. The same commenter asks whether community
water systems that supply water to bottled water facilities or to
bottled water sources must register.
(Response) FDA has determined that nonbottled drinking water
collection and distribution organizations and their
[[Page 58910]]
structures should not be included in the definition of ``facility'' for
purposes of registration. Under section 305(a) of the Bioterrorism Act,
the term ``facility'' includes ``any factory, warehouse, or
establishment.'' Congress did not specify any definitions for these
terms. According to Webster's II New Riverside University Dictionary
(1994), the most relevant definition of ``establishment'' is ``a
business firm, club, institution, or residence, including its
possessions and employees.'' Where, as here, the statutory language on
its face does not clearly establish Congressional intent, it is
appropriate also to consider other language in the section, the
language and design of the statute as a whole, and the larger context
to determine if the term is ambiguous. FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 132 (2000); Martini v. Federal Nat'l
Mortgage Ass'n, 178 F.3d 1336, 1345 (D.C. Cir. 1999), citing K Mart
Corp. v. Cartier, Inc., 486 U.S. 281 (1988).
Traditionally, the Environmental Protection Agency (EPA) has
exercised a primary role in the regulation of public water systems (see
44 FR 42775, July 20, 1979). Under the Safe Drinking Water Act (42
U.S.C. 300(f) et seq.) (SDWA), EPA regulates public water systems,
which are water systems that have at least 15 service connections or
serve 25 people per day for 60 days of the year. In addition, Title IV
of the Bioterrorism Act creates an extensive scheme for protecting from
bioterrorism threats community water systems serving over 3,300
persons. Title IV amends the SDWA to require that such community water
systems submit to EPA vulnerability assessments of their facilities and
emergency response plans to deal with the possibility of a bioterrorist
attack. EPA is authorized to provide funds to community water systems
to address critical security enhancements and significant public health
threats.
FDA believes that the language and design of the Bioterrorism Act,
which in Title IV lays out strategies under EPA's authority for
protecting the safety and supply of public drinking water, creates
ambiguity about whether Congress intended to require drinking water
facilities to register with FDA as food facilities. The traditional EPA
role in regulating public water systems, as established by federal
legislation and implemented by Federal agencies, also creates ambiguity
about Congressional intent to include drinking water facilities within
the scope of FDA's food registration scheme.
Based on EPA's primacy in regulating public water systems and on
the Bioterrorism Act scheme for water systems in Title IV, FDA
concludes that it is reasonable to interpret the term ``facility'' to
exclude nonbottled drinking water collection and distribution
establishments, such as community water systems. Therefore, FDA has
revised Sec. 1.227(b)(2) to exclude these nonbottled drinking water
establishments from the definition of ``facility.''
Bottled water, on the other hand, has traditionally been regulated
by FDA (see 21 U.S.C. 349, 21 CFR parts 129, 165). Moreover, Title IV
of the Bioterrorism Act does not address bottled water issues, but only
public drinking water systems. Therefore, FDA believes it is reasonable
to include establishments that manufacture/process, pack, or hold
bottled water in the definition of ``facility.''
FDA also has primary responsibility for drinking water that is used
in the manufacturing/processing of food that is not bottled water.
Thus, once drinking water enters a facility where it is used in food
manufacturing/processing, the water is regulated by FDA. Because such
facilities are food facilities in the first place, they already are
required to register with FDA without regard to the water source.
(Comment 61) Several commenters asked whether facilities that
produce water coolers, ozone equipment, carbon dioxide, water storage
silos, plastic resins, or chlorine must register with FDA.
(Response) Water coolers, ozone equipment, water storage silos, and
plastic resins are food-contact substances (section 409(h)(6) of the
FD&C Act) and therefore, facilities that manufacture/process, pack, or
hold such items are not required to register because these items are
not ``food'' as defined in this regulation. In contrast, carbon
dioxide, if used to make carbonated beverages or to aerate food, is a
component of food (section 201(f)(3) of the FD&C Act) that is intended
to have a technical effect in the food and therefore, is ``food'' as
defined in this interim final rule. Similarly, chlorine, if used in
bottled water, is also a component of food (section 201(f)(3) of the
FD&C Act) that is intended to have a technical effect in the food and
therefore, is ``food'' as defined in this interim final rule.
Accordingly, facilities that manufacture/process, pack, or hold carbon
dioxide or chlorine that will be used in food products must register.
Please see the response to comment 62, which addresses multiuse
substances.
(Comment 62) Commenters suggest that foreign facilities that
process or refine vegetable oils not intended for direct inclusion in
food or animal feed should be exempt from registration. These
commenters argue that where bulk ingredients have both food and non-
food uses, the standard for registration should be whether the
commodity has been sufficiently refined to be directly added to food.
(Response) This interim final rule requires that any domestic
facility that manufactures/processes, packs, or holds ``food'' must be
registered unless the facility satisfies one of the exemptions in Sec.
1.226. Foreign facilities are subject to the same registration
requirement except that a manufacturer/process or is not required to be
registered if a subsequent facility outside the United States performs
further manufacturing/processing of more than a de minimis nature. For
purposes of the interim final rule, ``food'' has the definition in
section 201(f) of the FD&C Act except that ``food contact substances''
(section 409(h)(6)) and ``pesticides'' (7 U.S.C. 136(u)) are excluded
from ``food.'' Under section 201(f), ``food'' means ``articles used for
food or drink'' (section 201(f)(1)) and articles ``used for components
of any such article'' (section 201(f)(3).) The determination of whether
a substance is ``food'' is not a question of intended use. Nutrilab v.
Schweiker, 713 F.2d. 335, 337 (7th Cir. 1983); U.S. v. Technical Egg
Products, 171 F.Supp. 326, 328 (N.D. Ga. 1959); U.S. v. 52 Drums Maple
Syrup, 110 F.2d 914, 915 (2d Cir. 1940). Courts interpreting the
``food'' definition in the act have held that articles at both ends of
the food continuum are ``food'' for purposes of the FD&C Act. United
States v. Tuente Livestock, 888 F. Supp. 1416 (S.D. Ohio, 1995) (live
animals for food use are ``food'' under the FD&C Act); U.S. v.
Technical Egg Products, supra, 171 F.Supp. at 328 (rotten eggs are
``food.'') Thus, FDA believes that a facility that manufactures/
processes, packs, or holds food must be registered (unless subject to
one of the exemptions in Sec. 1.226) even if the food is not yet in
the form in which it will be used for food. FDA will consider a product
as one that will be used for food if the owner, operator, or agent in
charge of the facility reasonably believes that the substance is
reasonably expected to be directed to a food use. In the case of
vegetable oil that is not yet food grade, FDA believes that a facility
that manufactures/processes, packs, or holds such oil must be
registered (assuming the facility does not qualify for an exemption in
Sec. 1.226) if the owner, operator, or agent in charge reasonably
believes that oil manufactured/processed, packed, or held at the
facility
[[Page 58911]]
is reasonably expected to be directed to a food use.
(Comment 63) Several commenters assert that processing aids, such
as defoaming agents and biocides, are used in the production of food
but are not food in and of themselves and thus facilities that
manufacture/process, pack, or hold such substances need not register.
(Response) FDA notes that there are a wide variety of processing
aids, including processing aids used in packaging and other food
contact materials and processing aids used in ``traditional'' foods.
The commenters do not specify which type or types of processing aids
they believe are not ``food'' such that establishments that
manufacture/process, pack, or hold these substances should not be
required to register.
Whether a facility that manufactures/processes, packs, or holds a
processing aid must be registered depends upon whether such a substance
is ``food'' under this rule. As noted, for purposes of the interim
final rule, ``food'' excludes ``food contact substances'' (section
409(h)(6)). In addition, ``food'' excludes ``pesticides'' (7 U.S.C.
136(u)). Thus, if the processing aid is not a pesticide and is intended
to have a technical effect in the food to which it is added, the
substance is not exempt from the definition of ``food'' and the
facility must be registered unless otherwise exempt under Sec. 1.226
(i.e., if it is a foreign facility, and food from such facility
undergoes further manufacturing/processing (including packaging) by
another facility outside the United States). In terms of processing
aids, this means that, generally speaking, facilities that manufacture/
process, pack, or hold processing aids used in the production of
``traditional'' food will be required to register. This is a reasonable
result in that such processing aids are intentionally and directly
added to ``traditional'' foods.
(Comment 64) Several commenters request an exemption for facilities
dealing with agricultural chemicals (fertilizer, pesticides) since
these are not food for consumption and they are already registered with
EPA. Several other comments asked whether facilities that manufacture/
process, pack, or hold anti-microbial pesticides used in or on food
must register.
(Response) As discussed in the response to comment 58, the meaning
of ``food'' in section 415 is ambiguous. Therefore, FDA may define
``food'' in a reasonable manner. FDA believes that excluding
``pesticides `` (7 U.S.C. 136(u)) from the definition of food is
reasonable. Agricultural pesticides, including those used in or on food
for human or animal use, are comprehensively regulated by the Federal
Government. Under the Federal Insecticide, Fungicide, and Rodenticide
Act, 7 U.S.C. 136 et seq., all pesticides (both food and nonfood use)
are registered with EPA. As part of the registration process,
establishments in which pesticides are produced must register with EPA
(40 CFR 167.3 and 167.20). As part of the importation process, prior
notice of all pesticide shipments must be given to EPA (19 CFR 12.112).
Importantly, the Federal regulatory scheme for pesticides was
substantially revised in 1996 by the Food Quality Protection Act (FQPA)
(Public Law 104-170), and EPA's authority over pesticides was
consolidated and also expanded. As a result of FQPA, pesticides and
their residues are subject to substantial and comprehensive regulation
by EPA. Where another Federal agency has the types of specific and
comprehensive authority described above to regulate the safety of
certain substances (here, pesticides), FDA believes that it is
appropriate to interpret ``food'' in section 415 of the FD&C Act to not
include such substances. Accordingly, FDA has revised the definition of
``food'' in Sec. 1.227(b)(4) to exclude pesticides as defined by FIFRA
(7 U.S.C. 136(u)). Therefore, FDA agrees that facilities that
manufacture/process, pack, or hold ``pesticides intended for use in or
on food'' need not register with FDA.
(Comment 65) Several comments asked whether facilities that
manufacture/process, pack, or hold antimicrobial pesticides used in or
on food must register.
(Response) As noted previously, for the purposes of this rule, the
term ``food'' is defined to exclude any substance defined as a
``pesticide'' in FIFRA (7 U.S.C. 136(u)). Anti-microbial pesticides
meet the FIFRA definition of ``pesticide.'' Thus, facilities that
manufacture/process, pack, or hold such substances are not required to
register.
(Comment 66) Several commenters question how live food animals
relate to the definition of food. One commenter indicates that many
small animals are shipped to the United States with the intention to
grow them in the United States for food and thus, such animals are not
animals for food at the time they are imported. This commenter asks FDA
to exempt live food animals from the definition of food.
(Response) As discussed in the response to comment 58, the meaning
of ``food'' in section 415 is ambiguous. Therefore, FDA may define
``food'' in a reasonable manner. FDA believes that it is reasonable to
interpret ``food'' in section 415 to include live animals. First, such
inclusion is consistent with the language in section 415(a), ``food for
consumption,'' in that live animals are raw material for, and thus
reasonably considered components of, items traditionally consumed for
taste, aroma, or nutritive value. Moreover, the products of live food
animals are an integral part of the food consumed in the United States,
and thus, it is logical to protect the raw materials (i.e., the live
animals) and such animal food products by including them under the
Bioterrorism Act's safeguards. Second, Congress provided several
statutory exemptions from the registration requirement, including
``farms,'' section 415(b)(2), which would reasonably include those
raising animals as well as those growing fruits and vegetables. By
exempting farms, Congress indicates that, absent an exemption,
establishments where fruits, vegetables, and animals are produced would
be ``food facilities'' subject to registration. Third, the inclusion of
live animals in the definition of ``food'' is consistent with the
statutory language of the Bioterrorism Act as a whole. In particular,
the recordkeeping, administrative detention, and prior notice
provisions of the Bioterrorism Act all include an explicit reference to
animals in the statutory standard, ``serious adverse health
consequences or death to humans or animals.'' (See, e.g., 21 U.S.C.
334(h)(1)(A), 350c(a), and 381(m)(2)(B)(ii).) In each of these
provisions, this standard serves as a trigger for FDA action. This
standard does not appear in the registration provision, because there
is no need for a trigger for FDA action in registration. FDA does not
believe that the fact that this standard does not appear in the
registration provision evidences the intent on the part of Congress
that facilities that manufacture/process, pack, or hold live animals
need not register. Accordingly, the interim final rule's definition of
``food'' includes live food animals.\2\ FDA notes, however, that a
facility that exports live food animals directly to the United States
may be exempt as a ``farm'' if it satisfies the definition in Sec.
1.227(b)(3).
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\2\ Defining ``food'' to include live animals is also consistent
with the case law interpreting the term ``food'' in the broader
context of the act. (See United State v. Tuente Livestock, 888 F.
Supp. 1416 (S. D. Ohio, 1995).)
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(Comment 67) Some commenters ask that research and development
(R&D) facilities and facilities that manufacture/
[[Page 58912]]
process, pack, or hold food samples should not be considered
``facilities'' for purposes of FDA registration. The commenters note
that R&D facilities typically hold food and often process it on a small
scale, but this food is intended for research purposes and not for
commercial sale or public consumption. The commenters explain that
sample facilities distribute samples internally to employees and are
not commercially distributed.
(Response) Under section 305 of the Bioterrorism Act, facilities
are required to register if they manufacture/process, pack, or hold
food for consumption in the United States. Therefore, R&D facilities
and sample facilities that manufacture/process, pack, or hold food that
is consumed in the United States, either by the facility's employees or
others are required to register. However, if R&D facilities and sample
facilities manufacture/process, pack, or hold food and this food is not
for consumption or actually consumed in the United States, the
facilities are not subject to registration.
(Comment 68) One commenter takes issue with FDA's inclusion of
animal feed within the definition of food. This commenter states that
in the legislative history of the Bioterrorism Act, Rep. Shimkus (R-IL)
repeatedly states that the registration requirement is intended to
apply to food for ``human'' consumption. The commenter also indicates
that the Conference Report to the Bioterrorism Act states that the
retail exemption applies to facilities that sell to the consumer ``for
human consumption,'' stating that FDA took comments on this issue in
the proposed rule. The commenter argues that because the recordkeeping,
administrative detention, and prior notice parts of the Bioterrorism
Act specifically refer to requirements regarding food for animals, as
well as for humans, while the registration part of the Bioterrorism Act
does not, FDA should limit the food definition to food for human
consumption.
(Response) As discussed in the response to comment 58, the meaning
of ``food'' in section 415 is ambiguous. Therefore, FDA may define
``food'' in a reasonable manner. As noted in the response to comment
66, sections 303, 306, and 307 of the Bioterrorism Act reflect
Congressional concern with the health and safety of ``animals.'' In
that response, FDA also explains why, logically, the standard in
question (``serious adverse heath consequences to human or animals'')
need not appear in section 305 of the Bioterrorism Act . One important
way in which to safeguard animals is to protect their food supply. FDA
believes that it is reasonable to include food consumed by animals in
the definition of ``food'' and thus, to require the registration of
facilities that manufacture/process, pack, or hold food for consumption
by animals. Accordingly, the interim final rule's definition of
``food'' in Sec. 1.227(b)(4) includes food for consumption by animals.
8. Holding
FDA received many comments regarding whether facilities that hold
products on a temporary basis are required to register as holders.
Because these comments also questioned whether these units fit within
the definition of ``facility,'' FDA has addressed those issues in
comment 44 and its response.
(Comment 69) Several commenters request that FDA clarify who is
required to register and pay the costs for storage if a manufacturer/
processor sends food to a warehouse for holding under the manufacturer/
processor's name before export to the United States.
(Response) FDA interprets this question as applying solely to the
warehouse, not the manufacturer/processor. Each facility that holds
unprocessed food that will be imported into the United States in its
unprocessed form for consumption in the United States must be
registered with FDA, unless it is exempted by this rule. Additionally,
each foreign facility that holds food destined for consumption in the
United States subsequent to the last foreign manufacturer/processor
must be registered with FDA, unless it is exempted by this rule.
Consistent with the plain language of the Bioterrorism Act, the interim
final rule places the responsibility of registering a facility on the
owner, operator, or agent-in-charge of such facility. Although the
interim final rule permits the owner, operator, or agent in charge to
authorize an individual to register the facility, the facility's owner,
operator, or agent in charge retains the legal responsibility to ensure
that the facility is properly registered with FDA. In the situation
raised in the comment, whether the warehouse or the manufacturer/
processor pays the cost of such storage is a private matter between the
manufacturer/processor and the warehouse.
On its own initiative, FDA has made an editorial change in this
section for clarity.
9. Manufacturing/Processing
(Comment 70) One commenter requests FDA to clarify whether
commercial ripening of fruit fits within the definition of
``manufacturing/processing.'' The commenter states that some cargo
containers are equipped with technologies that artificially ripen fruit
while in transit. The commenter states that ``such technological
advancements should not change the interpretation of what defines a
facility under the rule,'' and requests that FDA not consider this
activity manufacturing/processing.
(Response) Because this activity involves ``treating,''
``modifying,'' or ``manipulating'' food, it constitutes manufacturing/
processing as defined by the interim final rule (21 CFR 1.227(b)(6).
The fact that these manufacturing/processing activities occur in a
transport vehicle does not alter the fact that these activities are
manufacturing/processing. Thus, a vehicle engaging in the artificial
ripening of food while in transit is required to register.
On its own initiative, FDA has made several editorial changes in
this section for clarity.
10. Nonprofit Food Establishment
FDA received no comments on this issue. On its own initiative, FDA
has made several changes in this section to be consistent with the
legislative history for section 305 of the Bioterrorism Act (21 U.S.C.
415). FDA has also made several editorial changes in this section for
clarity.
11. Packing
(Comment 71) One commenter asks FDA to differentiate between
``packing'' and ``packaging.'' The commenter states that although
arguably the terms could be used interchangeably, they are in fact
materially different. The commenter states that this distinction is
especially important because FDA considers ``packaging material'' food
under Sec. 1.227(c)(4).
(Response) FDA agrees with the commenter and differentiates between
these terms in the interim final rule. The interim final rule defines
``packaging'' (when used as a verb) as ``placing food into the
container that directly contacts the food and that the consumer
receives.'' (Sec. 1.227(b)(8)). FDA has redefined ``packing'' as
``placing food into a container other than packaging the food'' (Sec.
1.227(b)(9)). FDA notes that packaging material is no longer included
in the definition of ``food'' as revised in this interim final rule.
(Comment 72) One commenter asks whether putting food into tote bins
and bulk containers is considered ``packing'' for purposes of this
rule.
(Response) Putting food into tote bins and bulk containers is
``packing'' as
[[Page 58913]]
defined in the interim final rule (Sec. 1.227(b)(9)), because it is
``placing [food] into a container other than packaging the food.''
12. Port of Entry
(Comment 73) Several commenters ask that the definition of ``port
of entry'' be modified so that it is consistent with the U.S. Customs
definition, which is ``the port at which Customs entry is made for the
shipment of imported food for consumption in the United States. This
port may be different than the Port of Arrival, which is defined as the
first port at which the carrier transporting the merchandise arrives.''
A commenter states that creating a new definition of ``port of entry''
is contrary to Congress's intent, which it may be presumed was based on
Congress's awareness of Customs' definition of the term.
One commenter states that two Federal Government agencies having
two definitions for the same term is potentially troublesome, and
``lays the groundwork for confusion and conflict regarding where and
when proper declaration is required.'' Another commenter states that
FDA's proposed definition of ``port of entry'' will create substantial
hardship for an importer of the food, who is usually located in close
proximity to the inland port and is better equipped to handle
compliance or clearance issues locally. The commenter states that,
under FDA's proposed definition of ``port of entry,'' imports would be
subject to review by two separate FDA Districts, that of the port of
arrival and that of the port of entry. This would greatly increase
FDA's workload. The commenter also indicates that FDA's proposed
definition of ``port of entry'' would create substantial problems if a
foreign facility fails to register, because there is no provision in
the statute for FDA to issue a refusal of admission that would enable
the importer to export the goods, or any provision for the goods to be
designated as general order status. In this case, the importer could
not file a consumption entry, after which FDA could issue a refusal of
admission under 21 U.S.C. 381(a), because a consumption entry cannot be
filed until the goods have arrived at the inland port.
These commenters also argue that FDA's concern that allowing food
to be shipped inland before verifying registration could result in loss
of government control over the food is inconsistent with the statutory
objective. This objective is to prevent food imports from being
released from Customs' control until FDA has had an opportunity to
screen the shipment and determine if it presents a risk of
bioterrorism. The commenter explains that, under Customs' regulations,
all food transported in bond to an inland port of entry is subject to
Customs' legal control until a consumption entry is filed and a permit
for release is issued. Even if cargo is bound for consumption entry in
an inland port, the cargo is still subject to detention or inspection
by Customs or FDA at the port of arrival. One commenter states that a
revised definition of port of entry would also assist express carriers,
who are required to hold a shipment in their control until all
regulatory agencies have released it.
(Response) As discussed in detail in response to comment 151, this
interim final rule does not include a provision regarding consequences
for failure to register on imported food. Because the definition of
``port of entry'' is only relevant to the consequences of failure to
register when attempting to import food, we have removed the definition
of ``port of entry'' from this interim final rule. FDA has defined the
term ``port of entry'' in the interim final rule on prior notice of
imported food published elsewhere in this Federal Register.
13. Restaurants
(Comment 74) One commenter asks FDA to specify that commissaries
that are a single source of food for large populations via large chain
restaurants should not be exempt from registration as restaurants.
(Response) FDA agrees with the commenter that facilities, such as
commissaries or central kitchens that provide food to restaurants that
subsequently serve the food to customers, are not restaurants. The
proposed definition of restaurant is limited to establishments that
prepare and sell food directly to consumers for immediate consumption.
Although central commissaries prepare food that is eventually served to
consumers, these facilities do not do so directly. Accordingly, FDA is
clarifying in the interim final rule that commissaries, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers are not restaurants and thus, are required
to register with FDA.
(Comment 75) Several commenters agree with FDA that the restaurant
definition (and therefore, the exemption) should include pet shelters,
kennels, and veterinary facilities. One of these commenters requests
that FDA include these facilities in the interim final rule itself, as
opposed to the preamble.
(Response) The preamble to the proposed rule stated that, by
analogy, pet shelters, kennels, and veterinary facilities were included
in the restaurant exemption. FDA received no comments disagreeing with
this approach. For clarity, the interim final rule's definition of
restaurant expressly includes pet shelters, kennels, and veterinary
facilities.
On its own initiative, FDA has made several editorial changes in
this section for clarity.
14. Retail Food Establishment
The interim final rule substitutes the statutory term ``retail food
establishment'' for the term ``retail facility,'' which was used in the
proposed rule.
(Comment 76) Some commenters state that the definition of retail
facility as ``a facility that sells food products directly to consumers
only,'' should be revised to delete ``only.'' This is based on the
following arguments: 148 Cong. Rec. H2858 specifies that retail food
establishments include those facilities ``attendant'' to retail
operations; because the proposed definition of retail food
establishment included commissaries, distribution facilities for
grocery stores, which are also attendant facilities, should be included
as well; the legislative history makes several references to retail as
``sale to consumers as its primary function,'' warehouse clubs should
be included in the definition of retail facility, based on this
language at 148 Cong. Rec. H2726: ``[Retail] does not include a
warehouse that does not provide articles of food directly to a retail
consumer as its primary function * * *.''
(Response) FDA agrees in part with these comments. Accordingly, we
have revised the definition of retail food establishment to eliminate
the restriction that such facilities must sell only to consumers to be
considered a retail food establishment. This interim final rule defines
``retail food establishment'' as ``an establishment that sells food
products directly to consumers as its primary function. A retail
establishment may manufacture/process, pack, or hold food if the
establishment's primary function is to sell from that establishment
food that it manufactures/processes, packs, or holds directly to
consumers. A retail food establishment's primary function is to sell
food directly to consumers if the annual monetary value of sales of
food products directly to consumers exceeds the annual monetary value
of sales of food products to all other buyers. The term `` `consumers'
does not include businesses. A `retail food establishment' includes
grocery stores, convenience stores, and vending machine locations.''
This change preserves the retail
[[Page 58914]]
exemption both for retail food establishments (such as grocery stores)
that sell or transfer some products to sources other than a consumer
(e.g., to other grocery stores), and for direct selling entrepreneurs,
as long as their primary function is to sell directly to consumers.
FDA further agrees that under the revised definition of retail food
establishment, certain warehouse clubs may be exempt from registration,
if, based on dollar volume of their sales, they sell food directly to
consumers as their primary function.
In addition, FDA has determined that an establishment ``attendant''
to a retail operation, if located separate from the retail food
establishment, is not a retail food establishment for purposes of this
rule. This is consistent with the Conference Report for the
Bioterrorism Act, which states that the term ``retail'' does not
include warehouses that do not sell directly to consumers as their
primary function (H.R. Conf. Rep. No. 481, 107th Cong., 2d Sess., 133
(2002)).
Regarding FDA's use of the term ``commissaries'' in Sec.
1.227(c)(11) of the proposed rule, FDA is clarifying that the term was
intended to refer to establishments on military bases that sell food
directly to consumers. As noted in the response to comment 74, FDA did
not intend to include other types of commissaries, such as central
kitchens for restaurants, within the restaurant exemption. To avoid
confusion, the interim final rule deletes the word ``commissaries'' as
an example of a ``retail food establishment'' because this term has
multiple meanings. Regardless of what an establishment is called, it is
exempt as a retail food establishment if--and only if--it meets the
definition.
(Comment 77) Several commenters argue that ``direct selling'' or
``multi-level selling'' home-based distributors should be considered
retail food establishments because their primary function is selling to
consumers. However, because these salespeople also transfer products
among themselves, they are not exempt under the proposed rule. The
parent company's manufacturing and distribution facilities would be
required to register. There are millions of direct selling
entrepreneurs and registering them all would flood the registration
system and not be meaningful. These salespeople are analogous to retail
chain stores that sometimes need to transfer inventory between them.
(Response) As discussed in the response to comment 7, private
residences of individuals are not facilities for purposes of this
interim final rule and, therefore, are exempt from registration.
Accordingly, these home-based distributors are not subject to
registration.
(Comment 78) One commenter asks FDA to clarify when operations of a
retail food establishment cease to be incidental to the activities of
the retail food establishment and cause the retail food establishment
to become a mixed-type facility that must register. This commenter
asserts that activities such as operating a juice bar, repackaging nuts
or dried fruits received in bulk into smaller packages, or unpacking
and displaying produce are good examples of incidental activities in a
retail food establishment.
(Response) The revised definition of ``retail food establishment''
clarifies that such establishments may manufacture/process, pack, or
hold food so long as the establishment's primary function is to sell
from that establishment food that it manufactures/processes, packs, or
holds directly to consumers. As noted, a retail food establishment's
primary function is to sell food directly to consumers if the annual
monetary value of sales of food products directly to consumers exceeds
the annual monetary value of sales of food products to all other
buyers. Therefore, if the establishment's primary function is to sell
food directly to consumers, repackaging nuts or dried fruit for sale
directly to consumers and unpacking and displaying produce for direct
sale to consumers are permissible activities. However, if an
establishment's primary function is to sell food to distributors, but
the establishment also conducts some minor sales directly to consumers,
repackaging nuts for sale directly to these consumers does not cause
the establishment to fall within the definition of ``retail food
establishment.'' Examples of manufacturing/processing that a retail
food establishment might perform include making potato salad for sale
at the delicatessen counter of a grocery store, filleting fish at a
fish market, and cutting cheese from a large block into slices for sale
directly to consumers based on the amount they request. Operating a
juice bar would be exempt as a ``restaurant'' because it involves
preparing and selling food directly to consumers for immediate
consumption.
(Comment 79) Some commenters argue that retail food establishments
should include retailers of animal food. They argue that the plain text
of the statute does not have a limitation on the scope of the retail
food establishment exemption and that because animal food is included
in the proposed rule's definition of food, the exemption should also
apply to both. These commenters further argue that it would not make
sense to hold animal food retailers to a standard higher than that for
retailers of human food and note that pet food is offered alongside
food for human consumption. Finally, these commenters assert that the
failure to exempt pet food retailers would be to eliminate the benefit
of the exemption for retail animal food facilities.
(Response) FDA agrees with these comments and advises that the
definition of ``retail food establishment'' includes animal food
retailers. FDA believes that this is consistent both with including
animal feed as ``food,'' as well as with the language of the
Bioterrorism Act. The agency has amended the definition of ``retail
food establishment,'' however, to clarify that the term ``consumers''
does not include businesses. As a result, an establishment that sells
animal food to pet owners and other individuals as its primary function
is exempt as a retail food establishment. An establishment that sells
animal feed to businesses, such as farms, as its primary function must
register.
(Comment 80) One commenter asks FDA to clarify whether wholesale
establishments are also included in the definition of ``retail food
establishment.''
(Response) Wholesale facilities are not covered by the definition
of ``retail food establishment'' because they do not sell food directly
to consumers as their primary function.
(Comment 81) One commenter asks FDA to clarify whether retail co-
ops are required to register in light of the proposed rule's statement
that ``FDA is proposing to require co-op facilities that manufacture/
process, pack, or hold food, and that are not subject to the farm
exemption, to register with FDA.'' The commenter states that ``retail
co-ops, aside from cooperative ownership, operate no differently than
any other retail establishment.''
(Response) FDA agrees that a retail food establishment that is
cooperatively owned is exempt from registration if it sells food
directly to consumers as the co-op's primary function. The
establishment's primary function must be to sell food, including that
manufactured/processed at the establishment, directly to consumers.
(Comment 82) Several commenters ask whether establishments
supplying food to consumers via Internet or mail-order sales are
covered under the definition of ``retail food establishment.''
(Response) Facilities selling food directly to consumers via the
Internet or mail-order are covered under the
[[Page 58915]]
definition of ``retail food establishment'' if they meet the other
criteria of the ``retail food establishment'' definition. FDA notes,
however, that many of these establishments may also manufacture/
process, pack, or hold food that is subsequently sold to consumers.
Unless the establishment's primary function is to sell food, including
the food it manufactures/processes, directly to consumers, it must
register with FDA.
(Comment 83) One commenter asks FDA to clarify whether warehouses
that hold food for sales in U.S.-based duty-free stores are required to
register. The commenter indicates that products stored in a duty-free
enterprise warehouse and sold in an airport duty-free store are
purchased solely by travelers departing from the United States, and
therefore, are not for consumption in the United States.
(Response) FDA's understanding of duty-free shops is that purchased
goods (including food) must be taken out of the United States by the
traveler before such goods may be consumed or used. Thus, the agency
agrees with the commenter that warehouses holding food for sale in
duty-free stores are not required to register as long as the food is
not for consumption or actually consumed in the United States.
In addition to the previous comments, FDA has made several
editorial changes in this section for clarity.
15. U.S. Agent
(Comment 84) Some commenters claim that FDA's requirements for U.S.
agents, and the responsibilities and liabilities of U.S. agents, are
not clear. The commenters state that because FDA's proposed
requirements are so general, it is difficult for a foreign facility to
know what qualifications its U.S. agent should have.
(Response) FDA has retained the criteria for U.S. agent as
proposed. As stated in the proposed rule, there are only two
qualifications for a U.S. agent: The agent is required to reside or
maintain a place of business in the United States and to be physically
present in the United States. As far as U.S. agent liability, FDA
generally does not intend to hold the U.S. agent responsible for
violations of the Bioterrorism Act that are committed by the foreign
facility, a position consistent with that articulated in the preamble
to the agency's drugs, biologics, and device registration regulations
(66 FR 59142, November 27, 2001). FDA, however, would consider legal
action against a U.S. agent where the agent knowingly submitted false
information to FDA or the agent and the foreign facility were
effectively the same entity. Liability issues between the facility and
its U.S. agent must be resolved between the private parties (i.e., the
facility and its U.S. agent), most likely through the terms of their
contractual relationship.
(Comment 85) Some commenters ask FDA to clarify whether it will
notify the U.S. agent or a facility's emergency contact in the event of
a bioterrorist attack or other food-related emergency that affects a
foreign facility.
(Response) Because the role of the U.S. agent is to act as a
communications link between the facility and FDA, FDA will communicate
with the U.S. agent in both routine and emergency situations. This
means that the U.S. agent needs to be accessible to FDA 24 hours a day,
7 days a week, unless the foreign facility opts to designate a
different person other than the facility's U.S. agent to serve as the
facility's emergency contact by providing the information specified in
Sec. 1.233(e) in the facility's registration. If a facility's
registration includes an emergency contact person provided under Sec.
1.233(e), FDA will notify this person instead of the U.S. agent during
emergencies, but will continue to use the U.S. agent for routine
communications with the facility.
(Comment 86) Some commenters argue that FDA's requirement that
facilities have a single U.S. agent is contrary to usual business
practices. The commenters state that a facility may have several U.S.
agents for different business functions, such as separate product lines
or different geographic areas.
(Response) FDA believes that it would be unreasonably complex to
allow facilities to have several U.S. agents for purposes of FDA
registration, as FDA would then have to determine with which agent to
communicate for each product line or geographic distribution area. This
would likely hinder communication between FDA and the facility and
thereby, thwart a chief purpose of the Bioterrorism Act--facilitating a
quick and effective response to a terrorist attack or other public
health emergency related to the U.S. food supply. Also, section 305 of
the Bioterrorism Act is written in the singular--that is, it states
that a foreign facility must include the name of its ``U.S. agent.''
Thus, allowing facilities to designate more than one U.S. agent would
be inconsistent with the plain language in the Bioterrorism Act.
FDA is clarifying in Sec. 1.227(b)(13)(iii) that having a single
U.S. agent for FDA registration purposes does not preclude a facility
from having multiple agents (such as foreign suppliers) for other
business purposes and that FDA is not requiring that all of a firm's
commercial business in the United States be conducted through the U.S.
agent designated for purposes of registration.
(Comment 87) Several commenters argue that the U.S. agent
requirement is onerous and potentially trade-restrictive. The
commenters state that there is no requirement for a third-party go-
between for domestic facilities; thus, this requirement is more
restrictive on foreign facilities than on U.S. producers.
(Response) FDA believes that it has structured the U.S. agent
requirement to be consistent with the statutory mandates of the
Bioterrorism Act. The rule sets out only two qualifications for a U.S.
agent: The agent is required to reside or maintain a place of business
in the United States and to be physically present in the United States.
Therefore, many foreign facilities are able to use existing contacts in
the United States as their U.S. agents. Moreover, FDA has clarified in
the interim final rule that the requirement of a single U.S. agent for
FDA registration purposes does not preclude facilities from having
multiple agents (such as foreign suppliers) for other business
purposes.
(Comment 88) Some commenters argue against the U.S. agent
requirement because they believe the requirement will hinder, not
enhance, communication with the foreign facility.
(Response) As discussed in the preamble to the proposed rule, the
purpose of the U.S. agent is to serve as a communications link between
FDA and an individual facility for a number of purposes, including both
emergency situations and day-to-day registration issues. These routine
issues may include FDA's need for information about that facility and
arranging both routine inspections and inspections or communications
with the facility due to a potential bioterrorism threat or other
public health emergency.
(Comment 89) Several commenters argue that FDA should allow the
U.S. agent to be located outside the United States. They state that
many foreign facilities do not have contacts within the United States,
so it will be difficult for them to locate a U.S. agent.
(Response) Section 305 of the Bioterrorism Act (which amends the
FD&C Act) states that the registration of a foreign facility ``shall
include with the registration the name of the United States agent for
the facility.'' Thus, requiring a foreign facility's U.S. agent to
reside or maintain a place of business in this country is consistent
with the plain language of the Bioterrorism Act. This approach is also
consistent with FDA's implementation of the statutory requirement for
drug, biologics, and device registration (21 U.S.C. 360(i)(1)),
[[Page 58916]]
66 FR 59138 ( November 27, 2001).) It is reasonable to impute to
Congress knowledge of FDA's implementation of this provision, which
specifies that the ``U.S. agent'' be a person in the United States,
when Congress incorporated this concept and language into the
Bioterrorism Act.
(Comment 90) Several commenters ask whether a foreign government
official in the United States, such as a representative from the
foreign country's embassy, may act as the U.S. agent for a foreign
facility.
(Response) The agency has concerns that acting as a U.S. agent may
conflict with the duties of foreign government representatives. Whether
it is proper for a foreign government representative to act as a U.S.
agent is a fact-specific inquiry, depending on the title and status of
the foreign government representative and the functions that the
representative assumes as a U.S. agent. FDA believes that the propriety
of a foreign government official acting as the U.S. agency of a foreign
facility is a determination best made in conjunction with the State
Department. If the issue arises after implementation, FDA will discuss
the particular situation with the State Department.
(Comment 91) A few commenters suggest that FDA allow registrants to
omit U.S. agent information if FDA uses information available from a
foreign government agency.
(Response) The Bioterrorism Act requires the owner, operator, or
agent in charge of a facility engaged in the manufacturing, processing,
packing, or holding food--both domestic and foreign--to register the
facility with FDA. The Bioterrorism Act also requires registrants of
foreign facilities to provide the name of their U.S. agent. Thus, FDA
is not permitted to use information maintained by foreign government
agencies or other domestic Federal or State agencies in lieu of having
the owner, operator, or agent-in-charge of a facility submit the
information to FDA.
(Comment 92) One commenter asks whether a U.S. agent must be one
individual or can it be a ``person'' consistent with the act's
definition of ``person'' as an ``individual, partnership, corporation,
or association.''
(Response) FDA agrees with the commenter and has clarified in the
definition of ``U.S. agent'' that a foreign facility's U.S. agent can
be a ``person'' as defined by the FD&C Act. This interpretation is
consistent with the drug, biologics, and device registration
regulations in 21 CFR 207.3(a)(11) and (b), 607.3(i) and (j), and
807.3(h) and (r).
(Comment 93) One commenter asks how FDA intends to ensure that a
person identifying itself as a U.S. agent does, in fact, meet the
requirements for a U.S. agent. The commenter states that some foreign
facilities may use a false U.S. agent name, address, or phone number
when registering. This commenter suggests that FDA confirm a
registration only through a facility's designated U.S. agent, via
postal mail.
(Response) FDA believes that there are several checks that will
help ensure that registrations are truthful and accurate. The
facility's owner, operator, or agent in charge who submits a
registration must certify that the registration information is true and
accurate. In addition, FDA has revised the interim final rule so that
an individual (other than the owner, operator, or agent in charge of
the facility) may be authorized to submit the registration on behalf of
the owner, operator, or agent. An individual (other than a facility's
owner, operator, or agent in charge) who submits the registration form
to the FDA must certify that he/she is authorized to submit the
registration on the facility's behalf and must identify by name the
individual who authorized submission of the registration. The
certification statement also states that anyone who makes a materially
false, fictitious, or fraudulent statement to the U.S. Government is
subject to criminal penalties under 18 U.S.C. 1001. As an additional
means to verify the identity of the person submitting the registration,
the interim final rule requires that for the paper and CD-ROM
registration options, the registration include the signature of the
person submitting the registration. FDA believes that the combination
of the signed certification statement and federal criminal liability
will be a powerful incentive for truthful registrations. Further,
because the Bioterrorism Act provides that an owner, operator, or agent
in charge is responsible for registering a facility, it would be
improper for FDA to confirm that registration only through a facility's
U.S. agent if the U.S. agent did not originally submit the
registration.
In addition to the changes noted previously, FDA has made several
editorial changes to this section on its own initiative.
16. Other Definitions Included in the Interim Final Rule
(Comment 94) One commenter requests that FDA define ``trade names''
in the interim final rule. This commenter states that the term ``trade
names'' is mentioned in both the Bioterrorism Act and the proposed rule
several times, yet is not defined. The commenter requests that ``trade
names'' be defined, ``to ensure that the scope of registration
reflect[s] the intent and objectives of the statute.'' The commenter
suggests that ``trade names'' be defined as ``the terms relating to the
business activity of the facility that denote the names under which the
facility conducts business or additional names by which the facility is
known.'' The commenter also requests that FDA clarify that ``trade
names'' ``denote terminology associated with the business of the
facility, and does not necessarily signify a brand name, which is
terminology associated with a product.'' The commenter provides some
examples of trade names, such as: ``Facility name: Jones Foods
Corporation; Trade Names: doing business as Joe Jones Fruit Processors,
doing business as Jones Family Pie Company.''
(Response) FDA agrees with the comment, and has added the following
definition for ``trade names'' to the interim final rule (Sec.
1.227(b)(12)): ``Trade name means the name or names under which the
facility conducts business, or additional names by which the facility
is known. A trade name is associated with a facility, and a brand name
is associated with a product.''
(Comment 95) Several commenters request that FDA clarify who is
required to register if a facility has multiple individuals who may
qualify as the owner, operator, or agent in charge.
(Response) The Bioterrorism Act and the interim final rule place
the responsibility for registering a facility on the owner, operator,
and agent in charge of the facility. If a facility has multiple owners,
operators, or agents-in-charge, all are collectively responsible for
registering the facility and any one of these individuals may register
the facility, or as noted in the response to comment 93, authorize an
individual to submit the registration for the facility. Although these
persons may decide themselves how, as a practical matter, their
facility will be registered, the existence of multiple owners,
operators, or agents in charge does not affect the legal obligation
each has under the rule to register relevant facilities.
(Comment 96) One commenter states that although FDA uses the terms
``owner,'' ``operator,'' or ``agent in charge'' throughout the proposed
rule and the draft registration form, in section 1b (Update of
Registration Information) and section 12 (Certification Statement) but
these terms are not defined. The commenter also states that although
FDA requests changes to the ``owner, operator, or agent in charge'' in
section 1b of the
[[Page 58917]]
registration form, FDA ``does not ask for specific information for the
owner, operator, or agent in charge elsewhere in the form.'' The
commenter states that it assumes FDA interprets the owner, operator, or
agent in charge of the facility ``as the facility itself (and not an
individual) for which specific information is requested in section 2 of
the form'' (facility name/address information). The commenter continues
that ``[o]nce the owner, operator, or agent in charge of the facility
has authorized an individual to submit the registration form, that
individual becomes synonymous with the `owner, operator, or agent in
charge.' '' The commenter states that if these assumptions are correct,
the last box under section 1b should be revised from ``Owner, Operator,
or Agent in Charge Change'' to ``Authorized Submitter [Change].''
The commenter also requests that section 12 be revised from its
current statement ``[t]he owner, operator, or agent in charge of the
facility must submit this form. By submitting this form to FDA, the
owner, operator, or agent in charge certifies that the above
information is true and accurate and that the facility has authorized
the submitter to register on its behalf.'' The commenter's suggested
revised statement is as follows: ``[t]he owner, operator, or agent in
charge of the facility must submit this form. By submitting this form
to FDA, the owner, operator, or agent in charge of the facility
certifies that the above information is true and accurate and that the
submitter has been authorized to register on its behalf'' (suggested
changes in italic).
(Response) These comments (and others) suggest that certain
provisions of the proposed rule and proposed Form 3537 may have been
ambiguous or otherwise created confusion about who should complete and
submit a registration. As discussed below and elsewhere in this
preamble, FDA has clarified several provisions in the interim final
rule and has revised Form 3537 as well. The agency believes that these
clarifications and revisions generally respond to the foregoing
comments. FDA's more specific responses to these comments are set out
below.
Regarding the commenter's request that FDA define ``owner,''
``operator,'' or ``agent in charge,'' FDA does not believe that it is
necessary to define these terms because the terms are self-explanatory.
Accordingly, the interim final rule does not include a definition for
owner, for operator, or for agent in charge.
FDA acknowledges that the provision in the proposal regarding the
certification statement was unclear due the language in proposed Sec.
1.232(g) stating that ``the person submitting the registration [must
be] authorized by the facility to register on its behalf.'' This
created ambiguity for three reasons. First, the use of ``person''
created ambiguity as to whether only an individual could submit the
registration because ``person,'' as defined in section 201(e) of the
act, includes an individual, partnership, corporation, and association.
However, as evidenced by the proposed certification requirement that
the name of the person submitting the registration be specified, FDA
intended to convey that an individual rather than a ``person'' must
submit the registration. Second, the statement that a person submitting
a registration must have been authorized by the facility is
inconsistent with the certification statement in the proposed rule,
which stated that ``the owner, operator, or agent in charge of the
facility must submit this form.'' Third, the former statement was
confusing because a facility itself cannot authorize an individual to
register.
The interim final rule resolves these inconsistencies by clarifying
who may register a facility. Although the Bioterrorism Act imposes the
legal obligation to register on the owner, operator, and agent in
charge of a facility, FDA believes that this provision does not prevent
the owner, operator, or agent in charge of a facility from authorizing
an individual to fill out, sign, and submit the registration.
Accordingly, the interim final rule provides that the owner, operator,
or agent in charge may authorize an individual to submit the facility's
registration.
In addition, for clarification and for the reasons discussed in the
responses to comment 110, in the interim final rule, Sec. 1.232(i) has
been added to provide that if the individual submitting the form is an
individual authorized to do so by an owner, operator, or agent in
charge, the individual must also certify that the individual is
authorized to submit the registration form on behalf of the owner,
operator, or agent in charge and must identify by name the authorizing
individual. This statement must include the individual submitter's
signature (for paper and CD-ROM options) and printed name. If the
individual submitter is authorized by someone other than the owner,
operator, or agent in charge, the authorizing individual's name,
address, and phone number must be included; the fax number and e-mail
address of the authorizing individual are optional.
FDA does not agree with the commenter's assumption that if a
facility authorizes an individual to submit a registration, the
individual then becomes synonymous with the owner, operator, or agent
in charge. Although the interim final rule permits an owner, operator,
or agent in charge to authorize an individual to submit the
registration on its behalf, that individual does not become the owner,
operator, or agent in charge for purposes of registration or otherwise
alter the legal obligation of the owner, operator, or agent in charge
to register. Therefore, we have not revised section 1b as requested by
the commenter.
FDA does not fully understand the import of the comment that the
agency considers that owner, operator, and agent in charge to be the
``facility itself.'' In some cases, the owner of the facility may be
the same as the facility (e.g., a corporation) while in other
instances, the two may be different. The revised Form 3537 reflects
these two possibilities in that it requests information about the
facility (Section 2, facility name and address) and the owner,
operator, or agent in charge (Section 12, owner, operator, or agent in
charge address and telephone number.) Form 3537 also recognizes that
information in section 12 may overlap with that requested in section 2.
F. Comments on ``When Must You Register?'' (Proposed Sec. 1.230)
(Comment 97) One commenter states that FDA's language in proposed
Sec. 1.230 (``[t]he owner, operator, or agent in charge of a facility
that manufactures/processes, holds, or packs food for consumption in
the United States must be registered no later than December 12, 2003'')
is contrary to the Bioterrorism Act, which requires registration by
facility, as opposed to by owner, operator, or agent in charge. The
commenter also states that language in proposed Sec. Sec. 1.225 and
1.226 might be interpreted to mean that the owner, operator, or agent
in charge is the entity to be registered, not the facility.
(Response) FDA intends to require that the facility be registered,
not the owner, operator, or agent in charge of the facility. In
response to these comments, FDA has revised the following language: In
Sec. 1.225, FDA has added the italicized language to paragraph (a):
``You must register your facility under this subpart if you are the
owner, operator, or agent-in-charge of either a domestic or foreign
facility * * *''. The agency also has added the italicized language to
paragraph (b): ``If
[[Page 58918]]
you are an owner, operator, or agent in charge of a domestic facility
* * *, you must register the facility * * *.''
FDA believes no revisions are needed to Sec. 1.226, because it is
clear in this section that the exemptions apply to facilities, not the
owner, operator, or agent-in-charge of the facilities.
In Sec. 1.230, FDA has made the following change indicated by the
italicized language: ``[t]he owner, operator, or agent in charge of a
facility that manufactures/processes, packs, or holds food for
consumption in the United States must register the facility no later
than December 12, 2003.''
In Sec. 1.233, in the first paragraph, FDA has made the following
change indicated by the italicized language: ``FDA encourages, but does
not require, you to submit the following items in your facility's
registration.''
(Comment 98) Several commenters submitted comments regarding when
to register. Some of these commenters request general information about
when they will be able to register with FDA. Others acknowledge the
proposed timeframe in which FDA expects to publish the final rule;
these commenters question why they cannot register, either
electronically or by mail, before publication of the interim final
rule. Some commenters ask that FDA publish a final rule and implement
its electronic registration system before October 12, 2003. Some
commenters suggest that, to alleviate the burden on FDA's electronic
system, FDA should either accept staggered registrations based on such
identifiers as last name of the facility, or that FDA should only
require registration 15 days before a facility's intended date of a
food shipment to the United States. One commenter requests that FDA
ensure that the final regulation and electronic system are in place by
October 12, 2003.
(Response) FDA understands that many commenters may view the
proposed 8-week timeframe for facilities to register as too brief.
However, this timeframe is limited due in large part to the
restrictions imposed by the Bioterrorism Act, which requires FDA to
develop both proposed and final regulations detailing the process by
which facilities must register by December 12, 2003. Within this
timeframe, FDA has also had to develop an electronic system that can
implement the requirements of this regulation. FDA has expedited the
process for developing and completing the proposed and interim final
regulations, as well as the electronic registration system. It is not
possible for FDA to complete a final rule in less than 16 months from
enactment of the Bioterrorism Act, or before October, 2003. Moreover,
because this interim final rule articulates the final requirements for
registration, which FDA must incorporate into its electronic
registration system, FDA could not allow registration in advance of
publication of the interim final rule, either electronically or by
mail. FDA also believes the time period for registration is reasonable.
Because both the proposed rule and this interim final rule have alerted
facilities to the general requirements of registration, facilities have
had ample time to prepare for registration pending the issuance of the
interim final rule.
(Comment 99) Some commenters argue that FDA should provide a 3 to
6-month grace period after December 12, 2003, in which it will accept
late registrations without penalizing the facilities that submit these
late registrations. These commenters state that they are concerned that
FDA will not be able to accommodate the large number of electronic
registrations that must be submitted within this 8-week timeframe, and
that this breakdown could cause large monetary losses to industry.
(Response) The Bioterrorism Act provides that the effective date
for registration is December 12, 2003. The statute further specifies
that, after this date, food imported or offered for import from
unregistered facilities must be held at the port until the facility is
registered (21 U.S.C. 381(l)). FDA has designed its electronic system
to be robust enough to handle the large volume of registrations
anticipated during this 8-week period. However, the planned capacity
will not be sufficient to process all of the registrations in 1 day;
thus, if all registrants wait until the last day to register (i.e.,
December 12, 2003), the system's capacity could be exceeded. Therefore,
FDA encourages facilities to register early.
(Comment 100) Some commenters indicate that the 8-week timeframe
does not allow paper registrations as a real alternative to electronic
registrations, because FDA states in the proposed rule that
registration by mail could take several weeks to several months. This
timeframe could render a facility out of compliance with the effective
date for registration, because even if a facility were to mail its
registration to FDA soon after October 10, FDA might not return the
registration number to the facility until after December 12.
(Response) The paper processing facility will be able to
electronically process over 1,800 Form 3537 submissions each business
day during the regulatory peak processing period of October 16, 2003,
through December 12, 2003 (41 business day period). This will result in
a total of 73,800 submissions processed in a 41 business day period.
All Form 3537 submissions will be processed in the order they are
received and will be turned around within a 24-hour period, if the
registration form is error free. Submitters should expect to receive
their registration number within 5 to 7 days after processing depending
on postal mailing delays if the number of submissions does not exceed
the processing capacity.
If the registration submissions should exceed the daily 1,800 Form
3537 processing capacity, a backlog will develop. FDA expects that if
backlogs occur, they are most likely near the end of the initial 41
business day registration period. If our estimates are correct, FDA
would expect a backlog of 2 to 3 weeks. However, if the number of
submissions and rejections being resubmitted exceed our estimates, the
backlogs will be longer. So including the mailing time, the backlog,
and processing times, the delay toward the end of the initial
registration period could be 3 to 6 weeks or longer if the number of
submissions exceeds our estimates.
If a submission has been rejected due to error the submitter made
or failed mandatory validation, the submission will be returned to the
submitter via postal mail. Depending on mailing delays, the submitter
should expect to receive the rejected submission with a letter
explaining the rejection within 5 to 7 days plus the time the
submission spent in the processing backlog (0 to 3 weeks). After the
submitter corrects their registration and resubmits it to FDA via
postal mail, the corrected registration will be processed in the order
received along with all other submissions and is subject to all of the
delays identified previously.
For the CD-ROM option, submitters are allowed to store a fill-in
PDF Form 3537 for each facility onto a CD as a separate file. FDA will
process the CD-ROM submission, presumably containing multiple
registrations, electronically as part of the paper process. This means
the PDFs on the CD-ROM will not be printed out and then keyed in
because they are already in the format that the paper process system
needs. The PDF files will be fed into the paper process queue in their
order of arrival as though they were a normal paper form. Each file on
the CD will go through the same validation checks as if it were a
normal paper submission. If the registration file on the CD-ROM is
processed successfully, the registration will be returned by postal
[[Page 58919]]
mail with a registration number. If the registration fails validation
checks or contains errors, the registration will be returned with a
letter explaining why registration was not successful and will need to
be resubmitted in order to complete registration.
The only way for a registrant to ensure a fast response to a
registration is to register the facility electronically on the
Internet.
(Comment 101) One commenter states that FDA does not mention the
registration requirements for facilities that form after December 12,
2003.
(Response) Section 1.230 of the interim final rule states ``* * * a
facility that begins to manufacture/process, pack, or hold food for
consumption in the United States on or after December 12, 2003, must be
registered before the facility begins such activities.''
FDA has made a small editorial change to this section for clarity.
G. Comments on ``How and Where Do You Register?'' (Proposed Sec.
1.231)
(Comment 102) Several commenters ask FDA to explain how they should
register their facilities with FDA.
(Response) As stated in Sec. 1.231, those wishing to register a
facility electronically must access http://www.fda/furls and follow the
directions on that Web site for registering. This Web site will be
available starting on October 16, 2003, at 6:00 p.m. eastern daylight
time. Registrants needing technical assistance with the paper or
electronic registration forms can call 1-800-216-7331 or 301-575-0156,
or can fax their questions to 301-210-0247 or e-mail them to
[email protected]. Starting on October 16, 2003, these phone numbers will
be staffed on business days from 7 a.m. until 11 p.m. eastern standard
time.
FDA had anticipated having the electronic and paper systems
operational on the date of this interim final rule's publication.
However, given the fluid and dynamic nature of developing the
electronic system in parallel with finalizing the regulation that
determines the requirements for the system and given the short deadline
imposed by the statute, much of the development and testing effort of
the system had to occur in the last 2 months. Accordingly, for much of
these 2 months, work on the system has been taking place 7 days a week.
Moreover, hurricane Isabel caused significant delays in the work for
the week of Thursday, September 18. Due to these delays, FDA determined
that if it postponed the launching of the system until Thursday,
October 16, there would be a much higher level of assurance that those
persons registering food facilities electronically would be able to do
so effectively and efficiently without user frustration or confusion.
FDA believes that the slight delay of the system will not affect
stakeholders substantially, as potential registrants will need several
days to become familiar with the rule and its requirements.
Therefore, beginning on October 16, 2003, the Web site will be
available 24 hours a day, 7 days a week, from wherever the Internet is
accessible, including libraries, copy centers, schools, and Internet
cafes. In addition, as noted previously, the owner, operator, or agent
of a foreign facility may authorize an individual to register the
facility; the owner, operator, or agent in charge may chose to
authorize an individual who has access to the Internet. In addition,
the Bioterrorism Act requires a foreign facility to designate a U.S.
agent. That agent (if an individual) could be authorized by the owner,
operator, or agent in charge of a foreign facility to register that
facility. If the U.S. agent does not have Internet access onsite, the
U.S. agent may register the facility electronically from a local
library or other public facility that offers Internet access either
free of charge or for a relatively small fee. Thus, all foreign
facilities will be able to receive an electronic confirmation of
registration and the facility's registration number, as will domestic
facilities that register electronically.
FDA strongly encourages electronic registration for the benefit of
both FDA and the registrant. FDA will be able to accept electronic
registrations from anywhere in the world where the Internet is
available 24 hours a day, 7 days a week. Electronic registration also
will enable a facility to be registered more quickly than if
registering by mail, because obtaining confirmation of registration and
the facility's registration number online should be instantaneous once
a facility fills in all required fields on the electronic registration
form.
As stated in Sec. 1.231(b), a registrant may also register by fax
or mail (for example, if none of the means of electronic access
mentioned previously are reasonably available). Processing of fax or
mail (including CD-ROM) registrations will also begin on October 16,
2003. In registering by mail or fax, a registrant also may fill out one
or more forms on behalf of one or more facilities. A registrant
registering by mail must call FDA at 1-877-FDA-3882 (1-877-332-3882) to
request a copy of the form, or send FDA a written request for the form
at U.S. Food and Drug Administration (HFS-681), 5600 Fishers Lane,
Rockville, MD 20857. Once the registrant receives the mailed or faxed
copy of the form, the form must be filled out completely and legibly,
and either mailed back to FDA at the same address, or faxed back to FDA
at 301-210-0247. FDA will process the registration forms in the order
received. An agency employee will check to make sure all mandatory
fields are filled out completely and legibly. If the form is not
complete or is illegible, it will be returned to the registrant for
completion, provided that the registrant's mailing address is legible
and valid. If the form is complete and legible, FDA will manually enter
the data on the form into the system as soon as practicable, which will
depend on the number of other registration forms awaiting manual entry
into the system. FDA will then mail or fax to the registrant a copy of
the registration as entered, confirmation of the registration, and the
facility's registration number. When responding to a registration
submission, FDA will use the means by which the form was received by
the agency (i.e., by mail or by fax). If the copy of the registration
form mailed or faxed back to the registrant contains incorrect
information, the registrant must update the incorrect information under
Sec. 1.234. Registration by CD-ROM, which is also permitted by the
interim final rule, is discussed in the response to comment 103.
(Comment 103) Several commenters request that FDA accept batched
multiple facility registrations via CD or XML format instead of
registering one facility at a time through the online system.
(Response) Due to the stringent timeframe that FDA had to develop
proposed and interim final regulations and in which to finalize the
electronic registration system, FDA is unable to accept multiple
registrations in XML format because it would take substantial
additional time and money for FDA to develop the compatibility
necessary to accept registrations in this format. However, FDA will
accept multiple submissions in CD-ROM format ISO 9660 (CD-R or CD-RW)
Data format. These registrations must be submitted on FDA's fill-in
Portable Document Format (PDF) rendition of the appropriate form (Form
3537) accompanied by one signed copy of the certification statement on
the registration form. Each submission on the CD-ROM must use the same
preferred mailing address in the appropriate block on Form 3537. The
CD-ROM can contain as many submissions as needed up to its capacity
(650-700 megabytes (MB) or about 1,300 submissions per CD-ROM).
Importantly,
[[Page 58920]]
however, each submission must have a unique file name up to 32
characters long, the first part of which may be used to identify the
parent company. If FDA receives a CD-ROM that does not comply with
these specifications, it will send the CD-ROM back to the registrant
unprocessed.
FDA notes that CD-ROM submissions are similar to submissions by
mail or fax in terms of how they are processed. FDA will process these
CD-ROM submissions along with the mailed and faxed submissions, in the
order received. Therefore, registrants wanting to ensure that they
receive their registration numbers quickly may wish to register
electronically, as described previously. The principal advantage CD-
ROMs offer over paper submissions is for firms that own many facilities
and do not have reasonable access to the Internet. Using a CD-ROM to
submit PDF typed registrations should increase legibility and save on
mailing expenses. FDA reiterates, however, that submission by CD-ROM
will be slower than submitting registrations electronically.
(Comment 104) Several commenters request that FDA's electronic
system provide a way in which a single registrant entering data for
many facilities can stop entering data on one day and resume from where
they left off on another day.
(Response) FDA's electronic system will save registration data
automatically with the completion of the entry of all data for a
facility. Thus, it will be possible to stop entering data upon
completion of the entry for one facility, and resume entering data for
a subsequent facility on another day without loss of any previously
entered data that would be applicable to both facilities, such as the
name and address of the owner. The information needed for a
registration is identified on the electronic registration form. A
registrant will know what information is required for the registration
before beginning to enter registration data into the system. Once a
registrant has all of the required information, the time to register
each subsequent facility should decrease, depending on how much of the
information can be autofilled from the account information from
previous registrations. However, the FDA electronic system does not
allow a registrant to save data in the middle of registering a
facility. Therefore, FDA suggests that registrants completely finish
registering a particular facility before ending an online session.
(Comment 105) Some commenters ask whether the electronic system
will allow multiple individuals from the same company to enter
registration information simultaneously.
(Response) The FDA electronic registration system is set up to
allow a company to establish an enterprise (master) account and
multiple subaccounts to allow several persons within a company to enter
registrations simultaneously. The enterprise account can be used to
enter facility registrations and it also can be used to establish and
manage subaccounts. The subaccounts can only enter facility
registrations, and unlike the enterprise account, they do not have
access to other subaccounts. Generally, the enterprise account has
access to all information entered via the subaccounts, unless, when
created, the subaccount stipulates that the enterprise account is not
to have access to that subaccount.
(Comment 106) Some commenters ask whether the electronic
registration system will minimize the reporting burden. These
commenters are concerned that the lack of detail FDA has provided
regarding the Internet-based electronic registration system has made it
difficult for them to evaluate the reporting burden.
(Response) FDA is working expeditiously to ensure that that there
will be a minimal reporting burden associated with registration in
general, and electronic registration in particular. Registering
electronically will be a relatively fast process once the registrant
has all of the pertinent information available. Once the facility is
registered electronically, its registration number should be provided
automatically and instantaneously. FDA has received very positive
comments at the several public demonstrations of the prototype of FDA's
electronic registration system. Throughout the next couple of months,
FDA will continue to conduct outreach activities to both foreign and
domestic registrants to explain how the electronic registration system
works to expedite registration.
(Comment 107) Some commenters express concern about the security of
the electronic system. They state that the registration number alone
should not be sufficient to access a facility's registration form in an
electronic environment, because registration numbers will be required
for prior notice of imports, and thus, are likely to be part of the
commercial documentation between parties. These commenters emphasize
that FDA must have procedures in place to ensure that only authorized
persons can access and change a facility's registration information.
(Response) FDA has taken comprehensive steps to ensure that our
electronic registration system is secure. A risk assessment has been
done and a formal security plan has been incorporated into the system
that addresses both physical and electronic security. The system has
undergone an independent security review and assessment as well as
complete industry standard certification and accreditation. The system
securely communicates with registrants using industry standard, secure
socket layer with 128-bit encryption.
A facility's registration number alone is not sufficient to access
a registration. To increase security, FDA has provided several layers
of controls in the electronic access to registrations, thus preventing
unauthorized access. First, an account ID and password must be
established. Second, each registration has a unique registration number
and PIN (Personal Identification Number), both of which are required to
gain access to the registration and are only provided to the
registrant. Only the registration number is disclosed as part of the
prior notice of an imported food shipment. Thus, to prevent
unauthorized access to a facility's registration, it is the
responsibility of persons registering to secure their account IDs,
passwords, and PINs.
(Comment 108) Some commenters request that the electronic system be
available in every world language. Others ask whether shipments will be
delayed if issues arise from translation discrepancies between a
facility's registration in the English translation of its name and its
prior notification with elements in the foreign language.
(Response) In response to the first part of the comment, FDA has
determined that registration instructions will be provided in three
languages: French, Spanish, and English. As noted, these are the three
official languages of the WTO.
In response to the second part of the comment, FDA has determined
that all registration information submitted must be in English.
However, a person's name, the name of a company, the name of a street,
or a trade name may be submitted in a language other than English. All
information, including these items, must be submitted using the Latin
(Roman) alphabet. These exceptions will ensure that inconsistencies
will not arise between a facility's registration and prior notice.
Submissions must be in English (with the exceptions noted) so that
FDA can understand the content of the registration, ensure that the
registration information is correct, and have a database of facilities
that its staff can readily access in the event of a
[[Page 58921]]
threatened or actual food-related emergency. To assist registrants who
do not speak English, FDA has given a foreign facility the option of
authorizing an individual (including its U.S. agent if an individual)
to register on its behalf.
(Comment 109) Some commenters question whether there will be a
contingency plan if the electronic registration system is not as
efficient as expected or if more facilities register than anticipated.
Some of these commenters question whether the paper system will be able
to handle the 8-week registration period.
(Response) The electronic system is designed to handle anticipated
peak loads. The paper-based system is being designed to handle the 8-
week registration period; however, depending on the number of paper
registrations received, and depending on when FDA receives the
registrations within this 8-week period, FDA may be unable to process
all paper registrations, confirm the registration, and provide a
registration number to each registrant within the 8-week period. For
this reason, FDA strongly encourages all facilities to register
electronically to ensure they are registered on time.
(Comment 110) Some commenters ask whether trade associations,
commodity groups, or parent companies can register on behalf of
facilities represented by their organizations.
(Response) As stated in the response to comment 96, we have revised
Sec. 1.232(i) and the certification statement on Form 3537 to permit
an authorized individual to submit the registration. Thus, a trade
association or commodity group cannot submit a registration because
these entities are not individuals. However, the owner, operator, or
agent in charge can authorize an individual from such a group to submit
the registration. We note that the definition of U.S. agent provides
that a U.S. agent may be a ``person'' as defined in section 201(e) of
the FD&C Act. Therefore, a foreign facility could designate a trade
association or commodity group as the facility's U.S. agent. However,
if the U.S. trade association or commodity group agrees to serve as the
U.S. agent and the facility authorizes the U.S. agent as the foreign
facility's agent in charge for registration, an authorized individual
from that association or group must submit the registration. In
addition, the interim final rule allows a parent corporation to
register on behalf of one or more of its facilities.
(Comment 111) One commenter asks whether FDA can build on the
Operational and Administrative System for Import Support (OASIS) that
FDA currently has to accept registrations. The commenter states that
some prospective registrants already provide information regarding
``shipper'' and ``manufacturer'' to FDA via OASIS, and that building a
new registration system would cause redundancy for these registrants.
(Response) Although FDA intends to use OASIS for cross-checking
registration information, both the required data elements and the
universe of facilities required to register are markedly different from
those entered into OASIS. Moreover, OASIS does not have the capacity to
accept all the registration information from all the facilities
required to register with FDA. Thus, FDA has developed a new system for
registration that will interface with OASIS.
(Comment 112) One commenter asks whether FDA will accept
photocopied versions of the mailed registration form.
(Response) FDA will accept a photocopy of a mailed registration
form or the certification statement submitted with a CD-ROM submission,
as long as the signature on each individual form is an original
signature. We recognize that for multiple facility registrations,
photocopying data elements that are common to each facility will reduce
the burden on the registrants in completing the forms. While those
common data elements may appear as photocopies, the forms must include
an original signature.
(Comment 113) One commenter asks how the electronic registration
form will allow registrants to proceed through the registration
process. For example, if each a registrant must answer each section to
proceed to the next section, how will the system address optional
information?
(Response) FDA has designed both its electronic and paper
registrations to specify which sections are mandatory. The electronic
registration system has been designed to highlight or mark a required
field that a registrant has left blank so that the submitter must fill
it in before proceeding further with the electronic registration
process.
(Comment 114) One commenter expresses concern that a registration
may get lost in ``cyberspace,'' even though it has been correctly
filled out and the facility has received a registration number.
(Response) The system saves all submitted information before
issuing a registration number. A submitter would only receive a
registration number upon a successful registration; if the registration
failed, a facility would not receive a registration number. The Web
system is a real time system with tape backups of the data entered.
Additionally, the system has battery backups in the unlikely event of a
power loss.
In addition to the changes noted previously, on its own initiative
FDA has made several editorial changes to this section for clarity.
H. Comments on ``What Information Is Required in the Registration?''
(Proposed Sec. 1.232)
1. General Comments
(Comment 115) Several commenters believe FDA should make the
registration process as simple as possible, limiting required
information to name, address, and trade names. These commenters state
that the scope, exemptions, definitions, and required information in
the proposed rule erode simplicity to the point that exemptions are
voided, and would require registrations from a vast array of small
facilities.
(Response) The Bioterrorism Act requires that a registration
contain each facility's name, address, and all trade names under which
the registrant does business (21 U.S.C. 350d(a)(2)). That statute
provides no exemption from registration for small-size facilities. FDA
believes that the information required for registration is necessary to
assist FDA in notifying facilities of a threatened or actual
bioterrorist attack or other food-related emergency. Together with the
other regulations FDA is developing to implement the Bioterrorism Act,
the information in the registration will assist FDA in determining the
source and cause of such an event.
Regarding the comment that the scope, definitions, exemptions, and
required information are unduly complicated, no comments FDA received
in response to the proposed rule argue that the interim final rule
should not include any definitions, exemptions, or specify the
information to be included in a registration. FDA has made every effort
to define clearly which facilities are required to register to ensure
that potential registrants will know whether they are subject to the
rule. FDA also has provided definitions for each exemption provided in
the Bioterrorism Act. Moreover, FDA believes that the registration
process itself is as uncomplicated and user-friendly as possible. A
facility registering electronically should be able to complete the
registration and receive its registration number expeditiously once it
has gathered all the requisite information.
[[Page 58922]]
(Comment 116) Several commenters state that the information in the
registration goes beyond the information required by the Bioterrorism
Act, thereby exceeding FDA's statutory authority. One of these
commenters states that ``there are no references, either in the
Bioterrorism Act or the legislative history, to the inclusion of
individual names in the registration.''
(Response) As noted in section I of this document, in issuing this
interim final rule, FDA is relying on the authority in section 305 of
the Bioterrorism Act, as well as section 701(a) and (b) of the FD&C
Act. Including information regarding both the facility's parent company
and the emergency contact will facilitate the efficient enforcement of
the act by enhancing FDA's ability to deter and respond quickly to a
food-related emergency. Accordingly, the provisions of this interim
final rule are consistent with FDA's statutory authority provided by
the Bioterrorism Act and the FD&C Act.
The only required elements of the registration that the
Bioterrorism Act does not specifically mention are the facility's
parent company name, address, and phone number, and emergency contact
information. Regarding the emergency contact information, the
information will make it possible for FDA to respond quickly to
emergencies that occur during nonworking hours by contacting facilities
when an emergency occurs.
FDA is also requiring the parent company information for emergency
situations. If an emergency occurs with respect to a particular
facility or group of facilities, FDA will need to alert the parent
company, as well as the affected facilities, because the parent company
has ultimate responsibility for the facility. Moreover, in terms of
inspections, the relationship between a facility and its parent company
is vital for FDA in tracking and investigating incidents.
With regard to that portion of the comment asserting the
Bioterrorism Act does not refer to individual names, the interim final
rule does not require the submission of an individual's name except for
the name of the authorized individual submitting the registration and,
if the submitter is authorized by another individual, the name of the
authorizing individual. Of course, if the owner, operator, agent in
charge, or U.S. agent is an individual, the name of that individual
must be submitted. If the emergency contact for a facility is an
individual, that name must be submitted as well. However, as stated in
responses to comments 124 and 137, the interim final rule does not
require an individual to be designated as the U.S. agent or an
emergency contact.
(Comment 117) One commenter believes that, contrary to FDA's
proposed use of the registration information to determine the source
and cause of a bioterrorist event, the proposed requirements are geared
to locating and contacting facilities that through some other means
have already been associated with the event, thus facilitating further
investigation.
(Response) FDA believes that registration both will help the agency
contact facilities that already have been the target of an event, and
will assist the agency in determining the source and cause of the
event. First, registration will provide FDA with a more complete and
up-to-date database of facilities to contact if the agency learns of an
actual or potential threat to the food supply. The specific
registration information, such as food product categories and
geographic location, will enable FDA to narrow down the facilities that
may be affected by a bioterrorist attack or other food-related
emergency, thus saving precious time. Second, registration will assist
FDA's implementation of the other regulations and guidance documents
that FDA is developing to implement the Bioterrorism Act, namely prior
notice, recordkeeping, records access guidance, and detention.
Registration, prior notice, and recordkeeping enable FDA either to
obtain information it does not currently have, or to obtain that
information more quickly than FDA was able to do prior to the enactment
of the Bioterrorism Act. This information gives FDA crucial tools to
protect the U.S. food supply. For example, registration will enable FDA
to fill in incomplete information for certain facilities derived
through records about a source of a bioterrorist attack or other food
related emergency, thus facilitating a traceback. In this example,
registration information would also allow FDA to contact some
facilities quickly during a traceback investigation.
(Comment 118) One commenter requests that FDA consider
registrations submitted more than once on behalf of a particular
facility as valid, since some foreign companies may register multiple
times both at the facility and corporate levels.
(Response) Once a facility is registered with FDA, the electronic
system will reject any additional registrations that are submitted on
behalf of the same facility. To have the system do otherwise does not
make sense, because each facility must only register with FDA once and
will only be assigned one unique registration number. Accepting
multiple registrations would also create confusion in FDA's database of
registered facilities, because FDA would not know who to contact in the
event of an emergency if there is different emergency contact
information in the registrations for the same facility. Once a facility
is registered, FDA will send a confirmation to the facility by e-mail,
mail, or fax, depending on how the facility registered. Thus, personnel
at the facility will be aware that the facility is registered.
(Comment 119) A commenter requests that FDA clarify whether it
requires a registrant to specify container/package size in its
registration. The commenter states that such a requirement would be
very time-consuming and introduce prohibitive costs both financially
and in terms of resources. The commenter further states that this
potentially could necessitate numerous and frequent updates to
registration information.
(Response) Neither the proposed rule nor the interim final rule
requires registrants to specify container or package sizes in its
registration.
(Comment 120) One trade association believes that FDA should
provide ``full translation services for non-English speakers and the
disabled as required under the Americans with Disabilities Act (ADA).''
(Response) Regarding translation services for non-English speakers,
this comment is not clear about whether it is requesting these services
for the registration itself, or for outreach activities related to
registration. FDA intends to translate all outreach-related slide
presentations and downlink transcripts for the interim final rule into
French and Spanish, similar to what FDA did for the outreach for the
proposed rule. As noted previously, FDA will require the registration
to be submitted in English. The owner, operator, or agent in charge of
a foreign facility that requires translation services may wish to
authorize an English-speaking individual to register on its behalf.
FDA is in full compliance with section 508 of the Rehabilitation
Act and provides an ``Accessibility Statement'' for disabled persons on
its Web site. FDA cannot identify from this comment if other
``translation services'' are being requested for the disabled.
2. Name, Full Address, Phone Number, Fax Number, and E-mail Address
(Comment 121) Several commenters object to FDA's requirement that a
registration include the facility's phone number, fax number, and e-
mail
[[Page 58923]]
address. These commenters state that the e-mail address of the facility
is not likely to be that of an individual person, but one for the
facility as a whole and is usually staffed by a facility's most junior
employee, who would not be the appropriate person for FDA to contact in
the case of a bioterrorism incident or other food-related emergency.
The commenters also state that FDA will have the phone number and e-
mail address of the emergency contact, so it should not be necessary
also to require the phone number and e-mail address of the facility as
a whole. Regarding the fax number, some commenters argue that they
might not have fax machines. Therefore, these commenters request that
FDA make the facility fax number and e-mail optional elements of
registration.
(Response) FDA agrees with the commenter that a facility's fax
number should be optional and that a facility's e-mail address also
should be optional unless the facility registers electronically and
provides an e-mail address for confirmation. Section two of the
proposed registration form states that the registrant is required to
provide its fax number and e-mail address ``if available.'' However, to
clarify in the rule that this information is optional, FDA has moved
these registration elements to the section in the interim final rule
entitled ``What optional items are included in the registration form?''
(Sec. 1.233). FDA has decided to retain the requirement that a
facility's phone number be provided because having that number will
facilitate routine communications with the facility. For domestic
facilities, the emergency contact information will only be used in the
event of an actual or potential emergency; the facility phone number
will be used for all other communications (e.g., to schedule an
inspection), unless the registration provides other contact information
in the ``Preferred Mailing Address'' section of the form. For foreign
facilities, the U.S. agent's information will be used for both routine
and emergency contacts, unless the facility chooses to provide a
different emergency contact. FDA, however, believes it is important to
have a contact phone number for a foreign facility itself, in case FDA
cannot contact the U.S. agent.
(Comment 122) Several commenters state that the fields in section 2
of the proposed registration form for facility name and address
correspond to addresses in the United States, such as ``zip code,'' and
do not take into account address formats used in foreign countries. For
example, in many Latin American countries, addresses are not
necessarily denoted by a street number and name, but may be identified
by a crossing of streets or even by specific reference points that may
involve other buildings or landmarks.
(Response) In the electronic registration, FDA intends to provide
flexibility to enable a foreign facility to include its street address
information in the format used in the foreign country. Regarding ``zip
codes,'' in the proposed registration form, FDA's electronic system is
designed to request zip code information only for facilities located in
the United States, and the postal code for countries that have postal
codes. For identification of a country, the electronic system employs a
pull-down menu that lists countries' two letter abbreviations as listed
in the International Standards Organization 3166. The printed
registration will also provide enough space for a registrant to enter
the facility's address information in whatever format is used in its
own country.
3. Name and Address of the Parent Company
(Comment 123) Several commenters believe that name and address of
the parent company should not be required. Another commenter states
that it does not object to this requirement.
(Response) The interim final rule retains the requirement that
parent company information be provided in a registration if applicable.
The parent company information enables FDA to ascertain the
relationship between a facility and its parent company, if the facility
is a subsidiary of the parent company, because not infrequently, a
facility or subsidiary may have a different name than its parent
company. FDA is also requiring the parent company information for
emergency situations. If an emergency occurs with respect to a
particular facility or group of facilities, FDA will need to alert the
parent company, as well as the affected facilities, because the parent
company has ultimate responsibility for the facility. Moreover, in
terms of inspections, the relationship between a facility and its
parent company is vital for FDA in tracking and investigating
incidents.
4. Emergency Contact Information
(Comment 124) Several commenters believe that FDA should give
facilities or their parent companies the option of identifying relevant
emergency contact information (phone number, whether cell or land line,
e-mail address) without necessarily identifying a specific individual.
These commenters state that because the purpose of an emergency contact
is for FDA to communicate in an emergency situation with the facility,
there is no need for FDA to contact a specific individual. Many
facilities already have emergency contact procedures in place for
responding to local emergencies; FDA's emergency contact information
should provide flexibility for facilities to utilize these existing
procedures. Also, requiring an individual to be identified by name may
mean a facility would need to provide frequent updates to its
registration, because the individual responsible for responding to
emergencies may change on a frequent basis. Other commenters request
that FDA allow a facility to designate an alternate emergency contact,
or that FDA require the emergency contact to be located at the
corporate headquarters, instead of at the facility.
Other commenters believe FDA has appropriately defined the scope of
information necessary to accomplish the goal of quick response and
notification in the case of a bioterrorist attack on the U.S. food
supply.
(Response) FDA has considered these comments and in response, has
modified the interim final rule so it does not require a facility to
provide an individual's name as part of the emergency contact
information. However, the facility must ensure that the information it
provides will enable FDA to contact a live person representing the
facility 24 hours a day, 7 days a week. FDA agrees that emergency
contact information should be specific to the facility's already
established emergency procedures; therefore, FDA will not necessarily
require contact information for a corporate headquarters. However, a
facility may designate the emergency contact information for its
corporate headquarters, if that is appropriate for operations at that
facility.
As noted, for foreign facilities, FDA will consider the facility's
U.S. agent as the emergency contact unless specified otherwise in the
registration. If a foreign facility designates someone other than its
U.S. agent as the emergency contact, FDA will utilize that information
to contact the facility instead of the facility's U.S. agent when an
emergency occurs.
5. Trade Names
(Comment 125) Several commenters agree that trade names should be
required as part of the registration. These commenters request that FDA
define ``trade names'' and provide examples. One commenter states that
requiring trade names for food
[[Page 58924]]
packaging is unworkable because ``brand codes'' and ``grade names''
change frequently, and would thus require continual updates.
(Response) The Bioterrorism Act specifically states that trade
names should be a required part of the facility's registration, and
thus, FDA agrees with the comment that trade names should be a required
registration element. FDA also agrees that it should define the term,
``trade names,'' and, as discussed previously, provides a definition of
``trade names'' in the interim final rule. In response to the comment
stating that ``brand codes'' and ``grade names'' change frequently, FDA
notes that the trade names definition does not include this
information, but only information about names the facility itself uses.
6. Product Categories Under Sec. 170.3
(Comment 126) Many commenters assert that registrants should not be
required to supply information regarding food product categories
associated with a facility. A variety of reasons are offered, including
that the categories are outdated and not relevant; the categories are
difficult to understand and apply; use of the categories would lead to
mistakes regarding a facility's selection of appropriate categories;
categories would require a facility to submit constant updates to FDA,
as a facility continuously changes the food it produces in response to
market demands; use of categories would impose an enormous burden and
increased cost; use of categories would limit targeted communications
because often one manufacturer's finished product is another's
ingredient, which would confuse FDA's efforts to notify affected
facilities; facilities would be subject to criminal penalties if
product category information is not correct or is outdated; under the
Bioterrorism Act, FDA has the discretion to require this information
and FDA should not exercise that discretion; use of categories
introduces huge uncertainties as to whether the appropriate facilities
would be contacted in the event of an emergency, which may lead either
to causing unnecessary concern or inadequate notification of affected
facilities; some categories overlap each other, yet many foods fall
into gaps between categories; and requiring categories would increase
the time to complete a registration. One commenter states that FDA
should include food product categories, because these categories would
help FDA to more closely focus inspection resources.
(Response) The interim final rule maintains the requirement that
food product categories be specified in a facility's registration. As
required by the Bioterrorism Act, FDA considered in guidance whether
such categories should be included and determined that such information
will be an important aid to the agency in the event of a foodborne
emergency (68 FR 42415). The interim final rule requires each facility
to submit the general food product category (as identified under Sec.
170.3) of the food manufactured/processed, packed, or held at such
facility. For ease of use, FDA lists the more common categories found
in FDA's product code builder at http://www.fda.gov/search/databases.html as the main categories on the registration form,
referencing the relevant food product category in Sec. 170.3 for each
FDA product code category. To relieve some of the burden of frequent
updates, FDA has added a ``most/all human food product categories''
option. Facilities that manufacture/process, pack, or hold food that
does not fit into one of the Sec. 170.3 categories are required to
check ``none of the above mandatory categories.'' These facilities may
also choose to check one or more of the optional boxes that correspond
to the category of food manufactured/processed, packed, or held at the
facility, as specified in section 11(a) or 11(b) of the registration
form.
FDA continues to believe that information regarding food product
categories is necessary for a quick, accurate, and focused response to
a bioterrorism incident or other food-related emergency. The categories
will help FDA to focus its response on the appropriate facilities,
saving crucial time. Some threats may be specific to a certain facility
type (e.g., a threat against beverage bottling facilities). Under these
circumstances, being able to target communications will allow FDA to
expedite and focus its response. The fact that in some instances a
threat cannot be isolated to a finite set of facilities does not mean
that this will be the case in all instances. Being able to focus
communications as much as possible based on a particular threat through
the use of food product categories will ensure that FDA is able to
respond as effectively and efficiently as possible.
(Comment 127) One commenter notes that in the proposed registration
form, FDA has stated that warehouses are not required to complete the
section on food product categories. The commenter states that this
exception for warehouses is not mentioned in the preamble or codified
of the proposed regulations, and asks FDA to clarify this exception.
(Response) To ensure that facilities have fully completed the
section on food product categories, FDA has changed this section to
require all facilities to check at least one box. As noted, as required
by the Bioterrorism Act, FDA considered in guidance whether such
categories should be included and determined that such information will
be an important aid to the agency in the event of a foodborne emergency
(68 FR 42415). Thus, this interim final rule requires registrants to
identify the food product category under Sec. 170.3 for food
manufactured/processed, packed, or held at each facility. FDA has also
provided that facilities that manufacture/process, pack, or hold food
in many different food product categories (such as many warehouses) do
not have to check every food product category, and may instead check
the ``most/all human food product categories.'' Importantly, however,
the interim final rule requires a warehouse that holds only one or a
limited number of different food products to identify those categories
listed in Sec. 170.3. Because the proposed rule would not have
required a facility to identify a food product category on the
registration form if it was manufacturing/processing, packing, or
holding food that did not fit into a category under Sec. 170.3, FDA
would not have been able to determine whether a registrant's food
product categories were not covered under Sec. 170.3, or whether the
registrant forgot to complete the section of the registration form on
food product categories. Therefore, the interim final rule requires
facilities that manufacture/process, pack, or hold food product
categories not covered under Sec. 170.3 to check ``none of the above
mandatory categories.'' Because the revised version of the Form 3537
requires all facilities to check at least one box in the food product
categories section, FDA has deleted the language in the form stating
that warehouses are exempt from completing the food product categories
section of the form.
7. U.S. Agent
FDA addresses comments related to the U.S. agent requirement in
section III.E.15 of this document.
8. Certification Statement
(Comment 128) One commenter notes that the requirements for
identifying personal information in the certification statement should
relate to the individual making the certification, not the individual
submitting the registration. This change would recognize that
administrative personnel, not responsible parties of the company, may
process the actual facility registration.
[[Page 58925]]
(Response) The Bioterrorism Act requires that the ``owner,
operator, or agent in charge of the facility shall submit a
registration'' to FDA. Accordingly, the certification statement on the
registration form requires the owner, operator, or agent in charge of a
facility to submit the registration, or to authorize an individual to
submit the facility's registration. Although administrative personnel
may prepare the registration, the owner, operator, or agent in charge,
or an individual authorized by the owner, operator, or agent in charge
to submit a facility's registration must certify that the information
included in the registration is true and accurate.
(Comment 129) One commenter states that the certification statement
is inadequate to ensure either the veracity of the information provided
or the identity and authority of the person submitting it. The
commenter states that ``[t]he regulation includes no protections that
would prevent intentional or unintentional abuse of the system, to the
potential detriment of both national security and of legitimate
businesses. Without some effective means of verifying at least the
identity and authority of the person submitting the registration, the
proposed system will be easily subject to misuse and mischief.''
(Response) The certification statement requires a person authorized
to submit a registration to certify that the registration information
is true and accurate, and that owner, operator, or agent in charge of
the facility has authorized the submitter to register on its behalf.
The certification statement also states that anyone who makes a
materially false, fictitious, or fraudulent statement to the U.S.
Government is subject to criminal penalties under 18 U.S.C. 1001. As an
additional means to verify the identity of the person submitting the
registration, the interim final rule requires that for the paper and
CD-ROM registration options, the registration include the signature of
the person submitting the registration. FDA believes that the
combination of the signed certification statement and Federal criminal
liability will be a powerful incentive for truthful registrations. In
addition, FDA has several methods by which to verify the identity of
both facilities and individuals submitting registrations by any of the
permissible means; however, for security reasons, FDA declines to
elaborate on these methods.
In addition to the changes noted previously, on its own initiative
FDA has made several editorial changes to this section for clarity.
I. Comments on ``What Optional Items Are Included in the Registration
Form?'' (Proposed Sec. 1.233)
1. General Comments
(Comment 130) One commenter states that the interim final rule
should remain focused on effectively implementing the legislative
requirements as is, neither expanding information requirements, nor
adding optional information. The submitter states that if the
information is not necessary, it should not be collected.
(Response) FDA notes that registrants are not required to submit
the elements of optional information specified in the proposed rule and
the interim final rule--that is the nature of ``optional'' information.
FDA continues to believe, however, that information described as
``optional'' will enable FDA to communicate more effectively with
facilities that may be the target of an actual or potential terrorist
threat or other food-related emergency and that better communication
about such emergencies will benefit both FDA and the registered
facility. For example, some food products are not covered in the
categories specified in Sec. 170.3, such as certain dietary
supplements, infant formula, and animal feed, but foods in these
categories may nevertheless be the focus of a food-related emergency.
Therefore, FDA encourages, but does not require, a registrant to submit
in a facility's registration the information identified as optional in
the interim final rule.
(Comment 131) Several commenters ask that FDA clarify what sections
of the registration form (Form 3537) are mandatory and which are
optional. One of these commenters states that FDA should mark optional
fields in some form, such as an asterisk, and program the electronic
downloadable file to allow the registration to proceed as long as the
mandatory fields have been completed. This commenter states that, at a
minimum, FDA should insert the word ``REQUIRED:'' or ``OPTIONAL:'' in
boldfaced, underscored, and all capital letters following the section
titles to clarify further which information is required and which is
optional. The commenter also suggests that instructions be provided for
filling out the form that include specific citations to those sections
where the information is required and where optional. Another commenter
suggested that FDA consider a second form for voluntarily-submitted
information. Otherwise, the commenter believes that the Food Facility
Registration Form will cause confusion as to which information is
required by law, versus information that is optional because the
optional sections of the form are interspersed with required
information sections.
One commenter states that the space on the Registration Form is
somewhat limited and proposes that the registration form be expanded to
accept appendices for registrants to submit additional information.
(Response) FDA believes its proposed registration form is
sufficiently clear as to which sections of the form are required and
which are optional. For each section of the registration that is
optional, FDA has included the word, ``OPTIONAL'' in bold. For the food
product categories section involving food for human consumption, FDA
has included the words, ``Optional Selection'' in bold after each
category that is not required. In the instructions for completing the
registration, FDA intends to specify which sections are required and
which are optional. FDA notes that the agency considered having a
separate form for optional information but rejected it after
determining that the order of the sections in the proposed registration
form was clearer and flowed more effectively when in a single form,
rather than two separate forms.
FDA further advises that the agency's electronic registration
system will be sufficiently flexible to permit a registrant to enter
all of the information the registrant needs to enter. FDA has revised
both the paper and electronic registration forms to provide ample space
for including all relevant information. However, for both the printed
and electronic versions of the registration, FDA is only accepting
information listed on the registration form; registrants should not add
information not identified as required or optional in this rule or
described on the registration form. Due to the large anticipated volume
of registrations, the registration system will not provide for the
submission of appendices to the registration form.
(Comment 132) Some commenters suggest that FDA include additional
optional sections on the registration form, including sections for type
or other facility registration number (e.g., the U.S. Customs Service
bonded facility Facilities Information and Resources Management System
(FIRMS) code, FDA establishment number, FDA-assigned Food Canning
Establishment number, Seafood Hazard Analysis and Critical Control
Point importer food number, FDA Affirmation of Compliance code, and the
location number of the U.S. domestic party responsible for FDA-
regulated goods imported by a foreign Importer of
[[Page 58926]]
Record), as well as an option for an ``other'' type of code; and the
appropriate registration number for each option that is checked. The
commenters state that this would minimize confusion, especially about
which of a facility's multiple registration numbers apply to what types
of activities.
(Response) FDA has decided not to implement this suggestion. In the
Bioterrorism Act, Congress specified what information must be required
in a facility's registration. After careful consideration, FDA has
concluded that a few additional elements of information are needed for
the efficient enforcement of the act in responding to a bioterrorist
threat or other food-related emergency. Because FDA believes the
additional information suggested by these comments would not
significantly further FDA's efforts in responding to such incidents, we
decline to include them as registration elements.
2. Type of Activity Conducted at the Facility
(Comment 133) Several commenters state that the option of including
on the registration form the ``category'' or ``type'' of food
warehoused, produced, or sold by a facility should be required. These
commenters state that this information appears to be critical in
determining who should be notified in case of a threat or actual
terrorist event targeting a particular type of food. One commenter
suggests that FDA use a ``simpler method'' to determine these
categories, such as that utilized for classifying an establishment
(e.g., 03 for bakeries, 16 for fishery products, 29 for soft drinks, 47
for food warehouses), which should suffice as a means of categorizing
establishments. One commenter states that FDA should either make
establishment type data mandatory or delete this information entirely.
This commenter states that FDA is unlikely to get full compliance
voluntarily with the request for establishment type information, when
no penalty would be imposed if this optional information were
inaccurate when submitted initially or became out of date.
(Response) FDA has required only what is specified in the
Bioterrorism Act and information that is necessary for the efficient
enforcement of the FD&C Act. Although we believe the information in the
optional items can be useful to FDA as well as to facilities in the
event of an emergency, we are requiring only those items required by
the Bioterrorism Act and those necessary for the efficient enforcement
of the FD&C Act.
3. Type of Storage, if the Facility Is Solely a Holding Facility
(Comment 134) FDA received several comments agreeing that a
facility that is ``solely a warehouse'' should only have to check a
simplified description of the type of warehousing provided, such as
``ambient storage,'' ``refrigerated storage,'' or ``frozen storage,''
rather than submit a detailed breakdown of the general food product
categories stored in the facility, as required in section 11 of the
draft form. These commenters state that this simplified option avoids
the need to determine and track food product categories for virtually
thousands of different food items that may enter or leave a warehouse.
The commenters ask, however, that FDA define what is meant by
``solely a warehouse.'' The commenters state that most, if not all,
public and contract food warehouses also provide ancillary services
that include labeling, relabeling, packing, and repacking, but the
warehouse typically provides these services without in any way
changing, contacting, or doing anything at all to the actual food. The
commenters state the warehouse never ``goes inside'' the primary
packing, thus avoiding any potential for contamination. The commenters
state that these services are incidental to the core function of
storing and handling and are performed strictly under the direction and
control of the customer.
(Response) As explained previously, to ensure that registrants have
completed the section of the form on food product categories, FDA has
decided to require that all registrants check at least one box in the
mandatory food product categories section of the form (section 11a).
Therefore, a facility that is solely a warehouse is required to check
either one or several food product categories covered under Sec.
170.3, ``the most/all human food product categories,'' or ``none of the
above mandatory categories.''
Regarding the question of what FDA means by ``solely a warehouse,''
FDA agrees that this term was confusing. We have revised Form 3537 to
eliminate that term. We are also providing that all food facilities
must complete section 11 which concerns general product categories. We
have revised section 10 of the form and Sec. 1.233(i) to refer to
facilities that are primarily holders.
4. Food Categories Not Included Under Sec. 170.3
(Comment 135) One commenter argues that FDA's proposed optional
food product categories should be mandatory, not optional. This
commenter asserts that FDA should use a simpler method of
classification of all food product categories, such as that used for
food establishments.
(Response) FDA believes that it is a reasonable choice for the
agency to make optional identification of food product categories that
are not listed in Sec. 170.3. There is a strong incentive for
facilities that handle foods in the optional categories to provide this
information, because with such information, FDA will be better able to
target its communications in case of a threatened or actual
bioterrorist event or other foodborne emergency. Getting prompter and
more accurate information will help a facility respond more quickly and
efficiently to any incident that may affect that facility. As discussed
previously, for ease of use, FDA is using the more common categories
found in FDA's product code builder at http://www.fda.gov/search/databases.html as the main categories on the registration form,
referencing the relevant food product category in Sec. 170.3.
(Comment 136) Several commenters submitted comments regarding the
``most/all human food product categories'' designation. Most of these
commenters agree with FDA's preliminary decision to include ``most/
all'' product categories. One commenter states that a facility that
normally carries all food categories and therefore has included ``most/
all food product categories'' in its registration should not be
required to amend their registration or be subject to penalties if they
have temporarily run out of products in a specific food category, but
intend to restock the items. Another commenter argues that FDA should
delete the ``most/all'' food product category. The commenter states
that in the event of an emergency, a delay could result since FDA would
be unnecessarily contacting facilities that do not manufacture/process,
pack, or hold the precise food in question. Also, a facility could
process different food products almost daily, but not be required to
notify FDA of any changes.
(Response) The interim final rule retains ``most/all human food
product categories.'' This category will enable facilities that
manufacture/process, pack, or hold many different types of food to
check the ``most/all'' category instead of having to update their
registrations frequently. In making this decision, FDA has balanced the
greater efficiency of the agency's having specific information
regarding food manufactured/processed, packed, or held at each facility
against the burden on facilities to submit initially and
[[Page 58927]]
update this information as circumstances change. While FDA agrees that
in some instances this may result in FDA contacting facilities that
check the ``most/all human food product categories'' box when they do
not handle a particular food product either at all or at that
particular time, on balance, these circumstances are likely to be
relatively infrequent compared to those contacts with a facility that
does manufacture/process, pack, or hold the food in question.
In addition to the changes noted previously, on its own initiative
FDA has made several editorial changes to this section for clarity.
J. Comments on ``How and When Do You Update Your Registration
Information?'' (Proposed Sec. 1.234)
(Comment 137) Several commenters state that the 30-day update
requirement is burdensome to industry. Information such as food product
categories and emergency contact information is constantly changing and
thus, registrants would need to submit updates continuously. Commenters
suggest varied timeframes for updates, including 14 days, 60 days, 90
days, 6 months, or every year. In addition, some commenters recommended
different update requirements for different information, such as more
frequent updates for emergency contact information. Another commenter
suggests that FDA require re-registration annually, instead of
requiring updates.
(Response) In response to these comments, FDA has decided to change
the period for an owner, operator, or agent in charge of a facility to
update its registration to 60 days for any change to any of the
required registration elements previously submitted. This timeframe
strikes a balance between the commenters' concern and FDA's requirement
under the Bioterrorism Act to keep our database current. Because
registration information will be used both to evaluate prior notice
submissions and to notify affected facilities in the event of a food-
related emergency, it is advantageous both to FDA and to registrants
that the agency's database be current.
In terms of the burden of updating food categories, as noted
previously, a facility has the option of specifying the ``most/all
human food product category'' in the food product category section of
the registration (if appropriate to the facility). To alleviate at
least in part registrants' burden to provide continuous updates, the
interim final rule provides that the emergency contact information need
only include an emergency contact phone number, instead of a person's
name or other individualized information.
(Comment 138) Some commenters ask for clarification regarding what
types of changes to a facility's registration require updates. One
commenter asks whether FDA requires an update for temporary plant
closures due to weather, fumigation activities, or line changeovers.
Another commenter asks whether temporary changes in the general food
product categories held or processed at the facility would require an
update. Another commenter states that numerous changes to production,
product lines, packaging, and establishment names should not require an
update.
(Response) The interim final rule requires updates for changes that
reflect a modification of a facility's operations, as it relates to the
required registration elements. Therefore, for facilities engaged in
ongoing operations that temporarily close for the reasons identified in
the comment, no update to a facility's registration information is
required. However, in considering whether to update temporary changes
to registration information, foreign facilities should keep in mind
that registration information will be matched with prior notice
information, and discrepancies in the two databases may cause FDA or
CBP to examine a shipment.
(Comment 139) Several commenters ask FDA to clarify whether an
update or a cancellation is warranted if a facility changes ownership
or goes through a merger or acquisition. One commenter indicates that
when a change in ownership occurs, the authority to make changes to a
registration would also likely change. Some commenters argue that a
registered facility should be able to keep its registration number
through change in ownership or management. At some point in the process
of ownership or management change, the former registrant should no
longer be authorized to make a change, and certainly could not
represent the information of the new owner.
(Response) Although the proposed rule and draft Form 3537 provided
for information regarding changes in owner, operator, or agent in
charge to be submitted as updates to the registration, neither the
proposed rule nor the form provided for such information to be
submitted in the initial registration. As noted in the response to
comment 96, the interim final rule at Sec. 1.232(c) and Form 3537 have
been revised and require that the name of the owner, operator, and
agent in charge to be provided as part of the initial registration.
FDA believes, however, that a change in the owner of a facility
triggers a new registration, because under the Bioterrorism Act, the
registration information is confidential, and the former owner should
not know the registration number assigned to the new owner. Moreover,
the Bioterrorism Act requires the owner, operator or agent-in-charge to
register the facility. Therefore, FDA is deleting the reference to
``owner,'' in ``Owner, operator, or agent in charge change'' in section
1b of the registration form. If a facility comes under new ownership,
the former owner must cancel the old registration in accordance with
Sec. 1.235, and the new owner must submit a new registration for the
facility in accordance with Sec. Sec. 1.230 and 1.231. FDA realizes,
however, that some old owners may not cancel their registrations.
Therefore, in new section 1c of the form, FDA is requiring new owners
to check the box ``Are you a new owner of a previously registered
facility?'' and asking new owners to provide the previous owner's name
and registration number, if known. If the new owner does not provide
the old registration number, FDA will keep the old registration in its
database until it independently affirms that the facility is under new
ownership. If the new owner provides the old registration number, FDA
will send a notification to the old owner seeking confirmation, and
will cancel the old registration upon receipt of confirmation, or FDA's
independent confirmation of a change in ownership, whichever occurs
first. If the former owner notifies FDA within this 60-day period that
it has not sold the facility, FDA will contact both owners to remedy
the discrepancy.
(Comment 140) Some commenters state that FDA should require
facilities that go out of business to submit a notice of cancellation
of their registration as soon as possible, or no later than 14 days
after the business operations cease. These commenters state that
updated information on a facility's business status would help ensure
that if there is a bioterrorism event, FDA is not wasting resources by
attempting to contact facilities that no longer exist or are out of
business. The commenters state that requiring cancellation of
registration would also help ensure that an organization or group
cannot threaten the American food supply by using a former business'
registration as a means to import into or distribute within the United
States tainted products. One commenter urges FDA to consider ways to
purge obsolete registrations from its database because
[[Page 58928]]
businesses that cease operations would not necessarily cancel their
registrations.
(Response) Because a registration cancellation is essentially an
update of registration information, FDA believes the time period for
canceling a registration should be 60 days, the same as that for
updates. Regarding purging its database of obsolete registrations, FDA
will cancel a registration if it independently verifies that the
registrant has gone out of business or if someone has registered a
facility that does not exist. If FDA cancels a facility's registration
that has gone out of business, FDA will mail a confirmation of the
cancellation to the facility.
(Comment 141) One commenter believes that the amount of information
FDA proposes to require in the cancellation notice is excessive. The
commenter requests that FDA require only the facility's registration
number, the name and contact information for the person submitting the
cancellation, and the certification statement for a cancellation.
(Response) The only elements the cancellation form includes in
addition to those listed in the commenter's request is the facility's
PIN number, whether the facility is domestic or foreign, and the
facility's name and address. FDA believes the information in the
cancellation form is necessary for FDA to verify that it is canceling
the correct registration, because canceling the wrong facility's
registration could have unintended consequences.
(Comment 142) Several commenters request that FDA clarify the
penalty for failure to update a registration within the required
timeframe. The commenters indicate that absent a coercive element, the
value of this tool is subject to failure.
(Response) The Bioterrorism Act requires owners, operators, and
agents in charge of facilities to register with FDA and also requires
FDA to keep its registration database current. Accordingly, Sec. 1.241
states that failure to submit a timely update to required registration
elements is a prohibited act, because obsolete information may hinder
FDA's efforts in responding to a threatened or actual bioterrorist act
or other food-related emergency. The FD&C Act provides for civil and
criminal sanctions for those who commit a prohibited act.
(Comment 143) Several commenters urge FDA to not require facilities
to update optional information previously submitted (such as the type
of activities conducted at the facility, as well as the optional food
categories or type of storage). One commenter requests that FDA state
in the interim final rule that the failure to update optional
information will not subject the registrant to penalties under the act
or FDA's implementing regulations. The commenter states that the
requirement to update previously submitted information in optional
fields ``could have a chilling effect on the willingness of companies
to provide the optional information in the first place.''
(Response) FDA has considered these comments and has revised Sec.
1.241(a) to delete the reference to optional information. The
Bioterrorism Act requires that a registrant notify the Secretary in a
timely manner of changes to information submitted in a registration (21
U.S.C. 350d(a)(2)). FDA believes that it is clear that the failure to
update required information is a prohibited act (21 U.S.C. 331(dd)).
The agency is concerned, however, that extending the prohibited act to
failure to update optional information will create a disincentive to
registrants to provide the optional information contrary to the
interests of the agency and registered facilities. Accordingly, FDA has
revised Sec. 1.234(a) to provide that only required information must
be updated and Sec. 1.241(a) to provide that failure to update
required information is a prohibited act.
Although the interim final rule will not make the failure to update
optional information a prohibited act, FDA emphasizes that updates of
registration information are very important, because obsolete
information may hinder FDA's efforts in responding to a bioterrorist
act or other food-related emergency. Accordingly, the agency strongly
encourages the owner, operator, or agent in charge of each registered
facility that provides FDA with optional information in a registration
to promptly update such information when it changes. In addition, FDA
encourages the owners, operators, and agents in charge of registered
facilities to update their registrations to delete optional information
that is obsolete.
(Comment 144) One commenter asks FDA to clarify whether FDA will
keep updated information on file as well as the reason for the change.
The commenter states that ``[i]n order to track activities of all
sides, if that is what the intended purpose is, a ``tracking and
activity mechanism'' would have to be in place. This would require,
however, that the agency has trained personnel that are able to spot
unreasonable irregularities and not go on a ``witch hunt.''
(Response) FDA intends to keep updated information on file. FDA
inspectors will compare a facility's registration information with the
information they obtain during the inspection of a registered facility.
The failure of an owner, operator, or agent in charge to register a
facility is a prohibited act, as is both the failure to update outdated
required registration elements within 60 days of the change, and the
failure to cancel a registration within 60 days if changes at the
facility warrant cancellation.
(Comment 145) One commenter requests that FDA's electronic
registration system be designed to permit a facility to use the
original information screen as the starting point for updating or
canceling the registration.
(Response) FDA advises that when a registrant accesses the
electronic system to update the registration for a particular facility,
the system is designed to provide the existing registration. Therefore,
the registrant will only need to edit the sections of the registration
that need to be updated.
(Comment 146) One commenter asks FDA to send an automatic e-mail
reminder to registrants on a yearly basis to remind them to update
their registrations.
(Response) As resources allow, FDA will to send periodic notices to
registrants, reminding them to update, as necessary, information in
their registration.
In addition to the changes noted previously, on its own initiative
FDA has made several editorial changes to this section for the purpose
of clarity. FDA has also added section Sec. 1.235 ``How and when do
you cancel your facility's registration information?'' This new section
contains information that was previously in section Sec. 1.234, ``How
and when do you update your registration information?'' FDA has added
this section for the purpose of clarity.
K. Comments on ``What Other Registration Requirements Apply?''
(Proposed Sec. 1.240)
(Comment 147) Many commenters state that they have already
registered with other U.S. Government agencies, as well as foreign
governments and States. The commenters state that requiring these
facilities to be registered with FDA as well is a burden. The
commenters also argue that FDA should coordinate with other agencies
and governments to avoid duplication.
(Response) The interim final rule maintains the registration
requirement as proposed, for several reasons. For all facilities that
FDA determines are subject to section 305 of the Bioterrorism Act, we
believe that the
[[Page 58929]]
statute requires the owner, operator, or agent in charge of those
facilities to submit a registration to FDA. Obtaining existing
registration information from other agencies would not guarantee that
FDA has the information for all facilities required by the Bioterrorism
Act's registration requirement because there is wide variation in the
purposes and information required by other registration or permitting
systems. For example, the laws administered by the Alcohol and Tobacco
Tax and Trade Bureau (TTB) do not require foreign alcohol beverage
producers to obtain permits, unless they are also engaged in the
business of importing alcohol beverages into the United States. In
addition, the information provided by alcohol beverage permittees to
TTB is not entirely identical to the information that must be provided
by facilities to FDA in accordance with the provisions of this interim
final rule.
Although it is theoretically possible for FDA to obtain information
from other agencies, the stringent timeframes for issuing this interim
final rule do not provide FDA adequate time to reconcile the different
information required or to work with the other agencies to have them
amend their existing requirements to capture all the information FDA
needs. We would also need to work with other agencies to ensure the
confidentiality of nonpublic registration information under relevant
information disclosure laws (e.g., Sec. Sec. 20.85 and 20.88 (21 CFR
20.85 (Federal agencies), 20.88 (State agencies), and 20.89 (foreign
governments))). Because the purpose of registration with FDA is to
assist FDA in responding to threatened or actual bioterrorist incidents
or other food-related emergencies, FDA must have the registration
information readily accessible. If FDA has to coordinate with other
agencies or governments to obtain from them the information necessary
to respond to such an emergency, FDA may be prevented from responding
to the emergency in a timely manner.
Regarding facilities that may be registered with FDA under existing
regulations (e.g., low acid canned food), like the registrations of
other agencies, these FDA registrations also do not contain all of the
information required in this interim final rule, because the purposes
of the regulations differ. FDA will continue to look for ways to
minimize duplicative registrations in the future, but could not do so
in the timeframe provided for developing this rule. On its own
initiative, FDA has made several editorial changes to this section for
the purpose of clarity.
L. Comments on ``What Happens if You Fail to Register?'' (Proposed
Sec. 1.241)
1. Revocation of Registration
(Comment 148) Several commenters submitted comments in response to
FDA's request for comments regarding the circumstances under which a
firm's registration should be cancelled and/or considered null and
void. One commenter states that neither the FD&C Act nor the
Bioterrorism Act authorize revocation of registration. One commenter
states that because the Bioterrorism Act's Rule of Construction notes
that registration is not a licensing or approval process, FDA cannot
extend or withdraw approval. This commenter suggests that a
registration may only be vacated through the ordinary criminal process
to prove fraud if the registration is made fraudulently. Another
commenter states that revocation should be reserved for extreme
situations of bioterrorism, intentional contamination, and other
criminal activity, and should afford a facility an opportunity for an
adjudicative hearing, since revocation effectively prohibits a facility
from manufacturing/processing, packing, or holding food for consumption
in the United States. A foreign commenter suggests that any revocation
of registration should occur only after a process that involves foreign
authorities within the same locale as the foreign facility, in
consultation with the U.S. Embassy. One commenter requests a clear
delineation of the circumstances warranting registration suspension,
suggesting that it should extend only to the parameters of the
Bioterrorism Act. Another commenter suggests that revocation of
registration should only be considered for facilities that have ceased
trading, or no longer handle food products. A commenter suggests that
FDA clarify the distinction between suspension and revocation:
Revocation should only be for facilities that have gone out of business
or that have submitted false information. FDA should employ the less
drastic penalty of suspension for submission of inaccurate, incomplete,
or untimely information. The commenter suggests that FDA notify a
facility that failure to submit all of the required information within
15 days will result in suspension. Registration could be reinstated
when this missing information is provided.
(Response) FDA does not agree that it should have a category of
registrations that have been suspended. A facility either is registered
by submitting a registration to FDA or it is not registered. Regarding
registration cancellation, FDA has determined that the only
circumstances under which it will cancel a registration are if the
agency independently verifies that a facility has gone out of business
or is under a new ownership, or if FDA establishes that the submitted
registration is for a facility that does not exist. FDA has clarified
this in the interim final rule by adding the following paragraph to
Sec. 1.241:
(b) FDA will cancel a registration if the agency independently
verifies that the facility is no longer in business or has changed
owners and the owner, operator, or agent in charge of the facility
fails to cancel the registration, or if FDA determines that the
registration is for a facility that does not exist. If FDA cancels a
facility's registration, FDA will mail a confirmation of the
cancellation to the facility at the address provided in the
facility's registration.
As mentioned previously, a facility under new ownership is required
to submit a new registration.
(Comment 149) One commenter asks that FDA not recall products
already distributed into commerce if it determines after confirmation
of the registration that the registration contains inadvertent errors.
(Response) Neither the proposed rule nor the interim final rule
provide for the recall of food distributed into commerce because FDA
subsequently determines that there are inaccuracies in the registration
of a facility at which the food was manufactured/processed, packed, or
held.
2. Prohibited Act for Domestic or Foreign Facility
(Comment 150) Several commenters request clarification on the
penalties that may be imposed for failure to register and who may be
subject to these penalties. One commenter states that failure to
register may be a simple omission rather than a terrorist act;
therefore, FDA should apply criminal actions according to the
consequences and characteristics of the act. Another commenter asks FDA
to clarify that although failure to register is a prohibited act,
importing food from an unregistered facility is not. A commenter asks
FDA to clarify that failure to register, although a prohibited act,
will not result in debarment. This commenter asks FDA to maintain a
public list of debarred individuals and firms, and make this list
available on the Internet.
(Response) FDA agrees that Sec. 1.241 was likely confusing and has
clarified this provision in the interim final rule. Specifically, the
interim final rule consolidates the two provisions relating to the
prohibited act of failing to register (21 U.S.C. 331(dd)) and makes
clear that
[[Page 58930]]
the causing of a prohibited act and being responsible for the
commission of a prohibited act are both subject to sanction under the
act (21 U.S.C. 331). Thus, under the interim final rule, the owner,
operator, or agent-in-charge of any facility that manufactures/
processes, packs, or holds food for consumption in the United States,
who is required to register the facility with FDA but fails to do so,
commits a prohibited act under section 301 of the FD&C Act. Similarly,
the owner, operator, or agent in charge that fails to update mandatory
information or cancel a registration within 60 days (if changes at the
facility require an update) commits a prohibited act.
FDA has also clarified that the disposition of a food from an
unregistered foreign facility when offered for import into the United
States will be governed by subpart I of this part (Prior Notice of
Imported Food). FDA is publishing elsewhere in this issue of the
Federal Register a interim final rule implementing section 307 of the
Bioterrorism Act, which requires, among other things, an importer to
submit to FDA prior notice of a shipment of food that is offered for
import. As discussed in response to comment 162, FDA addresses the
consequences for importation of food for failure to register in the
interim final rule implementing prior notice published elsewhere in
this issue of the Federal Register.
With regard to the comment on debarments, Sec. 1.241 merely
relates the grounds for debarment specified in section 306(b)(3)(A) of
the FD&C Act. The agency's implementation of the details of the
debarment provisions of the Bioterrorism Act are outside the scope of
this interim final rule.
3. Food Held at the Port
(Comment 151) Many commenters express concerns about the custody
and responsibility for products placed under hold. Several commenters
ask who is responsible for costs associated with food held at the port.
One commenter asks FDA to clarify that any party in the commercial
import process, including the shipper, could be responsible for
arranging the bonded hold, and that such arrangements are not FDA's
responsibility. A commenter requests that FDA be responsible for any
costs incurred from mistakes made in enforcement of the rule that
results in the holding of imported food. One commenter recommends that
a clear chain of custody and fiduciary responsibility must be
established for products placed on hold. One commenter requests that
FDA and Customs issue guidance on holding food before December 12,
2003.
(Response) In proposed Sec. 1.241, we described the consequences
of failure to register when food is imported or offered for import from
a foreign facility that is required to register under section 305 of
the Bioterrorism Act. At the same time, we included in the proposed
rule implementing the prior notice requirements of section 307 of the
Bioterrorism Act, a provision requiring the registration number of
certain facilities to be provided as part of the required prior notice
information. In the prior notice proposal, we also discussed the
consequences of failure to provide required information, including
required registration information, when importing food. We believe that
including consequences of failing to register for foreign facilities in
two different regulations may be confusing. Therefore, we have revised
Sec. 1.241 to include simply a cross reference to subpart I (Prior
Notice of Imported Food), which sets out how food imported or offered
for import from facilities not registered as required will be handled.
Thus, we have deleted Sec. 1.241(e) through (h). Although we no longer
have provisions regarding imported food in this interim final rule, we
are addressing the comments we received.
With regard to this comment, before the enactment of the
Bioterrorism Act, FDA's role was to make admissibility decisions as to
whether food imported or offered for import into the United States
should be refused admission under section 801(a) of the FD&C Act. Any
storage and transportation costs associated with FDA's refusal process
were borne by the relevant private parties according to their
contractual agreements. Nothing in the Bioterrorism Act changes who
bears the costs related to food that may not be admitted into the
United States. Although Sec. 1.241(f) has been removed from this
interim final rule, the prior notice interim final rule states that
neither FDA nor CBP are liable for transportation, storage, or other
expenses. The proposed registration rule and the proposed prior notice
rule provided for costs to be borne by the owner, purchaser, importer,
or consignee. FDA has reconsidered and believes that it would not be
appropriate to specify which parties are responsible for costs as this
is a commercial rather than a regulatory matter. Accordingly, the
interim final prior notice rule merely provides that FDA or CBP is not
liable for the costs.
(Comment 152) Several commenters request that FDA ensure that
appropriate and sufficient storage facilities (including climate
controlled storage) exist before the Bioterrorism Act is enforced and
that FDA release the food immediately once relevant facilities
register. One commenter requests that FDA not hold food based on simple
problems or errors in registration, such as misspelling. One commenter
asks if the ``secure location'' must be a Customs bonded facility.
Another commenter asks FDA to clarify the procedure it will follow to
notify a foreign facility when its products have been held at the U.S.
port because of failure to register. A commenter asks FDA to permit
prompt registration, ideally electronic, when failure to register is
discovered at the port of arrival. A commenter argues that if a
shipment appears likely to be held, the exporter should have the option
of taking it back or sending it to another country. This commenter
argues that if FDA delays a shipment too long for administrative
reasons, FDA should provide compensation. Another commenter states that
the proposed regulations should be amended to specifically provide for
release of compliant articles mixed with noncompliant articles. This
commenter argues that FDA should not hold compliant articles while it
is waiting for registration of the facilities that are associated with
the noncompliant articles.
(Response) As stated previously, a facility may register either
electronically (the preferred and fastest method) by mail (using paper
or CD-ROM), or by fax. A facility that is registered electronically
will receive its registration number almost instantaneously. FDA will
process registrations received by mail or fax in the order received. It
is the responsibility of the owner, operator, or agent in charge of
each facility subject to the requirements of this rule to register
before December 12, 2003, and before food from the facility is imported
or offered for import into the United States. The Bioterrorism Act
prohibits food from an unregistered foreign facility from being
delivered for distribution in the United States.
As explained in more detail in the preamble to the interim final
prior notice rule, the electronic systems for submission of prior
notice will not provide confirmation that prior notice has been
accepted by FDA for review unless the required registration information
is complete and facially correct. Thus, the transmitter of the prior
notice may be informed when there is a problem with the registration
numbers.
[[Page 58931]]
In addition, with regard to whether FDA will notify the foreign
facility that its food is being held for failure to register, we intend
that FDA or CBP will notify the carrier of the food that the food is
being placed under hold. Also, if a shipment includes both compliant
and noncompliant articles of food, segregation will be allowed as
provided for in the prior notice interim final rule.
If a facility is not registered and discovers this fact at the
port, the owner, operator, or agent in charge must register the
facility with FDA if they wish the food to be distributed in the United
States. FDA strongly encourages electronic registration, as that will
be the fastest method. FDA will continue to process registrations
submitted via other means in the order received. To do otherwise would
be unfair to the other registrants who have submitted their
registrations to FDA as required by this interim final rule ahead of
the facility whose food is at the port, particularly since many of
those facilities also will be importing or offering for import food
into the United States.
FDA agrees that appropriate storage and holding conditions must be
considered. This means, for example, that if the article of food
arrives in frozen condition and has been transported under frozen
conditions, the facility used for holding the product must provide
adequate frozen conditions.
(Comment 153) One commenter expresses concern that ``the entire
burden of proof lies with the facility'' regarding FDA's determination
to not allow food to enter the United States if ``registration has
[not] been completed.'' The commenter states that ``this may in our
view be problematic, especially in the case of registration by regular
mail.''
(Response) Registered facilities will receive their registration
numbers as confirmation of registration with FDA. For a registration
submitted electronically, a facility will receive its registration
number immediately following completion of the registration process.
For registrations submitted by mail, CD-ROM, or fax, FDA considers a
facility registered once FDA enters the facility's registration data
into the registration system and the system generates a registration
number. This means that FDA may consider a facility registered before
the facility receives its registration number and confirmation. To
ensure that facilities are registered as expeditiously as possible, FDA
encourages facilities to register electronically, or if registering by
mail, CD-ROM, or fax, to submit the registration as soon as possible
after publication of this interim final rule.
(Comment 154) One commenter asks FDA to provide a right for parties
adversely affected by a refusal of admission to challenge that
determination through judicial review.
(Response) As stated in the response to comment 151, the procedures
for imported food are set out in the interim final rule on prior notice
of imported food published elsewhere in this issue of the Federal
Register.
(Comment 155) One commenter asks FDA to include in its protocol
that FDA uses for holding food at the port of arrival due to a failure
of the facility to register a ``clear message to consumers that [the]
product is being held because of a registration issue and not because
the product poses some food safety or security risk.'' The commenter
states that ``poor communication could cause consumer alarm and erode
consumer confidence.''
(Response) This comment does not affect any of the provisions of
this interim final rule. Therefore, FDA will consider this comment as
it develops its training procedures. In this interim final rule, we
have changed the title of Sec. 1.241 to ``What are the consequences of
failing to register, update, or cancel your registration?''
M. Comments on ``What Does Assignment of a Registration Number Mean?''
(Proposed Sec. 1.242)
FDA received no comments on this issue. FDA made a minor editorial
change to this section for the purpose of clarity.
N. Comments on ``Is Food Registration Information Available to the
Public?'' (Proposed Sec. 1.243)
(Comment 156) One commenter states that FDA should not share
registration information with states or other Federal agencies and, if
it does, it must ensure that the other agencies and States protect the
confidentiality of the information.
(Response) FDA believes that in certain circumstances, it may need
to share information derived from its registration database with States
or other Federal agencies consistent with FDA's laws and procedures.
Any sharing with another Federal agency would be done under Sec. 20.85
which includes confidentiality provisions. Similarly, any sharing with
State officials would be under Sec. 20.88 which also includes
confidentiality provisions.
(Comment 157) Several commenters request that third parties,
particularly importers, should be able to verify that a particular
facility is registered.
(Response) As discussed in response to comment 158, FDA's list of
registered facilities and registration documents are not subject to
disclosure under the Freedom of Information Act (FOIA). In addition,
any information derived from the list of facilities or registration
documents that would disclose the identity or location of a specific
registered person also is not subject to disclosure under FOIA.
However, under the interim final rule on prior notice of imported food
published elsewhere in this issue of the Federal Register, the prior
notice must include the certain registration numbers. Therefore, the
submitter of the prior notice must obtain that information from the
facility.
(Comment 158) Some commenters suggest that FDA expand the
protection from disclosure specified by the Bioterrorism Act to all
information derived from registration documents that has not been
previously disclosed to the public.
(Response) Section 305 of the Bioterrorism Act states that FDA's
list of registered facilities and registration documents FDA receives
under the rule are not subject to disclosure under FOIA. Furthermore,
section 305 provides that any information derived from the list of
facilities or registration documents that would disclose the identity
or location of a specific registered person is not to be subject to
disclosure under FOIA. If the information derived from registration
documents is not exempt from disclosure by FOIA itself, the
Bioterrorism Act, or another statute, FDA does not believe that the
information is protected from public disclosure.
We realized that the proposed rule may been confusing with regard
to the information that is not subject to disclosure. Therefore, we
have revised the interim final rule to make it clear. Also, we have
made a conforming change to 21 CFR 20.100(c) to add ``Registration of
food facilities, in Sec. 1.243 of this chapter.''
(Comment 159) One commenter asks FDA to require facilities to
include their registration numbers on their finished food packaging, to
assist in traceback efforts.
(Response) FDA declines at this time to require facilities to
display their registration numbers on the food label. FDA believes that
it will be able to conduct appropriate traceback efforts using the
information presently required on the food label in conjunction with
the database of registration information. Moreover, FDA believes it
would not be feasible to require manufacturers/processors to place
registration numbers on their food labels prior to the
[[Page 58932]]
December 12, 2003, deadline for registration.
(Comment 160) One commenter requests that FDA provide a facility's
registration confirmation in the form of a certificate or card that
facilities can display so inspectors can see if the facility is in
compliance with the registration requirement.
(Response) FDA will send facilities a confirmation when FDA
receives their complete registration. Facilities may use this
confirmation to show their registration status.
IV. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
FDA has examined the economic implications of this interim final
rule as required by Executive Order 12866. Executive Order 12866
directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 12866
classifies a rule as significant if it meets any one of a number of
specified conditions, including having an annual effect on the economy
of $100 million, adversely affecting a sector of the economy in a
material way, adversely affecting competition, or adversely affecting
jobs. A regulation is also considered a significant regulatory action
if it raises novel legal or policy issues. FDA has determined that this
interim final rule is a significant regulatory action as defined by
Executive Order 12866.
This Final Regulatory Impact Analysis reflects changes made in the
regulation from the proposed rule to the interim final rule, as well as
changes in estimates in response to comments. It also includes
responses to comments on the Preliminary Regulatory Impact Analysis
(PRIA) (see 68 FR 5387 to 5413). Where there were no changes in the
estimates provided in the PRIA, the estimates are summarized here.
Interested persons are directed to the text of the PRIA for a fuller
explanation of the estimates about which there were no controversy or
changes. As noted in section III of this document, FDA received
approximately 350 submissions in response to the proposed rule, which
raised almost 200 issues. We continue with the discussion of the
comments and FDA's responses to those comments using the same
presentation as in section III, focusing here on the comments FDA
received on the PRIA. Accordingly, the word ``Comment'' again will
appear in parenthesis before the description of the comment, and the
word ``Response'' will appear in parenthesis before FDA's response. As
in section III, FDA has numbered each comment to make it easier to
identify a particular comment. The number assigned to each comment
below continues in sequence from section III and is purely for
organizational purposes; it does not signify the comment's value or
importance or the order in which it was submitted.
1. Description of Interim Final Rule
This interim final rule requires the registration of facilities
that manufacture/process, pack, or hold food intended for consumption
in the United States. In the event of an actual or threatened
bioterrorist attack on the U.S. food supply or other food-related
emergency, this information will help FDA and other authorities
determine the source and cause of the event, and communicate with
potentially affected facilities.
2. General Comments
(Comment 161) FDA received a number of comments that asserted that
the costs or benefits of the proposed rule were incorrectly estimated.
(Response) If the comment asserted costs or benefits were
incorrectly estimated without specifying which costs or benefits, there
was not sufficient information for FDA to respond to that comment.
However, comments that specified which costs or benefits were
incorrectly estimated are addressed in later sections of this analysis.
(Comment 162) FDA received a comment that asked what a line entry
is.
(Response) A line entry is a term used by FDA's automated system
for imports, the OASIS reporting system (Ref. 2). A ``line entry''
refers to a line on an invoice that reflects a certain article specific
to a manufacturer or packaging: e.g., 100 cases containing 48 6-ounce
cans of tuna.
3. Number of Facilities Affected
In the PRIA, FDA estimated the number of affected establishments by
counting facilities, not firms. A firm may be composed of many
facilities under the same ownership. The changes in behavior needed to
comply with this regulation may take place at the firm or facility
level. However, because facilities must be registered, and for ease of
analysis, FDA focused on the facility as the unit of analysis. For a
count of domestic facilities, FDA used the 2000 County Business
Patterns (Ref. 3), 1999 Nonemployer Statistics (Ref. 4), the FDA Field
Accomplishments and Compliance Tracking System (Ref. 5), the Census of
Agriculture (Ref. 6), 1997 Economic Census of Transportation and
Warehousing (Ref. 7), and information from direct selling marketing
trade associations (Refs. 8 and 9). The analysis relies primarily on
the Nonemployer Statistics for its count of very small businesses (no
paid employees) that may or may not be home-based. The Nonemployer
Statistics' primary source is administrative data from Internal Revenue
Service records. This may overcount the number of facilities required
to register, as some of the facilities may be exempt on the basis of
being an individual's private residence. Additional small facilities
that are direct marketers are counted using data from direct marketing
trade associations. FDA counted the number of facilities in the U.S.
outlying islands of Puerto Rico, Guam, Virgin Islands, and Northern
Mariana Islands using Economic Censuses available from the U.S. Census
Bureau (Refs. 10, 11, 12, and 13). To count the number of foreign
manufacturers/processors, FDA used FDA's OASIS database (Ref. 2). As
noted, OASIS is an automated FDA system for processing and making
admissibility determinations for shipments of foreign-origin FDA-
regulated products seeking to enter domestic commerce. FDA also
estimated that 16 percent of the foreign manufacturers/processors would
stop exporting to the United States because of the cost of complying
with this regulation. Also counted were foreign holders of products to
be exported to the United States. FDA did not have data on the number
of foreign holders and so assumed that they were equal to the number of
consignees, brokers, and importers of food products in the United
States. Foreign de minimis processors and packagers were not included
in the OASIS count and so were estimated using U.S. data on the number
of packer/repackers. Tables 3 through 7 of this document present the
counts of domestic and foreign facilities.
(Comment 163) FDA received a number of comments stating that the
number of affected facilities had been underestimated.
(Response) Many of these comments did not provide any specific
information about the categories of facilities that were undercounted
or not included or information about the correct number of facilities.
Without this additional information, FDA has no basis for responding to
these comments. However, FDA responds in the number of facilities
section to comments that
[[Page 58933]]
provided additional information about the category or number of
undercounted facilities.
(Comment 164) A comment suggests that FDA failed to include very
small facilities in its count of affected entities.
(Response) FDA disagrees with this comment. FDA included in its
count more than 68,000 very small facilities from the Nonemployer
Statistics published by the U.S. Census Bureau. These are all
facilities that are run by a single person with no paid employees.
Additionally, the majority of the facilities counted from the County
Business Patterns published by the U.S. Census Bureau are considered
small businesses under the Small Business Administration definition.
(Comment 165) FDA received a comment that the number of foreign
holders may be much larger than the number of U.S. consignees and
brokers, because a single broker may use multiple warehouses.
(Response) FDA agrees that a single broker may use multiple
warehouses, but FDA also believes the converse is true, that a single
warehouse may be used by multiple brokers. This comment did not provide
an alternative estimate of the number of foreign holders. Therefore,
FDA has not altered its estimate of the number of foreign holders.
(Comment 166) FDA received many comments that the count of
facilities failed to include transportation company facilities that
hold food temporarily, while the product is in transit. Comments
mention specific types of facilities, such as rail yards, container
yards, LTL truck terminals, FTL truck terminals, Customs bonded
Container Freight Stations, air cargo handling agents, and air, ocean,
and truck bulk cargo terminals. FDA also received comments that the
PRIA fails to include mobile facilities, such as river barges that pick
up cargo in one location and travel to an alternate location where the
barge may store product in its hull for several months prior to
delivering the shipment to the purchaser.
(Response) Transport vehicles are not facilities required to
register with FDA, if they hold food only in the usual course of
business as carriers. However, facilities that unpack and reload food
cargo from road, rail, water, or air transportation or hold food cargo
in a facility, or that hold food cargo not only in the usual course of
business as a carrier, are required to register. FDA agrees that not
all these facilities were counted in the PRIA.
To count these facilities, FDA used the 1997 Economic Census of
Transportation and Warehousing (Ref. 7) from the U.S. Census Bureau.
Table 1 shows a count of these facilities. This includes the 1,461
warehouses North American Industry Classification System (NAICS 49312
and 49313) counted in the PRIA. These facilities are subtracted from
the count of warehouses (NAICS code 493, all warehousing and storage)
when final computations of the number of facilities are made. Including
the transportation holding facilities in table 1 minus the warehousing
facilities already counted in the PRIA increases the total number of
facilities required to register by 33,666 facilities.
[GRAPHIC] [TIFF OMITTED] TR10OC03.049
(Comment 167) FDA received many comments that FDA underestimates
the number of facilities covered by the definition of substances and
components of substances that contact food. One comment states that FDA
does not include the ``upstream'' manufacturers that make ingredients
and components that go into food packaging and that any facility that
manufactures/processes, packs, or holds a material that could become a
component of packaging or other food contact article would be required
to register. The comment further states that there is no logical
conclusion to this chain. Also, some comments assert that FDA did not
account for warehouses that hold articles that can migrate to food from
food packaging or other articles that contact food.
Another comment states that FDA's count of the number of domestic
facilities is overly inclusive if FDA's
[[Page 58934]]
intention is to include only finished packaging and that the OASIS
database used for the count of foreign facilities does not include
suppliers of food contact articles.
(Response) Under the interim final rule, manufacturers/processors,
packers, and holders of food contact substances as defined in section
409(h)(b) of the FD&C Act are not required to register with FDA.
Therefore, it is unnecessary for FDA to respond to the comments
asserting the number of these facilities was underestimated. FDA also
removes the estimated count of 32,428 facilities in the PRIA from the
final analysis.
(Comment 168) One comment states that FDA's count of foreign
facilities from OASIS (Ref. 2) did not include manufacturers/processors
of articles that contact food and substances that could migrate to food
from food packaging.
(Response) FDA agrees with this comment. The count of manufacturer/
processors in OASIS (Ref. 2) did include manufacturers of food and food
additives, but did not include all manufacturers/processors of
substances that could migrate to food from food packaging. However,
these facilities are not covered under the interim final rule.
Therefore, FDA has not added them to the count of foreign facilities.
(Comment 169) A number of comments states that FDA had
underestimated the number of facilities by failing to include
individuals that market foods and dietary supplements through direct
selling. These individuals often hold food for sale to an intermediary
other than the final consumer. Estimates provided by comments were that
there are 10 million individuals in the United States and as many as
40,000 direct marketers with a single company. Another comment referred
to hundreds of thousands of direct sellers.
(Response) Direct marketers may be required to register if they
hold food for distribution to nonconsumers in the United States.
However, FDA does not agree that there are 10 million direct marketers
in the United States that could potentially be required to register.
FDA found estimates of 10 million (Ref. 9) and 12 million (Ref. 8)
direct marketers in the United States, but these estimates were of all
the direct marketers of both nonfood and food products in the United
States. FDA does not have a complete census of the number of marketers
of food versus nonfood products. To approximate the percentage of
direct marketers selling food, FDA divided the number of direct
marketing companies selling food by the number selling all types of
products, using data from the directory of companies on the Web site of
a large direct selling trade organization (Ref. 8). Of 141 companies in
the directory, 7, or 5 percent, market food/beverages. However, most of
these direct marketers of food may not be required to register. Direct
marketers may be exempt: (1) If their primary function is to sell
directly to consumers, or (2) if the establishment is an individual's
private residence. FDA assumes that most direct marketers of foods
would qualify for one of these exemptions.
To estimate how many direct marketers sell to consumers as their
primary function, FDA looked at the type of distributorship. If the
marketer has a one or two-person distributorship, FDA assumes that
their primary function is to sell to consumers. FDA assumes if a
marketer has a multiperson distributorship, they are likely to
distribute to other sellers as their primary function. (These are not
definitions that FDA will use to determine if selling to consumers is
the primary function of a facility; this is merely a method used to
provide an estimate for the economic analysis.) According to a large
direct selling trade organization (Ref. 8), 2.5 percent of direct
salespeople are multidistributorships. These numbers suggest that
approximately 12,400 (10 million x .025 x (7/141)) direct marketers of
food would be required to register with FDA. This number may be an
overestimate because some of these marketers may already have been
counted in the CBP (Ref. 3) or Nonemployer Statistics (Ref. 4) or may
distribute food from their private individual residence.
(Comment 170) FDA also received comments stating that there were
thousands and thousands of wineries in Europe that may not have been
included in the estimate of the number of foreign facilities.
(Response) FDA does not agree with this comment. FDA's estimate
includes approximately 27,000 European alcohol producers. FDA did not
have enough data to separate wineries from other types of alcohol
production facilities.
(Comment 171) One comment stated that FDA had failed to count
collectors of wild plants. The comment estimates that there are 100,000
individuals that harvest wild plants.
(Response) Only facilities are required to register with FDA;
individuals are not required to register. Harvesters of wild plants
that manufacture/process, pack, or hold product in facilities outside
of an individual's private residence would be required to register the
facility with FDA. FDA does not agree that there are 100,000 harvesters
that meet these requirements. FDA commissioned a Dietary Supplement
Enhanced Establishment Database (DS-EED) in 1999 (Ref. 14). This
database gathered data from the American Business Information (now
InfoUSA) electronic database, American Herbal Products Association
Membership Directory and Resource Guide, Council for Responsible
Nutrition Membership Directory, Harris Inc.'s U.S. Manufacturers
Database, Hoovers Corporation Infoseek, National Foods Merchandiser
'98-99 Retailer Purchasing Guide August 1998, National Products Expo
West, Show Directory, March 1998, Official Establishment Inventory, and
Thomas Food Industry Register on the Internet. The DS-EED listed 272
ingredient suppliers. The database may have underestimated the number
of ingredient suppliers, but only ingredient suppliers that
manufacture/process, pack, or hold product in facilities outside an
individual's private residence would be required to register the
facility with FDA. Some harvesters of wild plants may already be
counted in Census databases, and already be included in the count of
facilities. Therefore, FDA estimates that there are an additional 272
harvesters/ingredient suppliers for purposes of this analysis.
(Comment 172) Some comments claim that the number of farms that
would fall under FDA's definition of a mixed-type facility is much
higher than estimated in the PRIA. Under the proposed definition of
manufacturing/processing, which included trimming and washing, the
comment suggested that most farms wash, cool, or trim outer leaves and
so would be required to register.
(Response) Farms are not required to register with FDA. In this
interim final rule, FDA defines ``farm'' as a facility in one general
physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. Washing, trimming of
outer leaves of, and cooling produce are considered part of harvesting.
Some facilities located on farms may also manufacture/process, pack
or hold food, but not meet the definition for farm and therefore, would
be considered mixed-type facilities that are required to register. The
farm definition also provides that facilities that pack or hold food,
provided that all food used in such activities is grown, raised, or
consumed on that farm or another farm under the same ownership are
exempt as farms, as are facilities that manipulate food other than
washing, trimming outer leaves, or cooling, provided that all food used
in such
[[Page 58935]]
activities is consumed on that farm or another farm under the same
ownership. Some facilities located on farms may manufacture/process,
pack, or hold food but not meet the definition of farm and therefore,
would be considered mixed-type facilities that are required to
register. Activities that would be considered manufacturing/processing
include cutting, peeling, trimming, washing, waxing, eviscerating,
rendering, cooking, baking, freezing, pasteurizing, homogenizing,
mixing, formulating, bottling, milling, grinding, extracting juice,
distilling, labeling, or packaging. Farms that mix feed would be
considered mixed-type facilities if they manufacture/process feed on
the farm with ingredients obtained from another source, and the
resulting feed is then sold or transferred for final use offsite.
In the PRIA, FDA considered farms to be mixed-type facilities if
they washed, cooled, or trimmed outer leaves. FDA agrees that the PRIA
count of mixed-type facilities undercounted these facilities. In the
interim final rule, farms that wash, cool, or trim outer leaves are not
considered mixed-type facilities, and therefore, the count of mixed-
type facilities is unchanged from the count in the PRIA.
To estimate the number of facilities that would be considered
mixed-type facilities, FDA used the 1997 USDA National Agricultural
Statistics Service Census of Agriculture (Ref. 6), and data obtained
from various county level Cooperative Extension Service (CES) offices
(Ref. 15). FDA provides an estimate of the number of these mixed-type
facilities in table 2. The Census of Agriculture provides the total
number of farms producing specific commodities. To estimate the number
of farms that are mixed-type facilities, FDA used a sample of counties
with information from their respective CES offices. CES offices from
Clay County, Kansas; Monterey, Sonoma, Marin, and San Diego counties in
California; Jackson County, Wisconsin; Gillespie and San Saba counties
in Texas; Carroll County, Maryland; and Berks County, Pennsylvania
provide data on the percentage of farms producing specific commodities
to be considered mixed-type facilities (Ref. 15). FDA assumes that
other commodities, including vegetables (non-organic), other fruits,
and wheat, plus feed mixing on poultry and other livestock farms are
not mixed-type facilities based on CES interviews (Refs. 15 and 1).
BILLING CODE 4160-01-P
[[Page 58936]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.050
Tables 3 through 7 provide detailed counts of facilities as
included in the preliminary regulatory impact analysis and as revised
under the interim final rule. Tables 3 and 4 provide the number of
facilities counted from the CBP and Nonemployer statistics,
respectively, these counts were unchanged from the PRIA to the final
analysis. Table 5 provides revised counts of domestic facilities from
sources other than the CBP and Nonemployer statistics, including
several revised counts of facility types based on comments. Table 6
provides a breakdown of the count of foreign manufacturers/processors
obtained from OASIS, these estimates did not change from the PRIA to
the final analysis. Table 7 provides a summary of the counts of
domestic and foreign facilities.
[[Page 58937]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.051
[[Page 58938]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.052
BILLING CODE 4160-01-C
Table 5.--Revised Count of Domestic Facilities Required to Register of
Facilities From Other Sources
------------------------------------------------------------------------
PRIA Revised count
------------------------------------------------------------------------
Mixed-type facilities............. 30,497 30,497
Food contact substances........... 22,650 0
Transportation holders............ ................. 33,666
Ingredient suppliers.............. ................. 272
Direct sales marketers............ ................. 12,400
U.S. outlying islands............. ................. 315
53,147 77,150
------------------------------------------------------------------------
Table 6.--Count of Foreign Manufacturers/Processors Required to Register
From OASIS
------------------------------------------------------------------------
Type of product No. of facilities
------------------------------------------------------------------------
Foods............................................... 110,392
Food additives...................................... 2,979
Color additives..................................... 378
Infant formula...................................... 235
Vitamins............................................ 7,986
Animal feeds........................................ 3,330
Medicated animal foods.............................. 150
125,450
------------------------------------------------------------------------
Table 7.--No. of Affected Facilities
------------------------------------------------------------------------
------------------------------------------------------------------------
Domestic facilities:
CBP............................................. 80,475
Nonemployer statistics.......................... 58,646
[[Page 58939]]
Other sources................................... 77,150
-------------------
Total domestic.................................. 216,271
===================
Foreign facilities:
Foreign manufacturers/processors................ 125,450
Percent that will stop exporting................ 16%
===================
Adjusted number of manufacturers/processors..... 105,378
Foreign packers and holders..................... 100,027
-------------------
Total foreign................................. 205,405
===================
Total......................................... 421,676
------------------------------------------------------------------------
4. Costs
a. Time estimates.
In the PRIA, FDA anticipated that it would take four steps for a
domestic facility to comply with the regulation: (1) The facility
becomes aware of the regulation; (2) the facility learns what the
requirements are; (3) an administrative worker fills out the form; and
(4) the owner, operator, or agent in charge of the facility confirms
the submission is correct. FDA also anticipated that facilities with
Internet access that research and register online will have lower
registration costs than facilities without Internet access. The interim
final rule permits the owner, operator, agent in charge, or an
individual authorized by the owner, operator, or agent in charge to
submit the registration. Although the owner, operator, or agent in
charge is not required to make the actual submission, the owner,
operator, or agent in charge is still legally responsible for the
registration. Therefore, FDA expects that in cases in which the owner,
operator, or agent in charge authorizes an individual to submit the
registration on its behalf, the owner, operator, or agent in charge
will still take time to confirm that the information on the form is
correct before it is submitted to FDA by the authorized individual.
FDA anticipated that foreign facilities would follow the same four
steps to comply with the regulation as domestic facilities: (1) The
facility must become aware of the regulation, (2) the facility learns
the requirements, (3) an administrative worker fills out the form, and
(4) the owner, operator, or agent in charge of the facility or the U.S.
agent authorized by a foreign facility confirms the submission is
correct. In addition, foreign facilities could have fifth and sixth
steps to find and then hire a U.S. agent. To estimate the cost of
registration for foreign facilities, FDA assumed that they would incur
the same per facility costs as domestic facilities, plus additional
costs. Similar to domestic facilities, FDA estimated that facilities
that research and register electronically would incur lower costs than
facilities that do not. Tables 9 through 13 of this document summarize
the costs in the PRIA and the revised costs for the interim final rule.
Similar to domestic facilities, the interim final rule permits the
owner, operator, agent in charge of a foreign facility, or an
individual authorized by the owner, operator, or agent in charge to
submit the registration. While the owner, operator, or agent in charge
is not required to make the actual submission, the owner, operator, or
agent in charge is still legally responsible for the registration.
Therefore, FDA expects that in cases in which the owner, operator, or
agent in charge authorizes an individual to submit the registration on
its behalf, the owner, operator, or agent in charge will still take
time to confirm that the information in the form is correct before it
is submitted to FDA by the authorized individual.
(Comment 173) A number of comments stated that FDA underestimated
the time necessary to comply with the proposed rule. One comment
provided an estimate of 40 hours to read the proposed rule, submit
comments to FDA, implement any final rule internally, and verify
registrations of business partners. With 40 percent of these hours
managerial time and 60 percent administrative time, the approximate
cost was $1,500. The commenter also estimated that additional research
for any final rule would require another 4 hours. Another comment
estimated that the initial registration would take 3 hours, that
managerial expertise would be necessary to gather the information for
the registration, and that it would take a manager more than 15 minutes
to fill out the form.
Another comment stated that a manager or lead counsel would be
responsible for reviewing any final rule and formulating a plan for
implementation. This comment estimated that this process would take 10
hours of a manager's time at a cost of $567.40, in addition to 1 hour
of an administrative assistant's time. This comment also suggested
legal counsel may review the regulation for 5 hours at a total cost of
$1,500. Finally, another comment stated it would take 20 hours of staff
time to read, comprehend, gather the necessary data, and complete the
form. All of the estimates provided in these comments were for
facilities with Internet access and workers fluent in English. Several
of the comments suggested that FDA increase the time estimates for
facilities without Internet access and without staff fluent in English.
(Response) FDA estimated that domestic facilities with Internet
access and fluent in English would need, on average, 2 hours to
research the regulation and complete and certify the form; domestic
facilities without Internet access would need 3 hours. A facility would
require approximately 1 or 2 hours, depending on the availability of
the Internet, to find the requirements and determine if the facility is
required to register, 15 minutes to categorize products and enter them
in the appropriate food product categories, 30 minutes to find the
remaining registration information and enter it onto the form, and 15
minutes for confirming all the registration information is correct.
This estimate is on a per facility, not a per firm, basis. Also, this
estimate is approximate; some facilities may require more or less time.
FDA anticipates and estimated in the PRIA that firms with multiple
facilities will spend 2 hours per facility, if Internet is available,
researching and submitting registration information. The facility, or
the firm on behalf of the facility, is required to enter the
registration data; however, the facility, firm, or an industry or trade
group may research the regulation. Firms with many
[[Page 58940]]
facilities or industry groups representing hundreds or thousands of
facilities submitted all of the comments listed previously.
In the PRIA, a large firm composed of 1,000 facilities would spend
2,000 hours researching and registering all its facilities. Given the
estimates provided by the comments, this estimate is likely an
overestimate. FDA expects that firms composed of many facilities will
have lower per facility registration costs than single-facility firms.
Multifacility firms will learn from their experience gained while
registering their first facility and will be more efficient at
registering additional facilities. Also, the registration system has
built-in features that will allow common information to be transferred
easily from one facility to another within the same firm. FDA was not
able to estimate the reduction in time to register for these
multifacility firms on a per facility basis, and so retains its
original estimates. However, for this reason, FDA's time estimates are
likely overestimates for multifacility firms.
FDA does not anticipate that small facilities will read the Federal
Register. Instead, they will learn of their obligation to register from
trade groups, the press, or FDA outreach efforts, then go to the
registration Web site and using the information provided at the Web
site, including the interactive features of the registration system,
complete and submit their registration. The time estimates included in
the economic analysis represent an average facility time estimate
across small, medium, and large facilities, and thus, for some
individual facilities, the average time estimate will be too high and
for some it will be too low. Therefore, FDA did not alter its estimates
of the time to complete the registration process.
FDA was persuaded by the comments that managerial staff, rather
than administrative staff, would do any necessary research. FDA has re-
estimated the analysis using managerial time for researching and
administrative time for entering the registration data. Several
comments suggested that FDA underestimated the managerial wage, one
giving an alternative wage rate of $75 per hour. In the PRIA, FDA used
the Bureau of Labor Statistics estimate from the National Compensation
Survey (Ref. 16), doubled to include overhead costs. This estimate is
an average across many facilities. The higher wage estimate provided
was from a very large firm with over 1,000 facilities that FDA would
anticipate would have higher wages than most facilities. Therefore FDA
did not change its estimate of the average managerial wage.
FDA did not receive any specific estimates of the additional time
to register for facilities that lack Internet access and staff who do
not speak English. Therefore, because FDA has not increased the base
time for registration and has no new information to increase the
additional time for foreign language translation or mail submissions,
FDA has not increased its estimate of time costs for facilities without
Internet access and staff who do not speak English.
(Comment 174) One comment suggested that FDA ignores the effort
that will be required of large companies to identify all of the
manufacturing and holding facilities covered by the registration
requirement. The comment stated that one large supplier might have as
many as 1,000 facilities that would have to register.
(Response) FDA included in its cost estimate one hour of research
time for each facility to learn about the registration requirements,
including whether it needs to be registered. This time may not be used
by each facility, but by the firm that registers all its facilities.
Multifacility firms are likely to require less time on a per-facility
basis than FDA estimates. For a firm with 1,000 facilities, the PRIA
estimated the firm would spend 1,000 hours to learn about the
registration requirements, which is probably an overestimate of the
time required by the firm, as a large, multifacility firm should learn
from experience and become more efficient at registering additional
facilities.
b. Other costs.
(Comment 175) Many commenters were concerned about potential port
delays arising from FDA's failure to process registrations in a timely
manner, facilities not being aware of the registration requirements
prior to shipping food to the United States, or the receiver of the
shipment not being aware that the foreign facility is not registered.
Commenters mentioned costs associated with port delays including the
lost value of perishable goods, storage costs, and the need for larger
inventories for domestic facilities that receive imports.
(Response) FDA considered qualitatively in the PRIA potential costs
associated with port delays due to foreign facilities not being aware
of the registration requirement until their shipment reaches the port.
This included costs such as lost value of perishables, storage costs,
and transaction costs. Commenters did not provide any quantitative data
about the size of these costs. Therefore, FDA has not changed its
estimate of port delay costs.
(Comment 176) FDA received a number of comments that FDA
underestimated the cost of the proposed rule, because it failed to
include time for facilities to write and submit comments.
(Response) The function of the Regulatory Impact Analysis is to
measure the costs and benefits of the requirements of the rule.
Submitting comments is part of the rulemaking process, not a
requirement of the rule. Therefore, FDA did not include in the PRIA
costs associated with commenting on the proposed rule.
(Comment 177) FDA received comments stating that registration would
require changes in business activities to prevent comingling of product
or coding on product to reflect where it was manufactured/processed,
packed and held.
(Response) FDA disagrees with this comment. The interim final rule
requires all facilities that manufacture/process, pack, or hold food
for consumption in the United States to register with FDA. However, the
interim final rule does not require any additional labeling of food or
restriction of comingling of product.
(Comment 178) FDA received comments that FDA failed to include the
cost to facilities of confirming that trading partners are registered.
(Response) FDA did not explicitly include this cost because
confirming registrations of trading partners is not a requirement of
the interim final rule. However, FDA did include higher costs for
foreign facilities to learn about the interim final rule and comply
with the requirements, and this includes the higher transaction costs
for foreign trading partners. These costs may be borne in part by
domestic facilities that inform foreign facilities of the requirement
to register.
5. Alternative Options
In the PRIA, FDA considered eight different regulatory options. FDA
received many comments that suggested additional options. Suggestions
included accepting multiple submissions on a CD-ROM, deleting the
requirement to include product categories, different requirements for
time allowed to update registrations, different requirements for the
U.S. agent, and using other registration systems to gather information
for the FDA facility database.
a. Accept CD-ROM submissions.
(Comment 179) A number of comments requested that FDA accept
multiple registrations on a single submission, such as a specially
formatted CD-ROM with the registrations for all the facilities of a
[[Page 58941]]
single firm. Comments stated that this would lower the burden of
registration, particularly for firms with many facilities, and would
improve the accuracy of the registrations.
(Response) The interim final rule allows the submission of multiple
registrations on a single CD-ROM. The registrant must use a specially
formatted CD-ROM with a PDF version of the registration form. The
registrant then enters the facilities' registration information on the
CD-ROM and mails the CD-ROM to FDA. FDA will process CD-ROM submission,
along with paper submissions, in the order received. CD-ROM submissions
will be entered electronically into the registration system. This
option will result in additional costs to FDA for processing
submissions and training staff to process the submissions. FDA
estimates it will take an additional 100-150 hours to develop the
automated workflow process for CD-ROM submissions, integrate the
process into the existing process, and include the process in the
testing phases. At a labor cost of $100 per hour, the total cost for
the process control would be approximately $10,000 to $15,000.
Additional training costs for staff processing the CD-ROM submissions
would be about $8,000 to $10,500. These costs are incorporated into the
total FDA cost estimate.
FDA anticipates that this option will lower costs for some large,
multifacility firms. Only firms that can lower their costs by using
this option will do so. However, FDA does not quantitatively estimate
the cost savings.
b. Food product categories.
FDA proposed to require the inclusion of food product categories in
the registration information. Food product categories are necessary for
FDA to communicate directly with subgroups of facilities and to help
verify prior notices from facilities that are subject to both
registration and the prior notice requirements. FDA estimated that
including food product category information in the registration would
increase the time to complete each facility's registration by 15
minutes. Including food product categories in the registration form
also increases the number of updates facilities will have to submit to
FDA.
(Comment 180) FDA received numerous comments stating that including
the food product categories as a registration requirement would add to
the costs of the rule, without providing any benefits. Some comments
stated that the additional 15 minutes for facilities to include food
product categories underestimated the time needed to provide this
information. Also, large facilities may manufacture/process, pack, or
hold thousands of products and determining the food product categories
for all these products would be very difficult.
(Response) In responding to these comments, FDA breaks the comments
into three categories: (1) The time to research the food product
categories for the initial registration, (2) the effect of including
food product categories on the frequency of updates, and (3) the
benefits of including food product categories. FDA addresses the impact
on updates in the section on frequency of updates, and addresses the
last category of comments in the benefits section.
FDA does not agree with the comments that suggested FDA
underestimated the time to include food product categories as a
registration element. For facilities that handle many different types
of food, such as warehouses the registration form includes a ``most/all
human food categories'' to alleviate the burden of providing
information on each specific category of food at the facility. This
will allow facilities that handle a large variety of foods to fill out
the food product category section of the form very quickly. Also, the
electronic registration form includes extensive online help, with
descriptions of the food product categories and a link to the FDA
product code builder, which will interactively categorize foods. This
will simplify identification of the appropriate food product category.
For example, pudding is a product that some may believe may be
relatively difficult to categorize. On the registration form, it may be
unclear to a registrant whether pudding should be characterized as a
bakery product/dough/mix/icing or a gelatin/rennet/pudding mix/pie
filling. The online registration provides a link to the FDA product
code builder, which has a search function. Searching on ``pudding''
gives three possible categories, the two categories already given and
baby food, all with drop down menus. By using the drop down menus, a
list of products in those categories is provided. The registrant can
then find its product in the drop down menu. Moreover, most products,
such as alcoholic drinks, fruits, vegetables, and eggs, can simply be
characterized by reading the food product categories.
As previously mentioned, most facilities are small and do not
produce a large number of products. Therefore, FDA has not altered its
15 minute estimate of the time to fill in the food product categories.
c. Frequency of updates.
The proposed rule would have required registered facilities to
submit updates or cancellations of their registration information
within 30 days of a change in information previously submitted to FDA.
The interim final rule changes this requirement to 60 days. Facilities
that close or transfer ownership are required to cancel their
registrations. New facilities and facilities that change ownership must
register. Based on data from the Small Business Administration (Ref.
17), FDA estimated that 10 percent of facilities will cancel
registrations and 10 percent of facilities have to submit a new
registration each year. FDA also estimated that 20 percent of
facilities would have to update their registrations each year. Updates
and cancellations were estimated to take 1 hour. First-time
registrations in subsequent years were estimated to be as costly as
first-time registrations in the first year.
(Comment 181) FDA received many comments about how often facilities
will have to update their registrations. As noted, FDA estimated 20
percent of facilities would have to update their registrations each
year. Comments provided a number of other estimates of how frequently
updates would be required. Multiple comments estimated that 50 percent
of facilities would have to update their registrations each year. Other
comments did not provide an estimate of how often updates would be
required, but suggested that FDA require annual updates. Others
commented that facilities would have to update registration information
many times a year. Another comment did not provide an alternative
estimate of the frequency of updates, but disagreed with the 20 percent
per year estimate provided by FDA. Various comments suggested that the
most frequently changing components of the registration would be the
name of the emergency contact and, if ``trade name'' were defined
broadly, it would be the most frequently changing registration
information element.
Some comments suggested including food product categories in the
registration would lead to monthly registration updates. Comments
stated that there is constant fluctuation in the nature of products
produced at large facilities, which would require frequent updates. One
comment suggested that one in four large facilities that manufacture/
process food would have to submit updates each month. Comments stated
that the cost of maintaining the food product categories would exceed
the cost of the initial registration.
Comments most frequently suggested that FDA require updates every 6
to 12
[[Page 58942]]
months or annually. However, some comments suggest that to allow update
periods longer than 30 days would reduce the usefulness of the
database.
(Response) As stated in the definitions section of this rule, trade
names mean the terms under which the facility conducts business, or
additional names by which the facility is known. Trade names are terms
associated with the facility, as opposed to brand names, which are
terms associated with products. Therefore, comments that stated that
names associated with products change frequently, which would result in
the need for frequent updates, overestimate the frequency with which
facilities will have to update their registrations because brand names
are not included as an element of registration. FDA has also removed
the requirement that an individual be identified as the emergency
contact, another registration element that commenters mentioned was
likely to change frequently.
FDA does not agree that the cost of updates resulting from changes
in product lines will require facilities to submit monthly updates.
Some types of facilities, such as warehouses or wholesalers, are likely
to select the most/all human food category due to the large variety of
products handled at the facility. Manufacturers/processors are the most
likely facilities to have frequent changes in product lines. However,
the majority of these facilities are small. The 18,259 manufacturers in
the Nonemployer Statistics have only 1 employee, and due to their small
size, should not have frequent changes in product lines. In the CBP
data, 80 percent of the 29,149 manufacturers have fewer than 50
employees. It is unlikely facilities of this size will produce many
different product lines and that these product lines will change
frequently. This leaves a small number, approximately 3,700 large
manufacturers, that may have more frequent changes in product lines.
Also, the product categories included in the registration form include
many individual products; thus, a product line change may not change
the food product category. For example, a facility may change pudding
flavors or the level of fat in the pudding without changing food
product categories.
FDA does agree with the comments that the frequency of updates will
be greater than estimated in the PRIA. FDA has re-estimated the
frequency with which updates will occur for 60-day updates by using the
suggested frequency of updates in the comments for the 30-day update
period. For large manufacturing/processing facilities, FDA has used the
estimate provided by some commenters that one in four facilities would
have to submit an update each month with a 30-day update period. Large
manufacturing/processing facilities would then submit two updates per
year with a 60-day update period, rather than 3 times per year with a
30-day update period. For other facilities, FDA has used the estimate
that 50 percent of facilities would have to update each year (or
facilities would update once every 2 years) with a 30-day update. FDA
assumes that the number of updates will still be once every 2 years
with a 60-day requirement for updates. A weighted average of the two
estimates gives 55 percent of facilities updating each year. FDA has
also applied this estimate for domestic facilities to foreign
facilities.
FDA has also considered an alternative option in which facilities
are required to update their registration within a year of a change.
FDA assumes that for facilities that are not large manufacturers/
processors, updates by 50 percent of facilities per year is equivalent
to one change every 2 years. Under this approach, the frequency of
updates for facilities that are not large manufacturers/processors
would still be 50 percent of facilities each year, but no updates would
occur in the first year. Large manufacturers/processors would have to
update once a year, with no updates the first year. Without
incorporating zero updates in the first year, adopting this option
would give a weighted average of 51 percent of facilities updating each
year. To incorporate the lack of updates for the first year, we
included zero updates for 1 year in 20 years of the registration
system. This lowers the average for percent of facilities submitting
updates each year to 48 percent. See tables 11 and 12 of this document
for cost estimates for these options.
FDA also considers an option in which facilities are not required
to include food product categories in their registrations. FDA
estimates that it would take only 45 minutes to fill out and certify
the registration form and that 50 percent of all facilities would have
changes in their registration information each year.
Comments received in response to the proposed rule assumed that
changes in optional elements would result in updates. In the interim
final rule, FDA does not require a facility to update its registration
when changes occur in optional items. FDA does not have information to
adjust the estimates of frequency of update in response to changes in
optional information. However, FDA does believe that the estimate of
frequency of updates is an overestimate, as it is based on changes in
both optional and required information.
d. U.S. agent.
The Bioterrorism Act and the interim final rule require that all
foreign facilities required to register have a U.S. agent. The interim
final rule requires the U.S. agent to be a person residing or
maintaining a place of business in the United States, whom the owner,
operator, or agent in charge of a foreign facility designates as its
agent. FDA will recognize only one U.S. agent for purposes of
registration per foreign facility. The U.S. agent acts as a
communications link between FDA and the facility and FDA considers
providing information to the U.S. agent the same as providing
information directly to the foreign facility. A U.S. agent may submit a
registration to FDA, if the owner, operator, or agent in charge of the
foreign facility authorizes the U.S. agent (if an individual) to
register on behalf of the owner, operator, or agent in charge of the
facility.
U.S. Agent Assumptions
In the PRIA, FDA assumed, based on preliminary comments, that some
foreign facilities already have a U.S. representative that can function
as a U.S. agent. The U.S. representative may be a business partner,
broker, U.S. lawyer, or parent company. FDA assumes that the likelihood
that a foreign facility has an existing U.S. agent is related directly
to the quantity of product the foreign facility exports to the United
States.
FDA used data from OASIS on the average number of line entries and
the average number of manufacturers by country and product code to
estimate the number of line entries for foreign manufacturers (Ref. 2).
A shortcoming of these data is that entries are by product code, thus,
manufacturers that are exporting products in more than one product code
are in the count of manufacturers for every product code in which they
export. The OASIS data consequently have approximately twice as many
manufacturers as actually exist. To adjust for this double-counting,
FDA assumed the average foreign manufacturer exports in two product
categories. To find an approximate number of line entries per
manufacturer, FDA divided the total number of manufacturers into the
total number of line entries for each country and applied the average
number of line entries per manufacturer to all the manufacturers from
that country. This method will underestimate the number of very small
and very large
[[Page 58943]]
manufacturers, because it removes the variation in number of line
entries exported from countries with a large number of manufacturers
exporting to the United States.
To estimate the number of foreign facilities that would have to
hire a U.S. agent, FDA assumed that foreign facilities that export more
than 80 line entries each year into the United States, or 10 percent of
foreign manufacturers, already have a U.S. representative who can
function as a U.S. agent. FDA acknowledges that this is an uncertain
estimate; the true number of facilities that have an existing business
representative that would be willing to serve as their U.S. agent may
be much higher. FDA will test the impact of overall U.S. agent costs
under different assumptions.
For foreign facilities that do not have an existing business
representative willing to act as their U.S. agent for little or no
extra cost to the U.S. agent or facility, FDA estimated it would take
between 5 and 15 hours to hire a U.S. agent, depending on whether the
facility had Internet access and its personnel were fluent in English.
Additionally, FDA estimated an annual U.S. agent fee of $1,000 per
year, based on estimates of agent fees provided by U.S. agents for
other FDA-regulated products. This estimate of the U.S. agent fee
contemplates that the U.S. agent will register the foreign facility. If
the foreign facility chooses to register on its own behalf, the U.S.
agent fee may be lower; however, the facility itself will have higher
costs associated with registering. These costs include time to enter
the registration information, translate the registration information if
the facility is not fluent in English, and additional time for mailing
a postal registration if the facility does not have Internet access.
FDA acknowledges that these assumptions are uncertain. Accordingly,
as explained more fully in the following paragraphs, FDA provides
alternative assumptions regarding U.S. agent fees, based on U.S. agents
currently proffering their services as U.S. agents for the purposes of
the Bioterrorism Act. In general, current prices for other U.S. agent
activities (such as serving as a U.S. agent for drug or device foreign
establishments) and published prices for an emerging market may not be
precise predictors of the actual prices charged for this service.
FDA also assumed that the 16 percent of manufacturers that are
exporting 10 or fewer line entries to the United States would stop
exporting to the United States, rather than incur the expense of
registering, hiring a U.S. agent, and providing prior notice under 21
CFR part 1, subpart I. FDA includes the effect of prior notice on
foreign facilities ceasing trade with the United States, because both
will represent an increase in the cost of importing to the United
States. FDA is unable to separate the effects on foreign facilities
ceasing to export to the United States and so considers them both here.
These estimates are also uncertain as the value of and the return on
food shipments are variable and the cost for an individual food
facility to comply with the Bioterrorism Act regulations is uncertain.
Some facilities may ship very few shipments to the United States each
year, but may earn a very high return; these facilities will likely
continue to export to the United States. Conversely, some facilities
may ship many, low value, low return shipments to the United States and
may stop exporting to the United States as a result of the regulations
under the Bioterrorism Act. Foreign facilities may also have existing
business relationships with facilities in the United States. If a
domestic facility is willing to absorb the cost of registering and
providing U.S. agent services to a foreign facility, the facility may
continue to export to the United States. In the proposed rule, FDA
requested comments on these assumptions. No comments provided
quantitative estimates of the number of facilities that would stop
exporting or that already have U.S. agents. These estimates are
uncertain, as the value of and the return on food shipments are
variable and the cost for an individual facility to comply with the
Bioterrorism Act regulations is uncertain. Some facilities may ship
very few shipments to the United States each year, but may earn a very
high return; these facilities will likely continue to export to the
United States. Conversely, some facilities may ship many, low value,
low return shipments to the United States and stop exporting to the
United States as a result of the regulations under the Bioterrorism
Act. In the proposed rule, FDA requested comments on these assumptions.
No comments provided quantitative estimates of the number of facilities
that would stop exporting or that already have U.S. agents. Table 8
presents average numbers of line entries and the percent of foreign
manufacturers that export that number.
If 16 percent of foreign manufacturers/processors do choose to
cease exporting to the United States, the total effect on trade will be
much smaller than 16 percent. The facilities projected to cease
exporting to the United States represent a small fraction of total
trade. The 16 percent of facilities represents approximately 20,000
facilities exporting between 1 and 10 line entries to the United States
each year. If, on average, each would have exported 5 line entries, the
total number of line entries affected would be approximately 100,000,
which is less than 2 percent of all lines.
BILLING CODE 4160-01-P
[[Page 58944]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.053
BILLING CODE 4160-01-C
(Comment 182) FDA received many comments on requiring U.S. agents
for foreign facilities required to register with FDA. Comments centered
around five issues: (1) The role of the U.S. agent, (2) the cost of a
U.S. agent, (3) facilities choosing to cease exporting to the United
States, (4) alternatives suggested to the proposed U.S. agent
requirements, and (5) the benefits of requiring a U.S. agent. The
benefits of a U.S. agent are addressed in the benefits section VI.C of
this document; the remaining comments are summarized and responded to
in the following paragraphs.
Many comments were unclear about the role of the U.S. agent. A
common misperception was that the U.S. agent must be the importer or
broker the facility works with and that the facility would not be able
to import through other brokers. Another common misperception was that
the U.S. agent was required to have information about all the food
products the facility exports to the United States.
(Response) FDA believes that many foreign entities did not
correctly understand the role of the U.S. agent and how narrow are the
U.S. agent's responsibilities. The U.S. agent may be an importer or
broker if the facility chooses; however, the only requirement for a
U.S. agent in the proposed and interim final rule is that the U.S.
agent reside or maintain a place of business in the United States. In
this rulemaking, FDA does not place any new restrictions on foreign
facilities using import brokers, which may have been the source of some
of the confusion regarding the true impact of the agent requirement.
The U.S. agent is also not expected to have information about all the
shipments a facility sends to the United States. The U.S. agent's
responsibility is to be able to contact the facility and pass on
information from FDA in both emergencies and routine operations. A U.S.
agent may also register with FDA on behalf of the facility, if the
facility so chooses. The U.S. agent is considered to be the facility's
emergency contact, unless the facility designates an alternative
contact in accordance with Sec. 1.233(e). Therefore, FDA does not
include any costs due to changes in business practices, such as using a
single broker.
(Comment 183) FDA also received comments about costs of the U.S.
agent. One comment states that the costs of requiring a U.S. agent were
underestimated by a factor of 5 to 10. However, this comment provides
no basis for this cost estimate. Many comments also state that most
facilities do not already have a U.S. agent and would incur costs to
procure a U.S. agent. Finally, some comments state that FDA should
include the cost of a legal agreement between the foreign facility and
the U.S. agent.
[[Page 58945]]
(Response) FDA does not require a legal agreement between the U.S.
agent and the foreign facility, but the estimated total cost for
foreign facilities does include the costs of finding and hiring a U.S.
agent.
FDA agrees that many facilities do not already have a U.S. agent.
In the PRIA, FDA estimated that more than 90 percent of foreign
facilities do not currently have a U.S. agent. Again, if more than 10
percent of foreign food facilities already have a relationship to a
domestic entity that could serve as an equivalent to the role of the
U.S. agent as required in this interim final rule, the impact of this
rulemaking would be lower. FDA tests the sensitivity of this estimate
in the following paragraphs.
In the PRIA, FDA estimated that foreign facilities currently
without a U.S. agent would require 5 to15 hours to find an agent and
would pay an annual fee of $1,000. FDA's estimate of the U.S. agent fee
was based on the fees charged by U.S. agents for other FDA regulated
products with similar responsibilities to those required in the
proposed rule. Therefore, given the foundation for the fees cited in
the PRIA and the lack of evidence for higher fees, FDA does not
increase its estimate of the U.S. agent fee.
No comments suggested that FDA overestimated the fee that would be
charged by a U.S. agent. The $1,000 fee estimated in the proposed rule
was an estimate of an average fee for a U.S. agent under other FDA
regulations, based on fees quoted over the phone and Internet
advertisements. However, since publication of the proposed rule, a
number of companies have begun Internet advertising of their services
as a U.S. agent for foreign food facilities that are required to
register with FDA. These companies specify a range of costs, some with
discounts for multiple facilities under the same ownership or fees that
are a function of the number of shipments each year or additional fees
for registration updates. Based on the requirements in the proposed
rule, the lowest fee quoted was $399 for representation by a U.S. agent
for 1 year; other U.S. agents charged initial fees between $599 and
$1,400 (Ref. 18). Many of the U.S. agents intend to charge fees for
additional registration-related services, such as registration updates
or cancellations. Based on these new estimates of fees, FDA believes
that $1,000 still represents a reasonable estimate of a U.S. agent fee.
Ultimately, the fee that a foreign facility will pay to hire and retain
a U.S. agent will be a function of several factors; whether the
facility has Internet access, whether its employees are fluent in
English, whether it has existing relationships with potential U.S.
agents, and individual facility preferences.
Sensitivity Analyses
Many facilities will choose lower-priced U.S. agents; therefore,
FDA presents an estimate of the cost of the rule with a U.S. agent fee
of $700. In this situation, the total first year cost for foreign
facilities would be $247.6 million and annual costs would be $164.5
million. In addition, the assumed number of entities that would no
longer export to the United States would fall under this scenario; if
U.S. agent costs are lower, it would continue to make economic sense
for a larger number of foreign facilities to continue importing into
the United States. FDA does not provide an estimate of the decrease in
the number of facilities that will cease exporting to the United
States.
FDA also considers a higher U.S. agent cost of $1,200. This
represents the higher range of Internet estimates; however, fees
offered by facilities over the Internet may not represent the full
range of U.S. agent fees. Also, foreign facilities that do not have
Internet access or are not fluent in the languages commonly used in
trade may face higher fees. This gives a first year cost of $345.0
million and annual costs of $271.7 million.
As discussed previously, the assumption that 10 percent of foreign
facilities have an existing relationship that is equivalent to a U.S.
agent is uncertain. FDA considers as an alternative assumption that
those facilities that export 40 or more line entries per year, or 26
percent of facilities, already have a business partner in the United
States that serves the function of a U.S. agent and the foreign
facility will only incur the costs of registering. This lowers that
cost to foreign facilities to $283.9 million in the first year and
$209.7 in future years.
Alternatively, FDA considers that only facilities that export more
than 120 line entries per year, or 8 percent of facilities have a U.S.
business partner that will fulfill role of the U.S. agent. This will
increase the cost to foreign facilities to $308.8 million in the first
year and $231.2 million, annually.
Given the uncertainty surrounding the percent of facilities that
will stop exporting to the United States, FDA also considers two
alternative options. Eight percent stop exporting and 24 percent stop
exporting. If eight percent of foreign facilities that ship very small
numbers of line entries to the United States each year stop exporting
to the United States, then the quantified cost of the interim final
rule will increase to $320.4 million per year and $239.4 million in
subsequent years. However, this estimate does not account for a
decrease in the nonquantified costs. Foreign facilities that stop
exporting to the United States due to the Bioterrorism Act regulations
will earn lower returns on their product because they will shift to a
market with a lower return. Additionally, domestic facilities that
receive product from these facilities will not incur costs to find new
suppliers. Alternatively, if facilities that ship 20 or fewer line
entries per year to the United States, or 24 percent of facilities,
stop exporting, the quantified costs will decrease to $291.7 million in
the first year and $218.2 million in subsequent years. However, the
increase in nonquantified costs will offset these cost savings.
FDA considers the total cost for foreign facilities under the
combination of lowest and highest cost alternatives. The lowest cost
combination gives a total cost of $220.5 million for the first year and
$144.6 million in subsequent years. The highest cost combination gives
a total cost of $364.6 million in the first year and $267.4 million
annually.
Distribution of Costs
FDA has chosen to use the facility as its unit of analysis for two
reasons: (1) The Bioterrorism Act requires registration on a facility
basis, and (2) most information available to FDA is at the facility
level. For these reasons, costs are reported as average per facility
costs and total costs for facilities. However, FDA expects that all of
the costs will not be borne by the facilities. Economic theory shows
that, in the case of new costs, a portion of the costs will be borne by
the producer and a portion by the consumer. In this case, the costs may
be spread among the foreign facility, importers, exporters, domestic
food producers and distributors, and consumers. However the costs are
distributed, the total social cost of the rule will be unchanged.
Although the distribution of these costs is uncertain, the total cost
of submitting a facility's registration and U.S. agent services are
both costs of the requirements of this interim final rule for foreign
facilities. FDA requests comments on the distribution of costs between
submitting registrations and other services offered by the U.S. agent
and comments on the overall cost of hiring and retaining a U.S. agent
and the assumptions underlying FDA's estimates of these costs.
[[Page 58946]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.054
(Comment 184) Several comments predict that some foreign facilities
would cease exporting to the United States due to the cost of procuring
a U.S. agent. Comments mention this as a cost to both foreign
facilities and domestic facilities. For foreign facilities that ship
small quantities to the United States, some comments assert that the
cost of a U.S. agent could exceed the profits from shipping to the
United States. For these facilities, it would make economic sense to
stop exporting to the United States. Other comments assert that some
domestic facilities, particularly small businesses, might lose
important suppliers. These comments state that the loss of foreign
suppliers could have a significant negative impact on their businesses.
FDA also received comments on the effect of requiring a U.S. agent on
domestic small businesses.
(Response) FDA agrees that some foreign facilities may choose to
stop exporting to the United States because the cost of registering and
procuring a U.S. agent will exceed the benefits to the facility of
exporting food to the United States. As mentioned previously, the
number of foreign facilities that will choose to stop exporting to the
United States is uncertain, as it will depend on the cost of
registration for the individual facility and the return on the shipment
in the United States versus its return in other markets. No comments
provided any quantitative estimates of the number of facilities that
would stop exporting to the United States. These costs were included
qualitatively in the PRIA. The effect of requiring a U.S. agent on
domestic small businesses will be considered in the Regulatory
Flexibility Analysis.
(Comment 185) Several alternatives to the proposed requirement for
a U.S. agent are suggested by commenters, including making the U.S.
agent requirement optional, requiring a U.S. agent only if the facility
does not have an e-mail contact, and requiring that the U.S. agent
reside or maintain a place of business in North America.
(Response) FDA is constrained by the Bioterrorism Act, which
requires all foreign facilities subject to this rule to have a U.S.
agent. Also, FDA believes that the statute requires that the U.S. agent
reside or maintain a place of business in the U.S. proper, not North
America generally. Therefore, choosing not to require a U.S. agent or
having the person reside or maintain a place of business outside the
United States is not consistent with congressional intent. However,
while not a legally available option, FDA does provide an estimate of
the cost for an option in which a U.S. agent is not required.
e. Duplicate requirements with other licensing or registering
authorities.
(Comment 186) FDA received many comments that the registration
requirement duplicates other registration requirements for FDA, other
U.S. government agencies, other governments, and State and local
authorities. These comments suggest that FDA obtain the registration
information from these other authorities rather than require an
additional registration. Specific registration requirements mentioned
by commenters included FDA low acid canned foods, FDA feed
manufacturers, FDA seafood Hazard Analysis and Critical Control Point
importers, TTB, EPA, USDA, Australia, Iceland, New Zealand, Chile,
California, and FIRMS.
(Response) FDA has determined that it is most cost-effective for
FDA to require registration by all affected facilities under this rule.
Using data from other registration systems would be cost-effective, if
FDA could collect the data from other systems at a total lower cost, to
both facilities and FDA, than original collection of the data. For FDA
to use another regulatory agency's registration system, FDA needs to:
(1) Be able to get the data from the other agency; (2) capture all of
the required information; (3) avoid duplicate registrations; (4) verify
that the data are correct; (5) update the registration in a timely
manner; and (6) issue a new registration number and confirmation to the
registered facility.
Using other registration systems would likely increase costs for
FDA to get the data from the other system. This would require
interagency cooperation and compatibility of IT systems by the
statutory deadline of December 12, 2003. In addition to creating the
existing IT system, FDA would have to develop the ability to accept
large transfers of data from other systems. Additionally, accepting
data from other registration systems will require facilities to provide
any data elements not included in those registration systems to FDA
separately, which will also result in higher costs for FDA.
Using other registration systems would not lower the cost of
registration for covered facilities. Even if another registration
system is used, facilities will still incur research costs to learn
about the registration requirements to determine whether they need to
register or if they had already fulfilled the requirements, so research
costs for facilities will be unchanged under both
[[Page 58947]]
systems. Costs for submitting the data will be different if other
registration systems are used. For the costs of accepting duplicate
registrations to be lower for facilities, the alternate registration
system must include all the data elements required by the FDA
registration. The system that initially seemed most likely to match
FDA's requirements and most frequently mentioned in comments involved
the permit requirements applicable to the alcohol beverage industry
under laws enforced by TTB. FDA met with TTB to determine whether it
was feasible to use TTB's basic permit system. FDA and TTB determined
that TTB's regulations do not apply to all facilities required to
register under this interim final rule. For example, the laws
administered by TTB do not require foreign alcohol beverage producers
to obtain permits, unless they are also engaged in the business of
importing alcohol beverages into the U.S. FDA and TTB also determined
that several of the required data elements for FDA registration are not
mandatory information for alcohol beverage permittees, including some
of the emergency contact information required by this interim final
rule. Accordingly, even facilities with TTB permits would still have to
file immediately a registration update with FDA to provide missing data
elements. FDA concluded that accepting registrations in alternative
registration systems would not lower costs for facilities. If accepting
registrations does not lower costs for FDA or for facilities, it is not
a cost-effective alternative.
FDA assumes that if original data collection is not cost-effective
for domestic facilities, it will be less cost-effective for foreign
facilities, because foreign facilities will still have to obtain a U.S.
agent and submit to FDA the information for their U.S. agent.
f. FDA costs.
FDA costs include creating and maintaining a database, processing
paper submissions, and sending an annual mailing to registrants.
Developing and maintaining a database includes automatically entering
registrations into the database that arrive electronically and sending
an electronic receipt and facility registration number back to the
registrant. FDA estimates that four full-time equivalent employees
(FTEs) will be needed to oversee the database. Additionally, paper
submissions (i.e. those received by mail, fax, or on CD-ROM) will have
to be entered manually. Costs are presented for the first 5 years of
the system in table 9 of this document. Annual costs are discounted at
7 and 3 percent. No comments were received on FDA's cost estimates in
the PRIA. However, cost numbers were revised based on new information
obtained by FDA.
Tables 10 through 12 provide details of the components of total
costs for FDA, domestic facilities, and foreign facilities. For tables
11 and 12, FDA provides the estimate of the costs from the PRIA, and
from 4 options; the interim final rule, the interim final rule with
longer updates, the interim final rule without product categories, and
the interim final rule with no U.S. agent requirement. Details of the
costs that have not changed in response to comments may be found in the
proposed rule. Tables 13 and 14 summarize the total costs over the
first four years and provide a present value for a 20 year horizon for
a 7 percent and 3 percent discount rate, respectively. FDA acknowledges
uncertainty in these estimates; please see the proposed rule for a
fuller discussion of all sources of uncertainty, and the discussion and
sensitivity analysis under comment 192 regarding the uncertainty of the
U.S. agent estimate.
BILLING CODE 4160-01-P
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[[Page 58948]]
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[[Page 58949]]
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[[Page 58950]]
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[[Page 58951]]
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6. Benefits
In the PRIA, FDA asserted that requiring registration of
manufacturers/processors, packers, and holders of food would aid in
deterring and limiting the effects of foodborne outbreaks in four ways.
One, by requiring registration, persons who might intentionally
contaminate the food supply would be deterred from entering the food
production chain. Two, if FDA is aware of a specific food threat, a
registration database would make FDA better able to inform the
facilities potentially affected by the threat. Three, FDA would be able
to deploy more efficiently its domestic compliance and regulatory
resources. Four, FDA inspectors, using prior notice and registration,
would be better able to identify shipments for inspection.
Registering with FDA creates a paper trail, which would, even if
the information in the registration were falsified, provide evidence
that could link the registration to the false registrant. Persons who
might attempt to intentionally contaminate the U.S. food supply would
be deterred, by the creation of additional evidence that might be used
against them, from starting a business in the food supply chain.
Persons who might intentionally contaminate the food supply but refuse
to register would be subject to criminal and civil sanctions and, if
foreign, would risk having their product held at
[[Page 58952]]
a U.S. port. With emergency contact information and product categories,
FDA can quickly call or e-mail the emergency contact at both domestic
and foreign facilities that may be targeted by a specific food threat.
If FDA suspects a particular product is at risk, we can quickly
identify which facilities to contact. This quick communication will
allow facilities to respond quickly to a threat and possibly limit the
effect of a deliberate strike on the food supply, as well as public
health emergencies due to accidental contamination of food. In the
past, FDA field personnel (Ref. 19) have had difficulty notifying
facilities of recalls and other enforcement actions due to incomplete
information in existing agency records. In the past, for foreign
facilities, FDA has attempted to disseminate recall information through
foreign embassies. Contacting foreign facilities through their U.S.
agent (or their designated emergency contact) will be more efficient
and increase the probability that the facility will receive the
information in a timely fashion and act on it.
A complete list of facilities in the food supply chain will also
aid FDA in scheduling inspections and undertaking compliance
activities. FDA currently uses an OEI that we developed by obtaining
lists from State governments and adding firms to the OEI through
surveillance activities, such as reviewing phone books. The OEI is
incomplete and frequently out of date (Ref. 20). FDA has even less
information about foreign facilities that manufacture/process, pack, or
hold food for consumption in the United States. A complete list of
domestic facilities with correct contact information and food product
categories would aid inspectors in contacting facilities, and with
product information available, would help the agency to identify
facilities for inspections. Because of the turnover in the food
industry and the ratio of inspectors to food facilities, FDA never has
had a complete list of foreign or domestic facilities that provide food
for consumption in the United States. Also, a complete list of
facilities will aid FDA in understanding which facilities will be
affected by a future regulation, which will increase the agency's
effectiveness in targeting communication and outreach to these
facilities.
In conjunction with the prior notice requirements in part 1,
subpart I, this rule will make it possible for FDA to better identify
imported food shipments that require inspection prior to admission. The
registration will confirm the identity of the country of production,
which may not be the same as the country from which the product has
been shipped. This information will assist FDA in identifying specific
shipments to inspect, if, for example, we have information that a
particular type of food or shipments from a particular country may be
adulterated. Additionally, the database of registrants and products
also will aid FDA in verifying that a product is correctly identified
by where and by whom it was produced. For example, if the registration
information identifies a facility as producing only dairy products and
FDA receives a prior notice purportedly from the facility for a
shipment identified as nuts, FDA can decide whether to target that
shipment for verification based on the discrepancy.
FDA has conducted its own evaluation of the vulnerability of the
U.S. food supply and has also commissioned two threat assessments, one
through the Batelle Memorial Institute and a second through the
Institute of Food Technologists. These assessments determined the most
serious risks of intentional contamination during various stages of
food production and distribution. The results of these assessments are
classified. We have also received intelligence information regarding
threats to the food supply that are guiding our food security efforts.
However, to understand possible costs of an intentional strike on the
U.S. food supply, FDA presents in table 15 outbreaks resulting from
accidental and deliberate contamination, involving both domestic and
imported foods. These outbreaks do not represent all possible forms
that a terrorist attack might take, but merely illustrate the public
health costs of foodborne emergencies. It is likely that an intentional
attack on the food supply that sought to disrupt the food supply and
sicken many U.S. citizens would be more costly. However, the
probability of an attack occurring and the exact reduction in risk
resulting from registration is unknown.
[[Page 58953]]
[GRAPHIC] [TIFF OMITTED] TR10OC03.061
BILLING CODE 4160-01-C
a. Food-contact substances.
(Comment 187) Some comments stated that there would be no benefits
to requiring the registration of articles that contact food and their
components. Commenters noted that none of the foodborne outbreaks
included in the benefits section resulted from articles that contact
food. However, other comments noted the potential for articles that
contact food to leach into and contaminate food and concluded that it
was necessary to require the registration of articles that contact
food.
(Response) FDA has revised the interim final rule to exclude
facilities that manufacture/process, pack, or hold food-contact
substances, as defined in section 409(h)(6) of the FD&C Act.
Accordingly, FDA does not need to address these comments, because these
facilities are not subject to the interim final rule.
b. Food product categories.
(Comment 188) Many comments claim that, for several reasons,
including food product categories would have no benefits: One,
facilities would be unable to categorize their products correctly; two,
FDA would fail to communicate with facilities that use as ingredients
potentially affected foods; and three, the food product categories do
not make useful distinctions between categories. Comments claimed that
these limitations would make food product code categories useless and
even have a negative impact on FDA's ability to communicate with
facilities by diverting resources that could be better used elsewhere.
(Response) FDA disagrees with these comments. Consultations with
FDA field personnel identify food product categories as an essential
part of registration. FDA field personnel state that they would use
food product category information to identify facilities potentially
affected by a particular emergency, such as a terrorist threat or class
1 recall and for planning inspections. For example, needing to contact
only 200 facilities with information about a threat instead of 20,000
will enhance FDA's speed and the reliability of the message. FDA
believes that facilities can correctly categorize their products, and
FDA will provide interactive help menus as part of the electronic
registration system to aid facilities in correctly identifying the
appropriate food product categories for their products. Also, FDA will
provide a link to the agency's product code builder, which will allow
facilities to search for their particular products.
FDA staff have experience using food product categories in their
current enforcement activities and have found them to make useful
distinctions between foods. FDA is also aware that some products may be
ingredients in other food products and will use that information in
selecting which facilities
[[Page 58954]]
to inform of a threat. While FDA recognizes that in some instances and
depending on the nature of the threat, it may not be able to target
only certain facilities with which to communicate (e.g., a threat
against a food product used as an ingredient in many finished
products), this does not mean that having product category information
would not help FDA focus its resources in other situations (e.g., a
threat specifically against soft drink beverage facilities).
(Comment 189) Some comments stated that including food product
categories was necessary for the registration system to have any
utility.
(Response) FDA agrees with these comments and has chosen to include
product categories as a required element in the registration.
c. U.S. agent.
(Comment 190) Many comments state that requiring a U.S. agent would
generate no benefits and might even inhibit communications between the
facility and FDA. Comments offer alternatives such as not requiring the
U.S. agent to reside or maintain a place of business in the United
States, exempting facilities that provide an e-mail address from the
U.S. agent requirement, and making the U.S. agent optional.
(Response) FDA does not agree that a U.S. agent will inhibit
communications with FDA. The facility may opt to register with FDA
directly and have FDA communicate directly with the facility in case of
an emergency. Therefore, requiring a U.S. agent will not lower the
expected benefits, as FDA still would have a contact in the United
States for each facility with which the agency can communicate on
routine matters (e.g. issuance of new regulations or guidance
applicable to the facility). For some facilities that lack the ability
to communicate easily with the United States, due, for example, to
language barriers or lack of telephone or Internet access, the U.S.
agent will be an important link for both registering the facility, if
the owner, operator, or agent in charge authorizes the U.S. agent (if
an individual) to register the facility, and communicating with FDA.
For a facility that prefers to register and communicate with FDA
itself, the U.S. agent still provides additional benefits, such as of
being in the same, or nearby, time zone.
d. Frequency of updates.
(Comment 191) Many comments request that FDA require less frequent
updates of registration information on the basis of high costs to
update registration, without generating offsetting benefits.
(Response) FDA has lengthened the update period to 60 days, but has
not extended it to the 6 to 12 months requested in many comments. The
usefulness of the registration database depends in large part on its
accuracy. Allowing longer times for updates will considerably reduce
the accuracy of the database, while, as shown in the analysis of costs,
will not significantly lower the costs. For most facilities, there will
be little difference in costs for updates for 60 days versus annually.
The largest costs will be to large manufacturers/processors, which are
estimated to update twice a year, at a cost of approximately 2 hours of
labor. However, allowing yearly updates would mean that more than 50
percent of the registrations in the database would contain incorrect
information at any given point in time, versus less than 10 percent
with 60 day updates. Although, FDA is unable to quantify the benefit of
a more accurate database, the functionality of the database will be
substantially better with a smaller percentage of registrations
containing inaccurate information.
Additionally, when foreign food facilities attempt to import their
product into the United States, their prior notice will be checked
against the registration database. If there are discrepancies between
the registration database and information in the prior notice, the
shipment will be flagged for followup by FDA personnel, as deemed
appropriate. Discrepancies confirmed by FDA border inspections may
cause FDA or CBP to examine the shipment.
[GRAPHIC] [TIFF OMITTED] TR10OC03.062
V. Interim Final Regulatory Flexibility Analysis
FDA has examined the economic implications of this interim final
rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612).
If a rule has a significant economic impact on a substantial number of
small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would lessen the economic effect of the
rule on small entities. FDA has concluded that this interim final rule
would have a significant economic impact on a substantial number of
small entities. The following analysis, together with other relevant
sections of this document, serves as the agency's final regulatory
flexibility analysis under the Regulatory Flexibility Act.
(Comment 192) Several comments state that FDA underestimated the
impact of the registration on small entities. Small domestic facilities
may be adversely affected if their foreign trading partners stop
exporting to the United States and small entities may incur higher
costs than estimated in the
[[Page 58955]]
PRIA. Particularly, small facilities that operate in small niche
markets may incur large expenses finding new suppliers.
(Response) FDA did not include in the Preliminary Regulatory
Flexibility Analysis the cost of small entities losing foreign
suppliers. FDA has estimated that 16 percent of foreign facilities may
stop exporting to the United States to avoid the registration
requirements. FDA estimates that the impact of registration on the
number of line entries submitted for import into the United States will
be less than 2 percent of all food entries. This may result in a
significant impact on a substantial number of small entities. However,
FDA is not able to predict how many small entities will be adversely
affected or the size of the impact, and none of the comments provided a
basis from which to estimate this impact.
Of the 216,271 domestic entities covered under the interim final
rule, 99 percent are small according to the Small Business
Administration's (SBA's) regulations. The expected burden for small
entities is low, between $90 and $147. For some small facilities,
however, costs may be much higher than the expected burden. As stated
previously, there is a potential for large transaction costs associated
with finding new trading partners. Also, some small facilities may
experience unusual difficulties in registering, such as difficulty
understanding the requirements, difficulty finding the registration
form or website, or confusion over whether they are required to
register. With such a large number of facilities affected, if a
meaningful percentage of small entities experience a much larger
burden, a substantial number of small entities will experience a
significant economic effect. A discussion of options considered for
small entities was included in the proposed rule. Additional options
are also considered in the final regulatory impact analysis, which may
also be considered an analysis of options for small businesses because
the vast majority of affected entities are small.
VI. Unfunded Mandates
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires cost-benefit and other analyses before any rulemaking if
the rule would include a ``Federal mandate that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' The current inflation-adjusted
statutory threshold is $113 million. FDA has determined that this
interim final rule does not constitute a significant rule under the
Unfunded Mandates Reform Act.
VII. Small Business Regulatory Enforcement Fairness Act (SBREFA) Major
Rule
The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of Congressional
review as having caused or being likely to cause one or more of the
following: An annual effect on the economy of $100 million; a major
increase in costs or prices; significant adverse effects on
competition, employment, productivity, or innovation; or significant
adverse effects on the ability of U.S.-based enterprises to compete
with foreign-based enterprises in domestic or export markets. In
accordance with the SBREFA, the Office of Management and Budget (OMB)
has determined that this interim final rule is a major rule for the
purpose of Congressional review.
VIII. Paperwork Reduction Act of 1995
This interim final rule contains information collection
requirements that are subject to review by OMB under the Paperwork
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
provisions are shown later with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
Title: Registration of Food Facilities.
Description: The Bioterrorism Act contains a provision requiring
the Secretary to issue a regulation requiring that domestic and foreign
facilities that manufacture/process, pack, or hold food intended for
consumption in the United States register with FDA by December 12,
2003. Under the Bioterrorism Act, a foreign facility is one that
manufactures/processes, packs, or holds food for consumption in the
United States without further processing or packaging outside the
United States. Information FDA requires on the registration form
includes the name and full address of the facility; emergency contact
information; all trade names the facility uses; applicable food product
categories identified in Sec. 170.3, unless ``most/all'' human food
categories ``or none of the above mandatory categories'' is checked;
and a certification statement that includes the name of the individual
authorized to submit the registration form. Additionally, under the
interim final rule, facilities would be encouraged to submit their
preferred mailing address; type of activity conducted at the facility;
food categories not included under Sec. 170.3, but which are helpful
to FDA for responding to an incident; type of storage, if the facility
is primarily a holding facility; and approximate dates of operation if
the facility's business is seasonal. Under the interim final rule,
facilities would also be required to submit timely updates within 60
days of a change to any required information on their registration
form, and are required to cancel their registration when the facility
ceases to operate or is sold to new owners or ceases to manufacture/
process, pack, or hold food for consumption in the United States.
Description of Respondents: Domestic facilities that manufacture/
process, pack, or hold food for consumption in the United States are
required to register. Foreign facilities are required to register if
they manufacture/process food for consumption in the United States that
is not further processed or packaged before being shipped to the United
States or if they pack or hold such food. A food is not considered to
have been further processed solely because labeling was added or other
de minimis activity was performed with respect to the food.
Table 17.--No. of Respondents
------------------------------------------------------------------------
------------------------------------------------------------------------
Domestic facilities......................................... 216,271
Foreign facilities.......................................... 205,405
----------
Total..................................................... 421,676
------------------------------------------------------------------------
Burden: In the PRA analysis of the proposed rule, FDA estimated
that it would take an administrative worker with Internet access 1 hour
to read and understand the registration requirements; this time was
doubled to 2 hours of an administrative worker's time for those
facilities without Internet access. In response to comments, FDA has
revised this estimate to 1 or 2 hours of a manager's time to read and
understand the regulations. Foreign facilities' workers would need 1
hour to read and understand the registration requirements, if they have
access to the Internet and can read and write in English. An additional
5 hours would be needed if they do not have Internet access, and an
additional 5 hours would be needed if they do not read or understand
English. In subsequent years, facilities that enter the industry would
have to register, facilities that close would have to notify FDA of
their closure, and facilities that have changes in their registration
information would
[[Page 58956]]
have to provide updates to FDA. FDA estimated that annually 10 percent
of covered facilities would close, 10 percent would open (SBA Small
Businesses by the Numbers), and 20 percent of registered facilities
would have changes to their registration information.
Next, FDA estimates that filling out a registration form would take
a total of 1 hour: 45 minutes of an administrative worker's time and 15
minutes of an owner, operator, or agent in charge's time to verify that
the registration information is correct before submitting the form to
FDA. Foreign facilities' workers would need 1 hour to fill out the
form, if they have access to the Internet and can read and write in
English. An additional 1 hour would be needed if they do not have
Internet access and an additional 1 hour would be needed if they do not
read or understand English. Table 18 of this document shows the burden
by domestic and foreign facilities, availability of the Internet, and
fluency in English. FDA has information on the percentages of foreign
facilities without Internet access and without employees fluent in
English, but no information on the percentages of facilities with a
particular combination of these characteristics. To compute the burden
hours, for ease of computation and reporting, FDA assigned to zero
facilities the condition of Internet access and no employees fluent in
English and used the percentages of facilities without Internet access
and with no employees fluent in English to report numbers of facilities
with Internet and English-speaking employees, without Internet and
without English-speaking employees, and without Internet and with
English-speaking employees. FDA believes that facilities will only use
the CD-ROM option, if it will require the same, or fewer hours, than
another option.
In the following years, new facilities will have to register with
FDA. These new facilities will bear the same burden to register that
facilities incurred in the first year. Based on estimates by SBA that
10 percent of all businesses are new (SBA, Small Business by the
Numbers), FDA estimates that the number of new facilities each year
will be equal to 10 percent of the total number of facilities. Also, a
facility that goes out of business, changes ownership, or stops
manufacturing/processing, packing, or holding food for consumption in
the United States will have to cancel its registration. FDA estimated
that 10 percent of the total number of facilities will have to cancel
their registration, also based on SBA statistics. FDA estimated that it
would take these facilities approximately 1 hour to locate the correct
form, enter their information, and send it to FDA. Finally, facilities
for which there is a change of information submitted in their
registration will have to update their registration. FDA estimated that
each year 20 percent of facilities will have to update the information
submitted in their registration. This estimate is revised to 55 percent
based on comments. It will take these facilities approximately 1 hour
to locate the correct form, enter the updated information, and send it
to FDA. Table 19 of this document presents an estimate of the burden
hours for new facilities, and updates and cancellations for previously
registered facilities in future years.
Additionally, facilities that are not registered and are required
by FDA to move their food shipment to secure storage must also notify
FDA of the location of the secure storage. This paperwork burden is
already estimated in Prior Notice of Imported Food Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(68 FR 5428), which requires imports that fail to give adequate notice,
including failure to provide a required registration number, to place
their shipment in secure storage.
In response to comments, FDA added the option of submitting
registrations by CD-ROM. FDA believes that registrants will only use
this option if it will take them as the same as or less time than
submitting their registrations by Internet or mail. Therefore, the
total number of burden hours will remain the same or be decreased by
the availability of the CD-ROM option.
(Comment 193) FDA received numerous comments about the usefulness
of the information, number of respondents, and the hourly burden for
the respondents.
(Response) FDA has responded to comments relating to the usefulness
of the information collection in section IV. A.6 of this document
(Benefits). Similarly, the agency has responded to comments relating to
the number of respondents in section IV.A.3 of this document (number of
facilities affected). Finally, the agency has responded to comments
regarding the hourly burden in section IV.A.4.a of this document (time
costs).
(Comment 194) FDA received numerous comments that the PRA analysis
was incorrect, because it failed to include duplicative registration
requirements for many facilities.
(Response) The PRA analysis counts the burden hours resulting from
the provisions of the interim final rule. Burden hours for other
registration provisions would be counted in the PRA analyses for those
rules. Including burden hours for other registration provisions would
result in double counting of the burden hours. Therefore, FDA does not
agree with this comment.
(Comment 195) FDA received comments that FDA had underestimated the
frequency with which facilities would need to update their
registrations.
(Response) As noted, the interim final rule changes the requirement
for timely update from 30 to 60 days. FDA re-estimated the frequency
with which facilities would update their registrations. Instead of 20
percent, 55 percent of facilities will update their registrations each
year. A full discussion of how this estimate was reached is included in
the response to comment 197 (section IV.A.5.c of this document).
BILLING CODE 4160-01-P
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The information collection provisions of this interim final rule
have been submitted to OMB for review.
Prior to the effective date of this interim final rule, FDA will
publish a notice in the Federal Register announcing OMB's decision to
approve, modify, or disapprove the information collection provisions in
this interim final rule. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
[[Page 58959]]
IX. Request for Comments
FDA is issuing this rule as an interim final rule, with an
opportunity for public comment on specific issues identified below.
Although the agency is seeking comment on this interim final rule, it
is effective December 12, 2003. This means that the rule's requirements
will be in effect and have the force and effect of law from that date
until any subsequent modification by the issuance of a final rule.
Accordingly, as required by section 305 of the Bioterrorism Act, all
covered facilities must be registered with FDA by December 12, 2003.
As noted, elsewhere in this issue of the Federal Register, FDA is
publishing an interim final rule concerning prior notice of imported
food shipments. Given the relatedness of the prior notice and food
facilities registration rules, FDA is establishing a comment period for
the registration rule that coincides with the comment period on the
prior notice interim final rule. Thus, the comment period for the
registration interim final rule will open today for a period of 75
days. Moreover, to ensure that those commenting on this interim final
rule have had the benefit of FDA's outreach and educational efforts and
have had experience with the systems, timeframes, and data elements of
this interim final rule, the agency intends to reopen the comment
period for an additional 30 days in March 2004.
As noted elsewhere in this issue of the Federal Register, FDA's
economic analysis is based on a number of assumptions. To improve this
analysis, FDA invites public comment on the following issues:
1. The cost to foreign facilities of hiring and retaining a U.S.
agent. Specifically, FDA invites comment, and the submission of data or
other information, on the following:
a. The costs to a foreign facility of hiring a U.S. agent;
b. The number of foreign facilities that have hired a U.S. agent or
negotiated additional duties from someone with whom they have an
existing relationship in response to this interim final rule, instead
of relying on an existing relationship with a person who qualifies as a
U.S. agent;
c. The number of foreign facilities that have ceased exporting to
the United States because they have decided not to hire/retain a U.S.
agent for registration purposes.
d. The distribution of costs between submitting registrations and
other services offered by the U.S. agent;
e. The assumptions underlying FDA's estimates of the costs of
hiring and retaining a U.S. agent.
2. The effects on domestic small businesses, if any, if some
foreign facilities cease exporting to the United States due to the U.S.
agent requirement for registration. Specifically, FDA invites comment,
and the submission of data or other information, on the following:
a. The number of domestic small businesses that have been adversely
affected by trading partners that have ceased exporting to the United
States due to the U.S. agent requirement for foreign facility
registration; and
b. The costs incurred by these domestic small businesses due to the
loss of these trading partners.
FDA will seriously consider all comments submitted. FDA is
dedicated to updating this estimate with the best available information
in order to inform decision makers who may be considering regulatory
alternatives in developing a final rule.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this interim
final rule by December 24, 2003. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Submit one
electronic copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
As noted, this regulation is effective on December 12, 2003. The
agency will address comments received and confirm or amend the interim
final rule in a final rule. The agency, however, will not consider any
comments that have been previously considered during this rulemaking.
X. Analysis of Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded under 21 CFR 25.30(h) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.
XI. Federalism
FDA has analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the interim final rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency concludes that the interim final rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement has not
been prepared.
XII. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses in this document, but is not
responsible for subsequent changes to the Web sites after this document
publishes in the Federal Register.
1. Brown, Bradley, Memorandum to the file, July 21, 2003.
2. U.S. Census Bureau, 2000 County Business Patterns, available at
http://www.census.gov/epcd/cbp/view/cbpview.html.
3. U.S. Census Bureau, 1999 Nonemployer Statistics, available at
http://www.census.gov/epcd/nonemployer/index.html.
4. U.S. Food and Drug Administration, Field Accomplishments and
Compliance Tracking System (FACTS), fiscal year 2002.
5. U.S. Department of Agriculture, National Agriculture Statistics
Service, 1997 Census of Agriculture-United States Data, available at
http://www.nass.usda.gov/census/.
6. U.S. Census Bureau, 1997 Economic Census of Transportation and
Warehousing, available at http://www.census.gov/svsd/www/97trans.html.
7. Direct Selling Association, Direct Selling by the Numbers,
accessed at http://www.dsa.org/research/numbers.htm#DISTTYPE, 7/10/
2003.
8. Direct Sales World, Facts and Figures and Comment of the World of
Direct Sales, accessed at http://www.nmworld.com/pages/Countries/USA/index.html, 7/10/2003.
9. U.S. Census Bureau, Guam: 1997 Census of the Outlying Areas,
available at http://www.census.gov/prod/ec97/oa97e-6.pdf.
10. U.S. Census Bureau, Northern Mariana Islands: 1997 Census of the
Outlying Areas, available at http://www.census.gov/prod/ec97/oa97e-7.pdf.
11. U.S. Census Bureau, Puerto Rico: 1997 Census of the Outlying
Areas, available at http://www.census.gov/prod/ec97/oa97e-4.pdf.
12. U.S. Census Bureau, Virgin Islands: 1997 Census of the Outlying
Areas, available at http://www.census.gov/prod/ec97/oa97e-5.pdf.
13. U.S. Food and Drug Administration, Operational and
Administrative System for Import Support (OASIS), fiscal year 2002.
[[Page 58960]]
14. RTI, Survey of Manufacturing Practices in the Dietary Supplement
Industry, Prepared for FDA, May 17, 2003.
15. Brown, Bradley, Memorandum to file, November 22, 2002.
16. U.S. Department of Labor, Bureau of Labor Statistics, National
Compensation Survey: Occupation Wages in the United States, 2000,
Summary 01-04, available at http://www.bls.gov/ncs/ocs/sp/ncbl0354.pdf.
17. U.S. Small Business Administration, Office of Advocacy, Small
Business by the Numbers May 2002, available at http://www.sba.gov/advo/stats/sbfaq.html.
18. Cato, Todd, Memo to the record, May 23, 2003.
19. Gripp, Russell, Memo to the record, May 14, 2003.
20. Hennessy T. W., Hedberg C. W., Slutsker L, et al., and the
Investigation Team, ``A National Outbreak of Salmonella enteritidis
Infections From Ice Cream,'' The New England Journal of Medicine,
May 16, 1996, pp. 1281-1286.
21. Kolavic S. A., Kimura A, Simons S. L., et al., ``An Outbreak of
Shigella Dysenteriae Type 2 Among Laboratory Workers Due to
Intentional Food Contamination,'' The Journal of the American
Medical Association, 278:5:396-403.
22. Trook T. J., Tauxe R. V., Wise R.P., et al. ``A Large Community
Outbreak of Salmonellosis Caused by Intentional Contamination of
Restaurant Salad Bars,'' The Journal of the American Medical
Association, 278:5:389-397.
23. Lee L. A., Ostroff S. M., McGee H. B., et al. ``An Outbreak of
Shigellosis at an Outdoor Music Festival,'' American Journal of
Epidemiology, 133:6:608-615.
24. Herwaldt B. L., Ackers M. L., and Cyclospora Working Group, ``An
Outbreak in 1996 of Cyclosporiasis Associated With Imported
Raspberries,'' New England Journal of Medicine, May 29, 1997, pp.
1548-1556.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 20
Confidential business information, Courts, Freedom of information,
Government employees.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1 and 20 are amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1 is revised to read as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262,
264.
0
2. Subpart H (Sec. Sec. 1.225 through 1.243) is added to part 1 to
read as follows (subparts F and G are reserved):
Subparts F-G [Reserved]
Subpart H--Registration of Food Facilities
General Provisions
Sec.
1.225 Who must register under this subpart?
1.226 Who does not have to register under this subpart?
1.227 What definitions apply to this subpart?
Procedures for Registration of Food Facilities
1.230 When must you register?
1.231 How and where do you register?
1.232 What information is required in the registration?
1.233 What optional items are included in the registration form?
1.234 How and when do you update your facility's registration
information?
1.235 How and when do you cancel your facility's registration
information?
Additional Provisions
1.240 What other registration requirements apply?
1.241 What are the consequences of failing to register, update, or
cancel your registration?
1.242 What does assignment of a registration number mean?
1.243 Is food registration information available to the public?
General Provisions
Sec. 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are
the owner, operator, or agent in charge of either a domestic or foreign
facility, as defined in this subpart, and your facility is engaged in
the manufacturing/processing, packing, or holding of food for
consumption in the United States, unless your facility qualifies for
one of the exemptions in Sec. 1.226.
(b) If you are an owner, operator, or agent in charge of a domestic
facility, you must register your facility whether or not the food from
the facility enters interstate commerce.
(c) If you are the owner, operator, or agent in charge of a
facility, you may authorize an individual to register your facility on
your behalf.
Sec. 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:
(a) A foreign facility, if food from such facility undergoes
further manufacturing/processing (including packaging) by another
facility outside the United States. A facility is not exempt under this
provision if the further manufacturing/processing (including packaging)
conducted by the subsequent facility consists of adding labeling or any
similar activity of a de minimis nature;
(b) Farms;
(c) Retail food establishments;
(d) Restaurants;
(e) Nonprofit food establishments in which food is prepared for, or
served directly to, the consumer;
(f) Fishing vessels, including those that not only harvest and
transport fish but also engage in practices such as heading,
eviscerating, or freezing intended solely to prepare fish for holding
on board a harvest vessel. However, those fishing vessels otherwise
engaged in processing fish are subject to this subpart. For the
purposes of this section, ``processing'' means handling, storing,
preparing, shucking, changing into different market forms,
manufacturing, preserving, packing, labeling, dockside unloading,
holding, or heading, eviscerating, or freezing other than solely to
prepare fish for holding on board a harvest vessel;
(g) Facilities that are regulated exclusively, throughout the
entire facility, by the U.S. Department of Agriculture under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.);
Sec. 1.227 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) In addition, for the purposes of this subpart:
(1) Calendar day means every day shown on the calendar.
(2) Facility means any establishment, structure, or structures
under one ownership at one general physical location, or, in the case
of a mobile facility, traveling to multiple locations, that
manufactures/processes, packs, or holds food for consumption in the
United States. Transport vehicles are not facilities if they hold food
only in the usual course of business as carriers. A facility may
consist of one or more contiguous structures, and a single building may
house more than one distinct facility if the facilities are under
separate ownership. The private residence of an individual is not a
facility. Nonbottled water drinking water collection and distribution
establishments and their structures are not facilities.
[[Page 58961]]
(i) Domestic facility means any facility located in any State or
Territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico that manufactures/processes, packs, or
holds food for consumption in the United States.
(ii) Foreign facility means a facility other than a domestic
facility that manufactures/processes, packs, or holds food for
consumption in the United States.
(3) Farm means a facility in one general physical location devoted
to the growing and harvesting of crops, the raising of animals
(including seafood), or both. Washing, trimming of outer leaves of, and
cooling produce are considered part of harvesting. The term ``farm''
includes:
(i) Facilities that pack or hold food, provided that all food used
in such activities is grown, raised, or consumed on that farm or
another farm under the same ownership; and
(ii) Facilities that manufacture/process food, provided that all
food used in such activities is consumed on that farm or another farm
under the same ownership.
(4) Food has the meaning given in section 201(f) of the act (21
U.S.C. 321(f)),
(i) Except for purposes of this subpart, it does not include:
(A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)), or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or as
components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods,
candy, and canned foods.
(5) Holding means storage of food. Holding facilities include
warehouses, cold storage facilities, storage silos, grain elevators,
and liquid storage tanks.
(6) Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging.
(7) Nonprofit food establishment means a charitable entity that
prepares or serves food directly to the consumer or otherwise provides
food or meals for consumption by humans or animals in the United
States. The term includes central food banks, soup kitchens, and
nonprofit food delivery services. To be considered a nonprofit food
establishment, the establishment must meet the terms of section
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
(8) Packaging (when used as a verb) means placing food into a
container that directly contacts the food and that the consumer
receives.
(9) Packing means placing food into a container other than
packaging the food.
(10) Restaurant means a facility that prepares and sells food
directly to consumers for immediate consumption. ``Restaurant'' does
not include facilities that provide food to interstate conveyances,
central kitchens, and other similar facilities that do not prepare and
serve food directly to consumers.
(i) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
(ii) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
(11) Retail food establishment means an establishment that sells
food products directly to consumers as its primary function. A retail
food establishment may manufacture/process, pack, or hold food if the
establishment's primary function is to sell from that establishment
food, including food that it manufactures/processes, packs, or holds,
directly to consumers. A retail food establishment's primary function
is to sell food directly to consumers if the annual monetary value of
sales of food products directly to consumers exceeds the annual
monetary value of sales of food products to all other buyers. The term
``consumers'' does not include businesses. A ``retail food
establishment'' includes grocery stores, convenience stores, and
vending machine locations.
(12) Trade name means the name or names under which the facility
conducts business, or additional names by which the facility is known.
A trade name is associated with a facility, and a brand name is
associated with a product.
(13) U.S. agent means a person (as defined in section 201(e) of the
act (21 U.S.C. 321(e))) residing or maintaining a place of business in
the United States whom a foreign facility designates as its agent for
purposes of this subpart. A U.S. agent cannot be in the form of a
mailbox, answering machine or service, or other place where an
individual acting as the foreign facility's agent is not physically
present.
(i) The U.S. agent acts as a communications link between FDA and
the foreign facility for both emergency and routine communications. The
U.S. agent will be the person FDA contacts when an emergency occurs,
unless the registration specifies under Sec. 1.233(e) another
emergency contact.
(ii) FDA will treat representations by the U.S. agent as those of
the foreign facility, and will consider information or documents
provided to the U.S. agent the equivalent of providing the information
or documents to the foreign facility.
(iii) Having a single U.S. agent for the purposes of this subpart
does not preclude facilities from having multiple agents (such as
foreign suppliers) for other business purposes. A firm's commercial
business in the United States need not be conducted through the U.S.
agent designated for purposes of this subpart.
(14) You or registrant means the owner, operator, or agent in
charge of a facility that manufactures/processes, packs, or holds food
for consumption in the United States.
Procedures for Registration of Food Facilities
Sec. 1.230 When must you register?
The owner, operator, or agent in charge of a facility that
manufactures/processes, packs or holds food for consumption in the
United States must register the facility no later than December 12,
2003. The owner, operator, or agent in charge of a facility that begins
to manufacture/process, pack, or hold food for consumption in the
United States on or after December 12, 2003, must register before the
facility begins such activities. An owner, operator, or agent in charge
of a facility may authorize an individual to register the facility on
its behalf.
Sec. 1.231 How and where do you register?
(a) Electronic registration. (1) To register electronically, you
must register at http://www.fda.gov/furls, which is available for
registration 24 hours a day, 7 days a week. This website is available
from wherever the Internet is accessible, including libraries, copy
centers, schools, and Internet cafes. An
[[Page 58962]]
individual authorized by the owner, operator, or agent in charge of a
facility may also register a facility electronically.
(2) FDA strongly encourages electronic registration for the benefit
of both FDA and the registrant.
(3) Once you complete your electronic registration, FDA will
automatically provide you with an electronic confirmation of
registration and a permanent registration number.
(4) You will be considered registered once FDA electronically
transmits your confirmation and registration number.
(b) Registration by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in paragraph (a) of this section, you may register by mail or fax.
(1) You must register using Form 3537. You may obtain a copy of
this form by writing to the U.S. Food and Drug Administration (HFS-
681), 5600 Fishers Lane, Rockville, MD 20857 or by requesting the form
by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(1) of this
section or fax it to 301-210-0247.
(3) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will
use the means by which the form was received by the agency (i.e., by
mail or fax).
(4) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, along with CD-
ROM submissions, as soon as practicable, in the order FDA receives
them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by
which the registration was received by the agency (i.e., by mail or
fax).
(6) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration as specified in Sec. 1.234.
(7) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the
system generates a registration number.
(c) Registration by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods provided under paragraph (a) of this section, you may
register by CD-ROM.
(1) Registrants submitting their registrations in CD-ROM format
must use ISO 9660 (CD-R or CD-RW) data format.
(2) These files must be submitted on a portable document format
(PDF) rendition of the registration form (Form 3537) and be accompanied
by one signed copy of the certification statement that appears on the
registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) A CD-ROM may contain registrations for as many facilities as
needed up to the CD-ROM's capacity.
(5) The registration on the CD-ROM for each separate facility must
have a unique file name up to 32 characters long, the first part of
which may be used to identify the parent company.
(6) You must mail the CD-ROM to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the submitter unprocessed.
(8) FDA will enter CD-ROM submissions that comply with these
specifications into its registration system, along with the complete
and legible mailed and faxed submissions, as soon as practicable, in
the order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the registration(s) as entered, confirmation
of registration, and each facility's assigned registration number.
(10) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration as specified in Sec. 1.234.
(11) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the
system generates a registration number.
(d) Fees. No registration fee is required.
(e) Language. You must submit all registration information in the
English language except an individual's name, the name of a company,
the name of a street, and a trade name may be submitted in a foreign
language. All information, including these items, must be submitted
using the Latin (Roman) alphabet.
Sec. 1.232 What information is required in the registration?
Each registrant must submit the following information through one
of the methods described in Sec. 1.231:
(a) The name, full address, and phone number of the facility;
(b) The name, address, and phone number of the parent company, if
the facility is a subsidiary of the parent company;
(c) For domestic and foreign facilities, the names, addresses, and
phone numbers of the owner, operator, and agent in charge.
(d) For a foreign facility, the name, address, phone number, and
emergency contact phone number of its U.S. agent (if there is no other
emergency contact designated under Sec. 1.233(c));
(e) For a domestic facility, an emergency contact phone number;
(f) All trade names the facility uses;
(g) Applicable food product categories as identified in Sec. 170.3
of this chapter, unless you check either ``most/all human food product
categories,'' according to Sec. 1.233(e), or ``none of the above
mandatory categories'' because your facility manufactures/processes,
packs, or holds a food that is not identified in Sec. 170.3 of this
chapter;
(h) The name, address, and phone number for the owner, operator, or
agent in charge;
(i) A statement in which the owner, operator, or agent in charge
certifies that the information submitted is true and accurate. If the
individual submitting the form is not the owner, operator, or agent in
charge of the facility, the registration must also include a statement
in which the individual certifies that the information submitted is
true and accurate, certifies that he/she is authorized to submit the
registration, and identifies by name, address, and telephone number,
the individual who authorized submission of the registration. Each
registration must include the name of the individual registering the
facility submitting the registration, and the individual's signature
(for the paper and CD-ROM options).
Sec. 1.233 What optional items are included in the registration form?
FDA encourages, but does not require, you to submit the following
items in your facility's registration. These data will enable FDA to
communicate more quickly with facilities that may be the target of a
terrorist threat or attack, or otherwise affected by an outbreak of
foodborne illness. This information includes:
[[Page 58963]]
(a) Fax number and e-mail address of the facility;
(b) Preferred mailing address, if different from that of the
facility;
(c) Fax number and e-mail address of the parent company, if the
facility is a subsidiary of the parent company;
(d) For a domestic facility, emergency contact name, title, and e-
mail address;
(e) For a foreign facility, an emergency contact name, title, phone
number and e-mail address. FDA will consider the facility's U.S. agent
the facility's emergency contact unless the facility chooses to
designate another person to serve as an emergency contact under this
section;
(f) For a foreign facility, title, fax number, and e-mail address
of the U.S. agent;
(g) Type of activity conducted at the facility (e.g.,
manufacturing/processing or holding);
(h) Food categories not identified in Sec. 170.3 of this chapter,
which are provided in Form 3537 sections 11a (e.g., infant formula,
animal byproducts and extracts) and 11b (e.g., grain products, amino
acids);
(i) Type of storage, if the facility is primarily a holding
facility;
(j) A food product category of ``most/all human food product
categories,'' if the facility manufactures/processes, packs, or holds
foods in most or all of the categories identified in Sec. 170.3 of
this chapter;
(k) Approximate dates of operation, if the facility's business is
seasonal;
(l) The fax number and e-mail address of the owner, operator, or
agent in charge; and
(m) The fax number and e-mail address of the individual who
authorized submission of the registration.
Sec. 1.234 How and when do you update your facility's registration
information?
(a) Update requirements. The owner, operator, or agent in charge
must submit an update to a facility's registration within 60 calendar
days of any change to any of the information previously submitted under
Sec. 1.232 (e.g., change of operator, agent in charge, or U.S. agent),
except a change of the owner. The owner, operator, or agent in charge
may authorize an individual to update a facility's registration.
(b) Cancellation due to ownership changes. If the reason for the
update is that the facility has a new owner, the former owner must
cancel the facility's registration as specified in Sec. 1.235 within
60 calendar days of the change and the new owner must re-register the
facility as specified in Sec. 1.231. The former owner may authorize an
individual to cancel a facility's registration.
(c) Electronic update. (1) To update your registration
electronically, you must update at http://www.fda.gov/furls.
(2) Once you complete your electronic update, FDA will
automatically provide you with an electronic confirmation of your
update.
(3) Your registration will be considered updated once FDA transmits
your update confirmation, unless notified otherwise.
(d) Update by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in Sec. 1.231(a)), you may update your facility's registration by mail
or by fax:
(1) You must update your registration using Form 3537. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857 or by
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must legibly fill out the
sections of the form reflecting your updated information and either
mail it to the address in paragraph (d)(1) of this section or fax it to
301-210-0247.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a registration form for revision, FDA will use the means by
which the registration was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible updates into its
registration system, along with CD-ROM submissions, as soon as
practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the update as entered and confirmation
of the update. When responding to an update submission, FDA will use
the means by which the form was received by the agency (i.e., by mail
or fax).
(6) If any update information you previously submitted was
incorrect at the time of submission, you must immediately resubmit your
update.
(7) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
(e) Update by CD-ROM for multiple submissions. If, for example, you
do not have reasonable access to the Internet through any of the
methods provided under Sec. 1.231(a), you may update your facilities'
registrations by CD-ROM.
(1) Registrants submitting their updates in CD-ROM format must use
ISO 9660 (CD-R or CD-RW) data format.
(2) Update files must be submitted on a PDF rendition of FDA's
registration form (Form 3537) and be accompanied by one signed copy of
the certification statement on the registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain updates for as many facilities as needed
up to the CD-ROM's capacity.
(5) The update for each facility on the CD-ROM must have a unique
file name up to 32 characters long, the first part of which may be used
to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives an update CD-ROM that does not comply with
these specifications, it will return the CD-ROM to the registrant
unprocessed.
(8) FDA will enter CD-ROM update submissions into its registration
system, along with the complete and legible mailed and faxed update
submissions, as soon as practicable, in the order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the update(s) as entered and confirmation of
the update.
(10) If any update information you previously submitted was
incorrect at the time of submission, you must immediately resubmit your
update.
(11) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
Sec. 1.235 How and when do you cancel your facility's registration
information?
(a) Notification of registration cancellation. A facility canceling
its registration must do so within 60 calendar days of the reason for
cancellation (e.g., facility ceases operations, ceases providing food
for consumption in the United States, or the facility is sold to a new
owner).
(b) Cancellation requirements. The cancellation of a facility's
registration must include the following information:
(1) The facility's registration number;
(2) Whether the facility is domestic or foreign;
(3) The facility name and address;
[[Page 58964]]
(4) The name, address, and e-mail address (if available) of the
individual submitting the cancellation; and
(5) A statement certifying that the information submitted is true
and accurate, and that the person submitting the cancellation is
authorized by the facility to cancel its registration.
(c) Electronic cancellation. (1) To cancel your registration
electronically, you must cancel at http://www.fda.gov/furls.
(2) Once you complete your electronic cancellation, FDA will
automatically provide you with an electronic confirmation of your
cancellation.
(3) Your registration will be considered cancelled once FDA
transmits your cancellation confirmation.
(d) Cancellation by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in Sec. 1.231(a), you may cancel your facility's registration by mail
or fax.
(1) You must cancel your registration using Form 3537a. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857, or by
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must completely and legibly fill
out the form and either mail it to the address in paragraph (d)(1) of
this section or fax it to 301-210-0247.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a cancellation form for revision, FDA will use the means by
which the cancellation was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible mailed and faxed
cancellations into its registration system, along with CD-ROM
cancellations, as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the cancellation form a copy of the cancellation as entered and
confirmation of the cancellation. When responding to a cancellation,
FDA will use the means by which the form was received by the agency
(i.e., by mail or fax).
(6) If any information you previously submitted was incorrect at
the time of submission, you must immediately resubmit your
cancellation.
(7) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system and the
system generates a confirmation.
(e) Cancellation by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods described in Sec. 1.231(a), you may cancel your
facilities' registrations using a CD-ROM.
(1) Registrants submitting their cancellations in CD-ROM format
must use ISO 9660 (CD-R or CD-RW) data format.
(2) Cancellation files must be submitted on a PDF rendition of the
cancellation form (Form 3537a) and be accompanied by one signed copy of
the certification statement on the cancellation form.
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain cancellations for as many facilities as
needed up to the CD-ROM's capacity.
(5) The cancellation for each facility on the CD-ROM must have a
unique file name up to 32 characters long, the first part of which may
be used to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the registrant
unprocessed.
(8) FDA will enter CD-ROM submissions that meet the specifications
into its registration system, along with complete and legible mailed
and faxed submissions, as soon as practicable, in the order FDA
receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the cancellation(s) as entered and
confirmation of the cancellation.
(10) If any information you previously submitted was incorrect at
the time of submission, you must immediately resubmit your
cancellation.
(11) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system and the
system generates a confirmation.
Additional Provisions
Sec. 1.240 What other registration requirements apply?
In addition to the requirements of this subpart, you must comply
with the registration regulations found in part 108 of this chapter,
related to emergency permit control, and any other Federal, State, or
local registration requirements that apply to your facility.
Sec. 1.241 What are the consequences of failing to register, update,
or cancel your registration?
(a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of
certain acts or causing such acts to be done. Under section 302 of the
act (21 U.S.C. 332), the United States can bring a civil action in
Federal court to enjoin a person who commits a prohibited act. Under
section 303 of the act (21 U.S.C. 333), the United States can bring a
criminal action in Federal court to prosecute a person who is
responsible for the commission of a prohibited act. Under section 306
of the act (21 U.S.C. 335a), FDA can seek debarment of any person who
has been convicted of a felony relating to importation of food into the
United States. Failure of an owner, operator, or agent in charge of a
domestic or foreign facility to register its facility, to update
required elements of it's facility's registration, or to cancel its
registration in accordance with the requirements of this subpart is a
prohibited act under section 301(dd) of the act.
(b) FDA will cancel a registration if the agency independently
verifies that the facility is no longer in business or has changed
owners, and the owner, operator, or agent in charge of the facility
fails to cancel the registration, or if FDA determines that the
registration is for a facility that does not exist. If FDA cancels a
facility's registration, FDA will mail a confirmation of the
cancellation to the facility at the address provided in the facility's
registration.
(c) If an article of food is imported or offered for import into
the United States and a foreign facility that manufactured/processed,
packed, or held that article of food has not registered in accordance
with this subpart, the disposition of the article of food shall be
governed by the procedures set out in subpart I of this part.
Sec. 1.242 What does assignment of a registration number mean?
Assignment of a registration number to a facility means that the
facility is registered with FDA. Assignment of a registration number
does not in any way convey FDA's approval or endorsement of a facility
or its products.
Sec. 1.243 Is food registration information available to the public?
(a) The list of registered facilities and registration documents
submitted under this subpart are not subject to disclosure
[[Page 58965]]
under 5 U.S.C. 552 (the Freedom of Information Act). In addition, any
information derived from such list or registration documents that would
disclose the identity or location of a specific registered person, is
not subject to disclosure under 5 U.S.C. 552 (the Freedom of
Information Act).
(b) Paragraph (a) of this section does not apply to any information
obtained by other means or that has previously been disclosed to the
public as defined in Sec. 20.81 of this chapter.
PART 20--PUBLIC INFORMATION
Subpart F--Availability of Specific Categories of Records
0
3. The authority citation for part 20 continues to read as follows:
Authority: 5 U.S.C 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
0
4. Section 20.100 is amended by adding paragraph (c)(42) to read as
follows:
Sec. 20.100 Applicability; cross-reference to other regulations.
* * * * *
(c) * * *
(42) Registration of food facilities, in Sec. 1.243 of this
chapter.
Dated: October 2, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.
Dated: October 8, 2003.
Tom Ridge,
Secretary of Homeland Security.
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Note: The following appendix will not appear in the Code of
Federal Regulations.
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[FR Doc. 03-25849 Filed 10-9-03; 8:45 am]
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