[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  

[[Page 58894]]


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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;

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    [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.

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    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).
---------------------------------------------------------------------------

    \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).)
---------------------------------------------------------------------------

    (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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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

[[Page 58957]]

[GRAPHIC] [TIFF OMITTED] TR10OC03.063


[[Page 58958]]


[GRAPHIC] [TIFF OMITTED] TR10OC03.064

BILLING CODE 4160-01-C

    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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