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[Federal Register: October 10, 2003 (Volume 68, Number 197)] [Rules and Regulations] [Page 58893-58974] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10oc03-17] [[Page 58893]] ----------------------------------------------------------------------- Part VI Department of Health and Human Services ----------------------------------------------------------------------- Food and Drug Administration ----------------------------------------------------------------------- 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 [[Page 58894]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/furls, which is available for registration 24 hours a day, 7 days a week. This Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes, as well as through a foreign facility's U.S. agent or other authorized individual if the facility makes such arrangements; [sbull] Regardless of the mode of submission (electronic, paper, or CD-ROM), each registration must include the name and contact information for the facility and its parent company (if applicable); all trade names the facility uses; applicable food product categories as identified in Sec. 170.3 of this chapter; a statement certifying that the information submitted is true and accurate and that the person submitting the registration is authorized by the facility to register on its behalf; and if a foreign facility, the name of and contact information for the facility's U.S. agent. A domestic facility must provide emergency contact information; [sbull] No registration fee is required; [sbull] Updates to registration information or cancellation of registration must be submitted within 60 calendar days of any change to any of the required information previously submitted; [sbull] Failure of a domestic or foreign facility to register, update, or cancel its registration in accordance with this regulation is a prohibited act under section 301(dd) of the FD&C Act; [sbull] The disposition of food imported or offered for import from an unregistered foreign facility will be governed by the procedures set out in subpart I of this part 1 (21 CFR part 1) (Prior Notice of Imported Food); and [sbull] Assignment of a registration number to a facility means that the facility is registered with FDA. Assignment of a registration number does not in any way convey FDA's approval or endorsement of a facility or its products. B. Significant Changes Made to the Proposed Rule The significant changes FDA made to the proposed rule are as follows: [sbull] The interim final rule provides that private residences of individuals and nonbottled water drinking water collection and distribution establishments and structures are not facilities and, therefore, are not required to register; [sbull] The interim final rule clarifies that transport vehicles are not facilities if they hold food only in the usual course of business as carriers; [sbull] The definition of farm now states that washing, trimming of outer leaves, and cooling produce are part of harvesting; [[Page 58896]] [sbull] The definition of farm now includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; [sbull] The definition of food for purposes of the Bioterrorism Act excludes food contact substances as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)) and pesticides as defined in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136(u); [sbull] Packaging (when used as a verb) has been defined and means ``placing food into the container that directly contacts the food and that the consumer receives;'' [sbull] The definition of ``retail food establishment'' has been revised to an establishment that sells food products directly to consumers as its primary function. A retail establishment may manufacture/ process, pack, or hold food if the establishment's primary function is to sell from that establishment food that it manufactures/ processes, packs, or holds directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to the consumers exceeds the annual monetary value of sales of food products to all other buyers. The term `consumers' does not include businesses. A `retail food establishment' includes grocery stores, convenience stores, and vending machine locations. [sbull] FDA has added a definition for ``trade name'' as ``the name or names under which the facility conducts business, or additional names by which the facility is known. A trade name is associated with a facility, and a brand name is associated with a product;'' [sbull] FDA has determined that it will contact the foreign facility's U.S. agent when an emergency occurs, unless the registration specifies another emergency contact under Sec. 1.233(b); [sbull] FDA is clarifying that having a single U.S. agent for FDA registration purposes does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes. A firm's commercial business in the United States need not be conducted through the U.S. agent designated for purposes of registration; [sbull] FDA is allowing registrants to submit their registrations by fax or CD-ROM, which FDA will enter into its registration system, along with the mailed submissions, as soon as practicable, in the order received; [sbull] FDA has changed the timeframe in which registrants must update their registrations from 30 days to within 60 days of any change in the required information; [sbull] FDA has deleted the requirement to update optional information previously submitted, but encourages facilities to do so voluntarily; and [sbull] FDA has clarified that if a facility has a new owner, the former owner must submit a cancellation within 60 calendar days of the change and the new owner must re-register the facility. [sbull] FDA now provides that the failure of an owner, operator, or agent in charge of a facility governed by this interim final rule to register such facility, update required elements of its registration, or cancel its registration, is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). III. Comments on the Proposed Rule FDA received approximately 350 submissions in response to the proposed rule, which raised almost 200 major issues. To make it easier to identify comments and FDA's responses to the comments, the word ``Comment'' will appear in parentheses before the description of the comment, and the word ``Response'' will appear in parentheses before FDA's response. FDA has also numbered each comment to make it easier to identify a particular comment. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted. A. General Comments (Comment 1) Most commenters state that they generally support protection of the U.S. food supply under the Bioterrorism Act. Although some commenters assert that the proposed rule should be amended to reflect more accurately industry practices, other commenters believe the regulation should be strengthened to ensure that FDA has all the information required to identify foods that may pose a health or security threat. Other commenters question how the interim final rule would enhance FDA's ability to improve food safety and whether the benefits outweigh the costs. Some commenters argue that the proposed regulation should either be reproposed or not implemented at all. These commenters claim that the proposed rule is seriously flawed, unduly burdensome, and will unnecessarily interfere with trade. Some of these commenters also argue that FDA already has complete information to allow for identification of, and quick communication with, affected facilities before a shipment is introduced into U.S. commerce. (Response) In response to the comments regarding reproposing or not implementing the rule, these options are not available to FDA under the Bioterrorism Act, because that act requires FDA to ``promulgate proposed and final regulations for the requirement of registration'' by December 12, 2003. The Bioterrorism Act further states that the registration requirement takes effect on December 12, 2003, even if FDA does not have a final regulation in effect by the deadline. FDA believes that both the proposed rule and this interim final rule properly implement section 305 of the Bioterrorism Act, and thus, there is no need to repropose the regulation. Further, based on the many comments supporting the proposed regulation as well as those comments suggesting limited changes to the rule as proposed, FDA disagrees that the proposed regulation is so flawed that reproposal is required. FDA is aware that the registration regulation may alter industry practices to some extent. In enacting the Bioterrorism Act, Congress determined that registration with FDA was necessary to respond to bioterrorism and other food-related emergencies. Registration will give FDA information it does not currently have about facilities that manufacture/process, pack, or hold food for consumption in the United States, and current contact information for all of these facilities. FDA will be able to use this information to target its contacts to both domestic and foreign facilities in the event of a bioterrorist threat or other food-related emergency. Information about food product categories will permit FDA to screen food imports more carefully because the agency will be able to match a registrant's food product category with the product code and common or usual or market name submitted as part of a prior notice (21 CFR part 1, subpart I). Registration will also give FDA information that we can use to focus and better utilize the agency's limited inspection resources. Registering with FDA creates an information trail, which would, even if the information in the registration were falsified, provide evidence that could link the registration to the registrant. By creating this paper trail, persons in the food supply chain who might intentionally contaminate food may be deterred by the creation of additional evidence that might be used against them. Persons who might intentionally contaminate the food supply but refuse to register would be subject to criminal and civil sanctions and would risk having their product, if imported, held at the port. [[Page 58897]] To alleviate some of the burden registration may impose on industry, FDA has modified some of the elements of registration, including emergency contact information; the definitions for ``farm,'' ``facility,'' and ``retail food establishment,'' and the timing for submitting updates to FDA when required elements in a registration change. These changes will be discussed in the appropriate sections later in this document. FDA also believes that its electronic registration system will make registration an efficient and straightforward process. FDA has received positive comments from stakeholders who attended FDA's preliminary demonstrations of the electronic prototype registration system. (Comment 2) Some commenters request that FDA include a provision in the interim final rule that permits the agency to amend the system quickly to respond to flaws in the rule discovered through practice. Some of these commenters state that this arrangement would be especially helpful for countries that are able to reach a more efficient or effective registration arrangement with FDA that reflects actual reductions in risks through such arrangements. (Response) FDA always has the option to amend its regulations if the agency believes that improvements would serve the public interest, and interested persons may request such modification by following the procedures in 21 CFR 10.30, regarding citizen petitions. The process for any amendment to an existing FDA regulation must conform to the requirements of the Administrative Procedure Act (APA) (5 U.S.C. 551- 559). Notably, section 553 of the APA provides a process for issuing a final rule in an expedited timeframe if certain conditions are met. Importantly, however, FDA can only amend the interim final registration rule consistent with the requirements in the Bioterrorism Act. (Comment 3) FDA received several comments about the need for outreach efforts regarding the registration requirement. Some commenters encourage FDA to facilitate education regarding the new rule and to provide foreign facilities with information necessary to maintain the flow of trade to the United States. Other commenters encourage FDA to develop clear, definitive statements that outline registration requirements in a simple manner. Some commenters ask about the role of States in the outreach strategy. One commenter recommends that FDA reach out to State agencies and the relevant media to ensure that all affected industries are aware of the registration requirement. Finally, some commenters request that FDA establish consultation services staffed with both English and foreign language speakers to answer questions about the registration system and requirements and to give technical assistance to help foreign facilities meet the requirements of the regulation. (Response) FDA conducted extensive outreach on the proposed registration rule, including having relevant FDA staff attend 6 international meetings and over 100 domestic meetings to ensure that affected parties were aware of the Bioterrorism Act registration requirement. On January 29, 2003, FDA held a public meeting (via satellite downlink) to discuss the registration and prior notice proposed rules. (See 68 FR 1568, January 13, 2003, or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 n |
