FOOD & DRUG LAW Bioterrorism News FDA FOOD FACILITIES COMPLIANCE INFORMATION 04/06 FDA has published a compliance information document about the registration of food facilities. FDA stated it did so to provide it with adequate and reliable information about food and feed facilities in order to aid in the detection and quick response to actual or potential threats to the U.S. food supply. For more details see: http://www.cfsan.fda.gov/~furls/ffregsum.html 09/05 PRIOR NOTICE REJECTS 06/05 FDA and Customs have distributed yet another bulletin reminding the trade, there are too many repetitive prior notice rejects. Not surprisingly, the single biggest reason for rejects is registration related data. The biggest dilemma arises when the FDA manufacturer does not match the prior notice registration as to the ISO country or origin, name or address. What steps are you taking to make sure you are providing proper data? Busy Times for FDA and CBP   to download document in PDF format FDA Security Surveillance   to download document in PDF format FDA's Version of C-TPAT  for a printable version of this article 3/05 With passage of the Bioterrorism Act, FDA gained additional authorities related to food safety and security. See e.g., Bioterrorism Act §§ 303-309.  More significantly, the Bioterrorism Act amended the Food Drug & Cosmetic Act (FDCA) to require FDA to focus its imported food examinations on shipments where the agency is more likely to discover intentional adulteration of food. Specifically, section 302(a) of the Bioterrorism Act amended section 801 of the FDCA, adding new subsection (h)(1), which states: The Secretary shall give high priority to increasing the number of inspections under . . . section [801] for the purpose of enabling the Secretary to inspect food offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of food.  21 USC 381(h)(1) (emphasis added). Furthermore, Congress has mandated that FDA facilitate importation of certain foods into the U.S. BTA section 302(a) also added new subsection (h)(2) to FDCA section 801, which states: The Secretary shall give high priority to making the necessary improvements to the information management systems of the Food and Drug Administration that contain information related to foods imported or offered for import into the United States for purposes of improving the ability of the Secretary to allocate resources, detect the intentional adulteration of food, and facilitate the importation of food that is compliance with this Act.  21 USC 381(h)(2)  (emphasis added). Under section 302, foreign food manufacturers and exporters, and U.S. importers, have an argument available to them for the first time to pursue reduced FDA screening rates of their shipments crossing U.S. borders. Quality, safety and security management programs reducing the risk that imported foods violates the FDCA become the basis for seeking facilitation of the importation. Documenting Food Safety/Security Compliance Many foreign food companies are already in substantial compliance with FDA's requirements in sourcing raw materials, implementing manufacturing standards, routinely assessing and mitigating food security-related risks, and have developed relationships with shipping and transportation companies that enable distribution through secure supply chains. Documenting these controls can provide the basis for FDA to pass over shipments from such companies, as long as the agency is able to distinguish their shipments from unknown shippers/manufacturers or from those shipments for which the agency can clearly articulate a higher risk. Documentation may be accomplished through a combination of: third party certification by accredited international third party inspection companies to confirm conformance to regulatory requirements; verification of compliance through inspections by other U.S. federal agencies (e.g., Department of Defense or USDA); integration of independent private laboratory testing as validation of food GMPs, HACCP, and Sanitation SOPs; and inspection reports from home government inspectorates. For example, a 302 program might evaluate: a foreign manufacturer's receipt, testing and acceptance of raw materials; implementation of food GMPs, Codex Alimentarius standards and guidelines, or HACCP, as applicable; review of internal laboratory analysis procedures and quality control systems; SSOP and documentation review; pre-shipment inspection for quality and security at point of origin prior to export to the U.S.; use of C-TPAT certified shippers and transporters; As these steps are documented and the agency shifts from a transactional import model (reviewing and evaluating entry data or prior notice data only) to a life-cycle risk mitigation approach, FDA will have more reliable data to demonstrate compliance with food safety and security requirements and guidances to justify expedited release upon entry. While it is true section 302 is focused strictly on food importations, the very elements of FDA's version of C-TPAT can be brought to bear on other products subject to the agency's jurisdiction.   Final Rule:  Record Keeping under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002  for a printable version of this article On December 9, 2004, the U.S. Food and Drug Administration (FDA or “agency”) published in the Federal Register final regulations on the establishment and maintenance of records for food “non-transporters” and “transporters” under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act”). See Final Regulation Implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—Establishment and Maintenance of Records for Foods, 69 FR 71562 (Dec. 9, 2004) (“Record Keeping Rule”) (also available at: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket .access.gpo.gov/2004/pdf/04-26929.pdf) (last viewed Dec. 10, 2004); see also Pub. Law 107-188 (June 12, 2002).   On the same date, FDA issued guidance explaining the circumstances in and procedures by which FDA intends to request access to records under the Bioterrorism Act’s record keeping authorities.  See Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security Bioterrorism Preparedness and Response Act of 2002, at http://www.cfsan.fda.gov/~dms/secgui12.html (Dec. 9, 2004) (last viewed Dec. 10, 2004) (Guidance).  The first notice sets forth the regulations (21 CFR §§1.326-1.368) that implement FDA’s new record keeping requirements imposed by the Bioterrorism Act on persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States.  A number of exclusions are available under the regulations, which are identified briefly below.  These regulations require both non-transporters and transporters to establish and maintain certain records that will allow FDA to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, when FDA has “a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.” Note that these regulations focus on FDA’s requirements for the covered entities to establish and maintain certain information/records for food as well as the covered entities whose records are to be made available for viewing and copying upon the agency’s request when the evidentiary burden is met.  On the same date, FDA also issued a draft guidance document, Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, that represents FDA’s “current thinking” vis-à-vis its access to and copying of food distribution records when FDA believes the food to be adulterated and to present a threat to health under the Bioterrorism Act.  Note that the Guidance document only relates to FDA’s access to information/records for food FDA believes presents a threat of serious adverse consequences or death.  The Guidance itself does not require the creation of any documents/records, although the information/records covered by the Guidance may be information/records that the newly issued record keeping regulations require to be established maintained.   The new regulations and Draft Guidance both relate to and implement food record keeping authority established by the Bioterrorism Act and both are triggered by the same circumstances—namely,  …if (1) The Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (2) the records are necessary to assist FDA in making such a determination. 69 FR at 71657.    The newly published regulations are final rules that will be the subject of public meetings in early 2005 at which FDA will explain them.  We will be attending the first public meeting, scheduled for January 13, 2005, and will provide our analysis of FDA’s discussion upon your request.  Highlights of the Final Regulations  The following significant observations are readily observable from the current record keeping proposal:  Persons that manufacture, process, pack, transport, distribute, receive, hold or import food are subject to the access provisions of the regulation for records that such persons have regarding the packaging of their food.  That is, if you perform one of the above activities, you are not only required to establish and maintain records related to your food, and to grant FDA access to those records when the agency has the appropriate level of evidence to support a request for access, but you are also required to grant access to any records you may have respecting your food’s packaging (packaging includes the outer packaging of food that bears the label and does not contact the food directly);  FDA’s requirement to establish and maintain a record keeping system applies to any person, subject to certain exclusions identified below, who manufactures, processes, packs, transports, distributes, receives, holds, or imports food in the United States regardless of whether the food is intended for consumption in the United States; FDA’s definition of processing is remarkably broad, reaching washing, freezing, cooling, packaging, and labeling of food; These regulation do not apply to:  Farms Restaurants Persons performing activities on foods that are exclusively regulated by the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA); or Foreign persons, except such persons who are transporting food in the United States    The following facilities are excluded from the provisions requiring the establishment and maintenance of a records system but are not excluded from the records availability requirements: Fishing vessels not engaged in processing; Retail food establishments employing ten or fewer full time employee; Non-profit food establishments; and Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food contact surfaces other than the finished container that directly contacts the food   Non-transporters of food are defined as persons who “own foodor” who “hold, manufacture, process, pack, import, receive or distribute food for purposes other than transportation.” The disjunctive in this sentence reaches owners of food in the United States, who are not otherwise excluded from the regulation, whether or not the activity they conduct relates to such food. (emphasis added);  Transporters of food are defined as persons who have possession, control, or custody of food in the United States solely for the purpose of transporting that food.  The requirements for transporters apply equally to foreign persons who transport food in the United States, regardless of whether they have possession, custody, or control of the food for the sole purpose of transporting that food;   Retail establishments that also sell to persons other than consumers (i.e., facilities that sell food to both consumers and non-consumers) are subject to the record keeping requirements, with respect to their non-consumer sales, “only to the extent the information is reasonably available;”  Persons who manufacture, process, pack, transport, distribute, receive, hold or import food contact substances, other than the finished container, are exempt from the regulation except the access and availability provisions.  However, persons who “place food directly in contact with its finished container” are subject to all of the record keeping regulatory requirements;  Although restaurants are excluded from the regulation’s requirements, a “restaurant” is defined as a facility that “prepares and sells” food directly to consumers for immediate consumption. (emphasis added); and   Persons who distribute food directly to consumers are not required to establish and maintain records as to the food so distributed, but must establish and maintain records for food distributed to non-consumers. General Requirements Under the Record-keeping Regulations:  21 CFR Part 1, Subpart J—Establishment, Maintenance, and Availability of Record (§§1.326-1.368)  The regulations identify the specific information that covered persons are required to establish and maintain.  The required information is different for transporters and non-transporters of food. Non-transporters of food are required to establish and maintain specific detailed information about the food they receive, about the previous source of that food, and about the transporters that deliver that food to them.  Non-transporters of food are also required to establish and maintain specific detailed information about the food they release, about the nontransporters to whom they release the food, and about the transporters who transport the released food. Additionally, the records of these non-transporters must include information available to them that identifies the specific source of each ingredient used to make every lot of finished product they release.  Transporters of food are required to establish and maintain detailed information about each food they transport in the U.S.—whether by road, rail, air, or water. Transporters may fulfill the requirements for this information in a number of alternative ways, including:  Establishing and maintaining the records required by this regulation; Establishing and maintaining specified information that is in the records required of roadway interstate transporters by the Department of Transportation’s (DOT) Federal Motor Carrier Safety Administration (FMCSA) contained in 49 CFR  373.101 and 373.103 as of the date of publication of this final rule; or Establishing and maintaining specified information that is in the records required of rail and water interstate transporters by the DOT’s Surface Transportation Board (STB) contained in 49 CFR 1035.1 and 1035.2 as of the date of publication of this rule; or Establishing and maintaining specified information that is in the records required of international air transporters on air waybills by the Warsaw Convention as Amended at the Hague, 1995 and by Protocol No. 4 of Montreal, 1975 (Warsaw Convention); or Entering into an agreement with a nontransporter immediate previous source (if located in the United States) or immediate subsequent recipient (if located in the United States) to establish, maintain, or establish and maintain, the records required under the authority of the FMCSA or the STB. The agreement must contain the elements specified in §1.352(e).  Records Required to be Established and Maintained  The following records, or information contained in records, must be established and maintained by non-transporters of food:  If you are a non-transporter, the following records must be established and maintained: The name of the firm, address, telephone number and, if available, the fax number and e-mail address of the non-transporter immediate previous source, whether domestic or foreign; The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the non-transporter immediate subsequent recipient, whether domestic or foreign; An adequate description of the type of food received or released, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce); The dates you received and released the food; For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists); The  quantity and how the food is packaged (e.g., 6 count bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal) tank); The  name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate previous source (the transporter who transported the food to you); The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate subsequent recipient (the transporter to whom you released the food); and For non-transporters who release food in the United States, your records must include information reasonably available to you to identify the specific source of each ingredient used to make every lot of finished product.  If you are a transporter, you must establish and maintain the following records for all food you receive or release:  Names of the transporter’s immediate previous source and immediate subsequent recipient; Origin and destination points; Date shipment received and date released; Number of packages; Description of freight; The Route of movement during the time you transported the food; and Transfer point(s) through which shipment moved;  The regulations do not require the creation of new documents or duplication of existing records if the information is already contained in existing records. If the information does not already exist, new records with the requisite information must be created at the time of receipt and release of the food.  The regulations do not require covered entities to establish or maintain records, or to make available records, that are:  “recipes for food; financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).”   The regulations set forth the record retention periods for the required information.  There are different record retention periods whether or not one is a transporter. The retention periods are as short as six (6) months and as long as two (2) years after the date on which the food is received or released.  The length of each retention period relates to the type of entity (non-transporter or transporter) and the degree of risk of spoilage, loss of value, or loss of palatability for the food to which the records relate.  Access to Records  The persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S., and who are required by these regulations to establish/maintain the specific records/information required, must make these records/information “readily available for inspection and photocopying or other means of reproduction . . . as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.”  21 CFR §1.361.  FDA is authorized to gain access to these records “[w]hen FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.”  Section 1.363 provides that failure to comply with the requirements of these new regulations is a prohibited act under section 301 of the Food Drug and Cosmetic Act.  Draft Guidance for Records Access Authority:    The December 9, 2004 Federal Register Notice of the availability of this draft guidance indicates that it “is intended to clarify the circumstances under which FDA may access and copy records under the [Bioterrorism Act]…and establishes procedures to exercise its authority.” 69 FR 71657.    Section B of The Draft Guidance addresses the question, “What records may investigators access and copy under the Bioterrorism Act’s authority?”  Guidance at 3.  Depending upon the circumstances, FDA’s authority … may apply to some or all records that are required to be kept by [the new recordkeeping regulations], as well as any other appropriate records already maintained by the entity.  Records associated with an article(s) of food that meet the statutory criteria will be requested.  These records may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such food that are maintained by or on behalf of an entity subject to the recordkeeping regulation. The records may be in any format (including paper and electronic formats) and at any location.  Because the circumstances of a particular event are case specific, the scope of a record request will vary on a case-by-case basis.  Id. at 3-4 (emphasis added).   Section D addresses the procedures FDA will follow when it is necessary to access records under the authority of the Bioterrorism Act and pursuant to the new food record-keeping regulations.  It describes certain FDA internal procedures, including specific internal notifications, concurrences, consultations, and coordination.  See id., section D, at 4.   Section E of the Draft Guidance answers the question, “How does FDA intend t o make a request to access or copy records under the Bioterrorism Act?” in this way:  Once FDA … makes the necessary determination, an investigator or other FDA personnel upon presentation of credentials will submit a written notice, FDA 482 – Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and FDA’s legal authority to obtain these records.  FDA may request additional records related to the implicated food article at a later time under the same authority.  Id. at 4.  The Draft Guidance addresses the issue of confidentiality of “protected information in records it obtains. Basically, FDA invokes its general statutory and regulatory authority to obtain and obligation to protect certain “non-public confidential commercial or trade secret information.”  It states that “FDA personnel may disclose non-public information otherwise protected from disclosure to the public, if that disclosure is permitted by law and FDA’s procedures.”  Guidance at 5.  Effective Dates  This regulation is effective February 7, 2005; the compliance date is December 9, 2005 except for small businesses (with between 11 and 499 employees) have until June 9, 2006, and for very small businesses (with between 1 and 10 employees) until December 9, 2006.   *    *     * If you have any questions regarding the foregoing, please do not hesitate to contact us.   Customs Update:  New FDA Record-keeping Rules  (Published in the Journal of Commerce Online Dec. 28, 2004)  for a printable version of this article In the Dec. 9, 2004 Federal Register, the U.S. Food and Drug Administration (FDA) published final regulations regarding the establishment and maintenance of records for food "non-transporters" and "transporters" under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"). This notice sets forth the regulations implementing FDA's new record keeping requirements which are imposed on persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States (covered entities). A number of exclusions are available under the regulations, which are identified briefly below. These regulations require both non-transporters and transporters to establish and maintain certain records that will allow FDA to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, when FDA has "a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals." Note that these regulations focus on FDA's requirements for the covered entities to establish and maintain certain information/records for food as well as those entities whose records are to be made available for viewing and copying upon the agency's request when the evidentiary burden is met. On the same date, FDA also issued a document, Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, that represents FDA's "current thinking" vis-à-vis its access to and copying of food distribution records when FDA believes the food to be adulterated and to present a threat to health under the Bioterrorism Act. The Guidance document only relates to FDA's access to information/records for food FDA believes presents a threat of serious adverse consequences or death. The Guidance itself does not require the creation of any documents or records, although the information or records covered by the Guidance may be information or records that the newly issued record keeping regulations require to be established and maintained. The new regulations and Draft Guidance both relate to and implement food record keeping authority established by the Bioterrorism Act and both are triggered by the same circumstances, namely: ... if (1) The Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (2) the records are necessary to assist FDA in making such a determination. 69 FR at 71657. The newly published regulations are final rules that will be the subject of public meetings in early 2005 at which time FDA will explain them in further detail. The first such meeting is scheduled for Jan. 13, 2005. Highlights of the Final Regulations The following significant points are readily observable from the current record keeping proposal: * If you manufacture, process, pack, transport, distribute, receive, hold or import food, you are required to establish and maintain records related to your food, and to grant FDA access to those records when the agency has the appropriate level of evidence to support a request for access, but you are also required to grant access to any records you may have respecting your food's packaging (packaging includes the outer packaging of food that bears the label and does not contact the food directly) * FDA's requirement to establish and maintain a record keeping system applies to any person, subject to certain exclusions identified below, who manufactures, processes, packs, transports, distributes, receives, holds, or imports food in the United States regardless of whether the food is intended for consumption in the United States; * FDA's definition of processing is remarkably broad, reaching washing, freezing, cooling, packaging, and labeling of food; * These regulation do not apply to: o Farms o Restaurants o Persons performing activities on foods that are exclusively regulated by the U.S. Department of Agriculture under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA); or o Foreign persons, except such persons who are transporting food in the United States (for example, Canadian or Mexican trucking companies or railroads); * The following facilities are excluded from the provisions requiring the establishment and maintenance of a records system but are not excluded from the records availability requirements: o Fishing vessels not engaged in processing o Retail food establishments employing 10 or fewer full-time employees o Non-profit food establishments o Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food contact surfaces other than the finished container that directly contacts the food Put another way, these entities are not required to establish and maintain records, but if they have them, they are required to provide them to the FDA upon request. * Non-transporters of food are defined as persons who "own food or" who "hold, manufacture, process, pack, import, receive or distribute food for purposes other than transportation." The disjunctive in this sentence reaches owners of food in the United States, who are not otherwise excluded from the regulation, whether or not the activity they conduct relates to such food. * Transporters of food are defined as persons who have possession, control, or custody of food in the United States solely for the purpose of transporting that food. The requirements for transporters apply equally to foreign persons who transport food in the United States, regardless of whether they have possession, custody, or control of the food for the sole purpose of transporting that food. * Retail establishments that also sell to persons other than consumers (i.e., facilities that sell food to both consumers and non-consumers) are subject to the record keeping requirements, with respect to their non-consumer sales, "only to the extent the information is reasonably available." * Persons who manufacture, process, pack, transport, distribute, receive, hold or import food contact substances, other than the finished container, are exempt from the regulation except the access and availability provisions. However, persons who "place food directly in contact with its finished container" are subject to all of the record keeping requirements. * Restaurants are defined as a facility that "prepares and sells" food directly to consumers for immediate consumption and are excluded from the regulation's requirements. * Persons who distribute food directly to consumers are not required to establish and maintain records as to the food so distributed, but must establish and maintain records for food distributed to non-consumers. General requirements under the record keeping regulations The regulations identify the specific information covered persons are required to establish and maintain and is different for transporters and non-transporters of food. * Non-transporters of food are required to establish and maintain specific detailed information about the food they receive, about the previous source of that food, and about the transporters who deliver that food to them. * Non-transporters of food are also required to establish and maintain specific detailed information about the food they release, about the non-transporters to whom they release that food, and about the transporters who transport the released food. Additionally, the records of these non-transporters must include information available to them which identifies the specific source of each ingredient used to make every lot of finished product released. * Transporters of food are required to establish and maintain detailed information about each food they transport in the U.S. -- whether by road, rail, air, or water. Transporters may fulfill the requirements for this information in a number of alternative ways, including: o Establishing and maintaining the records required by this regulation; o Establishing and maintaining specified information that is in the records required of roadway interstate transporters by the Department of Transportation's Federal Motor Carrier Safety Administration as contained in 49 CFR 373.101 and 373.103 as of the date of the final rule's publication; or o Establishing and maintaining specified information that is in the records required of rail and water interstate transporters by the DOT's Surface Transportation Board contained in 49 CFR 1035.1 and 1035.2 as of the same date of publication; or o Establishing and maintaining specified information that is in the records required of international air transporters on air waybills by the Warsaw Convention as Amended at the Hague, 1995 and by Protocol No. 4 of Montreal, 1975; or o Entering into an agreement with a non-transporter's immediate previous source (if located in the United States) or immediate subsequent recipient (if located in the United States) to establish, maintain, or establish and maintain, the records required under the authority of the FMCSA or the STB. Records required to be established and maintained The following records, or information contained in records, must be established and maintained. For the non-transporter, the following records must be established and maintained: * The name of the firm, address, telephone number and, if available, the fax number and e-mail address of the non-transporter's immediate previous source, whether domestic or foreign; * The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the non-transporter's immediate subsequent recipient, whether domestic or foreign; * An adequate description of the type of food received or released, to include brand name and specific variety (e.g., Brand X cheddar cheese, not just cheese; or romaine lettuce, not just lettuce); * The dates the food was received and released; * For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists); * The quantity and how the food is packaged (e.g., six-count bunches, 25 pound (lbs.) carton, 12 ounce (oz.) bottle, 100 gallon (gal.) tank); * The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter's immediate previous source (the transporter who transported the food to you); * The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter's immediate subsequent recipient (the transporter to whom you released the food); and * For non-transporters who release food in the United States, your records must include information reasonably available to you to identify the specific source of each ingredient used to make every lot of finished product. Transporters must establish and maintain the following records for all food received or released: * Names of the transporter's immediate previous source and immediate subsequent recipient; * Origin and destination points; * Date shipment received and date released; * Number of packages; * Description of freight; * Route of movement during the time the food was transported; and * Transfer point(s) through which shipment moved. The regulations do not require the creation of new documents or duplication of existing records if the information is already contained in existing records. If the information does not already exist, new records containing the requisite information must be created at the time of receipt and release of the food. The regulations do not require covered entities to establish or maintain records, or to make available records, that are: "recipes for food; financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales)." The regulations set forth the record retention periods for the required information and are different whether one is a transporter or a non-transporter. The retention periods are as short as six (6) months and as long as two (2) years after the date on which the food is received or released. The length of each retention period relates to the type of entity and the degree of risk of spoilage, loss of value, or loss of palatability for the food to which the records relate. Access to records Persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S., and who are required by these regulations to establish or maintain the specific records or information required, must make them available for copying no later than 24 hours from receipt of an official written request by a duly designated agency employee. Failure to comply is considered a prohibited act under section 301 of the Food, Drug and Cosmetic Act. Draft Guidance for Records Access Authority: The Dec. 9, 2004 Federal Register Notice about the draft guidance indicates that it "is intended to clarify the circumstances under which FDA may access and copy records under the [Bioterrorism Act]...and establishes procedures to exercise its authority." "What records may investigators access and copy under the Bioterrorism Act's authority?" Depending upon the circumstances, FDA's authority ... may apply to some or all records that are required to be kept by [the new recordkeeping regulations], as well as any other appropriate records already maintained by the entity. Records associated with an article(s) of food that meet the statutory criteria will be requested. These records may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such food that are maintained by or on behalf of an entity subject to the recordkeeping regulation. The records may be in any format (including paper and electronic formats) and at any location. Because the circumstances of a particular event are case specific, the scope of a record request will vary on a case-by-case basis. "How does FDA intend to make a request to access or copy records under the Bioterrorism Act?" Once FDA...makes the necessary determination, an investigator or other FDA personnel upon presentation of credentials will submit a written notice, FDA 482 - Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and FDA's legal authority to obtain these records. FDA may request additional records related to the implicated food article at a later time under the same authority. The Draft Guidance addresses the issue of confidentiality of "protected information in records it obtains." Basically, FDA invokes its general statutory and regulatory authority to obtain and obligation to protect certain "non-public confidential commercial or trade secret information." It states that "FDA personnel may disclose non-public information otherwise protected from disclosure to the public, if that disclosure is permitted by law and FDA's procedures." Effective dates This new record keeping regulation is effective Feb. 7, 2005; the compliance date is Dec. 9, 2005, except small businesses (with between 11 and 499 employees) have until June 9, 2006, and for very small businesses (with between one and 10 employees) until Dec. 9, 2006.   MORE FDA CHANGES 08/04 During the AIDS crisis in the 1980s, many of those struck with that illness were able to import experimental drugs by relying on an exemption in the FDA's Regulatory Procedures Manual. It allowed the importation of unapproved drugs provided the amount involved was no more than a three (3) month supply. Of course, in many instances there were problems meeting that requirement as often American officials could not figure out the strength/dosage which qualified as a three (3) month supply. In the latest version of the Regulatory Procedures Manual issued in May 2004, FDA has changed this long-standing policy. Now Customs/FDA is to consider whether the treatment of a serious condition is involved and whether the product (drug, device, etc.) involves a significant health risk. Additional factors to be considered are whether effective treatment exists domestically, the parties distributing the product do not commercialize or promote it to U.S. residents, the product does not represent an unreasonable risk, the importer attests it is for personal use and provides contact data for his/her doctor AND provides evidence the product is for treatment begun in a foreign country. While the absolute of a three (3) month supply was altered to a recommended limit, it certainly seems that FDA has substantially changed the ground rules! Some would argue Big Pharma won another round! What do you think? REGISTRATION NUMBER WOES 08/04 When one looks at the statistics published by FDA about prior notice filings, it becomes immediately obvious the single biggest problem for filers is inaccurate registration numbers. From the beginning, American importers have cautioned the agency that without some way to confirm the correctness of the numbers provided by shippers, U.S. importers cannot be sure of the accuracy of the data being provided. FDA, quite properly, understands its obligation of confidentiality and has repeatedly acknowledged it is looking into the dilemma faced by American companies. So far, there is no solution. On the other side of the coin, one of the benefits of the FDA registration process is that grey market goods (legitimate product distributed outside normal channels of sale) can no longer enter the U.S. as the grey market buyer does not have the manufacturer's registration number! At the same time, FDA recognizes the legitimacy of importing and in Admin Message 04-1796, Customs announced a stop gap measure - transmit 11 zeros. Of course, this only works until October 31, when full enforcement of registration numbers takes effect. EXPECT FDA CIVIL PENALTIES TO START 06/04 During this phase of enforcement (Phase 3), if no prior notice is filed, goods will be refused admission and a civil penalty from Customs is possible. If prior notice is filed but the information is either inaccurate or untimely, a civil penalty is possible.  On August 13, 2004, penalties will become mandatory for all types of violations regarding prior notice. Are you ready? PRIOR NOTICE STATS 03/04 At a recent public forum, the FDA announced 12 week figures. In round numbers, there were 16,000 prior notice filings through the FDA website and 135,000 through ACS. Of those, 71,000 lines were complete, i.e., there was something entered in each line, not a guarantee the data was correct. In addition, 543 had no data and 64,000 were incomplete. In the end, 692 of the approximately 154,000 prior notices filed were rejected and of those only 11 lines were examined. FDA'S FIRST IMPRESSIONS 02/04   In the first month of operating its Prior Notice system, FDA ended up with approximately 176,000 firms registered, split about equally between foreign and domestic facilities.   There were approximately 65,300 submissions through FDA's Prior Notice (PNSI) portal of which approximately half were formal entries. FDA expects this number to drop as importers and brokers iron out the specifics of their new relationships. At the same time, more than 518,500 ABI Prior Notice submissions were transmitted. FDA identified the major errors as failing to list the actual manufacturer, incorrect registration numbers and failure to list the grower. The single biggest problem was incorrect registration numbers, but FDA still does not have a solution to how one can check FDA's database to determine the accuracy of a given registration number. Customs and FDA are still on track to issue their plan for additional coordination by March. It will be interesting to see if the two agencies figure out a way to reconcile their conflicting advance notice periods. .   EXPECT FDA CIVIL PENALTIES TO START 06/04 During this phase of enforcement (Phase 3), if no prior notice is filed, goods will be refused admission and a civil penalty from Customs is possible. If prior notice is filed but the information is either inaccurate or untimely, a civil penalty is possible.  On August 13, 2004, penalties will become mandatory for all types of violations regarding prior notice. Are you ready? FDA  HOSTS BTA SESSIONS 02/04 Due to the confusion which remains about implementation of its bioterrorism rules, FDA has set a series of outreach meetings in Denver (3/1), Fresno (3/4), El Paso (3/9), Salt Lake City (3/11), Kansas City (3/16), New Orleans (3/18), Raleigh (3/23) and Philadelphia (3/24). For more  details: www.cfsan.fda.gov/~dms/fsbtac18.html. WHAT HAPPENS NOW? 12/03 FDA's bioterrrorism regulations regarding prior notice and registration take effect today. Following the model of Customs' enforcement of the advance manifest rules, the two agencies originally said that education would be the method relied upon to gain compliance until April 2004 at which time enforcement would start. Yesterday, the newly issued Compliance Policy Guide advises that enforcement will be put off until August 12, 2004. As Customs, FDA and industry begin implementation, there are major questions which remain open. For example, how long will it take before FDA's software is able to screen for all the relevant risk factors? How will membership in any of Customs' security programs be factored into FDA's risk assessment? How quickly will FDA's personnel be integrated with Customs' staff at the National Targeting Center?  Will the ABI software upgrades requiring tweaking? If so, how long will it take to get them on line? Then, of course, there is the issue of when will the automatic detention and record keeping regulations be published? Finally, a reminder to all service providers to update their tariffs and service contracts to allow for the assessment of charges related to handling and/or storing FDA related goods if there are problems. MORE RE FDA BIOTERRORISM REGS. 11/03 The registration and prior notice Food & Drug Administration bioterrorism regulations take effect on December 12, 2003. Surprisingly few companies have registered, the last reliable count mentioned publicly was less than 4,000 companies! While both FDA and Customs have said discretion and flexibility will be the standard for the first few months, outright failure to comply will not be tolerated. If you are an importer or a service provider and wonder how these new regulations will impact your operations, check the hot button on our homepage labeled FDA Bioterrorism Regs. We have also posted to our website detailed information about the FDA related services Rodriguez O’DonnellGW now offers - see www.rorlaw.com. NEW FDA BIOTERRORISM REGS. 10/03 On October 10, 2003, FDA published what it is calling its interim final regulations regarding registration and prior notice. The agency took to heart the over 300 comments received and greatly improved the process, including finding ways with Customs and Border Protection in which the two agencies could work closely together to the benefit of both government and industry. Prior notice was originally required to be filed by noon the day before arrival. Now, the time frames are two (2) hours by truck, four (4) hours by rail and air, and eight (8) hours by ocean. For summaries of both sets of regulations, visit the Bioterrorism section. FDA MANDATES APPOINTMENT OF U.S. AGENT IN NEW REGS. 10/03 In its February prior notice proposal, FDA made appointment of a U.S. agent optional. In the prior notice materials published in October, FDA has mandated that foreign food suppliers appoint U.S. agents. FDA has defined the role of the agent as a conduit for information. However, since the agency may request formulas, methods of doing business, and American buyer data, most foreign suppliers are expected to be unwilling to appoint one of their American buyers. Instead, they are expected to ask U.S. based customs brokers or freight forwarders to act as their U.S. agents. To assist, we have developed an Appointment of U.S. Agent contract.   FDA REGISTRATION 9/03 As the time approaches for companies to register with the FDA, there is still no official word on the role of the U.S. agent. However, past history suggests there will be no liability to the FDA unless information is not timely and accurately transmitted from the shipper. FDA UPDATE 6/03 When FDA announced its prior notice regulations last April, the trade was caught off-guard by a proposal that the agency would build its own computer system. It turns out there was a miscommunication between FDA and Customs which took intervention from the trade to resolve. The good news is Customs and FDA have now worked out a way to allow importers to provide the required data to FDA through the existing Customs computer system. Separate and apart from that event, in the May 9, 2003 Federal Register, FDA published the last of the two major regulatory changes expected under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 which deal with record keeping and detention of goods.  Regulations regarding these two topics, along with the previously announced prior notice and registration provisions, will become effective no later than December 12, 2003. FDA Issues Alarming New Rules 04/03 In carrying out what is called the Bioterrorism Act (the Public Health Security and Bioterrorism Preparedness and Response Act of 2002) , the FDA has proposed far reaching regulations. One set requires every foreign facility which imports food or has anything to do with food production to register with FDA. The second set of proposed regulations will substantially change the way food importers do business. Under the second proposal, prior notice of importation will now be required for every shipment of food being imported into the U.S.; Customs is also working on a set of prior notice requirements, but these are substantially different. FDA will require notification no later than noon the day prior to importation and the data elements to be reported are identical to the ones your customs broker reports at time of entry. FDA claims it could not get Customs to upgrade its system to facilitate what FDA needed, but one has to ask - how is FDA going to build and program a new computer system in time to accept registration of foreign facilities by October 17, 2003? What happens if the computer system doesn’t work as expected? The new rules take effect on December 12, 2003. FDA admits it expects to receive Prior Notices for 20,000 shipments daily. How is it going to process all that work when it is already horribly backlogged? Customs Update: FDA's New Food Import Measures (Published Apr 8, 2003 - Journal of Commerce Online) CLICK HERE for a printable version of this article. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 resulted in sweeping changes to the legal and regulatory framework under which food importers will now operate.   The Act mandates that by Dec. 12, 2003: (1) All U.S. and foreign facilities that manufacture, process, pack, or hold human or animal food for consumption in the U.S. (including storage facilities such as grain elevators) must register with the Food and Drug Administration (FDA), and that a... (2) Notice of importation, prior to arrival, must be submitted for all imported food products, human and animal, including in-bonds, regardless of whether those products are intended for consumption in the U.S. These requirements go into effect on the stated date whether or not the FDA has issued final rules. The agency is creating a new computer system to handle the incoming data.   Registration provisions Highlights of the FDA proposed rules regarding registration include: 1) All foreign and domestic facilities with operations that have an affect or impact on food must register unless subject to specific exemptions such as farms, fishing vessels that merely transport and harvest fish, or facilities regulated exclusively by the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act. 2) FDA anticipates having a computer system built and operational by Oct. 12, 2003 so that registration takes place electronically. FDA will not accept registrations before the computer system is operational. Registration is a one-time event, requires no fee and must be submitted in English. A foreign facility subject to registration may designate a U.S. agent to register on its behalf. FDA encourages U.S. agents to have written agreements with their foreign vendors which clearly delineate the responsibilities of the parties. 3) Mandatory registration information includes the full name and address of the facility, phone and fax numbers and e-mail address, emergency contact information, trade name(s) used by the facility, name and address of U.S. agent, information about food categories processed, packed or stored at the facility; accompanied by a statement that the information is truthful and the person submitting it as the agent has proper authorization. 4) All changes must be updated within 30 days. 5) If a facility fails to register and is not exempt, that failure to register is considered a prohibited act which allows the government to file civil and/or criminal charges in federal court against the violator. If a felony conviction follows, FDA now has the power to request debarment, meaning that person would be denied the right to import. Similarly if a facility fails to register by Dec. 12, 2003, food from that facility is subject to detention. 6) The obligation to register under these new procedures is separate and apart from any current registration requirements of the FDA or any other government agency. 7) Registration and assignment of a number means only that the facility is properly registered with FDA. Facilities may not claim that a registration number means an approval or endorsement of that facility by FDA. Any such representation in the labeling of a food product will be deemed to misbrand the product. 8) Proprietary information, such as the identity or location of a facility, is protected by the Freedom of Information Act. 9) In these new rules, FDA is not changing the definition of food as previously defined in the Food Drug and Cosmetic Act, but does include some examples: raw agricultural commodities for use as food or components of food; animal feed, including pet food; food and feed ingredients and additives; substances that migrate into food from food packaging and articles that contact food; dietary supplements and dietary ingredients; beverages, including alcoholic beverages. In other words, even those who make goods used in food production may be affected. Prior notice Highlights of the prior notice proposed rules include: 1) "Originating country" is defined as the country from which the article of food originates, e.g. for fresh food, the originating country is where it is grown and harvested; for processed food, such as canned corn, the originating country is where the corn is canned. This rule ignores Customs' substantial transformation principles. "Port of Entry" is the port of first arrival and not where the entry is filed, so again Customs' definition differs. 2) All food that is imported or offered for import into the U.S., whether for consumption by people or animals and regardless of whether destined to stay in or move in-bond through the U.S., must have a prior notice filed. The four (4) exceptions are food carried by an individual traveler for personal consumption, and foods that are subject to the exclusive jurisdiction of USDA under the meat, poultry or eggs protocols mentioned above. 3) The purchaser or importer of an article of food who resides or maintains a place of business in the U.S. is the person authorized to submit prior notice. 4) As proposed, prior notice must be submitted no sooner that five (5) days prior to, and no later than noon the calendar day before the day of arrival. 5) As with the new registration system, FDA is proposing that prior notices be submitted electronically through the computer system to be developed and called FDA's Prior Notice System. As previously indicated, it is expected to be fully operational by Oct. 12, 2003. 6) Prior notice includes the name and address of the submitter and facility registration number if required, Customs entry type and Automated Commercial System (ACS) entry line number, product identity information, originating country, shipper, country of shipping, anticipated arrival information, including port of entry, date of arrival, and time of arrival, Customs entry port and date of Customs entry, plus the identity of the importer or owner and the carrier. 7) Once transmitted, information may only be changed in one of two ways: amendment or update. "Amendments" are allowed for clarification of product identity and "updates" for revision of arrival information. If a different food is added to the shipment, the prior notice process must be restarted. Both types of notice must be submitted at least two (2) hours prior to arrival and must be filed electronically. By way of example, an update would consist of changing the time of arrival of the vessel or other conveyance, whereas an amendment would clarify the number of cans per size of food previously reported. 8) If an article of food is imported or offered for import with no prior notice or inadequate prior notice, it will be refused admission under section 801(m) of the FDA Act. A Prior Notice is inadequate if it is inaccurate, incomplete, or not timely submitted. As with refused admission for failure to be properly registered with FDA under Section 801(l) of the FDA Act, a food that is refused admission under Section 801(m) will be detained at the port of entry. There is no appeal process if an importer contends his prior notice is complete but FDA disagrees. The only option is to start the prior notice process all over again. 9) Refused admission under the prior notice provisions has nothing to do with whether or not food "may proceed" or will be refused admission under the "regular" FDA procedures. 10) Failure to provide adequate prior notice is also a prohibited act and carries with it the same consequences as the failure to register, including criminal or civil proceedings or debarment.   For more details, review the FDA's Federal Register publications: Registration: Feb. 3, 2003 Fed. Reg. Vol. 68, No. 22, Pages 5378-5427. Prior Notice: Feb. 3, 2003, Fed. Reg. Vol. 68, No. 22, Page 5428-5468. Look also for additional regulations in the refused admission and record-keeping area which FDA is expected to propose in the coming months. FDA  Changes Import Rules Drastically - Is It Still Possible to  Import? 04/03 Click here for a summary of the prior notice and registration provisions proposed by FDA. The  comment period ends on April 4, 2003 - let FDA know what you think!