Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry Additional copies are available from: Office of Food Safety Division of Dairy, Egg and Meat Products HFS-306 Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 (Tel) 240-402 -1485 http://www.fda.gov/foodguidances You may submit written comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2016-D-4484 and with the title of the guidance document. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition June 2017 OMB Control No. 0910-0839 Expiration Date: 12/31/2017 *See additional PRA statements in Section III of this guidance
Table of Contents I. Introduction II. Discussion III. Paperwork Reduction Act of 1995 IV. References 2
Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction This guidance document is intended to notify the public of FDA s efforts to help U.S. manufacturers/processors (hereinafter referred to as establishments ) that wish to export milk and milk products, seafood, infant formula, and formula for young children to China. FDA is taking this action in response to China s State General Administration of the People s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145. AQSIQ Decree 145, among other requirements, mandates that foreign competent authorities, including FDA, provide the Certification and Accreditation Administration of China (CNCA) with a name list of overseas manufacturers of imported food applying for registration with CNCA for commodities that CNCA has deemed to require registration. Milk and milk products, seafood, infant formula, and formula for young children are among the commodities for which registration of overseas manufacturers is required under AQSIQ Decree 145. China has recognized FDA as the competent food safety authority in the United States to establish and maintain the lists of U.S. establishments that intend to export U.S. milk and milk product, seafood, infant formula, and/or formula for young children to China, and the corresponding products for each establishment intended for export to China. 3
This guidance document revises a guidance document issued in January 2014 entitled Guidance for Industry: Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China to add seafood, infant formula, and formula for young children and to clarify the procedures for establishing and maintaining the lists for each type of product. This revised guidance document explains how establishments should apply to be included on FDA s lists of exporters to China, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. II. Discussion A. Applications for Inclusion on FDA s Lists of Establishments Applying to Register with China For the purpose of identifying U.S. food product establishments wishing to apply to register with China, we are establishing and maintaining lists identifying U.S. milk and milk product, seafood, infant formula, and formula for young children establishments that: 1. Have expressed to FDA their interest in exporting one or more of these types of products to China; 2. Are subject to the jurisdiction of the Federal Food, Drug, and Cosmetic Act and relevant FDA regulations, have been found by FDA to be in good regulatory standing with FDA, and have, during the most recent facility inspection, been found to be in substantial compliance with all applicable FDA regulations, including, but not limited to, current good manufacturing practice requirements for the identified products for export to China; and 3. Have been certified by an acknowledged third-party certification body to meet the relevant standards, laws, and regulations of China for the identified food products for export to China. FDA provides the following guidance regarding the criteria FDA will evaluate in determining whether to add establishments to the applicable list of establishments with interest in exporting to China. 1. Expressing interest in exporting products to China a. Milk and milk products FDA requests that U.S. milk and milk product establishments provide certain information, as detailed below, if they currently export, or intend in the near future to export, their milk and milk 4
products to China and wish to be included on the list. For purposes of this guidance, we consider the terms milk product and milk products to include any milk product as defined in 21 CFR 1240.3(j), or products which are considered milk products under AQSIQ Decree 145. 1 Also note that CNCA requires that U.S. establishments exporting pasteurized milk, sterilized milk, modified milk, other disinfection milk, fermented milk, or flavored fermented milk provide an Establishment Registration Application 2 with additional information directly to CNCA. To either update the information included on the list or to be initially included on the list, the following information should be submitted through the FDA Unified Registration and Listing Systems (FURLS) Dairy Listing Module (DLM) found at https://www.access.fda.gov/oaa/logonflow.htm?execution=e1s1: 1. Parent company name and address the parent company name and physical address of the requesting establishment; 2. Name and address to be listed the name and physical address that will be provided to China (if different from the parent company name and address, this information must be part of a food facility's registration information); 3. Contact information the name, mailing address, email, telephone number, and fax number (if available) of the designated contact person for the requesting establishment; 4. Food Establishment Identifier (FEI), Food Facility Registration (FFR) numbers and establishment type, or other government-assigned plant identifier (if applicable); 5. List of products a list of products the establishment intends to export and/or currently exports to China, including the Schedule B/Harmonized Tariff Schedule (HTS) number, the unit of measure, the quantity, and the value of goods for all products expected to ship within the next two years; 6. Name of any governmental agencies that inspect the plant, date of last inspection, copy of last inspection notice, and, if other than an FDA inspection, copy of last inspection report; and 7. A written statement acknowledging that the firm or individual(s) representing the firm submitting the request to the FDA realize that they are subject to the provisions of Title 18 of the United States Code, Section 1001, which states that it is a criminal offense to knowingly and willfully make false statements of material fact to a United States government official in the performance of the official s duties. 1 For further information about the type of products covered under AQSIQ Decree 145, see (In Chinese) http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/tzgg/201604/t20160401_50869.html. 2 See the CNCA Import Pasteurized Milk Production Enterprise Registration Information Confirmation Form available (in Chinese) at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201504/p020150628608704650382.pdf and CNCA Imported Dairy Products (Sterilized Milk, Modified Milk, and Other Disinfection Milk) Offshore Production Enterprises Registration Information Confirmation Form available (in Chinese) at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201504/p020150628608704348839.pdf and CNCA Imported Dairy Products (Fermented Milk and Flavored Fermented Milk) Offshore Production Enterprises Registration Information Confirmation Form available (in Chinese) at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201608/p020160830369625777905.pdf 5
b. Seafood products We request that U.S. seafood establishments provide certain information, as detailed below, if they currently export, or intend in the near future to export, their seafood products to China and wish to be included on the list (see footnote 1 for further information about the type of products covered under AQSIQ Decree 145). To either update the information included on the list or to be initially included on the list, we ask that you contact your FDA District Coordinator found at https://www.fda.gov/food/guidanceregulation/importsexports/exporting/ucm129962.htm and provide the following information: 1. Parent company name and address the parent company name and physical address of the requesting establishment; 2. Name and address to be listed the name and physical address that will be provided to China (if different from the parent company name and address, this information must be part of a food facility's registration information); 3. Contact information the name, mailing address, email, telephone number, and fax number (if available) of the designated contact person for the requesting establishment; 4. Food Establishment Identifier (FEI), Food Facility Registration (FFR) numbers and establishment type (e.g., M, R), or other government-assigned plant identifier (if applicable); 5. List of products a list of products the establishment intends to export and/or currently exports to China, including the Schedule B/HTS number, the unit of measure, the quantity, and the value of goods for all products expected to ship within the next two years; and 6. A written statement acknowledging that the firm or individual(s) representing the firm submitting the request to the FDA realize that they are subject to the provisions of Title 18 of the United States Code, Section 1001, which states that it is a criminal offense to knowingly and willfully make false statements of material fact to a United States government official in the performance of the official s duties. c. Infant formula and formula for young children We request that U.S. infant formula and formula for young children establishments provide certain information, as detailed below, if they currently export, or intend in the near future to export, their infant formula and/or formula for young children to China and wish to be included on the list. For purposes of this guidance, the term infant refers to persons 0 to 12 months of age, 3 and the term young children refers to children 12 to 36 months of age. 4 Note that 3 See National Standards on Food Safety of P.R. China: National food safety standard, Infant formula, issued by the Ministry of Health of the People s Republic of China, March 26, 2010, available at http://china.nlambassade.org/binaries/content/assets/postenweb/c/china/zaken-doen-inchina/2013/productstandaarden-zuivel/gb10765-2010-infant-formula.pdf. 4 See National Standards of People s Republic of China: National food safety standard, Older infants and young children formula, issued by the Ministry of Health of the People s Republic of China, March 26, 2010, available at http://china.nlambassade.org/binaries/content/assets/postenweb/c/china/zaken-doen-inchina/2013/productstandaarden-zuivel/gb10767-2010-older-infants-and-young-children-formula.pdf. 6
depending on the intended use of the product, a formula could satisfy the definition of both infant formula and formula for young children. Also note that CNCA requires that U.S. infant formula and formula for young children establishments provide directly to CNCA an Infant Formula Export Application. 5 To either update the information included on the list or to be initially included on the list, we ask that you provide the following information in an email to CFSANExportCertification@fda.hhs.gov: 1. Parent company name and address the parent company name and physical address of the requesting establishment; 2. Name and address to be listed the name and physical address that will be provided to China (if different from the parent company name and address, this information must be part of a food facility's registration information); 3. Contact information the name, mailing address, email, telephone number, and fax number (if available) of the designated contact person for the requesting establishment; 4. Food Establishment Identifier (FEI), Food Facility Registration (FFR) numbers and establishment type, or other government-assigned plant identifier (if applicable); 5. List of products a list of products the establishment intends to export and/or currently exports to China, including the Schedule B/HTS number, the unit of measure, the quantity, and the value of goods for all products expected to ship within the next two years; 6. A written statement attesting that the information provided to CNCA in the form of the Infant Formula Export Application (discussed previously and in footnote 2) is not inconsistent with information provided to or obtained by FDA as the competent authority; 7. If applicable, the Infant Formula Notification (IFN) number associated with each infant formula product; and 8. A written statement acknowledging that the firm or individual(s) representing the firm submitting the request to the FDA realize that they are subject to the provisions of Title 18 of the United States Code, Section 1001, which states that it is a criminal offense to knowingly and willfully make false statements of material fact to a United States government official in the performance of the official s duties. 2. Evaluating good regulatory standing with FDA, including substantial compliance with applicable FDA regulations In evaluating good regulatory standing with FDA, we intend to review regulatory information relating to each establishment that has expressed interest in exporting milk and milk products, seafood, infant formula, and/or formula for young children to China. We consider good regulatory standing to mean that the establishment is not the subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending administrative action (e.g., warning letter). 5 See the CNCA Infant Formula Export Application available at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201407/p020150628608703568896.doc. 7
Establishments that are in good regulatory standing will be considered for inclusion on the list. FDA intends to deny listing a firm if the firm is not in good regulatory standing. In evaluating good regulatory standing, we further intend to evaluate each establishment interested in exporting products to China to ensure substantial compliance with applicable FDA regulations. In evaluating substantial compliance with applicable FDA regulations, we intend to ensure that, during the most recent facility inspection by FDA, or by another federal agency, or by state or local government regulatory agency acting under contract with FDA, the firm has been found to be in substantial compliance with all applicable FDA regulations, including, but not limited to, all applicable current good manufacturing practice requirements. We consider substantial compliance to mean that the most recent inspection identified no significant violations or, if such violations were identified, that the establishment has rectified such violations and provided evidence, to FDA s satisfaction, to prevent the recurrence of any violations. In the alternative, for milk and milk products as defined in 21 CFR 1240.3(j), we consider substantial compliance to include milk and milk product establishments that are on the Interstate Milk Shippers List or the U.S. Department of Agriculture list, Dairy Plants Surveyed and Approved for USDA Grading Service, for the products intended to ship. Additionally, for establishments that have expressed interest in exporting infant formula products to China that are subject to the requirements in section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), we consider substantial compliance to mean that the establishment has satisfied the requirements for new infant formula registration in accordance with 21 CFR 106.110 and new infant formula submission in accordance with 21 CFR 106.120. Establishments that are determined to be in substantial compliance with applicable FDA regulations will be considered for inclusion on the list. We intend to deny listing an establishment if the establishment is not in substantial compliance with applicable FDA regulations. 3. Third-party certification Pursuant to a Memorandum of Understanding between the Food and Drug Administration, Department of Health and Human Services of the United States of America and the Certification and Accreditation Administration of the People s Republic of China regarding Third-Party Certification Procedures under AQSIQ Decree 145, FDA and China have expressed a mutual goal to establish a registration process that provides assurances to CNCA that U.S. food manufacturers subject to AQSIQ Decree 145, and the food products subject to AQSIQ Decree 145 that the manufacturers offer for entry into China, are in compliance with the relevant standards, laws and regulations of China, as specified in AQSIQ Decree 145. To facilitate the goal set forth in the agreement, CNCA has established lists of third-party certification bodies for milk and milk product, seafood, infant formula, and formula for young children establishments for which CNCA intends to accept a facility certification from a third-party certification body regarding an establishment s compliance with the relevant standards, laws and regulations of China. These lists are included in Annexes 2 and 3 of the Memorandum of Understanding available at https://www.fda.gov/internationalprograms/agreements/memorandaofunderstanding/ucm56336 8
1.htm. Establishments that wish to register with CNCA and be added to FDA s lists of exporters should provide FDA with a copy of this certification from a third-party certification body that has been identified for this purpose. For milk and milk products, we intend to accept third-party certification of compliance with Chinese standards, law and regulations via the DLM. For seafood products, infant formulas, and formulas for young children, we intend to accept third-party certification of compliance with Chinese standards, law, and regulations via email to CFSANExportCertfication@fda.hhs.gov until updated or new procedures for processing requests for certification for these lists can be established. B. Establishing and Maintaining the Lists of Establishments and Products for Which Registration with China Has Been Requested The information identified above for submission to FDA is intended to help FDA establish and maintain the lists. For each product category, FDA provides China with the names and addresses of establishments that have applied and are eligible to be listed and products manufactured by those establishments intended for export to China. We consider the information on the lists, which is provided voluntarily with the understanding that it will be communicated to China and posted on the Internet, to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4). Application for inclusion on this list is voluntary. China has advised that milk and milk products, seafood, infant formula, and formula for young children from establishments not on this list could be prevented by Chinese authorities from entering commerce in China. To the extent we determine that an establishment no longer meets the criteria for inclusion on the list, we intend to notify the establishment of FDA s findings and, as appropriate, FDA s intent to remove the establishment from the FDA list. FDA intends to send a confirmation e-mail or letter to the applicants to notify them of FDA s decision with respect to whether the firm will be included on the list. C. Updating the Lists of Establishments and Products for Which Registration with China has been Requested We intend to provide Chinese authorities with updated lists of establishments and products four times per year. The quarterly updates will list any additional establishments that have applied to FDA within the previous three-month period that have been determined by FDA to meet the criteria for inclusion on the lists. We also intend to delete from the list on a quarterly basis those establishments that we have determined (either by notice from the establishment or by FDA inspection) have gone out of business or have indicated to FDA in writing that they no longer intend to export milk and milk products, seafood, infant formula, or formula for young children, generally, or to delete specific products within each category that an establishment indicates it no longer intends to export, to China. Every two years, we intend to send a letter to establishments that are currently listed, requesting that they update the information they initially provided and indicate whether they wish to continue being listed and, if so, if they have any changes to the list 9
of products. We intend to remove from the lists any establishments and their products that do not respond to this request for updated information. The quarterly update schedule along with the two-year request for updated information is intended to provide FDA and milk and milk products, seafood, infant formula, and formula for young children establishments with a structured and predictable schedule for updating the lists and to give FDA sufficient time to determine the eligibility or ineligibility of establishments applying for placement on the lists. If, after an establishment is listed, we determine the establishment is no longer in good regulatory standing, we intend to remove that establishment from the list and to send a revised list to Chinese authorities as soon as possible, usually within 48-72 hours after the relevant FDA action or finding. Because a lack of good regulatory standing, if associated with a food safety concern, necessitates a more expedient process to protect public health, we intend to remove such an establishment from the list as soon as possible, rather than to wait for the quarterly update described above. We intend for each issuance of lists, whether issued as a result of a scheduled quarter annual update or as a result of removal of an establishment due to a change in regulatory standing, to be dated to indicate the date of the most recent update. III. Paperwork Reduction Act of 1995 This guidance contains information collections that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The time required to complete this information collection is estimated to average 22 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to: FDA PRA Staff, Office of Operations Food and Drug Administration Three White Flint North, 10A63 11601 Landsdown St. North Bethesda, MD 20852 PRAStaff@fda.hhs.gov This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 1.101 have been approved under OMB Control No. 0910-0482. The collections of information in 21 CFR parts 106 and 107 have been approved under OMB Control No. 0910-0256. The collections of information in 21 CFR part 123 have been approved under OMB Control No. 0910-0354. The collections of information in 15 CFR part 30 have been approved under OMB Control No. 0607-0152. Other collections of information have been approved under OMB Control No. 0910-0509. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0839 (expires 12/31/2017). 10
IV. References We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of June 28, 2017, FDA had verified the Web site address for the references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to Non-FDA Web site references after June 28, 2017. 1. For further information about the type of products covered under AQSIQ Decree 145, see http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/tzgg/201604/t20160401_50869.html 2. See the CNCA Import Pasteurized Milk Production Enterprise Registration Information Confirmation Form available (in Chinese) at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201504/p02015062860870465038 2.pdf and CNCA Imported Dairy Products (Sterilized Milk, Modified Milk, and Other Disinfection Milk) Offshore Production Enterprises Registration Information Confirmation Form available (in Chinese) at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201504/p02015062860870434883 9.pdf and CNCA Imported Dairy Products (Fermented Milk and Flavored Fermented Milk) Offshore Production Enterprises Registration Information Confirmation Form available (in Chinese) at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201608/p02016083036962577790 5.pdf. 3. See National Standards on Food Safety of P.R. China: National food safety standard, Infant formula, issued by the Ministry of Health of the People s Republic of China, March 26, 2010, available at http://china.nlambassade.org/binaries/content/assets/postenweb/c/china/zaken-doenin-china/2013/productstandaarden-zuivel/gb10765-2010-infant-formula.pdf 4. See National Standards of People s Republic of China: National food safety standard, Older infants and young children formula, issued by the Ministry of Health of the People s Republic of China, March 26, 2010, available at http://china.nlambassade.org/binaries/content/assets/postenweb/c/china/zaken-doen-inchina/2013/productstandaarden-zuivel/gb10767-2010-older-infants-and-young-childrenformula.pdf. 5. See CNCA Infant Formula Export Application Available at http://www.cnca.gov.cn/bsdt/ywzl/jkspjwscpqzc/wjxz/wjxzrp/201407/p02015062860870356889 6.doc. 11
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Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile Contains Nonbinding Recommendations May 2003; Revised June 22, 2005 GUIDANCE Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2003D-0180 as listed in the notice of availability that publishes in the Federal Register. For questions regarding this document contact Ms. Esther Lazar at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 301-436-1485 (Updated phone: 240-402-1485), (Fax) 301-436-2632, or e-mail Esther.Lazar@fda.hhs.gov (mailto:esther.lazar@fda.hhs.gov). Additional copies are available from: Office of Plant and Dairy Foods Division of Dairy and Egg Safety HFS-306 Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 (Tel) 301-436-1485 (Updated phone: 240-402-1485) (Fax) 301-436-2632 http://www.cfsan.fda.gov/guidance.html Paperwork Reduction Act Public Burden Disclosure Statement According to the Paperwork Reduction Act of 1995, a collection of information should display a valid Office of Management and Budget (OMB) control number. The valid OMB control number for this information collection is 0910-0509 (Expires 12/31/2006). The time required to complete this information collection is estimated to average 90 minutes per response and 30 minutes per update every two years, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to:
Food and Drug Administration CFSAN (HFS-306) 5001 Campus Drive College Park, MD 20740 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. U.S.Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition Issued May 2003 Revised June 2005 Contains Nonbinding Recommendations Guidance for Industry and FDA Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile TABLE OF CONTENTS 1. Introduction 2. Discussion 1. Establishment of a List of U.S. Dairy Product Manufacturers/Processors 2. Inclusion on the List 3. Updating the List This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This guidance document is being published to notify the public of FDA's efforts to assist U.S. firms that wish to export dairy products to Chile. FDA took this action in response to discussions with Chile that were adjunct to the negotiations of the United States-Chile Free Trade Agreement. As a result of those discussions, Chile recognized FDA as the competent food safety authority in the United States to identify U.S. dairy product manufacturers and
processors eligible to export to Chile and concluded that it will not conduct individual inspections of U.S. firms identified on a list established by the FDA as eligible to export to Chile. The list identifies U.S. firms that have expressed interest to FDA in exporting dairy products to Chile, that are subject to FDA jurisdiction, and that are not the subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending warning letter. The List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile established by FDA is posted on FDA's Internet site and shared with Chile. Every two years, Chile passes an authorizing resolution accepting this list and provides the list to their ports of entry to facilitate the importation of U.S. dairy products. Chile has requested that this list be updated every two years at the expiration of the current authorizing resolution. Therefore, FDA intends to contact the U.S. firms that are on the list every two years to verify that the information they have provided to FDA is still valid. FDA intends to report this updated list to Chile so that Chile can reauthorize its resolution for another two-year period. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. This is a revision of the first edition of this guidance, which FDA issued in May 2003. II. DISCUSSION A.Establishment of a List of U.S. Dairy Product Manufacturers/Processors FDA has established and is maintaining a list identifying U.S. firms that have expressed to FDA their interest in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending warning letter. The list is sent to responsible authorities in Chile, and is posted on FDA's Internet site at: http://www.cfsan.fda.gov/~comm/expcllst.html. Subsequent to the publication of the draft guidance, Chile informed FDA that Chile needed more than just the names and addresses of the U.S. dairy firms eligible to export to Chile. Consequently, FDA is revising the list so that it will now include the plant numbers; names, telephone numbers, and e-mail addresses of the contact persons; and lists of products being exported to Chile, in addition to the names and addresses of the firms' manufacturing and processing plants. Application for inclusion on this list is voluntary. However, Chile has advised that dairy products from firms not on this list could be prevented by Chilean authorities from entering commerce in Chile. The term "dairy products" for purposes of this list is not intended to cover the raw agricultural commodity raw milk. FDA has requested that U.S. dairy product manufacturers and processors provide certain information, as discussed below, if they currently export, or intend in the future to export, their dairy products to Chile and wish to be included on the list. At Chile's request, FDA is now asking that this information be updated every two years in order to maintain the accuracy of the list. In order to either update the information included on the list or to be initially included on the list, the following information should be submitted to Ms. Esther Lazar, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, (Fax) 301-436-2632, or e-mail : 1. Business name and address; 2. Name, telephone number, and e-mail (if available) of contact person; 3. List of products presently shipped to Chile and those intended to be shipped in the next 3 years; 4. Name and address of the manufacturing plant for each product; 5. Name of any Federal, State, or local governmental agencies that inspect the plant, along with the government assigned plant identifier (e.g., plant number) and date of last inspection; and
6. Copy of last inspection notice and, if other than an FDA inspection, copy of last inspection report. The list on FDA's Internet site and the information shared with Chile, some or all of which may be posted on Chile's website, includes the plant numbers; names, telephone numbers, and e-mail addresses of the contact persons; and lists of products being exported to Chile, in addition to the names and addresses of the firms' manufacturing and processing plants. The other information identified above for submission to FDA is intended to assist FDA in establishing and maintaining the list. FDA considers the information on this list, which is provided voluntarily with the understanding that it will be communicated to Chile and posted on the Internet, to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4). B. Inclusion on the List For each manufacturer or processor that submits an application, FDA intends to review the applicant's recent inspection history, including FDA or other Federal or State agency inspections. FDA intends to place the names and addresses of firms that are not the subject of a pending judicial enforcement action (e.g., injunction or seizure) or a pending warning letter on the list. FDA intends to deny listing a firm if the firm is the subject of a pending judicial enforcement action or a pending warning letter. FDA intends to send a confirmation e-mail or letter to the applicants to notify them of FDA's decision with respect to their eligibility or ineligibility for inclusion on the list. Every two years, FDA also intends to send a letter to manufacturers that are currently listed, requesting that they update the information they initially provided and indicate whether they wish to continue being listed. C. Updating the List FDA intends to provide Chilean authorities with an updated list of firms on a quarter annual basis. The quarterly update will list any additional firms that have applied to FDA within the previous three-month period and have been determined by FDA to meet the criteria for inclusion on the list. FDA also intends to delete from the list on a quarter annual basis those firms that FDA has determined (either by notice from the firm or by FDA inspection) have gone out of business or have indicated to FDA in writing that they no longer intend to export dairy products to Chile. FDA also intends to remove from the list any firms that do not respond to FDA's request every two years for updated information. The quarter annual update schedule along with the two-year request for updated information is intended to provide FDA and dairy manufacturers/processors with a structured and predictable schedule for updating the list and to provide the agency with sufficient time to determine the eligibility or ineligibility of firms applying for placement on the list. If a listed firm subsequently becomes the subject of a pending judicial enforcement action or a pending warning letter, FDA intends to remove that firm from the list posted on the Internet and to send a revised list to Chilean authorities as soon as possible after the firm becomes the subject of the pending judicial enforcement action or pending warning letter, usually within 48-72 hours after the relevant FDA action. Since a pending judicial enforcement action or a pending warning letter, if associated with a food safety concern, necessitates a more expedient process to protect public health, FDA intends to remove such a firm from the list as soon as possible, rather than to wait for the quarter annual update described above. FDA intends for each issuance of the list, whether issued as a result of a scheduled quarter annual update or as a result of removal of a firm due to a pending judicial enforcement action or a pending warning letter, to be numbered sequentially and dated to indicate the date of the most recent update. The above document supercedes the previous version issued May 23, 2003.