|
November 20, 2003, Revised April 14, 2004 and August 26, 2004
Comments and suggestions regarding this guidance may be submitted at any time. For questions regarding this document, contact:
(General questions)
Ted Poplawski, Office of Regulatory Affairs (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-6553.
(Human food issues)
Salvatore Evola, Office of Compliance (HFS-606), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2164.
(Animal feed issues)
Frances Pell, Division of Compliance (HFV-235), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0188.
For single copies of this guidance, please contact:
Prior Notice Help Desk
Phone: 1-800-216-7331 or 301-575-0156
Fax: 301-210-0247
E-mail: furls@fda.gov
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Issued November 20, 2004
Revised April 14, 2004
Revised August 26, 2004
| This guidance document 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 alternate approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, please contact: (General questions) Ted Poplawski, Office of Regulatory Affairs (HFC-170), Office of Regional Operations, FDA, 5600 Fishers Lane, Rockville, MD 20857, 301-443-6553. (Human food issues) Salvatore Evola, Office of Compliance (HFS-606), Center for Food Safety and Applied Nutrition, FDA, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2164. (Animal feed issues) Frances Pell, Division of Compliance (HFV-235), Center for Veterinary Medicine, FDA, 7500 Standish Place, Rockville, MD 20855, 301-827-0188. |
On October 10, 2003, the Food and Drug Administration (FDA) published an interim final rule in the Federal Register requiring submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States (68 FR 58974). This guidance is being issued to help the food industry comply with the legal requirements established by the prior notice interim final rule. The Harmonized Tariff Schedule (HTS) codes listed in the table apply to prior notice submitted via the U.S. Customs and Border Protection's (CBP's) Automated Broker Interface of the Automated Commercial System (ABI/ACS) and via FDA's Prior Notice System Interface (PNSI).
This HTS codes table will be periodically updated to reflect changes in the HTS codes or in FDA indicators for those codes. Users of this list should ensure they are using the most current version of this table. The most current version is provided on FDA's website at http://www.cfsan.fda.gov/guidance.html. The date of issuance of this table is indicated at the top of the title page of the table. CBP will notify users of the ABI/ACS when changes in this table are made in ABI/ACS.
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.
The prior notice interim final rule implements section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)) which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188), which requires that FDA receive prior notice of food imported into the United States. Under the interim final rule, food has the meaning given in section 201(f) of the FD&C Act (21 U.S.C. 321(f)), except for purposes of prior notice, food does not include food contact substances or pesticides (21 CFR 1.276(b)(5)(i)).
FDA's interim final regulations on prior notice were effective on December 12, 2003, and allow for prior notice to be submitted either via the FDA Prior Notice System Interface (PNSI) or the U.S. Bureau of Customs and Border Protection (CBP) Automated Broker Interface of the Automated Commercial System (ABI/ACS) (21 CFR 1.276 - 1.285).
Except for certain informal entries such as mail and personal baggage, CBP requires any product, including food, offered for entry to the U.S. to be identified according to Harmonized Tariff Schedule (HTS) codes. CBP uses these tariff codes, in part, to determine which imports should be reviewed by other government agencies for admissibility. In addition, CBP has, for many years, also used HTS codes to program ACS to send entry information about FDA-regulated products to FDA electronically for review. HTS codes are "flagged" in ACS as follows to indicate that products are or may be under FDA jurisdiction:
FD0 - Indicates that FDA has determined the article, even though subject to FDA's laws and regulations, is acceptable for CBP release without further presentation of prior notice or other entry information to FDA.
FD1 - Indicates that the article may be subject to FDA jurisdiction, including FDA review under under 801(a) of the FD&C Act. For products not subject to FDA jurisdiction, a filer can "Disclaim" product from FDA notification requirements.
FD2 - Indicates that the article is under FDA jurisdiction and review of entry information by FDA under section 801(a) will take place. However, the article is not "food" for which prior notice information is required.
FD3 - Indicates that the article may be subject to prior notice under section 801(m) of the FD&C Act and 21 CFR Part1, subpart I. , e.g., the article has both food and non-food uses.
FD4 - Indicates that the article is "food" for which prior notice is required under section 801(m) of the FD&C Act and 21 CFR Part1, subpart I.
The table lists the HTS codes that apply to foods for which FDA believes prior notice is or may be required under the prior notice regulations. FDA provided this list to CBP so that CBP can modify or "flag" the HTS codes in its entry systems to screen for foods for which prior notice to FDA is required and to ensure that, as appropriate, prior notice has been provided. FDA is issuing this guidance to inform the food industry which HTS codes have been "flagged" in CBP entry systems with prior notice indicators.
The appropriate HTS code to use for a particular food, including animal feed, may be determined from the CBP duty rates/HTS website <http://www.customs.ustreas.gov/xp/cgov/import/duty_rates/>. After you have determined the appropriate HTS code from CBP, you may use the list included in this guidance to aid in determining if your product has been "flagged" with an FD3 or an FD4 indicator.
Effective April 14, 2004, CBP announced that the edits on the tariff numbers are being relaxed and ABI filers will now be allowed to file Prior Notice for all tariff numbers regardless of the FDA indicator. The only exceptions are those tariff records marked FD0. Additionally, the edits will also allow filers to submit a Prior Notice disclaimer for entries classified under tariff codes that have an FD3 flag but will allow submission of 801(a) entry data. These procedures are covered under CBP Admin message 04-0802.
Placebos are an example of a product which is classified under a tariff code that is flagged FD3. A placebo is a product that mimics a drug but contains no active ingredient and is normally classified as a food preparation, a classification for which Prior Notice would be required. However, under FDA regulations, a placebo is defined as a drug. The FD3 indicator will allow the filer to submit a Prior Notice disclaimer using an Affirmation of Compliance for shipments of product intended for use as a placebo.
This table should be used only for determining whether a specific HTS code has been "flagged" with an FD3 or an FD4 indicator for prior notice. The list of HTS codes in the table does not replace or otherwise modify the FD flags associated with FDA-regulated commodities that are not subject to the prior notice interim final rule.
These FD "flags" are informational in nature and do not supersede any provision of law or regulation. In particular, the absence of an FD flag does not mean that prior notice for an FDA regulated article of food is not required.
FDA is issuing this guidance document as level 2 guidance. Consistent with FDA's good guidance practice regulations (GGP) regulations, the agency will accept comment, but is implementing the guidance document immediately in accordance with 21 CFR 10.115(g)(4)(i)(B).
The revised Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators table has been updated. Material marked with an asterisk (*) is new or revised since the last issuance. The date of the revision is indicated at the top of the title page of the table. The table may be obtained by accessing http://www.cfsan.fda.gov/~pn/htscodes.html. A revision history list which identifies the new, changed, or deleted flags and/or codes for each revision of the table has also been developed. The revision history list can be obtained by accessing http://www.cfsan.fda.gov/~pn/htsrev.html. Those without access to the Internet may obtain single copies of the revised table or the revision history from Prior Notice Help Desk at Phone: 1-800-216-7331 or 301-575-0156 or Fax: 301-210-0247.
Persons with access to the Internet may obtain this guidance document at http://www.cfsan.fda.gov/guidance.html.
This document supercedes Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (April 14, 2004)
Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators
September 2, 2005
Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators Revision History
