|
December 2003
The latest version of this guidance issued in May 2004. Below is an earlier version.
Comments and suggestions regarding this guidance may be submitted at any time. For questions regarding this document, contact:
Domenic Veneziano
Office of Regulatory Affairs
Office of Regional Operations
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Phone: 866-521-2297
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
December 2003
| 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 may 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: Domenic Veneziano, Office of Regulatory Affairs, Office of Regional Operations, FDA, 5600 Fishers Lane, Rockville, MD 20857, Phone: 866-521-2297 |
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 food for animals, that is imported or offered for import into the United States (68 FR 58974). 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. This guidance document provides a list of questions that have frequently been asked about the requirements of the prior notice regulation, and the answers to those questions. This document is being issued to help the food industry and others comply with the legal requirements established by the prior notice interim final rule. We intend to issue additional guidance as new questions arise. 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.
FDA is issuing this "Prior Notice Questions and Answers" document as level 1 guidance. FDA has determined that prior public participation is not feasible or appropriate because the interim final rule is effective on December 12, 2003, and is immediately implementing this guidance document, consistent with FDA's good guidance practice (GGP) regulations (21 CFR 10.110(g)(3)). The agency will accept comment and revise the guidance if appropriate in accordance with 21 CFR 10.115(g)(3)(ii).
Prior notice is notification to the FDA that an article of food, including animal feed or pet food, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border. (68 FR 58974; October 10, 2003).
Additional information on the prior notice regulation may be found on FDA's web site at http://www.fda.gov, select Bioterrorism Act. If your question is not answered by information on that web site, you can submit the question by email to the following address: http://www.cfsan.fda.gov/~furls/helpf2.html.
For additional information on the U.S. Bureau of Customs and Border Protection's (CBP's) procedures for prior notice, you may want to consult the CBP website at http://www.customs.treas.gov.
Prior notice is required by new section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 801(m)). Section 801(m) requires advance notification to FDA prior to the arrival of food imported or offered for import into the United States.
The prior notice regulation is effective on December 12, 2003. FDA intends to provide an initial transition period during which we will emphasize education regarding the requirements of prior notice to achieve compliance. Specific details regarding that transition period will be provided in an FDA Compliance Policy Guide. The Compliance Policy Guide will be available on FDA's website at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
Since publication of the Prior Notice and Registration interim final rule on October 10, 2003, FDA has conducted extensive domestic and international outreach and education about the new rule. FDA and CBP held a satellite downlink public meeting on October 28, 2003, and a series of public meetings across the U.S. to discuss the prior notice and registration interim final rules. Public meetings are announced on FDA's web site at http://www.fda.gov. In addition, we have prepared several tools, such as tutorials, instructions, and question-and-answer documents, to help importers and other affected persons to submit prior notice under either through ABI/ACS or PNSI. These are available on FDA's web site at http://www.fda.gov. CBP continues to issue instructions to ABI/ACS filers and brokers on complying with the prior notice regulation.
Information on the prior notice regulation may be found on FDA's web site at http://www.fda.gov. Many of your questions can be answered by reading the prior notice interim final rule or by reviewing the tutorials, fact sheet, and other materials that are posted on the web site. If your questions are not answered by information on that web site, you can send an email to the following address: http://www.cfsan.fda.gov/~furls/helpf2.html. FDA plans to periodically issue guidance documents to answer those questions that are not directly addressed in the prior notice interim final rule or its preamble. Thus, you will not receive an individual response to your email. You should check our web site at http://www.fda.gov/oc/bioterrorism/bioact.html periodically to obtain a copy of these guidance documents.
For additional information on the U.S. Bureau of Customs and Border Protection's (CBP's) procedures for prior notice, you may want to consult the CBP website at http://www.customs.treas.gov.
Yes. Information about prior notice to FDA is available in other languages. Translations available are indicated at the top of the English version of documents located on the Internet at http://www.cfsan.fda.gov/~dms/fsbtact.html.
Food is defined in the prior notice regulation by reference to section 201(f) of the FD&C Act, which defines food as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles (21 U.S.C. 321(f)). However, for purposes of prior notice, the definition of food does not include food contact substances or pesticides (21 CFR 1.276(b)(5)(i)). Examples of food subject to prior notice include: fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods.
Yes, if a bulk commodity like raw cane sugar is food under the definition if it is for use as food, including for use as a component of food. Raw agricultural commodities for use as food or as components of food are food for prior notice purposes (21 CFR 1.276(b)(5)(ii)). FDA will consider an article as one that will be used for food if any of the persons involved in importing or offering the product for import (e.g., submitter, transmitter, manufacturer, grower, shipper, importer, owner, or ultimate consignee) reasonably believes that the substance is reasonably expected to be directed to a food use.
Live animals are food for purposes of prior notice (21 CFR 1.276(b)(5)(ii)) if any of the persons involved in importing or offering the live animal for import (e.g., the submitter, transmitter, manufacturer, grower, shipper, importer, owner, or ultimate consignee) reasonably believes that the live animal is reasonably expected to be directed to a food use (21 CFR 1.276(b)(5)). Note that live food animals are not excluded from prior notice under section 801(m)(3)(B) of the FD&C Act and 21 CFR 1.277(b)(4) or (5) because live food animals do not fall within the exclusive jurisdiction of USDA under the Federal Meat Inspection Act or Poultry Products Inspection Act.
Yes. Live food animals that are subject to border inspections by APHIS are also subject to FDA's prior notice requirements: FDA and APHIS may both have jurisdiction over live animals. Note that the requirement for prior notice to FDA for live food animals does not alter the role of APHIS in, or any APHIS requirements relating to, inspection of live animals imported into the U.S.
Yes, if any person involved in importing the animal reasonably believes the animal is reasonably expected to be directed to a food use, the animal is food for which prior notice is required. (21 CFR 1.276(b)(5)) So, for example, elk imported to stock a ranch where the elk are hunted and used for food would be food under the prior notice definition. By contrast, elk imported for repopulating a national park where hunting the elk is not permitted would not be food for which prior notice is required. Note that live food game animals are not excluded from prior notice under section 801(m)(3)(B) of the FD&C Act and 21 CFR 1.277(b)(4) or (5) because neither these live food animals nor the products derived there from, fall within the exclusive jurisdiction of USDA under the Federal Meat Inspection Act or Poultry Products Inspection Act.
Yes, chemicals that are used for food or drink or are used for components of any such articles are food and are subject to the prior notice rule. However, if the chemicals are used for food contact substances or components of food contact substances or pesticides, prior notice is not required. (21 CFR 1.276(b)(5))
Food packaging materials, empty food packages, ceramic dinnerware, brass drinking vessels, and corn husks to be used as tamale wrappers, are examples of food contact substances. Even though these foods are excluded from prior notice requirements in section 801(m) of the FD&C Act, they are still subject to other provisions of the FD&C Act, including section 801(a), and FDA will still make admissibility decisions about them.
The term "secondary direct food additive" is not a defined term. Under 21 CFR 1.276(b)(5), "food" excludes "food contact substances" and "pesticides." Thus, if the "secondary direct food additive" is a food contact substance or a pesticide, it is not included in the definition of food, for purposes of prior notice, and prior notice is not required.
For food that is in its natural state, the FDA Country of Production is generally the country where the food was grown or collected, including harvested and readied for shipment to the U.S. Articles of food grown, including harvested or collected and readied for shipment, in U.S. territories are considered to be grown in the U.S. (21 CFR 1.276(b)(4)(i)). However, for wild fish, including seafood, that is caught or harvested outside U.S. waters by a vessel that is not registered in the U.S., the FDA Country of Production is the country in which the vessel is registered. (21 CFR 1.276(b)(4)(i))
For food that is no longer in its natural state, the FDA Country of Production is generally the country where the food was made or processed. However, if the article is made from wild fish aboard a vessel, the FDA Country of Production is the country in which the vessel is registered. If food that is no longer in its natural state was made in a Territory, the FDA Country of Production is the United States. (21 CFR 1.276(b)(4)(ii))
The FDA Country of Production may be different from the CBP Country of Origin. For example, the CBP Country of Origin for beans that are grown and dried in the U.S., then rehydrated and canned in the Dominican Republic would be the U.S. The FDA Country of Production would be the Dominican Republic. However, for purposes of the prior notice provisions of the FD&C Act, the "article of food" is canned beans, not dried beans. From a food safety standpoint, FDA is most interested in knowing where the article of food was processed and canned. To avoid confusion between FDA's prior notice requirements and CBP requirements, the interim final rule uses the term "FDA Country of Production" instead of the term "originating country" or "country from which the article originates." "FDA Country of Production" is already familiar to customs brokers and self-filers using ABI/ACS interface with OASIS.
The term "international mail" only covers foreign national mail services. Express carriers, such as Federal Express, as well as express consignment operators, or other private delivery services are not considered international mail under the prior notice rule. (21 CFR 1.276(b)(7))
The port of arrival is the water, air, or land port at which the article of food is imported or offered for import into the U.S., i.e., the port where the article of food first arrives in the U.S. (21 CFR 1.276(b)(9)). Port of entry is given the same definition the CBP regulations use, which "refer[s] to any place designated by Executive order..., by order of the Secretary of the Treasury, or by Act of Congress, at which a Customs officer is authorized to accept entries of merchandise, to collect duties, and enforce the various provision of Customs and navigation laws..." (19 CFR 101.1)
Yes. The port of arrival is the port where the articles first arrive in the U.S. A consumption or warehouse entry or foreign trade zone admission documentation may be presented to CBP at a different port than the port of arrival. This port is often referred to as the "port of entry" or "port where entry is made." Note that timeframes for submission of prior notice are tied to the time of arrival in the port of arrival, not arrival in the so-called port of entry.
Yes. The prior notice interim final rule defines the United States to be the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico, but not the U.S. Territories (21 CFR 1.276(b)(13)). Therefore, prior notice is required for food that comes from outside the U.S. into Puerto Rico, but not for food shipped from Puerto Rico into the 50 states or the District of Columbia.
No. The prior notice interim final rule defines the United States to be the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico, but not the U.S. Territories (21 CFR 1.276(b)(13)). Therefore, prior notice is not required for food shipped into a U.S. Territory. However, prior notice is required for food coming from a U.S. Territory (e.g., Guam, the U.S. Virgin Islands, and the Northern Mariana Islands) into the 50 states, the District of Columbia or the Commonwealth of Puerto Rico.
Yes. Because the "United States" is defined for purposes of prior notice to be the Customs territory of the United States (21 CFR 1.276(b)(13)), food that is imported into the 50 states, the District of Columbia, or the Commonwealth of Puerto Rico from a country that is a signatory to the North American Free Trade Agreement (other than the United States) is subject to prior notice.
If the article that is shipped to the United States is food within the meaning of 21 CFR 1.276(b)(5), then prior notice is generally required, even if the item is intended for further processing, is not intended for consumption in the United States, or is not intended for commercial distribution. Thus, prior notice is required for all food for humans and other animals that is imported or offered for import into the United States for use, storage, or distribution in the United States, including food for gifts and trade and quality assurance/quality control samples, food for transshipment through the United States to another country, food for future export, and food for use in a U.S. Foreign Trade Zone.
Yes. Prior notice is not required for:
Prior notice also is not required under FDA requirements for food brought into the United States in a diplomatic pouch. (The Vienna Convention on Diplomatic Relations (1961) provides: "The diplomatic bag shall not be opened or detained." Art. 27(3) Any baggage or cargo marked "diplomatic bag" or "diplomatic pouch" is immune from search, including by electronic devices, and thus its contents are not subject to FDA's prior notice requirements.)
There are no exemptions from prior notice requirements for:
Yes. The requirement for prior notice is not based on whether registration is required. FDA registration requirements (21 CFR 1.266(b)) apply to facilities that manufacture/process, pack, or hold food for consumption in the United States. The prior notice requirements apply to articles of food imported or offered for import into the United States. Although registration of farms is not required, the articles of food grown, harvested, or collected on farms are not exempt form prior notice requirements. Thus, generally, the food that a foreign farm exports to the U.S. is subject to the prior notice requirements. (21 CFR 1.277)
No. Food intended for charity is not exempt from prior notice. Although the registration interim final rule exempts nonprofit food establishments in which food is prepared for, or served directly to, the consumer from the requirements to register their facilities, (21 CFR 1.266(e)), the prior notice interim final rule does not exempt food imported for use by those nonprofit food establishments. Thus, imported food that is imported for or by a U.S. charity is subject to prior notice. (21 CFR 1.277)
Yes. FDA has determined that, for the purposes of section 801(m) of the FD&C Act, the phrase "imported or offered for import into the United States" applies to articles of food of U.S. origin that are "reimported" back into the U.S. (68 FR 58990; 21 CFR 1.277). These reimportations are most often referred to as American Goods Returned or U.S. Goods Returned.
Yes. Prior notice requirements apply even when the food is not for consumption in the United States. You must submit prior notice for food for that is for transshipment, further processing and export, or storage and export. In contrast, the requirement to register facilities applies only to food facilities that manufacture/process, pack, or hold food for consumption in the U.S.
Yes. Prior notice is required for food for transshipment through the U.S. to another country and food for future export (21 CFR 1.277(a)).
Yes. Food for admission into a Foreign Trade Zone is subject to the requirements of the prior notice regulation (21 CFR 1.277). However, prior notice is not required when the food is withdrawn from the FTZ, either as an export or for use within the United States. However, if the food is withdrawn from the FTZ for consumption entry into the United States, FDA will be notified and make the admissibility decision about the consumption entry at that time.
If the food was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States, prior notice is not required (21 CFR 1.277(b)(2)). Other food products sent as gifts are subject to the prior notice requirement (21 CFR 1.277). FDA recognizes that, in these circumstances, the sender who purchased the food as a gift may not have the manufacturer/producer registration number. Thus, the sender can use the name and address of the firm that appears on the label. A registration number need not be provided (21 CFR 1.281(a)(6)).
If the aircraft food is consumed on the flight or discarded and is not entered into the U.S. for use, storage, or distribution, it is outside the scope of the regulation and prior notice is not required (21 CFR 1.277(a)). By contrast, prior notice is required for in-flight food that is moved to U.S. caterers for use on export flights (21 CFR 1.277).
No. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering the United States (e.g., is in his or her carry-on or checked baggage) when the food is for that individual's personal use (21 CFR 1.277(b)(1)). Personal use means that the food is for consumption by the individual or by the individual's family and friends and is not for sale or other distribution.
No, imported food transported into the U.S. via express carriers or express consignment operators is not exempt from the requirements of the prior notice regulation. Articles imported via these private delivery services are subject to prior notice, which must be submitted within the timeframe for the applicable mode of transportation (21 CFR 1.279).
No, food sent to the U.S. via international mail is not exempt from the requirements of the prior notice regulation. Articles imported via international mail are subject to prior notice, which must be submitted before the article is sent to the U.S. (21 CFR 1.279(c))
Yes. Food purchased abroad and sent to the U.S. (i.e., does not accompany the individual when arriving in the U.S.) is subject to prior notice. (21 CFR 1.277)
Yes, prior notice must be provided. The exception for food for "personal use" applies only when the food is carried by or otherwise accompanies an individual when arriving in the U.S. (21 CFR 1.277(b)(1)). This exception does not apply when the food is shipped to the U.S. Although you or any other person with knowledge of the required information may submit prior notice (21 CFR 1.278), it would make sense for the foreign shipper to provide prior notice because the PN Confirmation Number, which indicates that FDA has received and confirmed the prior notice for review, must accompany an article of food that is sent to the U.S. via international mail (21 CFR 1.279(e)).
Prior notice is still required. Food transported to the U.S. via express carriers or express consignment operators is not exempt from the requirements of the prior notice regulation. Articles imported via these private delivery services are subject to prior notice, which must be submitted within the timeframe for the applicable mode of transportation (21 CFR 1.279)
No. The exclusion for good carried by an individual applies when the food is for the individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States. (21 CFR 1.277(b)(1)) However, trade samples are imported or offered for import to generate sales, which is a commercial, not personal, use.
Yes.
If, at the time the food is imported or offered for import, the food is subject to the exclusive jurisdiction of the USDA's Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), the food is not subject to the requirements of prior notice. (21 CFR 1.277(b) (4)-(b)(6))
Any person with knowledge of the required information may submit prior notice for an article of food. This person is the submitter. The submitter may also use another person to transmit the required information on his or her behalf. The person who transmits the information is the transmitter. The submitter and transmitter may be the same person (21 CFR 1.278).
Yes. Note that if you transmit the required information on behalf of a submitter, you are the transmitter.
Yes. There are no geographic restrictions on the location of the submitter or the transmitter. (21 CFR 1.278)
Prior notice must be submitted and the submission must be confirmed by FDA no more than 5 days before arrival, except for food arriving by international mail, and no less than:
For article of food sent by international mail, prior notice must be submitted and confirmed by FDA before the food is sent (21 CFR 1.279(c)). The Prior Notice (PN) Confirmation Number must appear on the Customs Declaration that accompanies the package. (21 CFR 1.279(e))
If you are carrying an article of food or if it otherwise accompanies you (i.e., the food is in your checked baggage), and the food is not for personal use, you must submit prior notice according to the timeframe established for the mode of transportation you are using. You must receive confirmation from FDA and provide a copy of the confirmation, including the PN Confirmation Number, to CBP or FDA when arriving in the U.S. (21 CFR 1.279(f)
You must submit prior notice to FDA electronically either through the U.S. Bureau of Customs and Border Protection's (CBP's) Automated Broker Interface of the Automated Commercial System (ABI/ACS) or FDA's Prior Notice System Interface.
Both ABI/ACS and the FDA PNSI are available 24 hours a day, 7 days a week for information submission.
No. Prior notice must be submitted to FDA. If you are an authorized user of CBP's ABI/ACS you may submit prior notice to FDA through the ABI/ACS interface or through FDA's Prior Notice System Interface (PNSI) at www.access.fda.gov. If you are not an authorized user of CBP's ABI/ACS, you may arrange for prior notice submission by an authorized user or submit prior notice through PNSI. Except, however, prior notice for the following, must be made through FDA's PNSI:
Yes. You may submit prior notice through either system.
You provide prior notice to FDA through PNSI (21 CFR 1.280(a)(2)). Prior notice must be submitted and confirmed by FDA before the food is sent (21 CFR 1.279(c)). The Prior Notice (PN) Confirmation Number must appear on the Customs Declaration that accompanies the package (21 CFR 1.279(e)).
If CBP's ABI/ACS is not available or if your broker's or your self-filing system is not working, you must submit prior notice through the FDA Prior Notice System Interface at www.access.fda.gov. (21 CFR 1.280(b))
If we determine that our Prior Notice System Interface is not working, we will issue notification on our website (http://www.fda.gov) and on the Prior Notice System Interface, as well as through messages in ABI/ACS. If you do not use ABI/ACS, and the PNSI is down, you must submit prior notice by e-mail or fax to FDA.
If FDA determines that its automated import system (OASIS) is not working, FDA will issue notification on our website (http://www.fda.gov) and on the Prior Notice System Interface and all prior notices must be submitted to FDA by e-mail or by fax. The e-mail address and fax number, as well as more information on how to submit prior notice if FDA or CBP systems are not working, will be available at http://www.fda.gov.
If your computer is not functioning or there is no electricity to operate your computer but the Prior Notice System Interface and ABI/ACS are functioning, you must make arrangements to use a functioning computer to submit the required prior notice.
Tutorials on use of PNSI are available on FDA's website at http://www.fda.gov. If you are already familiar with how to use PNSI and you are having problems win an online submission through PNSI, in the U.S call toll-free 1-800-216-7331. From elsewhere, call 301-575-0156. You may send a fax to 301-210-0247. These phone numbers will be staffed on business days from 7 AM until 11 PM U.S. Eastern Time. Requests for assistance also may be emailed to furls@fda.gov. For assistance with ABI/ACS transmission, contact your CBP client representative.
You must submit all prior notice information in the English language, except that an individual's name, the name of a company, and the name of a street may be submitted in a foreign language. All information, including these items, must be submitted using the Latin (Roman) alphabet (21 CFR 1.280(a)).
If you are not comfortable with English, you may choose to use a transmitter to enter the information for you.
No. CBP allows submissions through ACS/ABI only by brokers or filers that are recognized by CBP, e.g., licensed brokers and filers. Individuals can contract with a broker to transmit prior notice for them. In this case, the submitter is the person responsible for providing the information, but the broker is the transmitter.
Brokers are licensed private individuals or companies that are regulated by CBP and who aid importers and exporters to move merchandise through CBP. Brokers provide the proper paperwork and payments to CBP for clients and charge a fee for this service. Before brokers apply for a license, they must pass the Customs broker examination. See:http://www.customs.gov/xp/cgov/import/broker_management/brokers.xml
Filers are licensed carriers and self-filers who submit entries on their own behalf. Filers are required to submit a written request to CBP port personnel for a filer code, which is subsequently assigned by CBP headquarters. See: Chapter 10 pp. 73-76., http://www.cbp.gov/ImageCache/cgov/content/import/brokers/broker_5fhandbook_2epdf/v1/broker_5fhandbook.pdf
Individuals who choose not to use a broker or who chose not to become recognized by CBP as a filer can submit their prior notice only through the FDA PN System Interface (PNSI).
Yes. The requirement to submit prior notice to FDA is different from the requirement to file a consumption entry with CBP. Some foods arriving in the United States do not require a CBP consumption entry at the time of arrival, such as entries that move under bond (in-bonds) from the port of arrival to an inland port and shipments into a Foreign Trade Zone. However, any article of food imported or offered for import into the United States requires prior notice, unless the food is specifically excluded from the requirement to submit prior notice (21 CFR 1.277).
No, not if the entry or admission contains food subject to prior notice requirements. You can not submit a CBP import entry or admission if you have not submitted prior notice to FDA for an article of food that requires prior notice, because the Harmonized Tariff Schedule (HTS) codes have been flagged to indicate foods that require or may require prior notice. You must submit prior notice either through the ABI/ACS (along with the CBP entry information) or through the FDA Prior Notice System Interface at http://www.access.fda.gov (21 CFR 1.280(a)).
When you submit prior notice through the FDA Prior Notice System Interface, you will receive a Prior Notice (PN) Confirmation Number (21 CFR 1.279(d)). If you subsequently submit import entry or admission information through ABI/ACS, you must enter the PN Confirmation Number for that submission as an Affirmation of Compliance when the CBP entry or admission is filed. The PN Confirmation Number will allow CBP to confirm that prior notice was submitted to FDA.
If you cannot or do not want to use ABI/ACS, you must submit prior notice through the FDA Prior Notice System Interface at http://www.access.fda.gov. (21 CFR 1.280(a)) You will receive a confirmation number when you complete the prior notice through the Prior Notice System Interface. (21 CFR 1.279(d)) The PN Confirmation Number must accompany the food when the article arrives in the U.S. (21 CFR 1.279(g))
The U.S. Bureau of Customs and Border Protection (CBP) has modified the Automated Broker Interface of the Automated Commercial System (ABI/ACS) interface to allow for submission of prior notice to FDA for IT and T&E entries. Prior notice for such entries also may be made through FDA's Prior Notice System Interface.
The time frame for submitting prior notice is based on the mode of transportation and the port of arrival, i.e., the port where the food first arrives in the United States. This port may be different from the port where the entry documentation is presented to CBP. Prior notice for food arriving by truck (by land by road) must be confirmed by FDA for review at least 2 hours before the truck arrives at the port where it is crossing the border into the United States (21 CFR 1.279).
If you are entering under bond and want to file your CBP entry in St. Louis, you can file your prior notice either through FDA's Prior Notice System Interface or through CBP's ABI/ACS interface (21 CFR 1.280(a)). If you submit the prior notice through the FDA Prior Notice System Interface, you will receive a Prior Notice Confirmation Number (21 CFR 1.279(d)). This Prior Notice (PN) Confirmation Number must be made available to CBP when entering the United States, and must be entered as an Affirmation of Compliance when you file your CBP entry information (21 CFR 1.279(g)).
No. FDA does not charge a fee for filing prior notice or for using FDA's Prior Notice System Interface. However, if you chose to use a broker to file the prior notice through the ABI/ACS interface, the broker may charge a fee for providing that service. The collection of duty by CBP is not affected by FDA's prior notice regulation.
The information required for prior notice varies, based on the type of entry, mode of transportation for the entry, and whether the food is in its natural state. You should refer to the interim final rule (21 CFR 1.281) for details on the required information. The preamble to the interim final rule includes a chart that summarizes the information requirements (68 FR 58980). The interim final rule is available on FDA's web site http://www.fda.gov. Tutorials on the FDA Prior Notice System Interface (PNSI) also are available on FDA's website to help guide you through the process for providing the required information when you submit prior notice through PNSI.
Most of the information required by 21 CFR 1.281 also is entry data required by CBP before December 12, 2003. The key differences are the information required about the identity of manufacturer, grower, owner, and submitter and the identification of the country from which the article is shipped.
For prior notice, anticipated time of arrival is the local time when the food will arrive at the border. (21 CFR 1.281(a)(11)(iii)) For vessels, this would be when the vessel will dock in the port where the shipment is off-loaded. For planes, this would be when the plane is scheduled to land. For land vehicles, such as trucks, buses, and trains, this would be when they will cross at the border.
No. Prior notice does not need to be resubmitted if the anticipated arrival information changes (21 CFR 1.282(a)(2)(ii)). Although a new prior notice submission is not required, FDA staff may need time to respond to the changes in arrival information.
The interim final rule requires that if required information (except estimated quantity, anticipated arrival information, and planned shipment information) changes after FDA has confirmed prior notice for review, the prior notice must be resubmitted (21 CFR 1.282(a)(2)).
If the prior notice was submitted as part of a multi-line ABI/ACS entry, and information about one or more of the products changes, the entry must be deleted and resubmitted. Prior notice for the new product can be submitted as part of a new entry. If you submitted the prior notice via the FDA Prior Notice System Interface, you should cancel the prior notice via the FDA Prior Notice System Interface (21 CFR 1.282(b)).
Changes in the estimated quantity, anticipated arrival information, or planned shipment do not require resubmission of prior notice after FDA has confirmed your prior notice submission for review (21 CFR 1.282(a)(1)(i)-(iii)). For all other changes, e.g., if the identity of the manufacturer changes, you should cancel the prior notice and you must resubmit prior notice if you still intend to import or offer the food for import into the U.S. (21 CFR 1.282).
No. Each article of food requires a separate prior notice (21 CFR 1.281(a)(5) and 1.281(b)(4)) and receives a unique confirmation number (21 CFR 1.279(d)). However, FDA is allowing prior notices to be grouped in an ABI/ACS entry, or in an "envelope" for the FDA Prior Notice System Interface (PNSI) entries and In-Bonds submitted through ABI/ACS, in order to reduce data entry for transmitters and to simplify CBP review at the border. For submissions through PNSI, no articles of food can be added to an envelope after the Prior Notice Confirmation Number(s) has been received. For submissions through ABI/ACS, no additional lines may be added after the entry is accepted by ACS.
New articles of food cannot be added to an entry, or prior notice envelope, after it has been submitted to FDA (21 CFR 1.282). If a new article of food is being added to a shipment for which prior notice(s) has already been submitted and confirmed, a separate prior notice must be filed for that article under a new entry/envelope (21 CFR 1.281(a) and (b)). The submission time for the new prior notice will be different from that of the rest of the shipment, and this may have an effect on the ability of the shipment to enter the United States (21 CFR 1.279). For example, if you add another food to a truck at 9:00am, that food is not covered by timely prior notice until 11:00am. The rest of the food on that same truck may be covered by prior notices submitted at 8:00 am and deemed timely at 10:00 am. It is recommended that the time for arrival be anticipated on the last article of food submitted and confirmed by FDA for review.
If the prior notice was submitted through ACS, you can delete the prior notice using the existing entry delete procedures. If you submitted the prior notice via the FDA Prior Notice System Interface, you should cancel the prior notice via the Prior Notice System Interface (21 CFR 1.282(b)).
The answer depends on how the prior notice submission is being made. If submitting through the CPB Automated Broker Interface of the Automated Commercial System (ABI/ACS), the ability to pre-fill or otherwise support submission will depend on the functionality of the software used by the filer. The ABI/ACS interface is concerned with the validity of the information in the submission, not with how it was generated.
If submitting through FDA's Prior Notice System Interface, the answer varies with the status of the submission. The Prior Notice System Interface will allow a transmitter to pre-enter information and save the draft until the time of actual submission. Before the draft is submitted, changes can be easily made to the draft because information previously entered will be pre-filled.
After the prior notice has been submitted to FDA, no changes can be made unless requested by FDA to correct an error found during the review process before a Prior Notice (PN) Confirmation Number issues to the transmitter. (21 CFR 1.282)
Yes. FDA will notify the transmitter that the prior notice has been confirmed for review with a reply message that contains a Prior Notice (PN) Confirmation Number. For prior notice submissions through the CPB ABI/ACS, the PN Confirmation Number together with the "PN received" message will be made available to the transmitter (broker or filer) through the ABI/ACS. For prior notice submissions through the FDA Prior Notice System Interface (PNSI), a PN Confirmation Number will be provided to the transmitter through PNSI as soon as FDA confirms your prior notice for review.
To ensure that entry proceeds as smoothly as possible, the carrier or individual should consider having a copy of the reply message that contains a PN Confirmation Number in his/her possession upon arrival.
For food carried by or otherwise accompanying an individual that is not for personal use, the individual must provide a copy of the PN confirmation to FDA or CBP. .Food covered by prior notice submitted through the FDA Prior Notice System Interface must be accompanied by a copy of the reply message that contains the PN Confirmation Number.
For international mail packages, the confirmation number must accompany the package.
No. Receipt of a PN Confirmation Number is evidence only that a prior notice has been received for FDA review. Based on review of the prior notice, FDA may determine that an article of food should not be allowed to proceed into the United States without further inspection and sampling at the border. The food may be refused under the prior notice regulation and section 801(m) of the FD&C Act and held if the prior notice is inaccurate or if it is untimely and FDA has not had sufficient time to receive, review, and respond to the prior notice information. In addition, FDA may examine or sample the food for food safety and security concerns and for determining whether the food is subject to refusal under section 801(a) of the FD&C Act.
The Prior Notice (PN) Confirmation Number is FDA's notice to you that that your prior notice was submitted to and received for review by FDA. It is the signal to you that the time frame for prior notice for the food covered by that prior notice submission has started. In addition, the PN Confirmation Number provides a mechanism for prior notice data, submitted to FDA, to be matched with an entry submitted to CBP. The timeliness of prior notice can not be assessed until the food actually arrives in the United States and, often, the accuracy of the prior notice can not be fully determined until the food is examined upon arrival.
Inadequate prior notice is when:
FDA's enforcement policies on inadequate prior notice are being set out in a separate guidance document. This Compliance Policy Guide will be available on FDA's website at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
The following examples of inadequate prior notice are for 5 articles of food (foods A, B, C, D, & E) arriving at the border by truck:
FDA's enforcement policies on inadequate prior notice are being set out in a separate guidance document. This Compliance Policy Guide will be available on FDA's website at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
Articles of food arriving with no prior notice, inaccurate prior notice, or untimely prior notice may be refused admission and, other than food arriving by international mail or carried by or otherwise accompanying an individual, if refused, will be handled in one of the following ways:
Refused food is considered general order merchandise under section 490(a) of the Tariff Act (19 U.S.C. 1490(a)) and may move only under appropriate custodial bond (21 CFR 1.283(a)(2)). If the refused article is moved, the submitter must notify FDA of the hold location within 24 hours of refusal. The refused food may not be delivered to the importer, owner, or ultimate consignee. (21 CFR 1.283(a)(2)(ii))
For food that is carried by or accompanies an individual arriving in the U.S. and the food is not for personal use, if adequate prior notice is not submitted or if the PN confirmation number cannot be provided to FDA or CBP, the food is subject to refusal. If before leaving the port, the individual does not arrange to have the food held at the port or exported, the article may be destroyed (21 CFR 1.283(b)).
For food arriving by international mail, if prior notice is inadequate or if the PN Confirmation Number is not affixed, the article will be held for FDA inspection and disposition. If refused and there is a return address, the parcel may be returned to sender. If there is no return address or the food in the shipment appears to present a hazard, FDA may dispose of or destroy the parcel at its expense. If FDA does not respond within 72 hours of the CBP hold, CBP may return the parcel back to the sender or, if there is no return address, destroy the parcel, at FDA expense.
FDA's enforcement policies on inadequate prior notice are being set out in a separate guidance document. This Compliance Policy Guide will be available on FDA's website at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
If arrival occurs before the anticipated arrival time, the food could be refused and held until the prior notice timeframe has elapsed (21 CFR 1.279) or until processing is complete, which ever comes first. However, if the prior notice has been fully processed by FDA, the food will not be refused because the anticipated arrival time has not yet come (21 CFR 1.283(a)(1)(ii)). However, if FDA plans to examine the food, it may be held to allow time for FDA staff to arrive.
The PN Confirmation Number only confirms that the submission is complete and facially valid. If FDA's review process determines that the prior notice is inaccurate after receipt of the prior notice is confirmed by issuance of the PN Confirmation Number, the article of food is still subject to refusal under 21 CFR 1.283(a)(1)(ii).
No, the food must meet the requirements of all other applicable regulations as well. If FDA decides to take no prior notice action for an article of food under 21 CFR 1.283 or 1.285(a), this decision has no bearing on whether the article of food is admissible or will be granted admission under other provisions of the FD&C Act or other U.S. laws. Thus, for imported food or food offered for import, FDA will continue its normal investigative and enforcement activities for food safety and security concerns and for determining whether the food is subject to refusal under section 801(a) of the FD&C Act.
FDA will communicate the decision to examine articles of food to CBP.
FDA intends to provide an initial transition period during which we will emphasize education regarding the requirements of prior notice to achieve compliance. Specific details regarding that transition period will be provided in an FDA Compliance Policy Guide. The Compliance Policy Guide will be available on FDA's website at http://www.fda.gov/ora/compliance_ref/ cpg/default.htm. (68 FR 58974)
Rather than hold or refuse admission of shipments that are in route before December 12, and arrive on or soon after December 12, FDA intends generally to provide information on the requirements of prior notice.
Persons with access to the Internet may obtain this document "Prior Notice Questions and Answers" at http://www.cfsan.fda.gov/guidance.html.
The latest version of this guidance issued in May 2004.
