FDA NEWS - AGENCIES ISSUE DRAFT GUIDANCE FOR INDUSTRY GOOD IMPORTER PRACTICES
January 15, 2009
Numerous Federal agencies have collectively issued the following document to assist importers with guidance to ensure their products are safe and comply with U.S. requirements.
Click here to view the document in PDF.
SNAILS INSPECTION AND PROTOCAL FOR CARGO ORIGINATING IN AUSTRALIA
December 15, 2008
The Australian Quarantine and Inspection Service have issued the two following documents advising the latest on market access to the USA with regards to snail contamination on shipping containers.
Click here to view the Market Access Advise Advisory issued by the AQIS.
Click here to view the Container Integrity and Snail Inspection Procedure.
THE LACEY ACT UPDATE
We have received the following from Harry G. Butler, the Editor of the U.S. Custom House Guide, providing an update of The Lacey Act.
The U.S. Department of Agriculture's Animal and Plant Health Inspection Service has at last made available the Plant and Plant Product Declaration Form for submission of voluntary declarations. The form can be found at
Click here to be taken to a copy of the Plant and Plant Product Declaration Form.
As a reminder, mandatory reporting will not take effect until electronic filing becomes possible, in April 2009 at the earliest.
We will be reporting further developments on the U.S. Custom House Guide Web site, www.customhouseguide.com as they arrise.
You can find links to an assortment of Lacey Act-related materials on our dedicated resource page.
Click here to be taken to the dedicated U.S. Custom House Guide resource page.
FINAL 10 + 2 RULING NOW PUBLISHED
December 2, 2008
The CBP's final 10 + 2 ruling has been formally published in the Federal Register. Please click the link below to view the complete ruling in PDF.
Click here to view the complete ruling in PDF.
NEW MANDATORY CPSC IMPORT DOCUMENTATION REQUIRMENTS
October 3, 2008
The following is an informative notification, published by Sandler, Travis & Rosenberg, P.A., a customs and international trade and law firm, regarding the new mandatory CPSC import documentation requirements,effective November 12th 2008.
Click here to view the publication in PDF.
GRACE PERIOD FOR THE IMPLEMENTATION OF THE FIRST SALE DECLARATION
August 20, 2008
The purpose of this memorandum is to inform Customs and Border Protection (CBP) Field Offices, the importing public, and all other interested parties of a grace period that is being granted to importers with regard to the implementation of the First Sale Declaration Requirement established under section 15422(a) in the Food, Conservation and Energy Act of 2008, commonly referred to as the Farm Bill.
The First Sale Declaration Requirement refers to the requirement for importers to provide a declaration to CBP at the time of entry for all goods entered for consumption or withdrawn from warehouse whether the value was determined on the basis of price paid by the buyer in the first or earlier sale occurring prior to introduction of the merchandise into the United States.
Click to read full text in PDF
MANDATORY CONTAINER SEAL REQUIREMENT
August 7, 2008
U.S. Customs & Border Protection (CBP) has issued a General Notice in the August 7, 2008 Federal Register stating that all maritime containers arriving by vessel at a port of entry in the United States on or after October 15, 2008, are required to be sealed with a seal meeting the ISO/PAS 17712 standard. This requirement is pursuant to the Implementing Recommendations of the 9/11 Commission Act of 2007 ("9/11 Act") signed into law by President Bush a year ago. ISO/PAS 17712 requires that container freight seals meet or exceed certain standards for strength and durability so as to prevent accidental breakage, early deterioration (due to weather conditions, chemical action, etc.) or undetectable tampering under normal usage. ISO/PAS 17712 also requires that each seal be clearly and legibly marked with a unique identification number.
All loaded containers, including foreign cargo remaining on board (FROB), are required to be sealed with a seal meeting the ISO/PAS 17712 standard. CBP recognizes there are certain types of containers that cannot be readily secured by use of a ISO/PAS 17712 standard container seal, such as tanks, non-standard containers (such as open top containers), or containers that simply cannot accommodate a seal meeting the ISO/PAS standard (such as custom built containers). These types of containers are not subject to the statutory requirement.
If a container arrives by vessel at a port of entry in the United States on or after October 15, 2008 either with no seal or with a seal that does not meet the ISO/PAS 17712 standard, CBP may assess a civil penalty against the responsible party for violation of the 9/11 Act under 19 U.S.C. 1595a(b) for the attempted introduction of merchandise into the United States contrary to law. CBP will be phasing in penalty assessment for such violations.
We ask that you please make sure your foreign suppliers are aware of this requirement.
The Federal Register notice is available at: http://edocket.access.gpo.gov/2008/pdf/E8-18174.pdf
HAPAG LLOYD AES REQUIREMENTS FOR US EXPORTS
August 4, 2008
The US Department of Commerce and Census have issued a final rule in the Code of Federal Regulations, requiring the mandatory use of AES export reporting for US shipped cargo.
Click here to view the advisory in PDF.
AES EXPORT PROCESSING FOR U.S. CUSTOMS & BORDER PROTECTION
July 21, 2008
U.S. Customs & Border Protection (CBP) will begin enforcing their new AES rule,effective September 30, 2008. This will require changes be made to the shipment processing for all cargo vessels that load at ports in the United States. The rule will have an impact on many of our customers, as it requires that both shippers and carriers adopt new disciplines and procedures to ensure timely manifesting and loading of cargo.
Click here to view the full text version from APL.
10 PLUS 2 UPDATE
July 18, 2008
We have learned from House Ways and Means Committee staff that CBP may be sending the proposed rule for 10+2 to the Office of Management and Budget (OMB) at the end of July for review, with a target publication date of 9/1/08.Any rules that are published by CBP or any other agency must first be reviewed by OMB.
WHEN CUSTOMS KNOCKS
June 27, 2008
Recent actions by Customs and Border Protection ("CBP") strongly suggest it has intensified enforcement efforts against small importers by showing up unannounced to conduct what it calls "importer premises visits."In the past, such visits have been routinely conducted by import specialists, but only after providing advance notice to the importer and with a focus limited to new or smaller importers "under the radar" of most data profiles conducted by CBP.In recent days, CBP has shown up unannounced with teams of import specialists and auditors at the offices of small importers who may have been the target of seizures for textile quota violations or of other less-concerning errors, including errors which were purely broker-generated. During these unannounced visits, CBP officials have asked questions regarding the importer's purchase, import and sale operations, and requested entry, production and accounting documents on the spot.
What are an importer's rights in such cases? Must CBP be allowed in when they knock?
Without a warrant issued by a court, CBP officials may be legally denied access to an importer's premises. When they show up unannounced, the importer may politely tell them that the time is inconvenient but would be pleased to meet with them at a mutually convenient time.Although it may seem intimidating to an importer to have a half a dozen CBP officials appear unannounced, the importer has the right to refuse to meet with them then and there.Importers have rights to request that CBP make an appointment and an opportunity to gather, review and make copies of documents requested by CBP for production.
Even if Immigration and Customs Enforcement ("ICE") special agents show up with guns and badges, they still must bear a court-issued warrant - rather than an administratively-issued subpoena - in order to enter an importer's premises without consent.Inspection of the document presented by the agents will clearly show whether it is a court-issued warrant or an administrative subpoena, and they should fully understand and respect your rights, if you exercise them, in response to a subpoena.
Should CBP or ICE arrive at your door without a warrant, you have the right to make them wait before you let them in while you contact appropriate company officials, counsel or other advisors to decide with their advice whether you are prepared to meet at that time or at a later time more convenient to you, other company officials, your counsel or your advisor.
Special thanks to Sandler, Travis & Rosenberg, P.A. for providing this information.
U.S. CUSTOMS AND BORDER PROTECTION - PROPOSED RULE ON 10+2 CARGO SECURITY FILING
January 2, 2008
The US Customs and Border Protection (CBP) have issued the following notice detailing the proposed rule change to the "10+2" Cargo Security Filing.
Click here to view the proposed rule change in PDF.
U.S. CUSTOMS AND BORDER PROTECTION - NOTICE OF PROPOSED RULEMAKING (NPRM)
The US Customs and Border Protection (CBP) have issued the following announcement regarding a Notice of Proposed Rulemaking to the Secutity Filing known as "10+2".
Click here to view the notice in PDF.
U.S. CUSTOMS AND BORDER PROTECTION NEWS RELEASE
CBP Expands Access To ACE
September 18, 2007
The United States Customs and Border Protection have issued the following news release regarding expanded access to ACE.
Click here to view the news release in PDF.
U.S. CUSTOMS AND BORDER PROTECTION AND DEPARTMENT OF HOMELAND SECURITY
CHANGES TO CBP'S ACE SYSTEM
August 10, 2007
The United States Customs and Border Protection (CBP), and the Department of Homeland Security (DHS), have announced that effective August 26, 2007, they will implement a new Automated Commercial Environment (ACE) system.
Click here to view the announcent in PDF. Click here for additional information in PDF.
U.S. CUSTOMS AND BORDER PROTECTION ANNOUNCEMENT
E-MANIFESTS FOR SHIPMENTS ENTERING FROM MEXICO OR CANADA
The United States Customs and Border Protection (CBP) have issued the following announcement pertaining to
E-Manifest Enforcement Clarification.
Click here to view the announcement in PDF.
TTB REGULATION 27.49 SAMPLES ENTERING OUR COMMERCE
January 30, 2007
The TTB has issued an alert to advise of the enforcement of Regulation 27.49, pertaining to the import of commercial samples of alcoholic beverages. The alert advises that samples over a specified weight, depending on the type, will require label approval. The alert also offers advice as to how importers can import these goods as samples and remain in compliance of this regulation.
Click here to view the alert in PDF.
CBP Cargo Systems Program Office Regarding ACE (Automated Commercial Environment Non-Portal Accounts for Importers
To encourage maximum participation in the Periodic Monthly Statement test, U.S. Customs and Border Protection (CPB) will no longer require that importers first establish ACE Portal Accounts in order to pay estimated duties and fees on a monthly basis as required by the Federal Register Notice (FRN) of February 4, 2004 (see 69 FR 5362). CBP will now allow the creation of ACE Non-portal Accounts for importers wishing to participate in the ACE test but not seeking the benefits of having an ACE portal account.
Importers who are certified partners in the voluntary Custom-Trade Partnership Against Terrorism (C-TPAT) Program and who are not current ACE accounts will automatically be established as ACE Non-portal Accounts and are eligible to participate in the Periodic Monthly Statement test. For additional details please refer to 70 FR 61466, published October 24, 2005, which can be found on the ACE Federal Register Notices link at www.cbp.gov/modernization. The creation of ACE non-portal accounts for importers and the automatic ACE non-portal account participation for C-TPAT importers who are certified partners is effective immediately upon the publication of 70 FR 61466. To create an ACE non-portal account for an importer, the broker must first establish their ACE portal account.
Importers are reminder that to participate in the periodic monthly statement test, a continuous bond covering duties and fees must be in place. Payment must be effected via Automated Clearing House (ACH) Debit or ACH Credit. Entry/entry summaries must be filed via the Automated broker Interface. Entries not eligible to be paid on a periodic monthly statement include reconciliation entries (entry type 09), NAFTA duty deferral entries (entry type 08) and entries requiring the payment of excise tax.
The steps to participate in the Periodic Monthly Statement test as an ACE non-portal account are as follows:
I. ACE Non-Portal Accounts for Certified C-TPAT Importers
o The certified C-TPAT importer notifies the broker they want to participate in periodic monthly statements and supplies a list of C-TPAT Importer of Record (IR) numbers.
o If the importer has a CBP Account Manager, the importer must provide the broker with the CBP Account Manager's name and email address.
o The importer must provide the broker with a copy of their C-TPAT certified letter (copy of CBP correspondence).
The broker does the following:
o Sends an email to periodic statements@dhs.gov with a list of the importer's IR numbers that will be flagged for periodic monthly statement and a scanned copy of the C-TPAT certified letter. The email subject line should read: "Activation Request".
o If applicable, the broker sends a carbon copy of the above referenced email notification to the importer's CBP Account Manager.
After successful completion of the above steps, CBP will set the switch to allow participation in periodic monthly statement.
o Upon activation an email notification will be sent to the broker with a copy to the importer's CBP Account Manager.
The broker will then notify the importer.
o Where an importer uses multiple brokers, the importer is responsible for notifying all applicable brokers, the importer is responsible for notifying all applicable brokers that they have been activated for participation in periodic monthly statements.
II ACE Non-Portal Accounts for Importers, Non-C-TPAT Certified
o The non-C-TPAT importer notifies the broker they want to participate in periodic monthly statement as a non-portal account and supplies a list of IR numbers through the creation of a 5106, Importer ID Input Record.
o The the importer has a CBP Account Manager, the importer must provide the broker with the CBP Account Manager's name and email address.
o Ensures a valid Power of Attorney for the importer is on file.
o Initiates a bond query via the Automated Broker Interface (ABI) to verify that the specific IR number is covered by a valid continuous bond (CB) on file with CBP.
o Compares the 5106 data to the data returned from the bond query.
Consistent data:
o If the bond data returned is consistent with the 5106 data, the broker sends an email to periodicstatement@dhs.gov with a list of the importer's IR numbers that will be flagged for periodic monthly statement along with a scanned image of the 5106 (s). The email subject line should read: "Activation Request". The top of the form must contain a note indicating "Periodic Monthly Statement Activation".
If applicable, the broker sends a carbon copy of the above referenced email notification to the importer's CBP Account.
Upon successful completion of the above steps, CBP will set the switch to allow participation in periodic monthly statement.
Upon activation, an email notification will be sent to the broker with a copy to the importer's CBP Account Manager.
The broker will notify the importer.
o Where an importer uses multiple brokers, the importer is responsible for notifying all applicable brokers that they have been activated for participation in periodic monthly statements.
OR
Inconsistent Data:
o If the bond data returned is not consistent with the 5106 data, the broker notifies the importer of the discrepancy.
If the im0porter states the 5106 is correct and the specific IR number is either the principal, co-principal, or an authorized user on the CB, then the importer must submit the 5106 as well as a bond rider showing the correct name and address information to the Revenue Division, Bond Section.
CBP will notify the broker when the update is complete.
The broker then sends an email to peridocstatement@dhs.gov with a list of the importer's IR numbers that will be flagged for the periodic monthly statement along with a scanned image of the 5106 (s). The email subject line should read: "Activation Request". The top of the form must contain a note indicating "Periodic Monthly Statement Activation".
If applicable, the broker sends a carbon copy of the above referenced email notification to the importer's CBP Account Manager.
o Where an importer uses multiple brokers, the importer is responsible for notifying all applicable brokers that they have been activated for participation in periodic monthly statement.
Importers are reminded that if they wish to establish ACE non-portal accounts to take advantage of periodic monthly statement processing through their Customs broker, the broker must first establish an ACE portal account. If the broker is not currently an ACE portal account, please direct the broker to the ACE Application Information link at www.cbp.gov/modernization or email ACENow@dhs.gov to learn how to enroll.
If more than one broker attempts to establish a non-portal account on behalf of the importer and the non-portal account has already been established, the broker will be notified by CBP that the switch for this IR number has already been set to allow participation in periodic monthly statement.
If you have any questions regarding these changes, please send an email to PMS.Mailbox@dhs.gov.
ALCOHOL, TOBACCO TAX & TRADE BUREAU (TTB) (formerly BATF) As a result of the Homeland Security Act of 2002 signed into law November 25, 2002, the functions previously performed by the Bureau of Alcohol, Tobacco and Firearms (ATF) will now be handled by the newly named Tax and Trade Bureau.
TTB falls under the jurisdiction of the:
U.S. Department of the Treasury
Washington, DC 20226
Website: www.ttb.gov
This government agency handles import permits, label requirements/approvals and other alcoholic beverage-related matters dealing with importing and selling alcoholic beverages in the US.
The TTB requires retailers of beverage alcohol products to register, pay special tax and maintain certain records.
Wholesalers and importers of beverage alcohol products must also register, pay special tax and maintain certain records. In addition, wholesalers and importers must obtain a permit and follow more requirements.
For Frequently Asked Questions, go to:
U.S. CUSTOMS AND BORDER PROTECTION (CBP) The US Customs and Border Protection (CBP) became an official agency of the Department of Homeland Security on March 1, 2003. It combined employees from the Department of Agriculture, the Immigration and Naturalization Service, the Border Patrol and the US Customs Service. Unifying the agencies improves the way the US government manages the border. It will be far more effective and efficient than when the border responsibilities were fragmented into four agencies in three different departments of government.
Strategy
As the single unified border agency of the United States, the CBP mission is vitally important to the protection of America and the American people. The strategy is to improve security and facilitate the flow of legitimate trade and travel and includes:
Modernization & ACE
Modernizing Customs and Border Protection (CBP) automated systems and information technology is critical to the successful protection of the American people and the American economy in the 21st century, and development of the Automated Commercial Environment (ACE) is an important project for CBP. Ultimately, ACE will enhance border security and deliver efficiencies to the trade community and participating government agencies by providing inter-agency information sharing and real-time, cross-government access to more accurate trade information. By centralizing and integrating the collection and analysis of information, ACE will enhance the ability to target illicit cargo, illegal persons and unsafe conveyances. Trade data will be analyzed prior to arrival of goods, allowing enhanced inter-agency assessment of risks and threats to determine which goods and people must be scrutinized.
"24-Hour Manifest Rule"
US Customs established a new security regulation, effective December 2, 2002, that required ocean carriers and non-vessel-operating common carriers to file detailed manifests to CBP, 24 hours prior to loading their containerized freight in overseas ports. The purpose of this regulation is to give CBP adequate time to stop "high risk" containers for inspection before loading on US-bound ships.
The US Customs and Border Protection began enforcement of the 24-hour advance manifest filing rule for seaborne imports on May 4, 2003.
Customs said it would fine companies that do not electronically submit their cargo declarations on time and issue "do not load" messages to vessel operators for containerized cargo that has an invalid or incomplete cargo description.
Initially, enforcement efforts focused on significant violations of the cargo description requirements such as the vague terms "freight all kinds," "said to contain," or "general merchandise."
Effective May 15, 2003, Customs will issue "do not load" messages if the consignee's name and address are not clearly labeled or left blank. Customs will also penalize companies for invalid cargo descriptions and late submittals for shipments known as "foreign remaining on board," that enter the United States, but are not unloaded at the first port of call. Carriers may be assessed a $5,000 penalty for the first violation and $10,000 for any subsequent violation attributable to the master of the ship.
Customs said it will no longer accept vague freight descriptions, such as "freight of all kinds" (F.A.K.) or "said to contain" (S.T.C.), or broad descriptions, such as "chemicals" or "food stuffs." Many ocean carriers, NVOs and importers have traditionally used these types of cargo descriptions to protect the privacy of their business information from competitors and reporting services.
Customs officials told the industry that they must either provide a more detailed cargo text description or use the first six digits of the Harmonized Tariff Schedule numbers.
More in-depth cargo descriptions on manifests will help the agency speed up non-intrusive inspections of "high-risk" containers and perhaps reduce the need to de-van some boxes. Failure to comply may result in US Customs disallowing loading of the cargo.
Ocean carriers claim to incur added administrative costs as a result and have started to implement "security manifest documentation" charges. These charges have become part of new charges that can be either prepaid or will now appear on the bill of lading. Most charges are $25-$30 per bill of lading and supplier. WSSA sent a summary of those charges to the membership.
The new "24-hour rule" is part of another of the government initiative C-TPAT (see below) in America's fight against terrorism and to protect the security of cargo entering the United States.
The US Customs and Border Protection website can be accessed at www.cbp.gov.
Customs Clearance of Imported Merchandise
Once goods arrive at a US port, they will need to be cleared through Customs.
Customs brokers that are licensed by US Customs and Border Protection can provide this service and conduct Customs business on behalf of importers. They take the burden of filling out paperwork and obtaining a Customs bond off of the importer's hands. Some importations can be particularly complex.
The importer is always ultimately responsible for knowing Customs requirements and for ensuring their importation complies with all federal rules and regulations. However, use of a Customs broker can save you from making costly mistakes. The use of a broker is not a legal requirement and many importers do their own clearance.
For a list of brokers, visit CBP main webpage, www.customs.gov, click on Ports. Then click on the state in which you will be importing into, click on the city, below the city information there is a link for broker listing.
Otherwise, look in your yellow pages under Customs Brokers. Customs cannot recommend individual brokers.
CUSTOM TRADE PARTNERSHIP AGAINST TERRORISM (C-TPAT)
In April 2002, (the then still called) US Customs Service launched a new initiative in America's fight against terrorism, the Customs-Trade Partnership Against Terrorism, or C-TPAT.
This joint initiative between government and business is designed to protect the security of cargo entering the United States while improving the flow of trade. C-TPAT requires importers to take steps to assess, evolve and communicate new practices that ensure tighter security of cargo and enhanced security throughout the entire supply chain. In return, their goods and conveyances will receive expedited processing into the United States.
Through C-TPAT, Customs is asking businesses to ensure the integrity of their security practices and communicate their security guidelines to their business partners throughout the supply chain.
By participating in C-TPAT, companies will ensure a more secure supply chain for their employees, suppliers, and customers. Besides giving their cargo faster processing at the border, Customs will offer additional potential benefits to C-TPAT members, including:
Businesses must apply to participate in C-TPAT. Membership is available to importers, carriers, brokers, warehouse operators, manufacturers, domestic port authorities and marine terminal operators. Participants will sign an agreement that commits them to the following actions:
C-TPAT benefits can begin once Customs has completed a company risk assessment encompassing both security and trade compliance. Highly compliant importers who have already been evaluated for risk will be accepted into C-TPAT upon submission of a signed C-TPAT agreement.
Seven companies helped initiate the program - its charter members were: BP America, Daimler Chrysler, Ford Motor Company, General Motors Corporation, Motorola Inc., Sara Lee Corporation, and Target. Customs also invited more than 200 highly compliant importers to join C-TPAT. As of today, any company that imports into the United States may apply to become a C-TPAT participant.
As of late December 2003, 1,125 companies signed C-TPAT agreements; 764 are importers, 252 customs brokers/freight forwards, and 99 carriers.
Visit the Customs website for further enrollment information.
CONTAINER SECURITY INITIATIVE (CSI)
CSI, launched by Customs in January 2003, is a Customs initiative intended to prevent terrorists from smuggling weapons of mass destruction and other contraband in cargo containers.
The security initiative includes cooperation between the Customs authorities of participating countries and aims to pre-screen US-bound containers.
CSI is built upon four core elements:
A team of inspectors and analysts assigned to each foreign port will use the agency's automated systems to identify potentially high-risk containers that pose a terrorist threat. For those containers identified as "high-risk," officials will take the lead in screening them to ensure they don't contain terrorists or weapons of mass destruction.
CSI is operational in many major ports including, but not limited to, Rotterdam, LeHavre, Antwerp, Bremerhaven, Hamburg, Singapore and Marseilles.
Customs inspectors are also in place at the Canadian seaports of Montreal, Halifax and Vancouver to pre-screen cargo off-loaded at those ports and bound for the US.
FOOD AND DRUG ADMINISTRATION (FDA)
Import Program System Information
The Food and Drug Administration (FDA) mission is to enforce the Federal Food, Drug and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health, safety and pocketbook. These laws apply equally to domestic and imported products.
With the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation, as defined in the FD&C and related Acts, are subject to examination by FDA when they are being imported or offered for import into the United States. Most meat and poultry products are regulated by the US Department of Agriculture.
All imported products are required to meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; radiation-emitting devices must meet established standards; and all products must contain informative and truthful labeling in English.
As defined in the FD&C Act, the term adulteration has to do with the content of a product (such as the addition of a substance which makes a product inferior, impure, not genuine, etc.) while misbranding includes statements on labels or labeling that are false or misleading.
FDA's Import Program/General Procedures
To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with the US Customs Service (Customs) pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs with whom FDA has an excellent working relationship. For specific information on US Customs procedures, requirements, forms, etc., contact your local Customs office.
FDA is notified by Customs of the entry and makes a decision as to the article's admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into United States commerce.
Generally, if FDA decides to examine an entry, an FDA representative will collect a sample from the shipment for laboratory evaluation. If the analysis indicates the product is in compliance, the shipment may be released into United States commerce. If there is a violation, the product will be refused admission. The FD&C Act, Section 801, directs FDA to refuse admission of any article that appears to be in violation of the Act.
When a sample of an article offered for import has been requested by FDA, the owner or consignee shall hold the shipment and not distribute it until further notice is received regarding the results of the examination of the sample. If it appears that the article is violative, FDA issues a Notice of Detention and Hearing to the owner or consignee of the article specifying a place and period of time whereby the individual may introduce testimony either verbally or in writing.
The importer is provided an opportunity to submit a petition to recondition the product to bring it into compliance. The owner or consignee may submit an application to FDA to re-label or perform other actions to bring the article into compliance or render the article other than a food, drug, device, or cosmetic. An application for authorization to re-label or perform other actions to bring the article into compliance shall contain a detailed proposal and specify the time and place where such operations will be carried out and the approximate time for completion as specified by regulation. All petitions to recondition a product are subject to FDA review and approval.
If the product is refused, the importer is required to either re-export or destroy the article under US Customs or other approved supervision. If the refused product is not destroyed or re-exported, Customs issues a notice for redelivery to the importer of record. Failure to redeliver the refused product may result in Customs assessing liquidated damages against the importer's bond.
Detention Without Physical Examination
In some instances, a product may be detained as soon as it is offered for entry into the United States. This procedure is the administrative act of detaining a product without physical examination and is based on past history and/or other information indicating the product may be violative. A product may be subject to a detention without physical examination (DWPE) recommendation until the shipper or importer proves that the product meets FDA guidelines or standards.
Occasionally, FDA identifies products from an entire country or geographic region for DWPE when the violative conditions appear to be geographically widespread. Detention recommendations of this breadth are rare and are initiated only after other avenues for resolving the problem have been exhausted (see FDA Regulatory Procedures Manual (RPM), Chapter 9-25-00, for details on Detention Without Physical Examination - formerly known as Automatic Detention).
Import Alerts
Import Alerts have been developed to communicate guidance to FDA field offices. The purpose of an Import Alert is to identify and disseminate import information (problems, violative trends, etc.) to FDA personnel, thus providing for more uniform and effective import coverage. Import Alerts identify problem commodities and/or shippers and provide guidance for import coverage. They will identify products or shippers that have met the criteria for DWPE (see RPM, Chapter 9-25-00). For additional information or questions regarding DWPE, import alerts or import bulletins policy, contact the Division of Import Operations and Policy (DIOP), HFC-170, 5600 Fishers Lane, Rockville, MD 20857.
Computerization
To assure the expeditious handling of imported products, FDA has automated its import operations. By combining FDA's Operational and Administrative System for Import Support (OASIS) and Customs Automated Commercial System (ACS), a FDA reviewer will be able to more efficiently evaluate and process each import entry. The import filer transmits the required shipment-specific FDA data into the ACS. Within several minutes, the filer receives notification that either their shipment has been released or FDA wishes to review it. This system provides FDA with data files to develop profiles on specific products, shippers, and manufacturers. Eventually, all filers processing entries through Customs ACS will provide FDA information electronically.
How to Access the FDA (including Registration of Facilitates and Prior Notice)
The FDA has set up a help line which is available Monday through Friday from 7:00 a.m. to 11:00 p.m. US Eastern Time. Contact information is as follows:
ENFORCEMENT REMINDER - FDA Bio Terrorism Rule - Prior Notification
May 10, 2004. This Client Advisory is a reminder to food importers that the FDA will begin enforcing its Prior Notification Rule on May 13, 2004 and sums up the status of FDA enforcement quite well.
United States Deparment of Agriculture (USDA) Regulatory Alert - USDA/APHIS.
July 2005.
APHIS has published the Final Rule for new requirements concerning the importation of wood packaging material. The implementation date for regulatory enforcement shall be September 16, 2005. The delay between publication and implementation shall allow an appropriate amount of time for countries to establish programs to become compliant with ISPM 15 and the Final Rule . APHIS has set standards for Wood Packaging Material imported into the USA through 7 CFR 319.40 - Importation of Wood Packaging Material, as published on September 16, 2004. This rule states that all regulated wood packaging material shall be appropriately treated and marked under an official program developed and overseen by the National Plant Protection Organization (NPPO) in the country of export.
Until September 16, 2005, as the designated enforcement date, APHIS will follow its current requirements for imported wood packaging material. Please note that PPQ is in the process of updating all references to SOLID WOOD PACKAGING to reflect the September 16, 2004 rule for REGULATED WOOD PACKING MATERIAL.
September 2005: The United States Department of Agriculture (USDA) and Animal and Plant Health Inspection Service (APHIS): Wood Packaging Regulations Update:
Operating Procedures for Trade Community Regarding Implementation of the
Wood Packaging Materials (WPM) Regulation
Background:
The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has revised its import regulation for wood packaging materials (WPM), 7 CFR § 319. The final rule was posted in the Federal Register September 16, 2004, with an effective date of September 16, 2005.
The regulation requires regulated WPM used in international trade to be treated to kill harmful insects that may be present. WPM must be marked with the International Plant Protection Convention (IPPC) logo, the two-letter International Organization for Standardization (ISO) code for the country that treated the WPM, the treatment facility number assigned by the national plant protection organization, and either the abbreviation HT (heat treatment) or MB (methyl bromide). The rule states that regulated wood packaging materials must be marked in a visible location on each article, preferably on at least two opposite sides of the article, with a legible and permanent mark that indicates that the article meets the new requirements. Paper treatment certificates will no longer be required or accepted. An example of an acceptable WPM mark is:
The regulation restricts the importation of many types of wood articles, including wooden packaging materials such as pallets, crates, boxes, and pieces of wood used to support or brace cargo. The regulations currently refer to these types of wood packaging materials as solid wood packing materials, defined as ''wood packing material other than loose wood packing material, used or for use with cargo to prevent damage, including, but not limited to, dunnage, crating, pallets, packing blocks, drums, cases, and skids.'' Effective September 16, 2005, the U.S. regulation allows non-compliant regulated WPM to be reexported. CBP recognizes that the usage of this term may be confusing. For purposes of CBP implementation of the USDA regulation, "reexport" will refer to the immediate export of violative WPM and, where the violative WPM cannot be separated from the accompanying merchandise, the immediate export of the violative WPM and any accompanying merchandise. By regulation, no treatment options for WPM being imported into the United States are available.
For the purposes of this rule, WPM imported as cargo, such as a container or truckload of new or unused pallets, will still be considered WPM and subject to the rule. Its status as merchandise is irrelevant.
Non-regulated and Exempt Wood and Wood Products:
Regulated WPM do not include any manufactured items, such as worked wood items, even if those items are used to contain other non-regulated merchandise. Examples of such non-regulated manufactured items might include such things as carved or formed wooden bottle stoppers, ammo crates, wooden boxes built to house fuel gauges or armaments, etc . Wine crates for any vintage year prior to 2006, are also non-regulated; wine crates for vintage year 2006 and beyond are regulated.
Regulated WPM do not include any manufactured wood, such as fiberboard, plywood, polywood, whisky and wine barrels, strand board, and veneers, nor do they include "loose wood packing materials" as defined in 7 CFR § 319.40-1. Examples of loose wood packing materials include excelsior (wood wool), sawdust, and wood shavings, produced as a result of sawing or shaving wood into small, slender, and curved pieces. Dunnage is not always loose wood packing materials; when it is not, it is regulated.
The regulation allows importation without marking of otherwise-regulated WPM used by the U.S. Department of Defense to package non-regulated articles, including commercial shipments pursuant to a DOD contract.
By reciprocal regulations, WPM made from Canadian origin wood or U.S. origin wood (or a combination of Canadian origin wood and U.S. origin wood) will be exempt from treatment and marking under this regulation when used in trade between these two countries. For purposes of enforcement of this exception, and absent acceptable proof to the contrary, U.S. Customs and Border Protection (CBP) will consider the country of origin of merchandise coming from Canada to be the country of origin of the accompanying WPM.
The only remaining exemption for imports from Mexico permits importation of unmarked firewood, mesquite wood for cooking, and small, noncommercial packages of un-manufactured wood for personal cooking or personal medicinal purposes as long as these items arrive directly from Mexican Border States.
Phased Compliance:
CBP conducted a special operation during the month of July 2005 to determine the baseline level of WPM compliance. Based on examination results, CBP will perform phased-in compliance enforcement of the USDA WPM regulation.
Phase I , beginning September 16, 2005, will be an informed compliance period, with no stoppage or reexport of shipments for non-compliant WPM. During this phase, all visual exams of cargo performed by CBP Officers or Agriculture Specialists will include a WPM component. If WPM are present and are not marked as having been treated, the broker and the importer will be informed of the non-compliance and given further information. (See "Sample Notice of Violation", attached)
Phase II , beginning February 1, 2006, will continue informed compliance measures on all regulated WPM except pallets and crates. CBP will begin full enforcement of the ban on violative pallets and crates. Beginning with Phase II, reexport of all shipments containing violative pallets or crates will be ordered if the Port Director determines that it is not feasible to separate merchandise from the violative WPM. IT and T&E shipments found to contain violative WPM will not be permitted to transit. All expenses incurred for the services of CBP Officers and Agriculture Specialists involved in the separation of cargo will be billed to the importer or other party of interest. WPM and associated merchandise will be exported at the expense of the importer or other party of interest.
Phase III , beginning July 5, 2006, will represent full enforcement of the WPM ban regulated by 7 CFR § 319. CBP will no longer conduct informed compliance at the shipment level. In Phase III, reexport of all shipments containing violative WPM will be ordered if the Port Director determines that it is not feasible to separate merchandise from the violative WPM. IT and T&E shipments found to contain violative WPM will not be permitted to transit. All expenses incurred for the services of CBP Officers and Agriculture Specialists involved in the separation of cargo will be billed to the importer or other party of interest. WPM and associated merchandise will be exported at the expense of the importer of other party of interest.
Informed Compliance
September 16, 2005 through January 31, 2006
. Phase I of the WPM implementation will consist of an informed compliance initiative relative to CBP efforts to implement and enforce the WPM rule.
. During Phase I, if CBP discovers WPM that are not properly marked (that is, lacking the proper IPPC logo) during the course of any visual examination of any cargo, a Notice of Violation will be posted in a prominent location on the goods. A copy will also be included in the entry packet where possible. The intent of these steps is to notify the broker and the recipient that a violation has occurred and that CBP has chosen to temporarily exercise its enforcement discretion. These discoveries are considered violations of the WPM rule.
. The enforcement of WPM requirements is a separate process from the normal course of pest interdiction duties conducted by CBP Agriculture Specialists. In every case of the discovery of a pest infestation, the protocol associated with safeguarding or eradication of the pest threat will supersede WPM enforcement. Once a pest threat has been eliminated, the WPM enforcement will be applied.
. National and port account managers will work with their accounts to answer questions and encourage compliance with the regulation.
Wooden Pallets and Crates
February 1 through July 4, 2006
. Phase II continues informed compliance efforts started in Phase I. However, enforcement of the rule will begin to impact cargo shipments that have non-compliant wooden pallets or crates
.
The term "pallets", when used in this document, will include single wooden pallets and all pallets that are part of a unitized packaging container, such as wooden pallets that comprise the base of a carton or crate (for example, in shipments of motorcycles, machinery parts, pipe fittings, etc.) Wooden crates or lift vans constructed solely of manufactured wood (for example, plywood) are not regulated by the WPM rule. However, if other lumber is used in these crates, those pieces are covered by the WPM rule. (See also "WPM--Specific Exemptions", attached)
. During Phase II, if CBP discovers WPM (other than pallets or crates) that are not properly marked (that is, lacking the proper IPPC logo) during the course of any visual examination of any cargo, a Notice of Violation will be posted in a prominent location on the goods. A copy will also be included in the entry packet where possible. The intent of these steps is to notify the broker and the recipient that a violation has occurred and that CBP has chosen to temporarily exercise its enforcement discretion. These discoveries are considered violations of the WPM rule.
Shipments Containing Non-Compliant Wood Pallets or Crates
The shipment will be held and will not be released. IT and T&E shipments found to contain violative WPM will not be permitted to transit.
The Agriculture Specialist will complete a USDA Emergency Action (EAN) Notification (PPQ-523) on the violative materials.
The Agriculture Specialist will follow the general guidelines for completing actions under the EAN procedures.
The importer, or the importer's representative (if one is available), will be notified by CBP of the situation.
. The importer or other party of interest may request separation of the imported merchandise from the violative WPM.
. If the Port Director determines that separation of the non-compliant crates from the cargo is not feasible , or if separation is not requested, then the entire shipment (violative WPM, compliant WPM, and merchandise) shall be ordered exported from the U.S. in accordance with the rule.
The Port Director shall order the shipment to be exported from the U.S. at the importers' or party of interest's expense. It is irrelevant if the shipment contains a mixture of compliant and violative WPM.
The authority to order exportation of violative WPM is contained in the USDA regulations at 7 CFR § 319.40.
If the entire shipment is ordered exported, any original entry must be cancelled and an Immediate Exportation entry (entry type 63) must be executed and provided to the Port Director to document the export movement.
If movement outside of the original U.S. port becomes necessary to cause the ordered exportation, it will be on a restrictive Transportation and Exportation entry (entry type 62) in conjunction with an appropriately executed USDA Emergency Action Notification (EAN) (PPQ-523). The EAN will provide and document restrictions as to routing, diversion and authorized timeframe to complete the restricted transportation and exportation movement.
In the event that the identity of the importer is unknown or otherwise not available to CBP, the importing carrier may be held liable for expenses related to the costs of exportation of the non-compliant WPM and associated cargo.
In the event that the merchandise is abandoned, the shipment will go to General Order (G.O.) and be handled under established procedures. If G.O. merchandise is ultimately auctioned, all noncompliant WPM must be exported at the expense of the successful bidder.
. If the Port Director determines that separation of the violative WPM from the cargo is feasible , then the cargo will be separated at the importer's expense at a time and place determined by the Port Director.
. After separation, the Port Director will order violative WPM to be exported per 7 CFR § 319.40 at the importers' or party of interest's expense.
. If only the violative WPM is to be exported, the importer or party of interest (working in conjunction with the exporting carrier) must supply evidence sufficient to Port Director's satisfaction that the non-compliant WPM will be removed from the U.S. This proof may include, but is not limited to, a bill of lading, statement on carrier letterhead, U.S. export or foreign entry documents, etc.
. In the event that the identity of the importer is unknown or otherwise not available to CBP, the importing carrier may be held liable for expenses related to the costs of exportation of the non-compliant WPM.
Full Enforcement
July 5, 2006, and beyond
. All informed compliance efforts at the shipment level under the WPM rule are discontinued.
. During Phase III, if CBP discovers any WPM that are not properly marked (that is, lacking the proper IPPC logo) during the course of any visual examination of any cargo, the shipment will be considered in violation of the WPM rule.
. All other operational elements of Phase II remain in effect.
TO: Importer
FROM: U.S. Customs & Border Protection Port Director
SUBJECT: Violative Wood Packaging Materials
USDA has revised its import regulation for wood packaging materials (WPM). Effective, September 16, 2005 , WPM coming into the U.S. must to be treated and marked. Paper certificates of treatment or fumigation are no longer acceptable. The approved treatments are either heat treatment to a minimum wood core temperature of 56º C for a minimum of 30 minutes or fumigation with methyl bromide (MB).
An acceptable mark is determined by the national plant protection agency of each country and must include the trademarked ISPM-15 stamp. Contact information for representatives of national plant protection organizations can be accessed at: https://www.ippc.int/IPP/En/nppo.jsp
CBP has tentatively determined that this shipment is not in compliance with the USDA requirement.
In cases of noncompliance, a CBP Officer or Agriculture Specialist at the port of first arrival may order the immediate export of regulated wood packaging materials (along with the accompanying cargo) at your expense. Please ensure your shipper's compliance, as this will affect whether you receive your goods in a timely manner.
For this shipment CBP is using its enforcement discretion and is not ordering this shipment to be exported. This discretionary enforcement period will cease on February 1, 2006. On or after February 1, 2006, non-compliant WPM detected by CBP Officers or Agriculture Specialists will be subject to immediate exportation AT YOUR EXPENSE.
Please ensure that your suppliers are aware of this requirement.
There are certain exceptions to the new requirements. More information is available from USDA at 1-866-738-8197 during the months of September and October or at www.cbp.gov .
. The rule does not authorize domestic destruction of non-compliant WPM. The rule does not authorize fumigation in lieu of proper marking for WPM. Exportation of non-compliant WPM is the only recourse under the U.S. regulation.
. Separation of non-compliant WPM from compliant WPM or associated merchandise is not an absolute right; it is an option left to the government's discretion. All expenses related to the movement, inspection, separation, safeguarding, storage, and ultimate disposition of non-compliant WPM are at the expense of the importer or party of interest.
. When a shipment is held by CBP for non-compliance with the WPM rule, the importer, or their representative or other party of interest, may make a request to CBP for the ability to separate WPM from the imported commodities. The requesting party shall submit a completed CBP 3499 - Application and Approval to Manipulate, Examine, Sample or Transfer Merchandise, to the CBP Port Office within one business day after the hold has been placed. In the case of a consolidated shipment, any affected importer or party of interest may make application under the guidelines of this protocol. All appropriate forms and evidentiary materials required by this Appendix must be presented to the Port Director, and all expense will accrue to the applicant.
. The importer, or their representative or other party of interest, must submit to the Port Director evidence of their commitment to export the non-compliant WPM that are separated from the merchandise referenced in the CBP 3499. This evidence must be presented at the time of submission of the CBP 3499 and may consist of various elements, but will usually include the participation of a carrier. This requirement is critical, as the Port Director must ensure that the non-compliant WPM are properly exported and the government does not incur any expense.
. Other parties of interest may apply to CBP for the WPM separation process only if the importer has no U.S. presence. These other parties must clearly define for CBP their interest in the merchandise. Carriers may not apply for the WPM separation process solely based on recovering or repositioning their property (containers). All parties applying for WPM separation must provide for the continuity of the cargo and the prompt and proper exportation of the non-compliant WPM.
. The Port Director will determine whether to approve the CBP 3499. Once the decision is made, the Port Director will notify the importer. The decision of the Port Director is final .
. If the decision is made to approve the separation request, the Port Director will determine the time, place, and supervision requirements of the separation.
. If the separation request is granted, the process should commence under CBP supervision as soon as practical.
. CBP may assign an Agriculture Specialist or CBP Officer to supervise the separation because the non-compliant WPM may present a pest risk.
. If WPM are to be exported due to non-compliance with the WPM rule, the WPM lose the entry status of an instrument of international traffic. An IE or T&E entry will be filed with CBP, and the WPM should be fully described with an additional caption that "The material is non-compliant with the ISPM-15 Standard."
. Under normal circumstances, services performed under a CBP 3499 may only be performed at CBP Bonded Warehouses. For the purposes of this application, the services may be performed at any location that the Port Director deems appropriate for that purpose. This will usually be where CBP Officers or Agriculture Specialists perform examination work, such as a CES, carrier facility, or bonded warehouse.
. After the cargo is successfully separated from the non-conforming WPM, the CBP Officer or Agriculture Specialist will be responsible for removing the hold and completing any entry-related processing that would normally occur to release the merchandise from CBP custody.
. CBP will bill the importers or other party of interest for their services.
. Considering the restrictions above, the importer (or their representative or other party of interest) must consider that in many cases it may be cost prohibitive or logistically impractical to do request WPM separation.
. If the decision is made to disapprove the separation request, the importer must make arrangements with the importing carrier to export the entire shipment at the first available opportunity . If the importer fails to make those arrangements, CBP and/or USDA will make the arrangements for the importer, and the importer will be billed accordingly. Because CBP and USDA are not in the shipping business, USDA's subsequent billing to the importer for these logistics services may be exceptionally significant.
. Shipments will not be authorized to move in bond to another port for separation consideration under the WPM program.
The USDA import regulation for wood packaging materials (WPM), 7 CFR § 319, offers the following definition of regulated wood packaging materials: wood or wood products (excluding paper products) used in supporting, protecting or carrying a commodity, including dunnage, other than:
. manufactured wood materials,
. loose wood packing materials (defined as excelsior [wood wool], sawdust, and wood shavings, produced as a result of sawing or shaving wood into small, slender, and curved pieces), and
. pieces of wood that are less than 6 mm thick in any dimension, that are used or for use with cargo to prevent damage, including, but not limited to, dunnage, crating, pallets, packing blocks, drums, cases, and skids, whether in actual use as packing for regulated or non-regulated articles or imported as cargo.
Regulated WPM may be imported into the United States under a general permit in accordance with the following conditions:
. The WPM must have been either heat treated to achieve a minimum wood core temperature of 56° C for a minimum of 30 minutes or fumigated with methyl bromide in an enclosed area for at least 16 hours at approved dosages and then aerated to reduce the concentration of fumigant below hazardous levels.
. The wood packaging materials must be marked in a visible location on each article, preferably on at least two opposite sides of the article, with a legible and permanent mark that indicates that the article meets the treatment requirements.
There are specific exceptions for some WPM. These exceptions are:
Manufactured wood materials such as fiber board, plywood, whisky and wine barrels, and veneer,
Loose wood materials as defined above,
. Pieces of wood that are less than 6 mm (0.24 in) in any dimension,
WPM used by the U.S. Department of Defense (DOD) to package non-regulated articles, including commercial shipments pursuant to a DOD contract, and
Firewood, mesquite wood for cooking, and small, noncommercial packages of unmanufactured wood for personal cooking or personal medicinal purposes coming directly from Mexican border states.
By reciprocal regulations in Canada and the U.S, WPM made entirely from Canadian origin wood or U.S. origin wood are exempt from the treatment and marking requirements when accompanying shipments being shipped in either direction between these two countries.
USDA has grandfathered in all wine crates for vintage years preceding 2006. This means that wine crates for any wine with a vintage year through 2005 are exempt from treatment and marking requirements. Wines of vintage year 2006 and beyond will be required to be in crates that have been treated and marked.
Articles of wood that are manufactured to transport a specific non-regulated commodity (for example, fuel gauges, armaments, etc .) are not considered WPM and are not required to be treated and marked.
WPM that are part of any bundle of imported lumber are excepted from the rule. Other WPM used in the transport of bundled lumber (for example, pallets or planks) are not exempted and are regulated WPM.
Since the regulation of WPM is an international standard with 138 signatory countries actively participating in its enforcement, it is likely that some shipments of U.S. exports will contain WPM that are not compliant with the standard that may be detected by our counterparts in other countries. They may determine the WPM to be inadmissible and order that non-compliant WPM be re-exported to the United States. Not all signatory countries are phasing in their WPM requirements.
Further information on the requirements of any country may be received from the appropriate official listed at https://www.ippc.int/IPP/En/nppo.jsp .
If CBP Officers or Agriculture Specialists encounter a shipment of returned U.S. merchandise that contains non-compliant WPM, CBP will provide a sectional release for the merchandise and WPM upon reasonable submission of proof that the merchandise did not enter the commerce of any other country as provided for under 19 CFR 4.35(g).
Returns To or From Canada & Mexico
CBP continues to work very closely with counterparts in both Canada and Mexico to develop the most effective methodology for implementing this WPM initiative. Since we share common land borders and high traffic volume in both directions it was decided among the customs administrations that none of the three countries would implement their WPM action plan unilaterally. All three countries have agreed to implement their WPM initiatives modeled on U.S. CBP's phased implementation approach.
Because some exemptions exist for Canadian origin WPM that do not exist for Mexican origin material, we anticipate more instances of returned WPM on our southern border. At this time CBP is still in discussion with colleagues in both Canada and Mexico on the best way to implement returns of non-compliant WPM. Detailed instructions on this aspect of our WPM implementation will be issued during Phase I, for implementation in Phase II.
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