Need To Know
FDA
FDA DUNS Portal
FDA is now requiring every importer who brings commodities that require prior notice to have a DUNS number. Please visit this link for more information: https://importregistration.dnb.com/QUICK%20USER%20GUIDE_FDA_DUNS_Portal.pdf
Food Facility Registration
Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register with FDA before beginning these activities. FDA registrations need to be renewed biennially between October and December of even numbered years. In order for a Foreign Facility to obtain a registration, they must first have a DUNS on file. Please view or print the information in section two of the valid Food Facility Registration and the information on the DUNS Portal (at Dun & Bradstreet) for the facility name and address. The information on both web sites must match exactly. The matching includes words typed in all caps, punctuations, abbreviations, upper case letters and lower-case letters. The Facility name, the street address, the city, state/province/territory and the five-digit zip code (or your country’s postal code) must match exactly or the Food Facility Registration will be canceled. A DUNS for foreign facilities maybe obtained in https://www.cialdnb.com/es/numero-d-u-n-s/
Foreign Supplier Verification Program (FSVP)
An FSVP (Foreign Supplier Verification Program) is a program required by the FDA for importers to verify that the food they are importing meets U.S. safety standards. Unless exempt your Customs Broker will require contact information for the individual they should contact in case your firm gets selected for an audit and a DUNS will be required. The importer DUNS maybe obtained at https://www.dnb.com/duns-number/lookup.html
Here are a few steps to follow in order to create an FSVP:
- Identify the Foreign Supplier: The first step is to identify the foreign supplier of the watermelon and obtain information about their food safety practices. This information may include documentation of their food safety plan, hazard analysis, and preventive controls.
- Evaluate the Hazards: Evaluate the hazards associated with the product, including any biological, chemical, or physical hazards. Consider the likelihood of occurrence and the severity of the potential harm.
- Verify the Supplier’s Food Safety Practices: Verify that the foreign supplier’s food safety practices are adequate to control the identified hazards. This may include an onsite audit of the supplier’s facilities and processes or a review of their documentation.
- Establish Written Procedures: Establish written procedures for ensuring the safety of the imported commodity, including steps for verifying the supplier’s food safety practices, procedures for handling and storing the watermelon, and steps for correcting any identified problems.
- Maintain Records: Maintain records of all activities related to the FSVP, including documentation of the supplier’s food safety practices, verification activities, and any corrective actions taken.
It is important to note that the FSVP requirements are complex and may vary depending on the specific products being imported and the countries of origin. It is recommended that you consult with a qualified professional to ensure that you are in compliance with all applicable regulations.
FDA Import Alerts
An FDA import alert is a public notification issued by the U.S. Food and Drug Administration (FDA) to inform the agency’s field staff and the public that there is enough evidence to allow for detention without physical examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations governing the safety , efficacy, and quality of FDA-regulated products. The alerts may be issued for several reasons, such as the presence of harmful contaminants, mislabeling, or other violations. Import alerts are issued to help prevent the entry of potentially harmful or non-compliant products into the U.S. market and to protect public health. An import alert can also be issued to a company or country when the FDA has past evidence of a shipment being violative.
There are two different types of automatic detention. One is caused when the shipper has been sampled and found violative. This causes the shipper to be placed on an import alert and placed on a list known as Detention without Physical Examination which is known to be a red list.
The second type of automatic detention is based on a few commodities who have had a history of violations and may be country specific . These commodities are considered to be of high risk and a private lab analysis is required unless the shippers have met the criteria and are placed on a list of exclusion of Detention Without Physical Examination which is also known as the green list. If the shipper is in the list in the enclosed link then they are exempt from having to do private labs.
Visit https://www.accessdata.fda.gov/cms_ia/default.html for a list by country and or industry
Please visit this link for more information on how an entity can be removed from DWPE https://www.fda.gov/industry/import-alerts/removal-import-alert
Import Trade Auxiliary Communications System (ITACS)
FDA has deployed ITACS for use by the trade community. It gives the trade community the ability to electronically check the status of FDA-regulated entries and lines, submit entry documentation, submit the location of goods availability for those lines targeted for examination by the FDA, and check the estimated laboratory analysis completion dates for lines which have been sampled. If you
ITACS basic functionality may be accessed at https://itacs.fda.gov.
Overweight Vehicles Permits/Fines
Overweight Permits
Specialized overweight permits are permitted within the Hidalgo County Regional Mobility Authority (HCRMA). For a fee of $80 per shipment the transportation company could apply for the Mexican carrier to transport no more than 125,000 lbs at once. This overweight permit will be issued to a transportation company for every tractor trailer that submits the fee with application. Please visit the following link for detailed explanation of permit requirements and truck required routes https://texas.promiles.com/hidalgo/Default.aspx
Annual over axle/over gross weight tolerance permits are also available through the Texas Department of Motor Vehicles. Please visit https://www.txdmv.gov/motor-carriers/oversize-weight-permits/annual-over-axle-over-gross-weight-tolerance#how-to-apply for more information. This permit allows a vehicle to operate by a tolerance of 10% and the legal gross weight by a tolerance of 5%.
Texas Department of Public Safety Overweight Fines
The Texas Department of Public Safety is strategically located outside the US Import lot in several ports of entry. Although the maximum weight allowable is 80,000 per truckload, overweight fines are placed on all loads exceeding 1,000 lbs over the 34,000 allowable per axle. If the weight is between 35,000-37,500 lbs, a penalty will be issued but no merchandise will have to be unloaded.
USDA
Animal Plant and Health Inspection Services (APHIS)
APHIS has developed a website to facilitate information for import requirements for Agricultural Commodities Import Requirements (ACIR). Please visit link to obtain up to date information on the commodities you are interested in importing:
https://acir.aphis.usda.gov/s/
USDA Permits
if ACIR advises you that you need an import permit, visit the permits APHIS E-file system at:
Wood Packing Material
All wood packing material must be marked and treated by either of two methods, heat treatment or methyl bromide. Examples of WPM includes but not limited to pallets, skids, pallet collars, containers, crating/crates, boxes, cases, bins, reels, drums, load boards, dunnage. Wood packaging made of exempt materials but combined with solid wood components must still be treated and marked. Enclosed is the example of the marking which contains the Country where it was marked, the facility identification code that treated the WPM, the treatment method, and the inspection agency logo.
Failure to treat or properly mark each pallet in the shipment will result in inadmissibility and the cargo will be refused by Agriculture. A fine equal to the value of the merchandise will also be imposed. ALL WPM must be visible, and clearly marked. Multiple IPPC logos belonging to various treatment facilities within the same and/or added wood pieces to reconstruct a pallet that is not marked will also result in a refusal.
Please visit this link for more information: https://www.cbp.gov/border-security/protecting-agriculture/wpm
