Types of importation documents
Certificate of Analysis (CoA) is added to a Bill of Lading, Customs Form, Commercial Invoice, Packing List, and Warehouse documents.
Laboratory test results document food safety methods, processes, and methods.
Importers' preventive controls should deter the risk of import detention.
Laboratory documents generated from production steps are key to substantiating food safety measures
FDA Detention Expediting
Food Importers to the USA market
In-house laboratories can provide ISO 17025 laboratory results to immediately resolve detention issues, keeping your buyer's products moving and keep your supply chain moving.
Receiving an FDA Detention Notice
Unnecessary challenges and dread are minimized with a complete transportation documentation package presented at the USA Port of Entry.
The US FDA Notice of Detection can be also minimized with sufficient prepared documentation.
The laboratory team prepares the analytical packet to be submitted to the US FDA via the Import Trade Auxiliary Communications (ITACS) System, which is a U.S. Government information system.
Detentions can result in delays to market
Buying customers often do not understand the complexities of international border crossings.
Decrease Warehouse Storage Fees
Immediate bacterial pathogen test results can minimize the "wait time" so the shipments can quickly be presented to US Port authorities.
Frustrated Buyers Waiting for Delivery
Buying customers are pleased with 'on time' deliveries from international sellers.
Avoid Loss of Reputation and Revenues
In-house laboratory results presented to authorities can expedite the cross-border experience for both the seller and the buyers.
The US FDA Protects US Consumers
The US FDA works hard to protect US consumers and their food supply. The Federal Food, Drug and Cosmetic Act grants the FDA authorization to detain shipments that they suspect violate the act. The FDA can collect samples to analyze themselves, or, they can detain a shipment without physical examination (DWPE) if the manufacturer is red-listed under an import alert.
Detention without Physical Examination (DWPE)
DWPE is applied when products in a shipment violate or appear to violate US FDA laws and regulations. The US FDA sends the manufacturer a notice of a DWPE action, which provides a detailed explanation for why the entry is detained, the due date for a response, and the compliance officer assigned to the entry.
Manufacturers have the opportunity to have a testing laboratory collect samples for analytical testing.
Labs will prepare a private laboratory analytical package to submit as evidence and testimony to the FDA for their review.
After a thorough review of the results and lab package, an FDA compliance officer will determine whether the product can be released into US commerce or if it will be refused entry. works hard to protect US consumers and their food supply.
The Federal Food, Drug and Cosmetic Act grants the FDA authorization to detain shipments that they suspect violate the act.
The FDA can collect samples to analyze themselves, or, they can detain a shipment without physical examination (DWPE) if the manufacturer is red-listed under an import alert.
References:
FDA DWPE Overview: This page on the FDA website provides an overview of DWPE, including what it is, when it is used, and how it works. It also includes links to related resources and information. https://www.fda.gov/industry/import-basics/detention-without-physical-examination-dwpe
FDA Import Alerts: This page on the FDA website provides information on import alerts, which are used to provide notice to the public and FDA field personnel that the agency has enough evidence to detain products that violate FDA regulations. https://www.accessdata.fda.gov/cms_ia/importalert_3.html
FDA Compliance Program Guidance Manual: This manual provides guidance to FDA personnel on the enforcement of FDA regulations, including DWPE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-manual-fda-regulatory-policy-compliance-program-73481
FDA Import Procedures: This page on the FDA website provides information on the import procedures that must be followed to comply with FDA regulations, including information on DWPE. https://www.fda.gov/industry/import-basics/fda-import-procedures
FDA Import Operations: This page on the FDA website provides information on the FDA's import operations, including how it uses DWPE to enforce its regulations. https://www.fda.gov/industry/import-basics/fda-import-operations
Prohibited Pesticides testing by USA Agencies
USA Agencies Tests Food Products for Prohibited Pesticides
The U. S. Environmental Protection Agency (EPA) approves the use of pesticides and may establish tolerances for pesticide chemical residues that could remain in or on food. A tolerance is the EPA established maximum residue level of a specific pesticide chemical that is permitted in or on a human or animal food in the United States.
The Food and Drug Administration is responsible for enforcing the EPA tolerances for domestic foods shipped in interstate commerce and foods offered for import into the U.S., except for meat, poultry, catfish, and certain egg products that are regulated by the U.S. Department of Agriculture.
Testing Prior to Shipment to USA
HSG-AME suggests the testing of food products for prohibited pesticides prior to presentation to the US authorities.
GCMS and LCMS Equipment, Consumables and Training
HSG-AME can install, train, support, and certify your test to perform these tests prior to shipment across international borders to the USA.
References
Environmental Protection Agency (EPA) website: The EPA is responsible for regulating pesticides in the United States. Its website provides information on the agency's policies and procedures related to pesticide testing, including information on prohibited pesticides. https://www.epa.gov/pesticides
USDA's Food Safety and Inspection Service (FSIS) website: The FSIS is responsible for ensuring the safety of meat, poultry, and egg products in the United States. Its website provides information on the agency's policies and procedures related to pesticide residues in food products. https://www.fsis.usda.gov/
FDA's Pesticide Residue Monitoring Program: The FDA's Pesticide Residue Monitoring Program tests a variety of foods for pesticide residues to ensure compliance with federal regulations. Its website provides information on the program's policies and procedures, including information on prohibited pesticides. https://www.fda.gov/food/pesticide-residue-monitoring-program
National Institute of Environmental Health Sciences (NIEHS) website: The NIEHS is a research organization that studies the effects of environmental factors, including pesticides, on human health. Its website provides information on pesticide exposure and its health effects. https://www.niehs.nih.gov/health/topics/agents/pesticides/index.cfm
Centers for Disease Control and Prevention (CDC) website: The CDC is responsible for tracking and investigating outbreaks of disease in the United States. Its website provides information on pesticide-related illness and injury. https://www.cdc.gov/niosh/topics/pesticides/
Agency for Toxic Substances and Disease Registry (ATSDR) website: The ATSDR is a federal public health agency that investigates the health effects of toxic substances, including pesticides. Its website provides information on pesticide exposure and its health effects. https://www.atsdr.cdc.gov/toxfaqs/tfacts.asp?id=32&tid=6
USA Land Port of Entry
In the USA a Land Port Of Entry (LPOE), or border station, provides controlled entry to the United States for food materials.
The Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) inspect food imports.
FSMA requires a 3rd-party certification.
HSG-AME can equip, train, support, and certify your team to provide documentation for each load crossing into the USA.