Imports into the U.S. have been increasing 10% to 15% per year over the last decade, and those percentages are expected to continue to rise. Although American exports were down in 2015, for the first time since the recession of 2009, the U.S. continues to be the world’s third biggest exporter. With all this coming and going, how is a food manufacturer to know what regulations apply when bringing food into the country or sending it out?
IMPORTS. The overarching rule of imports, as required by FDA and USDA is that they meet the same standards as domestic goods.
The most recent ruling of FDA is, of course, the Food Safety Modernization Act (FSMA) which adds new import mandates and FDA authorities: For the first time, importers must verify that their foreign suppliers have preventive controls; FDA can require that high-risk imported foods have a third-party certification or other assurance of compliance; and FDA can refuse entry of food from a foreign facility if it, or the country in which it is located, denies FDA access.
To implement these new rules, the agency was tasked with establishing a system to recognize accreditation bodies that can certify foreign food facilities to facilitate import entry. FDA is also to establish the voluntary qualified importer program that provides for expedited review and entry of foods from participating importers. For more information on any of these, see the full text of the law.
In addition to the new mandates and authorities of FSMA, pre-existing rules of FDA’s import program remain in effect. For example, prior to being allowed entry into the U.S., FDA-regulated products are electronically screened and FDA is authorized to conduct a field examination of any product, inspect its label, or collect samples to ensure it is in compliance. If a shipment fails to pass the inspection, it is subject to refusal.
Incoming shipments also may be on the “red list” for an Import Alert, by which a shipment can be subject to Detention Without Physical Examination (DWPE) based upon past violations or other information indicating the product may be in violation of FDA laws. At any time, a product also can be refused entry if it appears to be adulterated, misbranded, or a forbidden or restricted-sale product. FDA also regularly compares entry documents to the data which was electronically submitted to ensure the two are the same and accurately reflect the incoming product.
Should any of the examinations, evaluations or samples result in a violation, the imported product or firm can be subject to penalties, such as seizure by Customs and Border Protection (CBP) or FDA, civil fines, bond actions, state embargo/stop sale, food importer debarment, or prosecution.
USDA also requires that imported meat and poultry products follow the same sanitation and health requirements as those set for domestic products. This doesn’t mean that the sanitary measures of all countries’ food regulatory systems need to be exactly the same as those of the U.S., rather determinations of equivalence are made through U.S. evaluation of whether the regulatory system employs equivalent sanitary measures that provide the same level of protection against food hazards as is achieved domestically. This evaluation is conducted by USDA’s FSIS through document reviews, on-site audits, and port-of-entry reinspection.
EXPORTS. While an exporter will need to know and comply with the regulations and standards of the specific countries to which its food is to be exported, there are also FDA and USDA export requirements.
The primary FDA regulation for any food being exported from the U.S. is that of recordkeeping to demonstrate that the product meets FD&C requirements. These include records that demonstrate that the product:
- Meets the foreign purchaser’s specifications, with sufficient information to match those specifications to a particular export.
- Is not in conflict with the laws of the importing country (e.g., a letter from a foreign government agency, department, or other authorized body or a notarized certification by a U.S. company official).
- Is labeled on the outside of the shipping package, or on the shipping documents if the product does not have a shipping package/container.
- Is not sold or offered for sale in the U.S. (e.g., production and shipping records and promotional materials).
USDA EXPORTING. USDA also created a seven-step checklist for food providers to follow when exporting meat, poultry, or processed egg products from the U.S.:
- Consult the export requirements for the countries to which you are exporting food. For those not listed, exporters are advised to work closely with the importer.
- Check USDA’s list of U.S. establishments eligible to export to a specific country. Most countries accept products from all federally authorized establishments, but some require pre-certification of the establishment through an Establishment Application for Export form (#9080-3).
- For products that are eligible for export to a specific country, the exporter is to complete an Application for Export Certificate (Form #9060-6) certifying that the products meet the import requirements of the receiving country. 4.
- The application is then to be signed by the export-reinspection FSIS inspector, and a blank export certificate or its serial number provided to the exporter.
- Stamp the certificate’s serial number on each shipping container with the export stamp as required by 9 CFR 322.1 and 9 CFR 381.105.
- Present the export certificate for signature to the FSIS signing official along with any other certificates required by the country.
- The original copy of the certificate is then provided to the exporter and the importing country with the shipment.
While following these guidelines, exporters also are advised to work closely with their importers to ensure that when the product arrives at its international destination, it will be allowed entry.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.