IMPORT SAFETY (FOOD SAFETY) / “The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures … that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections” that apply to domestic food producers.

“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals”

July 29, 2013. Proposed Rule.

 

 

 

 

Administrative Action – U.S. Department of Agriculture Animal and Plant Health Inspection Service is amends “the regulations concerning the importation of plants and plant products by establishing the controlled import permit as a single type of authorization for the importation into the United States of otherwise prohibited or restricted plant material for experimental, therapeutic, or developmental purposes. Currently, some sections of the regulations provide for those articles to be imported under a departmental permit, while other sections provide for their importation under administrative instructions or conditions specified by the Administrator or Deputy Administrator. This action will consolidate and harmonize the conditions for obtaining authorization for the importation of otherwise prohibited or restricted plant material for scientific or certain other purposes.”

“Controlled Import Permits.”

May 2, 2013. Final Rule.

Note well: The U.S. Department of Agriculture Animal and Plant Health Inspection Service also issues two proposed rules (here and here) and a notice on safety of importation of specific food (plant) items (here).

USDA AGRICULTURAL ANIMAL AND PLANT HEALTH INSPECTION SERVICE / Proposed rules from U.S. Department of Agriculture Animal and Plant Health Inspection Service relating to a restructure of regulations governing the importation of plants for planting in which the proposed structure, restrictions on the importation of specific types of plants for planting would no longer be found in the regulations, but instead would be found in the Plants for Planting Manual.

“Restructuring of Regulations on the Importation of Plants for Planting.” 

Aril 25, 2013. Notice of Proposed Rule Making

“…As part of this restructuring, [U.S. Department of Agriculture Animal and Plant Health Inspection Service] would group together restrictions in the plants for planting regulations that apply to the importation of most or all plants for planting, and [U.S. Department of Agriculture Animal and Plant Health Inspection Service] would add general requirements for the development of integrated pest risk management measures that [it] would use to mitigate the risk associated with the importation of a specific type of plants for planting. [U.S. Department of Agriculture Animal and Plant Health Inspection Service] would also amend our foreign quarantine regulations to remove various provisions regarding the importation of specific types of plants for planting that are not currently subject to the general plants for planting regulations; these provisions would also be found in the Plants for Planting Manual. This action would not make any major changes to the restrictions that currently apply to the importation of plants for planting. These changes would make restrictions on the importation of specific types of plants for planting easier for readers to find and less cumbersome for [U.S. Department of Agriculture Animal and Plant Health Inspection Service] to change.”

IMPORT SAFETY / Note two notices from the U.S. Department of Agriculture Animal and Plant Health Inspection Service relating to (1) importation of fresh oranges from Egypt to the U.S., and (2) Plants for planting whose importation is barred pending pest risk analysis.

Agency announcements in Federal Register here and here.

IMPORT SAFETY (U.S.D.A. ANIMAL AND PLANT HEALTH INSPECTION SERVICE) / The U.S. Department of Agriculture Animal and Plant Health Inspection Service is amending its regulations governing import of animals and animal products from the European Union effective April 15.

We are amending the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union (EU) as the Animal and Plant Health Inspection Service (APHIS)-defined EU poultry trade region and adding it to the list of regions we consider to be free of Newcastle disease. We are taking this action based on a risk evaluation that we prepared in which we determined that the region meets our requirements for being considered free of Newcastle disease. We also determined that the region meets our requirements for being considered free of highly pathogenic avian influenza (HPAI). In addition, we are establishing requirements governing the importation of live birds and poultry and poultry meat and products from the APHIS-defined EU poultry trade region and updating avian disease terms and definitions. We are also allowing importation from the APHIS-defined EU poultry trade region of hatching eggs under official seal, including those that have transited a restricted zone established because of detection of HPAI within the boundaries of the APHIS-defined EU poultry trade region.”

“Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European Union” 

March 29, 2013. Final Rule.

See article in Journal of Commerce.

IMPORT SAFETY (ANIMAL AND PLANT HEALTH INSPECTION) / Animal and Plant Health Inspection Service of U.S. Department of Agriculture announces availability of, “a document that describes the revised methodology that APHIS will use to conduct plant health pest risk assessments for imported fruit and vegetable commodities.”

March 6, 2013, Notice of Availability.

“We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has prepared a document that describes the revised methodology that APHIS will use to conduct plant health pest risk assessments for imported fruit and vegetable commodities. These new guidelines are necessary to incorporate advancements in pest risk assessment methods, provide clearer and more transparent analyses, and streamline the market access analysis process.

“On October 17, 2000, under the authority of the Plant Protection Act (7 U.S.C. 7701 et seq.), the Animal and Plant Health Inspection Service (APHIS) began using a specific set of guidelines to conduct pathway-initiated, qualitative pest risk assessments (PRAs) for imports of fruits and vegetables. A PRA is defined by the International Plant Protection Convention (IPPC), of which the United States is a member, as an “evaluation of the probability of the introduction and spread of a pest and the magnitude of the associated potential economic consequences.” Following the characterization of the risk of the pest in the PRA, APHIS produces a risk management document to determine appropriate pest risk mitigation methods.

“APHIS has determined that it is necessary to update the previous guidelines, which were developed over 10 years ago, in order to provide a more streamlined and efficient process for developing PRAs. Revising the PRA guidelines allows APHIS to incorporate advancements in PRA methods, provide a clearer, more transparent, and more logical order of progression of the assessment, and more closely align the assessments to the IPPC’s international standards for phytosanitary measures. The new guidelines provide a more technically correct method of assessing risk by recognizing that the likelihood of pest introduction is multiplicative rather than additive; i.e., if one necessary step for the introduction of a pest has a low likelihood of occurring, there is an overall low likelihood of introduction of the pest, regardless of the likelihood of other steps. The new guidelines also address uncertainty, a principle not explicitly addressed in the previous guidelines. In addition, because the new guidelines are designed to make the PRA drafting process more efficient, we expect the time required to produce the PRAs and respond to market access requests to decrease.

“The PRA guidelines document, entitled “Guidelines for Plant Pest Risk Assessment of Imported Fruit & Vegetable Commodities,” may be viewed on the Regulations.gov Web site at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0077 or in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming. In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT.”

IMPORT PROTECTION (U.S. CBP, U.S. DEPARTMENT OF AGRICULTURE, U.S. FDA) / Appeal of criminal convictions for importing food products from Central America for distribution into the U.S. based on criminal conspiracy statutes (18 U.S.C. § 545 and § 371) to violate U.S. Customs and Border Protection entry documentation regulations adopted in 2007 (19 C.F.R. § 141.113(c)) – held: Convictions vacated because § 141.113(c) is strictly civil in nature with monetary penalties – not criminal. Note well: 11th Circuit’s opinion is a concise primer on the three federal layers of import safety imposed by federal law on food imports – requirements and related legal authority: (1) U.S. CBP, (2) U.S. Department of Agriculture, and (3) U.S. Food & Drug Administration.

Convictions vacated because violation of 19 C.F.R. § 141.113(c) border entry documentation adopted in 2007 is civil in nature – not criminal.

U.S. v. Izurieta, 2013 WL 673918 (U.S. Court of Appeals for the 11th Circuit, February 22, 2013). Free copy available here.

Three layers of federal import safety requirements for food products

“… As part of the U.S. importation regime for food products, all imports are screened upon entry at three distinct stages. First the goods are examined by officials from Customs and Border Protection (“Customs”) for compliance with entry documentation regulations. See 19 C.F.R. § 141.86(a). The goods are then approved for entry by the Department of Agriculture. See 19 C.F.R. § 12.8. Finally, food products are subject to inspection by the Food and Drug Administration (“FDA”) under the Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-399f). To facilitate the importation and storage of covered goods, the FDA and Customs permit importers to take possession of their goods under a conditional release, pending test results or further inspection, provided the goods are securely stored in the importer’s warehouse pursuant to “such bond or other security as may be prescribed by [the Secretary of the Treasury] . . . .” 19 U.S.C. § 1499(a)(1). The goods are considered to be on “hold” and may not be distributed until formal authorization for entry into the commerce of the United States is provided by the FDA. 21 U.S.C. § 381. Under the regulations, an importer may be required to make the held goods available for inspection. See 19 C.F.R. § 141.113(c); 21 C.F.R. § 1.90. Ultimately, if the goods are found to be adulterated, the FDA may demand under the applicable regulation that the goods be “redelivered” to Customs for exportation or supervised destruction. See 21 U.S.C. § 381(a); 19 C.F.R. § 141.113(c).”

Legal violations here civil not criminal

“Although reference to a criminal statute is made in 21 U.S.C. § 381(q)(6) in connection with falsification of entry documents, no reference is made to the conduct or the criminal statute, 18 U.S.C. § 545, actually charged here. Similarly, although 21 U.S.C. § 331 lays out dozens of prohibited acts in violation of the Federal Food, Drug, and Cosmetics Act subject to criminal penalties, this statute does not specify as a crime the simple failure to hold, redeliver, export, and/or destroy.[11] 19 C.F.R. § 141.113(c) itself, which specifically addresses such a failure, specifies only liquidated damages, not criminal punishment, for failure to comply with the regulation.

“The regulation at issue, 19 C.F.R. § 141.113(c), is clearly a substantive regulation establishing obligations for importers. It primarily acts to establish the general contractual terms between Customs and the importer regarding temporary release and storage of the imported goods, along with agreed-upon liquidated damages for non-compliance. See 19 C.F.R. § 141.113(c); see also 19 C.F.R. § 113.62 (laying out the basic entry bond conditions used by Customs, including a requirement to hold the goods for inspection). The regulation fails to qualify as a “law” for purposes of criminal liability under 18 U.S.C. § 545 not because it has no effect as a law but because that law is civil only, and in particular reflects contractual requirements.

“While some regulations may fall under the criminal prohibitions of 18 U.S.C. § 545, the text of 19 C.F.R. § 141.113(c) along with the comments issued during its promulgation certainly indicate to the average person that liability is strictly civil and monetary, capped at most at three times the value of the merchandise secured by bond, and is not aimed at punishment. See 19 C.F.R. § 141.113(c)(3); see also Assessment of Liquidated Damages Regarding Imported Merchandise That Is Not Admissible Under the Food, Drug and Cosmetic Act, 66 Fed. Reg. 16,850, 16,852-53 (Mar. 28, 2001) (noting that the liquidated damages claimed for failure to redeliver is not intended to be punitive). In reality, the text of 19 C.F.R. § 141.113(c) sets forth the terms of the contract between the importer and Customs by delineating the obligations of the importer upon conditional release and the damages for a breach of those contractual obligations. In this case, the statutory and regulatory structure and the history of the regulation demonstrate the vagueness and ambiguity of both the statute and regulation in terms of defining criminal liability. We disagree with the conclusion of our sister circuit in Mitchell that 18 U.S.C. § 545 is not grievously ambiguous, at least with respect to its effect of criminalizing conduct in violation of 19 C.F.R. § 141.113(c). See Mitchell, 39 F.3d at 470 (discussing a different regulation having the effect of law). Rather there is, at a minimum, great doubt as to whether violation of this regulation per se gives rise to criminal liability. Under principles of lenity, charges of violations of this regulation under 18 U.S.C. § 545 do not charge a crime, and the protections intended by Grand Jury indictment were not afforded the Izurietas. Accordingly, the convictions of both of the Izurietas on Counts 2-7 are vacated.”

IMPORT SAFETY / Administrative Rule (Proposed) – For action prior to importation into the U.S.: The Environmental Protection Agency proposes significant new use rules (SNURs) under the Toxic Substances Control Act for 37 chemical substances which were the subject of premanufacture notices (PMNs).

“Seventeen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action would require persons who intend to manufacture, import, or process any of these 37 chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.”

February 25, 2013, Proposed Rule.

IMPORT SAFETY / Amending the fruits and vegetables regulations to allow the importation of several varieties of fresh citrus fruit, as well as Citrus hybrids and the Citrus-related genus Fortunella, from Uruguay into the continental United States.

February 6, 2013, Proposed rule.

“The USDA Animal and Plant Health Inspection Service proposes to amend the fruits and vegetables regulations to allow the importation of several varieties of fresh citrus fruit, as well as Citrus hybrids and the Citrus-related genus Fortunella, from Uruguay into the continental United States. As a condition of entry, the fruit would have to be produced in accordance with a systems approach that would include requirements for importation in commercial consignments, pest monitoring and pest control practices, orchard sanitation and packinghouse procedures designed to exclude the quarantine pests, and treatment. The fruit would also be required to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Uruguay with an additional declaration confirming that the fruit is free from all quarantine pests and has been produced in accordance with the systems approach. This action would allow for the importation of fresh citrus fruit, including Citrus hybrids and the Citrus-related genus Fortunella, from Uruguay while continuing to provide protection against the introduction of plant pests into the United States.”

IMPORT SAFETY / U.S. Department of Agriculture Food Safety & Inspection Service issues standards for specified foreign food facilities exporting food products to the U.S.

January 25, 2013, Notice.

“The Food Safety and Inspection Service (FSIS) is describing the new methodology it is employing to conduct ongoing equivalence verifications of the regulatory systems of countries that export meat, poultry, or processed egg products to the United States. Continue reading