CropLife America Spring Conference. EPA s FIFRA Import Requirements and Enforcement. April 23, Washington, D.C.

Transcription

1 CropLife America Spring Conference EPA s FIFRA Import Requirements and Enforcement April 23, 2015 Washington, D.C. Lisa M. Campbell Bergeson & Campbell, P.C. Washington, D.C.

2 Pesticide Importation -- Background/ Requirements For importation into the United States: Pesticides must be registered under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3 or exempt from pesticide registration requirements Devices must be compliant with FIFRA Section 3 For registered pesticides and devices: FIFRA compliance and Notice of Arrival (NOA) form Unregistered pesticides that meet the requirements in 40 C.F.R also may be imported For unregistered pesticides: NOA form and additional requirements depending on the reason for importation Label issues important to review Import enforcement issues of increasing concern 2

3 Importing Pesticides -- NOA NOA (U.S. Environmental Protection Agency (EPA) Form ) -- Required for import of registered pesticides, unregistered pesticides, and pest control devices into the United States Importer completes Part I of the NOA and submits to the EPA Regional Office having jurisdiction over the state/territory in which the Port of Entry is located prior to the arrival of the shipment EPA completes Part II of the NOA, indicating the disposition to be made of the shipment of pesticide or device upon its arrival in the United States, and return the completed NOA to the importer Upon arrival of the shipment of pesticide or device, the importer must present the completed NOA to Customs 3

4 NOA Form EPA revised the NOA form on January 18, 2013, available at notice-arrival-pesticides-and-devices Changes: Instruction clarifications (e.g., define licensed customs broker and importer of record) Recommendation to attach to NOA a copy of the label for the imported product Optional sections to provide information regarding unregistered pesticides (e.g., provide basis supporting the importation, providing establishment numbers 4

5 NOA Review Different EPA Regions take different amounts of time to review and return NOAs EPA Region 9 states it typically processes NOAs within 24 hours, but still requests submitting NOAs a couple weeks before the shipment is expected to be imported Any Region can take longer depending on backlog, need for additional review, etc. E-File -- EPA Regions (e.g., Regions 6 and 9) have electronic NOA submissions 5

6 NOA Review and Detention EPA may deny entry of a pesticide or device by refusing to accept the NOA, issuing a Notice of Detention and Hearing, issuing a Stop Sale, Use or Removal Order (SSURO), and/or seeking penalties If Customs receives the Notice of Detention, it will refuse delivery to the consignee Consignee has 90 days to request a hearing or export the pesticide or device or Customs will oversee destruction of the pesticide or device 2015 Bergeson & Campbell, PC. All Rights Reserved. 6

7 Import Label Issues Generally, pesticide labels must comply with 40 C.F.R. Part 156 and cannot deviate from EPA-approved labeling Recent issues with importation of pesticides bearing both EPA-approved and foreign labeling Not misbranding provided product distributed directly to establishment where non-epa language can be removed or obscured prior to further distribution 7

8 Import of Unregistered Pesticides EPA regulations (40 C.F.R ) provide two exemptions to the general prohibition under FIFRA prohibiting the transfer of unregistered products: Pesticides transferred between registered establishments operated by the same producer; and Pesticides transferred between registered establishments not operated by the same producer, if three conditions are met 8

9 Import of Unregistered Pesticides (cont d) Other transfers, including import, of unregistered pesticides permitted if: In accordance with the requirements of an experimental use permit or for research and development (R&D) purposes For export only Sold or distributed under an emergency exemption For purposes of disposal In accordance with existing stock order (for cancelled or suspended pesticide) 9

10 Import of Unregistered Pesticides -- Transfer between Establishments Operated by the Same Producer Operated by the same producer Means the registered establishment relabeling the product is either owned by, or leased for operation by and under the control of, the entity from which the pesticide was shipped Does not apply to establishments owned or operated by different persons, regardless of contractual agreement between such persons 10

11 Import of Unregistered Pesticides -- Transfer between Establishments Operated by the Same Producer (cont d) Unregistered pesticide as transferred must be labeled in accordance with 40 C.F.R. Part 156 No Part 156 requirements are currently applicable to unregistered pesticides EPA proposed requirements in 1984, which, although they were never promulgated, provide guidance on what EPA might consider necessary to prevent the pesticide from being considered "misbranded" under FIFRA Section 2(q). 49 Fed. Reg (Sept. 26, 1984) 11

12 Import of Unregistered Pesticides -- Transfer between Establishments Operated by the Same Producer (cont d) FIFRA Section 2(q) lists minimum label requirements that a pesticide must meet to avoid being labeled as "misbranded." The proposed, but never promulgated, requirements state that the label must: Clearly indicate the producer's name and address; List the establishment number of the producing establishment from which the product is shipped (and then the label of the product when relabeled must include the establishment number of the facility that conducted the relabeling); 12

13 Import of Unregistered Pesticides -- Transfer between Establishments Operated by the Same Producer (cont d) Include an ingredients statement that includes the name and percentage, to the nearest whole number, of each active ingredient; List the average net weight or measure of the product's contents (unless specifically stated to be the minimum content), in standard United States units or metric units, exclusive of containers or wrappers; Include any hazard warning statement that EPA normally would require of a registered pesticide; Include clearly legible, conspicuously displayed contents; Print label text in English (bilingual text is permitted) at least 2 mm in size (based on the height of the upper case letters) on a solid background of a contrasting color; and Not include any false or misleading statement 13

14 Import of Unregistered Pesticides -- Transfer between Establishments Not Operated by the Same Producer Three conditions: Transfer is solely for the purpose of further formulation, packaging, or labeling into a product that is registered; Each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either: (1) a registered product; or (2) a pesticide that is produced by the registrant of the final product; and The product is transferred and labeled in accordance with the pertinent FIFRA regulations (i.e., the same relabeling requirements applicable to transfers between establishments operated by the same producer apply) 14

15 OECA s NPMG Enforcement Priorities -- Focus on Border Compliance EPA s National Program Managers Guidance (NPMG) set forth the priority-setting strategies and actions EPA and its state and tribal partners will undertake to identify the most important areas of work for protecting the environment and human health Since Fiscal Year (FY) 2014, the Office of Enforcement and Compliance Assurance (OECA) has identified FIFRA importation as one of its enforcement priorities Draft FY NPMG identified Border Compliance as one of three FIFRA Focus Areas 2015 Bergeson & Campbell, PC. All Rights Reserved. 15

16 OECA s NPMG Enforcement Priorities -- Focus on Border Compliance (cont d) Main issues: Address illegal importation of unregistered or otherwise noncompliant pesticide products Place special emphasis on high-risk unregistered pesticides and importers with history of noncompliance or significant importation activities from countries frequently associated with noncompliant shipments Oversee transition of manual review of NOAs to an automated processing system in FY the Automated Commercial Environment in the International Trade Data System (ACE/ITDS) 2015 Bergeson & Campbell, PC. All Rights Reserved. 16

17 OECA s NPMG Enforcement Priorities -- Border Compliance Activities To achieve border compliance, NPMG suggested activities for EPA Regions that include: Monitoring import compliance through inspections at entry ports and designated destination points (e.g., after imported products released by Customs and have entered U.S. commerce) Collecting samples and submitting to labs for formulation analysis to ensure product composition complies with terms of registration Screening NOAs for potential Confidential Statement of Formula (CSF) discrepancies related to source of active ingredient and countries of origin 2015 Bergeson & Campbell, PC. All Rights Reserved. 17

18 OECA s NPMG Enforcement Priorities -- Next Generation and ACE Database One of OECA s National Areas of Focus is Next Generation Compliance Focus on advances in emissions monitoring and information technology to be more effective and efficient In response to February 19, 2014, Executive Order (EO) on Streamlining the Export/Import Process for America's Businesses, Customs has been developing ACE/ITDS electronic system for importing and exporting goods Pilot programs with Customs, EPA, and the Food Safety and Inspection Service (FSIS) to test technical capabilities for imports at select locations and with pre-identified industry partners 2015 Bergeson & Campbell, PC. All Rights Reserved. 18

19 OECA s NPMG Enforcement Priorities -- Next Generation and ACE Database (cont d) By the end of 2016, ACE/ITDS will become the Single Window -- the primary system through which the trade community will report imports and exports and the government will determine admissibility EPA plans to use ACE to process the majority of NOAs, significantly reducing the need for manual review and approval by EPA Next Generation Compliance, in conjunction with ACE/ITDS, will enhance EPA s ability to detect import violations and could result in a surge of enforcement actions 19

20 Enforcement Trends Violations generally involve: Failure to submit NOA Unregistered pesticides Misbranding (e.g., label differed from EPA approved label) Type of enforcement Notice of Warning and civil penalties (per shipment violation) EPA can issue SSUROs where product being sold and distributed in the U.S. After 2011, EPA increasingly refusing imports based on identified issues (e.g., unregistered and/or misbranded pesticides) 2015 Bergeson & Campbell, PC. All Rights Reserved. 20

21 THANK YOU Lisa M. Campbell BERGESON & CAMPBELL, P.C Pennsylvania Avenue, N.W., Suite 100W Washington, D.C