EPA’s FIFRA Import Requirements and...

© 2015 Bergeson & Campbell, P.C. All Rights Reserved.

Lisa M. Campbell

Bergeson & Campbell, P.C.

Washington, D.C.

www.lawbc.com

CropLife America Spring Conference

EPA’s FIFRA Import Requirements and Enforcement

April 23, 2015

Washington, D.C.

http://www.lawbc.com/


Pesticide Importation -- Background/ Requirements

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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. § 152.30 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


Importing Pesticides -- NOA

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NOA (U.S. Environmental Protection Agency (EPA) Form 3540-1) -- 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


NOA Form

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EPA revised the NOA form on January 18, 2013, available at http://www2.epa.gov/compliance/epa-form-3540-1-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

http://www2.epa.gov/compliance/epa-form-3540-1-notice-arrival-pesticides-and-devices

© 2015 Bergeson & Campbell, P.C. All Rights Reserved. 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

© 2015 Bergeson & Campbell, PC. All Rights Reserved.

NOA Review and Detention

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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


Import Label Issues

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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


Import of Unregistered Pesticides

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EPA regulations (40 C.F.R. § 152.30)

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


Import of Unregistered Pesticides (cont’d)

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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)


Import of Unregistered Pesticides -- Transfer between Establishments Operated by the Same Producer

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“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


Import of Unregistered Pesticides --Transfer between Establishments Operated by the Same Producer (cont’d)

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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. 37960 (Sept. 26, 1984)



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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);



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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


Import of Unregistered Pesticides -- Transfer between Establishments Not Operated by the Same Producer

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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)


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 2016-2017 NPMG identified “Border Compliance” as one of three “FIFRA Focus Areas”

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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 2016 -- the

Automated Commercial Environment in the

International Trade Data System (ACE/ITDS)

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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

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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

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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

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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)

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THANK YOU

Lisa M. CampbellBERGESON & CAMPBELL, P.C.

2200 Pennsylvania Avenue, N.W., Suite 100WWashington, D.C. 20037

[email protected]

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