Implementing NAFTA Labels
- Guidance on How to Develop a NAFTA Label
- Completion of the Notice of Arrival (NOA) Form of NAFTA Labeled Products
- Own Use Import (OUI) Program
- NAFTA TWG on Pesticides
- Letter to stakeholders about first hamonized label for pesticide product (1 page, 22 Kb, about PDF)
- Process for Applying for a NAFTA Label
- Initial Registration of NAFTA Labels
- Process for Amendments to NAFTA Labels
- Amendment to a Product Registered with a NAFTA Label
- Current NAFTA Label Candidates and Their Priority
- Importing Pesticide Products With A NAFTA Label Into the United States
The goal of the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) is to develop a coordinated pesticide regulatory framework among NAFTA partners to address trade irritants, build national regulatory/scientific capacity, share the review burden, and coordinate scientific and regulatory decisions on pesticides. Read more basic information.
At its December 2005 meeting the Executive Board of the NAFTA TWG agreed to facilitate a stakeholder process to explore options for developing and implementing NAFTA labels. This was the result of continued requests by stakeholders to speed up the processes that would allow cross-border movement of pesticide products between Canada and the United States, subject to applicable U.S. Canadian Customs regulations.
A stakeholder work group was formed that consists of U.S. and Canadian growers, industry, agricultural retailers, and government representatives. There are now over 50 participants in the work group. There were six work group meetings in 2006, and two work group meetings in 2007. The work group is working on two approaches:
- a short-term strategy -- the U.S. OUI program, which allows United States growers access to certain priority pesticides that are substantially similar in formulation and are registered in both Canada and the U.S. (but not jointly), and
- a long-term strategy -- the development of NAFTA labels (jointly registered products).
These strategies will continue to evolve in further discussions of the work group as necessary. However, it is expected, as NAFTA labels are developed, the need for the OUI program will diminish.
On January 31, 2007, EPA and Canada’s Pest Management Regulatory Agency (PMRA) announced the acceptance of the first NAFTA label (PDF) (9 pp, 584K, About PDF) for a conventional agricultural pesticide. The product, Far-Go Herbicide (in the United States) and Avadex MicroActive Herbicide (in Canada), is produced by the Gowan Company. On May 16, 2007, the second NAFTA label (PDF) (19 pp, 1,012K, About PDF) was accepted for Gavel 75DF Fungicide, a Dow product that is a broad spectrum protectant fungicide.This work demonstrates that the major regulatory barriers to developing NAFTA labeling have been resolved. The development of a NAFTA label represents the culmination of years of work on pesticide regulatory harmonization that has been conducted by the NAFTA Technical Working Group.
Registrants may volunteer products for NAFTA label development at any time. Existing products, for which substantially similar formulations are registered by the same registrant in both Canada and the United States, and new products/chemicals are acceptable. As part of the work group process, U.S. growers developed a prioritized list of pesticide products (PDF) (2 pp, 37K, About PDF) that they wished to have access to in Canada. However, any pesticide product can be volunteered. It is not necessary that the product be on the growers' priority list.
The registrant should review the information provided in the "Guidance on How to Develop a NAFTA Label." Ultimately, a joint submission of the proposed label and the U.S. and Canadian product specifications must be made to EPA and PMRA. In the United States, the submission should be as a label amendment. However, because EPA and PMRA continue to develop this process and refine the guidance for NAFTA label development, the first step should be to contact either EPA or PMRA to obtain the most current information and to discuss the submission.
Diane Isbell (firstname.lastname@example.org) - (conventional pesticides), 703-308-8154
ShaRon Carlisle (email@example.com) - (antimicrobial pesticides), 703-308-6427
Linda Hollis (firstname.lastname@example.org) - (biological pesticides), 703-308-8733
Nelida Sterkenburg (email@example.com) - (for all products regulated under the Pest Control Products Act), 613-736-3622
Therapeutic Products Directorate (TPD) contact:
As noted above, this information will be updated as more labels are worked through and their associated issues are addressed. It is recognized that labels may have unique issues. Since labels may have unique issues, please contact the appropriate person if you have questions.
Ian Chisholm (firstname.lastname@example.org) - (for products regulated under the Food and Drugs Act, with the exception of food contact sanitizers (hard surface disinfectants and disinfectant/sanitizers)), 613-941-1271
For existing registrations, the U.S. and Canadian label review will run essentially independently, with each regulatory authority having independent responsibility for the booklets for use in the appropriate country and shared responsibility for the container label. Specifically, the container label would be reviewed by both regulatory authorities, while review of the booklets that contain the directions for use would be independent of each other.
For an initial registration, the regulatory processes would run concurrently. The regulatory agencies would commit to the current accelerated timeframes for joint reviews. In the event of one country lagging behind in the registration process, and hence delaying approval of its label, the registrant could proceed with essentially the same label, absent the NAFTA language, and using only the directions for use for the country that is ready to proceed with registration.
The work group has been focusing on the initial development of NAFTA labels. In addition, there is clear awareness of the need to consider the regulatory processes that will be necessary to handle future changes to these labels. Work in this area is under way, and the following provides some background and an indication of the likely future direction in this area.
The process required for registration or amendment of a NAFTA label is dependent on the format chosen for the labels. The preferred label format consists of separate U.S. and Canadian booklets with the respective directions for use. This format has the advantage of resulting in essentially independent regulatory processes for many types of label amendments. This approach is advantageous for registrants because it allows many types of label amendments to move ahead at the pace they normally would, without necessitating delay, repackaging, or other issues that are inherent in a single label approach.
There are several types of potential registration amendments. For the purpose of the NAFTA label, they are divided as follows:
- Registration amendments limited to changes that are exclusive to the country-specific booklets that contain directions for use, (e.g., addition of a pest, change to pre-harvest interval, application timing, etc.) and that do not affect the container label.
- Registration amendments affecting the container label (e.g., product name change, change to precautionary statements, etc.) that may or may not affect the booklet(s).
- Amendment to change the product formulation. This may or may not directly affect the NAFTA label but could have implications for the determination that the products are substantially similar.
The registration of a NAFTA label for a product is based on the product formulation being substantially similar in both countries and manufactured by the same registrant. Any application to amend the formulation would be required to be made to both agencies simultaneously to ensure that substantial similarity is maintained. The regulatory processes would run concurrently and would require review by both countries (the review may or may not include a review of the product label). The agencies would be bound by their respective timeframes for the action, but commit to trying to achieve the shorter timeframe (between the two agencies) where possible.
The U.S. and Canadian processes would run essentially independently of each other, with each regulatory authority taking responsibility for the content exclusive to the appropriate country-specific booklet. The container label would be reviewed as part of the amendment (since it forms part of the NAFTA label for each country). If no changes to the container label are made, the label amendment may be approved by the country involved with the booklet change. If a change to the booklet would require changes to the container label, these changes to the container label would be provided immediately to both Agencies for their simultaneous review.
This type of amendment would require review by both countries. If the registrant desires to have the regulatory processes run concurrently, the regulatory agencies would be bound by their respective timeframes for the amendment, but commit to trying to achieve the shorter timeframe (between the two agencies) where possible.
There are currently 10 additional products that have been volunteered for NAFTA label development. The work group arranged the schedule for NAFTA label development by looking at the production schedules for the products, which determines when the labels could actually be used on product, together with the remaining issues to be worked out the for the label. In this way, the regulatory agencies were able to give priority to those labels with a chance of completion before the next production run. Three of the chemicals are new, that is, never-before-registered chemicals. In these cases, NAFTA labels will be done when the products are registered.
The list of 12 products that have been volunteered is provided below, with the active ingredient/product name company name and expected time of label approval/expected time product will actually appear on the market with the NAFTA Label.
|Zoxamide & Mancozeb/Gavel||Dow||Complete/'07|
|Spinosad/Naturalyte Fruit Fly Bait||Dow||'07/'08|
|Cymoxanil & Famoxadone/Tanos||Dupont||'07/'08|
|Phenmedipham & Desmedipham/Betamix||Bayer||'07/'08|
|Bifenthrin||FMC||No schedule yet|
*On the U.S. growers' priority list.
At the June 25-26, 2007, meeting of the work group registrants withdrew two previously volunteered candidates. Everest was withdrawn due to the cost of making the change to a NAFTA label. Betamix was withdrawn because it is no longer an active product. Serious issues were noted with two other candidates, Clarity (trademark issue) and Tanos (precautionary labeling issues). In the discussion that followed, the growers' priority list was reviewed in detail, and registrants (Dow, Syngenta, and Bayer) agreed to reconsider 13 products as possible NAFTA label candidates. One additional candidate from the priority list, Avadex/Far-Go (liquid), was volunteered for a NAFTA label at the meeting. Several registrants indicated that they are investigating new candidates that are not on the priority list.
It is illegal to import pesticide products into the United States unless they are registered in the United States. Products with NAFTA labels, regardless of whether they are purchased in Canada or the United States, are registered in the United States. They have both United States and Canadian registration numbers and are easily identified by the “IMPORTANT NOTICE” label.These products may be purchased by U.S. growers in Canada where they are available and where Canadian provincial requirements allow. Some provinces in eastern Canada and British Columbia in the west have licensing requirements that may prevent U.S. growers from purchasing products. The work group is still in the process of looking into these requirements and determining how to address them. Special provincial licensing requirements are not an issue in Manitoba and provinces westward of Manitoba (except British Columbia). Any grower interested in purchasing product in Canada is encouraged to contact the retailer of the product for information on provincial licensing requirements.
However, to bring NAFTA-labeled products across the U.S. border, it is necessary to have a completed and EPA-approved NOA form to present to U.S. Customs officials. It is also necessary to pay any appropriate duty. The NOA form must be signed by the EPA Regional Office with jurisdiction over the state in which the Port of Entry is located. You should familiarize yourself with U.S. Customs requirements, including the duty that may be charged on the product. You may also wish to familiarize yourself with the services offered by customs brokers in the case that you decide to use these services or are referred by U.S. Customs officials to a broker. There are numerous Internet sites that explain and offer the services of import brokers who facilitate the import process (for a fee).
- EPA information on importing/exporting pesticides and the NOA form (Form 3540-1) may be found on the Trade Issues Web page.
- For general information on customs regulations, select “Import” at the top.
- The specific customs regulations governing the importation of pesticides:
- After accessing this site, under “Most Current 50 Titles ” select “Browse and/or search the CFR."
- In the table “Available CFR Titles on GPO Access" select Title 19 “Customs Duties” by selecting the box above the most recent date and then "Continue" at the bottom of the page.
- Under “Browse Parts” in the table select “1-140.”
- Pesticide regulations may be found beginning at Part 12.112, by first selecting Part 12, then Part 12.112 and the following relevant Parts.
- The tariff schedules may be found the International Trade Commission Web page.
The following explains in more detail how the NOA form should be completed for importation of NAFTA-labeled pesticide products. Note that these directions are different from the ones that address how the NOA form should be completed for importation of pesticide products using the U.S. Own Use Import program.