crop-chem-docs/corpus/epa_ppls/5905-622.md

HM-1638 Herbicide

• EPA Reg No: 5905-622
• Registrant: HELENA AGRI-ENTERPRISES, LLC, D/B/A HELENA CHEMICAL COMP
• Signal word: Caution
• Active ingredients: MCPA, 2-ethylhexyl ester (27.3%); Bromoxynil octanoate (25.47%); Fluroxypyr 1-methylheptyl ester (10.07%)
• Label accepted: 2022-12-21
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/005905-00622-20221221.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

December 21, 2022

Bill Washburn Registration Manager Helena Agri-Enterprises, LLC d/b/a Helena Chemical Company 225 Schilling Boulevard, Suite 300 Collierville, TN 38017

Subject: Registration Review Label Amendments Incorporating Mitigation Measures from the Interim Decisions for MCPA and Fluroxypyr and the National Marine Fisheries Services’ (NMFS) Biological Opinion on the Effects of Bromoxynil on Pacific Salmonids Product Name: HM-1638 Herbicide EPA Registration Number: 5905-622 Application Date: 6/15/2021, 7/30/2021, and 8/20/2021 Decision Number: 577445, 581056, and 585961

Dear Bill Washburn:

The Agency, in accordance with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, has completed reviewing all the information submitted with your application to support the Registration Review of the above referenced product in connection with the MCPA and Fluroxypyr Interim Decisions. The Agency has concluded that your submission is acceptable.

This letter also addresses the label mitigation resulting from the NMFS’ Biological Opinion on the effects of Bromoxynil on Pacific salmonids. The Agency has concluded that your submission is also acceptable. The label referred to above, submitted in connection with registration under FIFRA, as amended, is acceptable.

Should you wish to add/retain a reference to the company’s website on your label, then please be aware that the website becomes labeling under the Federal Insecticide Fungicide and Rodenticide Act and is subject to review by the Agency. If the website is false or misleading, the product would be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40 CFR 156.10(a)(5) list examples of statements EPA may consider false or misleading. In addition, regardless of whether a website is referenced on your product’s label, claims made on the website may not substantially differ from those claims approved through the registration process. Therefore, should the Agency find or if it is brought to our attention that a website contains false or misleading statements or claims substantially differing from the EPA approved registration, the website will be referred to the EPA’s Office of Enforcement and Compliance.

Page 2 of 2 EPA Reg. No. 5905-622 Decision No. 577445, 581056, and 585961

A stamped copy of your labeling is enclosed for your records. This labeling supersedes all previously accepted labeling. You must submit one copy of the final printed labeling before you release the product for shipment with the new labeling. In accordance with 40 CFR 152.130(c), you may distribute or sell this product under the previously approved labeling for 12 months from the date of this letter. After 12 months, you may only distribute or sell this product if it bears this new revised labeling or subsequently approved labeling. “To distribute or sell” is defined under FIFRA section 2(gg) and its implementing regulation at 40 CFR 152.3.

If you have any questions about this letter, please contact Quinn Gavin at gavin.quinn@epa.gov.

Sincerely,

Linda Arrington, Branch Chief Risk Management and Implementation Branch 4 Pesticide Re-Evaluation Division Office of Pesticide Programs

Enclosure

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