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

---
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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