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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY


AND POLLUTION PREVENTION

December 30, 2019

Jennifer DePietro
Regulatory Assurance Specialist
Lonza, LLC
412 Mt. Kemble Avenue, Suite 200S
Morristown, NJ 07960

Subject: Label Amendment – Update Precautionary Statement Language


Product Name: Lonzabac 12
EPA Registration Number: 6836-283
Application Date: 10/31/2019
Decision Number: 557511

Dear Ms. DePietro:

The amended label referred to above, submitted in connection with registration under the Federal
Insecticide, Fungicide and Rodenticide Act, as amended, is acceptable. This approval does not
affect any conditions that were previously imposed on this registration. You continue to be
subject to existing conditions on your registration and any deadlines connected with them.

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 18 months
from the date of this letter. After 18 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.

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.

Your release for shipment of the product constitutes acceptance of these conditions. If these
conditions are not complied with, the registration will be subject to cancellation in accordance

FQPA Label Acceptable v.20150320


Page 2 of 2
EPA Reg. No. 6836-283
Decision No. 557511

with FIFRA section 6. If you have any questions, you may contact Perri Moeller at 703-347-8618 or
via email at Moeller.Perri@epa.gov.

Sincerely,

Eric Miederhoff
Product Manager 31
Regulatory Management Branch I
Antimicrobials Division (7510P)
Office of Pesticide Programs

Enclosure
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Lonzabac 12
EPA Reg. No. 6836-283
EPA Notification 2019-12-04 Page 1 of 3
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Lonzabac 12
EPA Reg. No. 6836-283
EPA Notification 2019-12-04 Page 2 of 3
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Lonzabac 12
EPA Reg. No. 6836-283
EPA Notification 2019-12-04 Page 3 of 3

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