Makhteshim Agan of North America, Inc., d/b/a ADAMA Settlement

(Washington, DC - January x, 2017) - EPA today announced that Makhteshim Agan of North America, Inc., d/b/a ADAMA has paid a civil administrative penalty of $216,000, related to an EPA order issued in April of 2015 stopping the sale, production and distribution of the pesticide Fluensulfone 480EC due to violations of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

On this page:

• Overview of Company
• Violations Background
• Violations Summaries
• Health and Environmental Benefits
• Civil Penalty
• Comment Period
• Contact

Overview of Company

ADAMA is a chemical company doing business in the United States. 

Violations Background

On September 11, 2014, ADAMA registered the pesticide, Fluensulfone 480EC, a nematicide containing the active ingredient Fluensulfone, which was assigned the EPA Registration Number 66222-243 and registered with the alternate brand name “Nimitz.” Fluensulfone 480EC is intended to be applied to cucurbits and fruiting vegetables, including tomatoes, crops that are intended to be used for food or animal feed.

Section 408(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and its implementing regulations at 40 C.F.R Part 180 provide that any pesticide chemical residue in food is unsafe unless the quantity of the pesticide chemical residue is within the limits of an established tolerance or an exemption from the requirement of a tolerance for those residues is in effect.

A pesticide tolerance is expressed in terms of a permitted residue concentration limit and can be established by the EPA upon petition by a pesticide registration applicant. Any food with unsafe pesticide residue levels is considered “adulterated” under the FFDCA and it is a violation to introduce such food into commerce.

The EPA’s regulations require petitioners for pesticide tolerances to submit full reports of tests and investigations made with respect to the safety of the pesticide chemical and the nature and amount of the pesticide chemical residue that is likely to remain in or on any food.

The FFDCA and its implementing regulations provide that where a pesticide chemical residue tolerance is established for a raw agricultural commodity, a separate tolerance for food processed from that commodity is not required if: (1) the pesticide was used in conformity with the tolerance, (2) the pesticide chemical residues were removed to the extent possible in good manufacturing practice; (3) and the residue concentration in the processed food was not greater than that found in the raw agricultural commodity.

While registering Fluensulfone 480EC, ADAMA sought and received a tolerance of 0.50 parts per million (ppm) for residues of Fluensulfone in or on curcubits and fruiting vegetables. The EPA did not establish a separate tolerance for residues of Fluensulfone in foods processed from treated raw agricultural commodities (e.g., tomato paste) because the data provided to the EPA by ADAMA did not indicate that a tolerance on processed foods might be necessary. 

On or about February 3, 2015, Health Canada, Government of Canada, informed the EPA that they had received from ADAMA a tomato processing study involving Fluensulfone. The study was completed on October 4, 2013 – over eleven months before EPA granted registration of Fluensulfone 480EC – and showed pesticide chemical residues of Fluensulfone concentrating in tomato paste at levels above the approved tolerance of 0.50 ppm for Fluensulfone.

Where residues of Fluensulfone in processed tomato products exceed the established tolerance for residues of Fluensulfone in fruiting vegetables, a separate pesticide tolerance for processed tomato products is required in order for those products not to be considered unsafe or adulterated.

Based on the test data contained in the study, the EPA issued a Stop Sale, Use, or Removal Order (SSURO) to ADAMA on April 23, 2015, prohibiting the sale, use, or removal of Fluensulfone 480EC. In response to SSURO, ADAMA halted its distribution and sale of Fluensulfone 480EC and voluntarily recalled the product outside of its ownership and control. In the course of its investigation, EPA determined that ADAMA distributed and sold Fluensulfone 480EC on thirty (30) separate occasions. 

Subsequently, ADAMA petitioned for, and was granted, a pesticide tolerance for pesticide chemical residues of Fluensulfone in tomato paste. On October 5, 2015, the EPA approved an amended FIFRA label for Fluensulfone 480EC, allowing it to be applied on tomatoes intended for processing into tomato paste. 

Violations Summaries

Violation of FIFRA Sections 12(a)(2)(N) and (S)

As part of the registration process for Fluensulfone 480EC, ADAMA was required by FIFRA and its implementing regulations to submit the study to the EPA to enable the agency to make a determination that the use of this pesticide would generally not cause unreasonable adverse effects on the environment. ADAMA’s failure to submit the study to the EPA is a violation of section 12(a)(2)(N) (failing to file reports required under FIFRA) and section 12(a)(2)(S) (noncompliance with FIFRA regulations).

Violation of FIFRA Section 12(a)(2)(B)(ii)

Once the EPA registered Fluorosulfone 480EC, ADAMA was obligated under section 6(a)(2) of FIFRA and its implementing regulations to submit the study to the EPA because the study contained information concerning Fluorosulfone and unreasonable adverse effects on the environment. ADAMA’s failure to submit the study is a violation of section 12(a)(2)(B)(ii) of FIFRA, 7 U.S.C. § 136j(a)(2)(B)(ii) (refusing to submit reports required under section 6).

Violations of FIFRA Section 12(a)(1)(E)

As described in greater detail in the attached CAFO, EPA considered the distribution and sale of Fluensulfone 480EC before a residue tolerance was established for Fluensulfone in tomato paste to be the distribution and sale of a misbranded pesticide. Prior to the EPA granting a pesticide tolerance for pesticide chemical residues of Fluensulfone in tomato paste, the labeling for Fluensulfone 480EC did not contain any restrictions against using this pesticide on tomatoes destined to be processed into tomato paste. Absent such a restriction, use of Fluensulfone 480EC on tomatoes destined for processing could have resulted in the production, sale, and consumption of food that would be considered adulterated under the FFDCA with unsafe pesticide residue levels and prohibited from being introduced into commerce. For this reason, Fluensulfone 480EC was misbranded in accordance with section 2(q)(1)(F) of FIFRA, 7 U.S.C. § 136(q)(1)(F), because the labeling accompanying the pesticide did not contain directions for use that were necessary for effecting the purpose for which the product is intended and, if complied with, were adequate to protect health and the environment.

Fluensulfone 480EC was also misbranded as defined under section 2(q)(1)(G) of FIFRA, 7 U.S.C. § 136(q)(1)(G), because its label did not contain a warning or caution statement which may have been necessary and, if complied with, was adequate to protect health and the environment. 

Each distribution or sale of a misbranded pesticide product is a separate violation of FIFRA section 12(a)(1)(E) (distribution and sale of a misbranded pesticide). 

Health and Environmental Benefits

EPA-established tolerance levels protect Americans from food with unsafe pesticide residues. Due to EPA's swift action in stopping the sale and distribution of this unlawful pesticide, no human or animal consumed food or feed treated with this pesticide before EPA obtained the necessary data to make a science-based decision on acceptable residue tolerances.

Civil Penalty

This settlement includes a civil administrative penalty of $216,000.

Comment Period

The settlement, Docket No. FIFRA-HQ-2016-5006, was filed with the U.S. EPA Environmental Appeals Board and approved on May 05, 2016.

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