UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES

CERTIFIED AND ELECTRONIC MAIL

Benjamin Baker

1393 E ast Highland Rd

. T winsburg , Ohio 44087 H.R. McLane, Inc. 7210 Red Road, Suite 206A Miami, Florida 33143

- 5321

Subject : Outstanding data for m alathion PDCI

Registrations : 45385

- 66,

- 65,

- 43

Dear M r. Baker :

In accordance with the malathion PDCI

, data were submitted by CTX

- Cenol ; however

,

the toxicological and storage stability submissions were found inadequate and these requirements

have not been fulfilled

. These data requirements were originally due in O ctober 2009. Since the

initial deficient submissions, CTX

- Cenol has made no substantial progress in fulfi lling these data

requirements . Th e listed product s are not in compliance with the malathion PDCI. Within 10

days of receipt of this letter you are required to contact the Agency and submit the required data

for your malathion product s

. Failure to comply within this timeframe will result in a Notice of

Intent to S uspend the registration s of your malathion product s

. If you have any questions, please

contact me at (703) 3 47

- 8028

.

Sincerely,

Eric Miederhoff

, Chemical Review Manager Risk Management and Implementation Branch III

Pesticide Re

- evaluation DivisionAttachment I : Suspension Report

– Product List

List of products:

EPA Reg. No s

.

CTX

- Cenol Incorporated

45385

- 43

– MAL 50% EC

45385

- 65

- Chem Tox Malathion 3%

45385

- 66

– Chem

- Tox MAL 50

- OSA TTACHMENT II

– REQUIREMENT LIST

Outstanding Product Chemistry And Acute Toxicity Data:

870.1100 Acute Oral Toxicity

870.1200 Acute Dermal Toxicity

870.1300 Acute Inhalation Toxicity

870.2400 Acute Eye Irritation

870.2500 Acute Dermal Irritation

870.2600 Acute Eye Sensitization

830.6317 Storage Stability

830.6320 Corrosion CharacteristicsATTACHMENT III

- EXPLANATORY APPENDIX

On June 30 , 20 09

, the Agency issued the Phase 5 Reregistration Eligibility

D ecision (RED) Product Data Call

- In Notice pursuant to sections 3(c)(2)(B) and 4(g)(2)(B) of FIFRA which required the registrants of product s containing

malathion used as an active ingredient to develop and submit certain data. The
data/information w ere determined to be necessary to satisfy the reregistration requirements of section 4(g). Failure to comply with the requirements of a P hase 5 Reregistration Eligibility D ecision Product Data Call

- In Notice (PDCI) is a basis for suspension under section 3(c ) ( 2 ) ( B) of FIFRA.

CTX

- Cenol Incorporated ( CTX ) received the malathion RED/PDCI

, as evidenced by the US Postal Service domestic retur n receipt card which was

si gned and dated on July 6, 2009

. The 90

- day response to the PDCI was due on
October 6 , 2009 but was not received by the Agency until April 5, 2010

. Agency
review of CTX’s submissions found that some requirements of the PDCI had been fulfilled, but others had not. To date, adequate data to fulfill the following data requirements required for th e s e product s ( EPA Reg. Nos. 45385

- 66, 45385

- 65, 45385

- 43) have not yet been received by the A gency : Guidelines

870.1100 Acute Oral Toxicity ; 870.1200 Acute Dermal Toxicity ; 870.1300 Acute Inhalation Toxicity ; 870.2400 Acute Eye Irritation ; 870.2500 Acute Dermal

Irritation ; 870.2600 Acute Eye Sensitization ; 830.6317 Storage Stability and

830.6320 Corrosion Characteristics. The Agency reviewed the data citations to existing data and the new submissions provided in the 90

- day response and transmitted reviews of these CTX submissions by certified US Mail to CTX on May 4 and August 19 , 2010. CTX recei ved these reviews on May 10 and August 30, 2010, respectively. Further discussion about these overdue data requirements appears below.

On August 17, 2011, the last correspondence received to date by the Agency from CTX

, stated that two product chemistry studies, Guidelines 830.6317 and 830.6320, Storage Stability and Corrosion Characteristics, respectively, were in progress at a contracting laboratory, and the results would be submitted by the end of August 2011. CTX’ s April 5, 2010 90

- day response to

the PDCI included statement s intended to fulfill Guideline s 830.6317 and

830.6320 , Storage Stability and Corrosion Characteristics

, for products 45385

- 43,

- 65, and

- 66. These statements were found to be inadequate to fulfill the requirement s for storage stabi lity and corrosion characteristics data. This finding was transmitted to CTX in a letter dated May 4, 2010 and received by CTX on May 10, 2010, as evidenced by a USPS d omestic return receipt card. No further

submissions have been made to fulfill the requir ements for storage stability and

corrosion characteristics data.CTX has also failed to submit adequate data to fulfill the requirements for 6 acute toxicological studies: 870.1100 Acute Oral Toxicity, 870.1200 Acute Dermal Toxicity, 870.1300 Acute Inh alation Toxicity, 870.2400 Acute Eye Irritation, 870.2500 Acute Dermal Irritation, and 870.2600 Acute Eye
Sensitization . CTX’ s April 5, 2010 90

- day response to the PDCI included
citations for 6 existing studies which were found inadequate to support the CTX products

. The citations were to studies submitted to support a different malathion product. The Agency’s review found that the subject product of the cited studies substantially differed from the CTX products and therefore the data

we re not applicable to CTX’s products. This fi nding was transmitted to CTX in a

letter dated August 19, 2010 and received by CTX on August 30, 2010, as evidenced by a USPS domestic return receipt card. In a telephone conversation on July 24, 2012

, CTX indic ated they would contact another registrant to see if they might have acute toxicity data that could be cited for CTX’ s products. To date, no further communications or submissions have been received from CTX to fulfill these data requirements.

On July 19 , 2013 , the Agency sent CTX a letter in which it stated that
CTX’s product s ( EPA Reg. Nos. 45385

- 66, 45385

- 65, 45385

- 43) w ere not in compliance with the PDCI and that, unless CTX complied by sending the required data within ten days following its receipt o f the Agency’s letter, a Notice of Intent to Suspend would be issued. CTX received the July 19 , 2013 letter o n July 24 , 2013, as evidenced by a USPS domestic return receipt card, which was signed and dated by Tammi Chase for CTX

. To date there has been no response from the registrant.

To date, satisfactory data to address the following data requirements required for th e s e product s ( EPA Reg. Nos. 45385

- 66, 45385

- 65, 45385

- 43) have not yet been received by the Agency : Guidelines 8 70.1100 Acute Oral Toxicity ; 870.1200 Acute Dermal Toxicity ; 870.1300 Acute Inhalation Toxicity ; 870.2400 Acute Eye Irritation ; 870.2500 Acute Dermal Irritation ; 870.2600 Acute Eye Sensitization ; 830.6317 Storage Stability ; and 830.6320 Corrosion
Characteristics. Therefore, this Notice of Intent to Suspend is being issued.