UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES

 AND TOXIC SUBSTANCES

CERTIFIED AND ELECTRONIC MAIL

Benjamin Baker

1393 East Highland Rd.

Twinsburg, Ohio 44087

H.R. McLane, Inc.

7210 Red Road, Suite 206A

Miami, Florida 33143-5321

Subject: Outstanding data for malathion PDCI

Registrations: 45385-66, -65, -43

 

Dear Mr. 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 October 2009. Since the 

initial deficient submissions, CTX-Cenol has made no substantial progress in fulfilling these data 

requirements. The listed products 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 products. Failure to comply within this timeframe will result in a Notice of 

Intent to Suspend the registrations of your malathion products. If you have any questions, please 

contact me at (703) 347-8028.

Sincerely,

Eric Miederhoff, Chemical Review Manager

Risk Management and Implementation Branch III

Pesticide Re-evaluation Division
Attachment I: Suspension Report – Product List

List of products:

EPA Reg. Nos. 

CTX-Cenol Incorporated 

45385-43 – MAL 50% EC 

45385-65 - Chem Tox Malathion 3%

45385-66 – Chem-Tox MAL 50-OS
ATTACHMENT 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 Characteristics 
ATTACHMENT III - EXPLANATORY APPENDIX

On June 30, 2009, the Agency issued the Phase 5 Reregistration Eligibility 

Decision (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 products containing 

malathion used as an active ingredient to develop and submit certain data. The 

data/information were determined to be necessary to satisfy the reregistration 

requirements of section 4(g). Failure to comply with the requirements of a Phase 

5 Reregistration Eligibility Decision 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 return receipt card which was 

signed 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 these products (EPA Reg. Nos. 45385-66, 45385-

65, 45385-43) have not yet been received by the Agency: 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 received 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 statements intended to fulfill Guidelines 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 

requirements for storage stability 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 domestic return receipt card. No further 

submissions have been made to fulfill the requirements 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 Inhalation 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 

were not applicable to CTX’s products. This finding 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 indicated 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 products (EPA Reg. Nos. 45385-66, 45385-65, 45385-43) were not in 

compliance with the PDCI and that, unless CTX complied by sending the 

required data within ten days following its receipt of the Agency’s letter, a Notice 

of Intent to Suspend would be issued. CTX received the July 19, 2013 letter on 

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 these products (EPA Reg. Nos. 45385-66, 45385-65, 45385-43)

have not yet been received by the Agency: 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. Therefore, this Notice of Intent to Suspend is being issued.