EPA v. ZEP, INC.

Case summary

4/16/12 - STOP SALE, USE OR REMOVAL ORDER ISSUED. ON OR ABOUT MAY 26, 2011, EPA INSPECTOR INSPECTED RESPONDENT'S FACILITY LCOATED AT 1420 SEABOARD INDUSTRIAL BLVD, NW, ATLANTA, GA. DURING THE INSPECTION, THE INSPECTORS COLLECTED A PHYSICAL SMAPLE OF THE PESTICIDE PRODUCT, ZEP FORMULA 165, WHICH BORE THE EPA REGISTRATION NUMBER (REG. NO.) 49403-6-1270. ZEP FORMULA 165 WAS PRODUCED, DISTRIBUTED OR SOLD BY RESPONDENT AS THOSE TERMS ARE DEFINED IN FIFRA 2(w) AND 2(gg). 40 CFR 152.132 STATES THAT A REGISTRANT MAY DISTRIBUTE OR SELL HIS REGISTERED PRODUCT UNDER ANOTHER PERSON'S NAME AND ADDRESS INSTEAD OF (OR IN ADDITION TO) HIS OWN. SUCH DISTRIBUTION AN DSALE IS TERMED SUPPLEMENTAL DISTRIBUTION AND THE PRODUCT IS REFERRED TO AS A DISTRIBUTOR PRODUCT. CLARIANT CORP PRODUCED, DISTRIBUTED OR SOLD THE PRODUCT LABELED BY RESPONDENT AS ZEP FORMULA 165 UNDER EPA REG. NO. 49403-6. PRIOR TO APR 21, 2010, RESPONDENT PRODUCED, DISTRIBUTED OR SOLD ZEP FORMULA 165 PRUSUANT TO A SUPPLEMENTAL DISTRIBUTION AGMT WITH CLARIANT CORP UNDER EPA REG NO 49403-6-1270. 40 CFR 152.135(a) STATES THAT A REGISTRANT MAY TRANSFER THE REGISTRATION OF A PRODUCT TO ANOTHER PERSON. ON APR 21, 2010, CLARIANT CORP TRANSFERRED THE REGISTRATION OF EPA REG NO 49403-6 TO LANXESS CORP. EPA ASSIGNED THE NEW REG NUMBER EPA REG NO 39967-81 TO THE TRANSFERRED PRODUCT. ON JAN 10, 2012, LANXESS CORP REGISTERED DISTRIBUTOR PRODUCT ZEP FORMULA 165 UNDER EPA REG NO 39967-81-1270. ZEP FORMULA 165 IS A PESTICIDE IN THAT IT IS A SUBSTANCE OR MIXTURE OF SUBSTANCES INTENDED FOR PREVENTING, DESTROYING, REPELLING, OR MITIGATING A PEST. RESPONDENT DISTRIBUTES OR SELLS PESTICIDES. RESPONDENT PRODUCES PESTICIDES. ZEP FORMULA 165 IS AN ANTIMICROBIAL PESTICIDE . ZEP FORMULA 165 IS AN ANTIMICROBIAL PESTICIDES REGISTERED FOR USE AS A HOSPTIAL DISINFECTANT. THE REGISTRATION DOCUMENTS ACCEPTED BY EPA FOR EPA REG NO 39967-81 STATE THAT IT CONTAINS 1.25% OF THE ACTIVE INGREDIENT PARA-TERTIARY--AMYL PHENOL. EPA LAB TESTING OF THE SAMPLE COLLECTED DURING THE INSPECTION WAS CONDUCTED USING THE ANALYTICAL METHOD SOP FOR THE ANALYSIS OF PHENOLS AND THEIR SALTS IN ANTIMICROBIAL PRODUCTS. ANALYTICAL RESULTS SHOWED THAT THE PRODUCT CONTAINED 1.41% PARA-TERTIARY-AMYL PHENOL, WHICH EXCEEDS THE UPPER CERTIFIED LIMIT THAT WAS ESTABLISHED FOR THAT INGREDIENT AS PART OF THE REGISTRATION FOR EPA REG NO 39967-81. FIFRA 12(a)(1)(C) STATES THAT IT SHALL BE UNLAWFUL FOR ANY PERSON IN ANY STATE TO DISTRIBUTE OR SELL TO ANY PERSON ANY REGISTERED PESTICIDE THE COMPOSITION OF WHICH DIFFERS AT THE TIME OF ITS DISTRIBUTION OR SALE FROM ITS COMPOSITION. THE LABEL ON ZEP FORMULAT 165 PROVIDES DIRECTIONS FOR USE TO KILL MYCOBACTERIUM TUBERCULOSIS. EPA LAB TESTING WAS CONDUCTED USING THE ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS (AOAC) CONFIRMATIVE IN-VITRO TEST AS PART OF THE EPA ANTIMICROBIAL EFFICACY TESTING PROGRAM. ANALYTICAL RESULTS SHOWED THAT IT WAS INEFFECTIVE AGAINST MYCOBACTERIUM TUBERCULOSIS, WHICH USED ACCORDING TO THE LABEL DIRECTIONS FOR A CONTACT TIME OF 10 MINTUES. FIFRA 2(q)(1)(A) STATES, A PESTICIDE IS MISBRANDED IF ITS LABELING BEARS ANY STATEMENT, DESIGN, OR GRAPHIC REPRESENTATION RELATIVE THERETO OR TO ITS INGREDIENT WHICH IS FALSE OR MISLEDING IN ANY PARTICULAR. THE LABEL ON ZEP FORMULA 165 WAS FALSE AND MISLEADING REGARDING ITS EFFECTIVENESS AGAINST MYCOBACTERIUM TUBERCULOSIS. FIFRA 12(a)(1)(E) STATES THAT IT SHALL BE UNLAWFUL FOR ANY PERSON IN ANY STATE TO DISTRIBUTE OR SELL TO ANY PERSON A PESTICIDE THAT IS MISBRANDED. ORDER REQUIRES: RESPONDENT IS HEREBY ORDER NOT TO DISTRIBUTE, SELL, USE OR REMOVE THE FOLLOWING PESTICIDE PRODUCT: ZEP FORMULA 165, EPA REG NO 39967-81-1270 FOR FORMER EPA REG NO 49403-6-1270.

Defendants (1)

• ZEP, INC.Named in complaintNamed in settlement

Facilities (1)

• ZEP, INC.

  1420 SEABOARD INDUSTRIAL BLVD NW, ATLANTA, GA, 30318-2827

  Registry ID: 110043715628

Statutes cited

• FIFRA 12A1C — Composition Difference
• FIFRA 12A1E — Adulterated/Misbranded

Enforcement conclusions (1)

• ZEP, INC.entered 2012-04-16

  Primary law: FIFRA

Timeline (2 milestones)

• 2012-04-16Final Order Issued
• 2012-05-01Enforcement Action Data Entered