EPA v. ZEP, INC.

Case summary

3/12/14 - COMPLAINT FILED. ALLEGATIONS: ON MAY 26, 2011, EPA INSPECTED RESPONDENT'S SEABOARD DR, ATLANTA, GA, FACILITY. DURING THE INSPECTION, INSPECTORS COLLECTED PHYSICAL SAMPLES OF THE ANTIMICROBIAL PESTICIDE PRODUCTS, ZEP FORMULA 165, WHICH BORE THE EPA REG NUMBER 49403-6-1270 ON ITS LABEL, AND RESPONDENT PROVIDED DISTRIBUTION OR SALES RECORDS RELATED TO THIS PESTICIDE. ON SEPT 28, 2011, AND SEPT 29, 2011, EPA CONDUCTED AN INSPECTION OF THE LAB LOCATED AT RESPONDENT'S FACILITY. THE INSPECTOR REVIEWED 3 STUDIES, CONDUCTED BY RESPONDENT AT ITS FACILITY, WHICH HAD BEEN SUBMITED TO EPA ON OR ABOUT MAR 25, 2009, WHICH INCLUDED: A. STORAGE AND STABILITY TESTING AND CHEMICAL AND PHYSICAL PROPERTIES DETERMINATION FOR ENFORCER ROACHMAX BAIT; B. STORAGE AND STABILITY TESTING AND CHEMICAL AND PHYSICAL PROPERTIES DETERMINATION FOR ENFORCER ANTMAX BAIT; C. STORAGE AND STABILITY TESTING AND CHEMICAL AND PHYSICAL PROPERTIES DETERMINATION FOR ENFORCER FIRE ANT BAIT. EPA CONDUCTED A LAB TEST OF THE SAMPLES COLLECTED. BASED ON EPA'S LAB TEST RESULTS, WHICH SHOWED THAT THE HOSPITAL DISINFECTANT ZEP FORMULA 165 WAS INEFFECTIVE AGAINST MYCOBACTERIUM TUBERCULOSIS, ON APR 16, 2012, EPA ISSUED A STOP SALE, USE, OR REMOVAL ORDER, DOCKET NO. FIFRA-04-2012-3265, TO STOP THE SALE AND DISTRIBUTION BY RESPONDENT. IN RESPONSE TO A REQUEST FROM RESPONDENT, EPA AMENDED THE SSURO TO ALLOW RESPONDENT TO CONDUCT A VOLUNTARY RECALL AND DESTROY ALL QUANTITIES OF ZEP FORMULA 165 UNDER ITS OWNERSHIP, CUSTODY OR CONTROL. ON MAY 2, 2012 EPA CONDUCTED AN INSPECTION OF THE WAREHOUSE AND OFFICES AT SEABOARD DR. THE INSPECTOR INVESTIGATED THE DISPOSITION OF THE PESTICIDE PRODUCT, ZEP FORMULA 165. THE INSPECTOR ALSO COLLECTED BATCH RECORDS AND RESPONDENT PROVIDED ADD'L RECORDS DOCUMENTING THE DISTRIBUTION OR SALE OF THIS PESTICIDE. VIOLATIONS: DISTRIBUTION OR SALE OF AN UNREGISTERED PESTICIDE; DISTRIBUTION OR SALE OF A MISBRANDED PESTICIDE; SUBMISSION OF A FALSE COMPLIANCE CERTIFICATION STATEMENTS. 7/8/2014 - CONSENT AGMT ISSUED, ASSESSING A PENALTY OF $905,000, DUE WITHIN 30 DAYS. FOR IMMEDIATE RELEASE July 15, 2014 Zep Inc. Pays $905,000 for Alleged Violations of FIFRA ATLANTA-Zep Inc., located in Atlanta, GA, has agreed to pay $905,000 to resolve alleged violations of FIFRA EPA announced today. As part of the settlement, Zep Inc., has certified that it is now in compliance with FIFRA. The alleged violations are related to the sale and distribution of the unregistered and misbranded pesticide, “Formula 165”, as a supplemental distributor without first obtaining a supplemental distribution agreement with the registrant between Apr 21, 2010, and Jan 6, 2012. The lack of a supplemental agreement also meant that ZEP Inc. was not authorized to manufacture or sell or distribute the pesticide. In addition, EPA alleged that Zep Inc., gave false certifications of compliance with FIFRA Good Laboratory Practices (GLP) on documents associated with the registration of 3 pesticides in its line of Enforcer brand insecticides - Enforcer RoachMax Bait, Enforcer AntMax Bait and Enforcer Fire Ant Bait. Pesticide registrants are required to certify their compliance with the GLP on any testing or studies submitted to the EPA in support of a registration. Under EPA’s antimicrobial testing program, ZEP Formula 165 was evaluated, and EPA’s testing showed that contrary to labeling claims, the product was ineffective against Mycobacterium tuberculosis. A pesticide is misbranded and in violation of FIFRA if it makes false or misleading label claims.

Defendants (1)

• ZEP, INC.Named in complaintNamed in settlement

Facilities (6)

• ZEP, INC.

  1310 SEABOARD INDL. BLVD, ATLANTA, GA, 30318-2825

  Registry ID: 110000357694

• ZEP, INC.

  1310 SEABOARD INDL. BLVD, ATLANTA, GA, 30318-2825

  Registry ID: 110000357694

• ZEP, INC.

  1310 SEABOARD INDL. BLVD, ATLANTA, GA, 30318-2825

  Registry ID: 110000357694

• ZEP, INC.

  1310 SEABOARD INDL. BLVD, ATLANTA, GA, 30318-2825

  Registry ID: 110000357694

• ZEP, INC.

  1310 SEABOARD INDL. BLVD, ATLANTA, GA, 30318-2825

  Registry ID: 110000357694

• ZEP, INC.

  1310 SEABOARD INDL. BLVD, ATLANTA, GA, 30318-2825

  Registry ID: 110000357694

Statutes cited

• FIFRA 12A2Q — Falsify Testing Information
• FIFRA 12A1E — Adulterated/Misbranded
• FIFRA 12A1A — Unregistered Pesticide

Enforcement conclusions (1)

• ZEP, INC.entered 2014-07-08

  Primary law: FIFRA

  Federal penalty: $905,000

Timeline (3 milestones)

• 2014-03-12Complaint Filed/Proposed Order
• 2014-04-07Enforcement Action Data Entered
• 2014-07-08Final Order Issued