(Boston, Massachusetts - July 31, 2013) - EMD Millipore Corporation, of Billerica, Mass., has agreed to pay $2,681,500 in civil penalties to settle E.P.A. allegations that it violated the federal pesticide law and regulations on numerous instances over many years.
In a Consent Arrangement and Final Order (CAFO), E.P.A. alleged that EMD Millipore Corporation violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on numerous occasions since 2008 by producing, importing, distributing and selling pesticidal devices in violation of federal pesticide requirements. The devices were used in labs for research, development and manufacturing purposes. Although the allegations of noncompliance were serious and involved numerous violations over years, E.P.A. is not aware of any specific human health or environmental harm caused by the violations in this case.
The $2.6+ million penalty is the 2nd biggest civil penalty ever paid in an E.P.A. enforcement case under FIFRA, and is the biggest such penalty levied by E.P.A. in New England.
The types of violation resolved by this settlement include: 1) importing regulated pesticide devices into the U.S. for distribution or sale without submitting "Notice of Arrival" forms to EPA; 2) selling misbranded pesticide devices that lacked important label information about where they were made; 3) producing pesticide devices in a then-unregistered establishment in Jaffrey, N.H.; and 4) filing incomplete yearly production reports with E.P.A. by failing to list pesticide devices that were produced at a facility in Molsheim, France and then imported into the U.S.
"Companies that produce, import and sell FIFRA-regulated devices in the U.S. are obligated to carefully follow applicable requirements which help to ensure that E.P.A. has accurate information for making informed decisions that result in protecting the health of Americans and our environment," said Curt Spalding, regional administrator of EPA's New England office. "These companies share an important role in ensuring that regulated devices, just like chemical pesticides, are made and sold in full compliance with the law so that our families and communities are not subject to unacceptable risks."
EMD Millipore operates as the Life Sciences Division of Merck KGaA, Darmstadt, Germany (MDG). EMD Millipore was created in 2011 after MDG had acquired Millipore Corporation, a predecessor company that was also the subject of a FIFRA enforcement case settled with E.P.A. in 2010. EMD Millipore distributes and sells a variety of products, including many that are regulated as "devices" under FIFRA. EMD Millipore produces devices at several facilities in the U.S. and Europe but the allegations arose from the Jaffrey, N.H. and Molsheim, France operations. The devices in question are used, in part, to help ensure the safety and integrity of biotech and pharmaceutical drug therapies, as well as beverage-making.
The settlement requires EMD Millipore to certify that it is currently operating in compliance with FIFRA and its implementing regulations and that it has fully addressed the alleged violations. EMD Millipore also certifies that it provided E.P.A. with true and accurate information during the investigation of the case. Under the CAFO terms, EMD Millipore does not admit liability for the violations.
FIFRA is the federal law that regulates the production, sale, distribution, use, and importation into the U.S. of pesticides and pesticide devices. FIFRA classifies devices essentially as physical contrivances intended to mitigate pests and, as such, they are subject to fewer FIFRA requirements than chemical pesticides. While pesticide devices need not be registered under Section three of FIFRA, they are required to be produced in registered establishments and to comport with certain labeling provisions. Devices also are subject to FIFRA reporting requirements when they are produced, imported, or sold.
The FIFRA requirements at issue in this case are intended to ensure the integrity of the national pesticide plan and protect against unreasonable risks to human health, welfare, and the environment from pesticides and devices.
The prohibition against selling or distributing "misbranded" pesticides/devices is important because it helps ensure that end-users and members of the public have the most accurate and up-to-date information accessible about pesticide products and where they were made. The requirement to file Notice of Arrival (NOA) forms prior to importing a pesticide or device provides vital product information to E.P.A. before any sale or distribution can occur. Information from NOAs helps inform E.P.A. about whether an import poses adverse risks and provides critical contact information in the event of an emergency related to the movement of potentially harmful pesticide products. Finally, registering production establishments under FIFRA is important because registered establishments must submit yearly production and sales data to E.P.A. which are crucial for the Agency to carry out FIFRA compliance, risk assessment, and risk reduction functions. Without proper establishment registrations, E.P.A. cannot determine where and in what manner pesticides and devices are being produced, sold, and distributed.
For more information:
- Enforcing pesticide requirements in New England (http://www.epa.gov/region1/enforcement/pesticides/index.html)
- General information on E.P.A. regulation of pesticides (http://www.epa.gov/pesticides/regulating/index.htm)
