IITRI's Biopesticide Testing Services
Pass Muster with Regulatory Agencies

Have you ever read the EPA or Canadian biopesticide guidelines and asked yourself, "What are they looking for?" You are not alone. IITRI specializes in assisting companies in answering some of these tough questions. Because of our years of interactions with government scientists and our years of serving industrial clients, IITRI has the unique perspective of understanding government regulatory concerns as well as your financial and business pressures.

Unfortunately, in some instances, the government regulations can be misinterpreted and companies may perform testing unnecessarily. In many instances, IITRI scientists can assess your business plan and projected biopesticide use and recommend a testing schedule that will meet government guidelines and save your company time and money.

IITRI's Experience Breeds Success

A recognized leader in biological agent testing services for nearly two decades, IITRI helped forge many of the regulatory standards in place today. Since 1985, our Microbiology and Molecular Biology Division has been actively involved in microbial pesticides testing, particularly in the development and validation of mammalian toxicity and pathogenicity testing methods.

Our expertise is evidenced by the numerous biopesticide registrations obtained by our Sponsors. Because of our intimate knowledge of U.S. Environmental Protection Agency (EPA) and Canadian (Health Canada and Agricultural Canada) guidelines, our Sponsors are assured studies conducted at IITRI will meet or surpass all U.S. EPA and Canadian requirements.

IITRI also aids our Sponsors in safety assessment of microbials used for bioreactors, as currently requested by the Organization for Economic Cooperation and Development (OECD).

IITRI's Research Esteemed by Regulators

Dr. Robert Sherwood, IITRI Asst. VP and Manager of the Microbiology and Molecular Biology Division, served as an expert reviewer on several workshops that helped develop the revised Canadian biopesticide and genetically modified organism guidelines. He served as the Principal Investigator on several EPA-sponsored cooperative agreements that validated the current EPA toxicicity/pathogenicity guidelines for injection and pulmonary exposure. He has also served as the Study Director on numerous studies conducted under EPA Good Laboratory Practice (GLP) guidelines for industrial clients. Dr. Bruce Gingras and Mr. William Mega have worked for years with Dr. Sherwood and have themselves served as Study Directors on numerous studies conducted under EPA or OECD GLP guidelines for industrial clients.

From 1985 to 1994, IITRI investigated methods for testing toxicity and virulence of microbial pest control agents (MPCAs) under a cooperative agreement with the U.S. EPA. As a result of IITRI's research, FIFRA Subdivision M guidelines (now OPPTS guidelines) for testing acute toxicity/pathogenicity of MPCAs were significantly modified:

• Requirements for inhalation exposure of test animals were replaced with protocols for intranasal or intratracheal challenge.
• Number of animals required for testing, as well as the interim sacrifice times for determining microbial clearance rates, were based on IITRI results.
• Protocols for determining acute mammalian toxicity/pathogenicity by pulmonary and oral challenge routes were validated at IITRI.

IITRI Offers Comprehensive Testing Services

IITRI's experienced scientists are well versed in the registration process and consistently help Sponsors meet the regulatory standards quickly and efficiently, so they can get their products to market. IITRI provides scientifically sound studies that follow regulations and produce valid results accepted by the regulatory agencies. Methods and results are presented in clear, comprehensive reports, audited by our Quality Assurance Unit, and delivered on time according to Sponsor and regulatory specifications. Studies are conducted in our biosafety level 2 facility under Good Laboratory Practice (GLP) guidelines, unless requested by the Sponsor.

Specialty Services

Cell culture testing for viruses
Consulting

With experience and knowledge of the testing and registration process on our side, IITRI is well positioned to help our customers reach their goal of bringing their products to market.

Please visit our Research Services web page or contact us at LSGInfo@IITRI.org for more information on the studies we perform.