James B. Messina

Mr. Messina has over 18 years experience in FIFRA regulatory affairs and specializes in new pesticide product registration at the Federal, State, and International levels, pesticide regulations and policies, and has expertise in the areas of regulatory affairs and general registration strategies.

Mr. Messina has managed Federal and State registrations under EPA’s FIFRA guidelines. This work includes preparation of EPA registration strategies, implementation of the strategies and successful approval of the EPA pesticide products. His experience also includes the management of more than 70 registered biopesticide products. Mr. Messina is experienced with providing FIFRA regulatory support for new active ingredients, food-use and non-food use pesticide products, new end-use products, new uses of registered products, and supplemental/distributor registrations. He has also managed international registration efforts for pesticide products in Canada, Mexico, Europe, Central America, South America, Australia, and Asia.

In addition, Mr. Messina managed the data development for several chemicals in support of Federal and State pesticide registration, EPA Registration Review, special reviews, and other data requirements under FIFRA and TSCA. He has successfully managed industry Task Forces and their efforts to reinstate pesticide product registrations and tolerance exemptions. Mr. Messina also performed general regulatory consulting services, coordinated client and laboratory interactions, and managed and monitored ongoing health and safety studies at contract laboratories.

Mr. Messina managed an industry Task Force focused on the reinstatement of tolerance exemptions for inert (other) ingredients. This work involved development of a strategic plan, implementation of the strategy, placement and monitoring of toxicology data, preparation and submission of petitions for tolerance exemption and tracking of EPA submissions.

Mr. Messina managed new chemical products, including preparation and submission of Pre-Manufacture Notices (PMNs) and tolerance exemption petitions for use of a chemical as an inert (other) ingredient.

Messina JB. New US EPA regulatory requirements for adjuvants. Proceedings of the 9th International Symposium on Adjuvants for Agrochemicals, ISAA Society, pp. 213–220, 2010.

Presentations

Messina JB. New US EPA regulatory requirements for adjuvants. Presentation at the 9th International Symposium on Adjuvants for Agrochemicals, Freising, Germany, August 16, 2010.

Messina JB. The Joint Inerts Task Force (JITF), an effective task force model. Presentation at the American Chemical Society National Meeting, San Francisco, CA, March 21, 2010.

Messina JB, Daniels CL, Polakoff BM, Tucker KD. Registration? But it’s a natural product. Presentation at the American Chemical Society National Meeting, New York, NY, September 9, 2003.

• Project Manager, Novigen Sciences, Inc., 2001–2002
• Senior Registration Manager, Thermo Trilogy Corporation, 1998–2001
• Senior Product Manager, Jellinek, Schwartz & Connolly, Inc., 1996–1998
• Product Manager, Jellinek, Schwartz & Connolly, Inc., 1994–1995
• Assistant Product Manager, Jellinek, Schwartz & Connolly, Inc., 1993–1994
• Wildlife Research Assistant Volunteer, U.S. Fish & Wildlife Service, 1992–1993
• Biological Technician, U.S. Department of Agriculture, 1989–1990
  

Prepared FIFRA regulatory strategy to obtain multiple new product approvals under a limited timeframe. This work included preparation of multiple registration packages, including all required supporting data, submission of registration packages to EPA, negotiation of review timeframes with EPA, and monitoring the EPA review and approval process.

Preparation of a tolerance exemption petition for a new inert (other) ingredient, including submission of all supporting data and tracking of the EPA review and approval of the new food-use inert ingredient.

Preparation of a tolerance exemption petition for a polymer (qualifying for polymer exemption), including submission of all supporting data and tracking of the EPA review and approval of the new food-use polymer inert ingredient.

Preparation and submission of a new non-food use inert (other) ingredient application to EPA.

Managed industry task force consisting of multiple companies, including pesticide registrants and chemical suppliers. Provided FIFRA strategy and support to maintain tolerance exemptions important to task force members. Managed data development program to support task force goals. Prepared and submitted supporting information to EPA and then tracked the submissions to completion.

Managed strategy and data development program for multiple new active ingredients. Provided EPA guidance and strategy on how to obtain EPA registration of new active ingredients. Managed data development programs to generate necessary data. Prepared registration application submissions to EPA and states.

Provided data compensation negotiation support for registration of pesticide product under FIFRA. Performed evaluation and valuation of data. Directed compensation negotiations between companies.

Managed successful reduced risk/OP replacement submissions to EPA. Prepared registration strategy and support documentation to obtain registration of new active ingredient(s) in a more timely manner.

• Member of Biopesticide Industry Alliance—BPIA, 2002–present
• Member of Responsible Industry for a Sound Environment—RISE, 2002–present
• U.S. Coast Guard Merchant Marine Officer, 2002–present
• National Capitol Area Regional Society of Quality Assurance, 1996–2002