Abamectin - Label Change Request Receipt for Agri-Mek 2/97
New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides & Radiation
Pesticide Product Registration Section
50 Wolf Road, Albany, New York 12233-7257 John P. Cahill
Phone 518-457-7446 FAX 518-485-8990 Acting Commissioner
February 14, 1997
RETURN RECEIPT REQUESTED
Ms. Patricia A. Sheehy
Manager, Regulatory Affairs,
Coordination and Planning
Agricultural Research & Development
Merck & Co., Inc.
P.O. Box 450
Three Bridges, NJ 08887-0450
Dear Ms. Sheehy:
Re: Application for Registration of a Major Change in Labeling for
Abamectin, Contained in the New Pesticide Product Agri-Mek 0.15 EC
Miticide/Insecticide (EPA Reg. No. 618-98)
This letter is to confirm the receipt of your letter, dated February 13,
1997, which requests a waiver of the pesticide product registration decision
date for Agri-Mek 0.15 EC Miticide/Insecticide (EPA Reg. No. 618-98) in New
York State. The letter requested a waiver of the registration decision date of
February 14, 1997 to April 30, 1997. Merck & Co., Inc. has requested the
waiver in order to assemble information needed to meet with the Department's
technical and regulatory staff.
The Department would like to take this opportunity to "spell-out" our
concerns and what exactly the Department is asking Merck & Co., Inc. to do in
order to mitigate our concerns.
The Department is concerned about the potential for Agri-Mek 0.15 EC
Miticide/Insecticide to cause developmental effects in laboratory animals. The
Department of Health has requested that the following wording be added to the
product's label in order to inform all users of the need to be scrupulous
about use of Personal Protective Equipment:
"Abamectin and related compounds cause developmental effects in
laboratory animals. Risks can be reduced by closely following
use directions and precautions and by wearing the Personal
Protective Equipment (PPE) specified on the label."
Concerns also remain regarding the potential for Agri-Mek 0.15 EC
Miticide/Insecticide to cause acute lethal toxicity to small mammals in and
around the treatment area (orchards), and that runoff from treated orchards
has the potential to cause acute, lethal toxicity to aquatic invertebrates.
Registration of Agri-Mek 0.15 EC Miticide/ Insecticide will not be granted
unless the manufacturer can provide data that specifically shows that toxic
impacts will not occur. If the data does not already exist, the Department's
Bureau of Environmental Protection has recommended that the following three
specific studies be conducted to evaluate the real-world potential for Agri-
Mek 0.15 EC Miticide/Insecticide to be toxic to small mammals and aquatic
1. Carcass Search: For 3-5 days following an application of Agri-Mek
0.15 EC Miticide/Insecticide, the floor of the orchard and the ground
immediately downwind of a treated orchard should be thoroughly
searched for dead mammals. Any dead mammals found should be evaluated
to determine if death was the result of abamectin toxicity.
2. Small Mammal Feeding. Study: Small herbivorous mammals are fed
vegetation treated at the labeled application rate and evaluated for
3. Surface Water Runoff/Aquatic Invertebrate Toxicity Study: Either a
small-plot runoff study or a field runoff study is conducted to
determine actually how much abamectin will be transported in runoff.
Using the runoff study to determine test concentrations, communities
of compatible aquatic invertebrate species (microcosm) are exposed to
abamectin in a static test to determine if actual runoff
concentrations will be acutely toxic.
The Department would like to schedule a technical meeting as soon as
possible in order to discuss our concerns and resolve this issue in a timely
fashion. If data currently exists which would address the Department's
concerns regarding developmental, small mammal and aquatic invertebrate
toxicity, please submit it immediately in order to allow Departmental review
in advance of a technical meeting.
The requested registration decision due date of April 30, 1997 may not be
acceptable because it is very close to the State's apple and pear growing
season and may not allow ample time for the growers to plan pesticide
applications. Hopefully, knowledge of the issues will lead to the suggestion
of an earlier registration decision date.
Please contact Ms. Jeanine Broughel, of my staff, at (518) 457-7446, if
you have any questions.
Maureen P. Serafini
Pesticide Product Registration Section
cc: N. Kim/A. Grey - NYS DOH
W. Smith - Cornell PMEP