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glufosinate-ammonium (Rely, Finale) NYSDEC Registers Rely Herbicide 5/96

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7250
Phone 518457-6934 FAX 518-457-0629
MAY 0 2 1996
Mr. Victor A. Dorr
Manager, Regulatory Affairs
AgrEvo USA Company
Little Falls Centre One
2711 Centerville Road
Wilmington, DE  19808
Dear Mr. Dorr:
Re:  Registration of New Active Ingredient, Glufosinate-Ammonium, 
Contained in the Pesticide Products Rely Herbicide (EPA Reg. No. 45639-
187) and Finale Herbicide (EPA Reg. No. 45639-187)
AgrEvo USA Company applied for New York State registration, on August 
16, 1994, for five new pesticide products which contain the new active 
ingredient glufosinate-ammonium.  The five products are:  Rely Herbicide 
(EPA Reg. No. 45639-187), Finale Herbicide (EPA Reg. No. 45639-187), 
Glufosinate-Ammonium Grass & Weed Killer Super Concentrate (EPA Reg. No. 
45639-191), Glufosinate-Ammonium Grass & Weed Killer Ready-to-Use (EPA 
Reg. No. 45639-192) and Glufosinate-Ammonium Grass & Weed Killer 
Concentrate (EPA Reg. No. 45639-193).  The New York State Department of 
Environmental Conservation (the Department) determined the application 
to be complete for purposes of review on January 23, 1995.
The Department registered Glufosinate-Ammonium Grass & Weed Killer Super 
Concentrate (EPA Reg. No. 45639-191), Glufosinate-Ammonium Grass & Weed 
Killer Ready-to-Use (EPA Reg. No. 45639-192), and Glufosinate-Ammonium 
Grass & Weed Killer Concentrate (EPA Reg. No. 45639-193) on June 27, 
1995.  The three products were labeled for nonselective weed control of 
emerged weeds in residential outdoor locations.
Rely Herbicide (EPA Reg. No. 45639-187) is labeled for application as a 
foliar spray for the nonselective weed control of emerged weeds in 
apples, grapes, and tree nuts.  The maximum application rate is 4.5 lbs. 
active ingredient per acre per year.
Finale Herbicide (EPA Reg. No. 45639-187) is labeled for nonselective 
weed control of emerged weeds in noncrop areas.  Finale Herbicide may be 
used for:
     - trimming and edging landscape areas;
     - industrial, recreational and public areas (airports, commercial
       plants, storage and lumber yards, highways, educational
       facilities, fence lines, ditch banks, dry ditches, schools,
       parking lots, tank farms, pumping stations, parks, utility
       rights-of-way, roadsides, railroads, other public areas and
       similar industrial and nonfood crop areas);
     - ornamentals and Christmas trees;
     - greenhouse and shade house (not for use in greenhouse or shade
       houses containing edible crops); and
     - farmsteads.
AgrEvo USA Company had waived the registration decision for Rely 
Herbicide and Finale Herbicide until updated labels were received by 
AgrEvo USA Company from the United States Environmental Protection 
Agency (EPA), which would prohibit the use of the products in Nassau and 
Suffolk Counties, and agreement could be reached on the production of a 
management brochure addressing the use of these products in sandy soils 
which may impact groundwater.
The Department received the updated labels for the two products on July 
5, 1995.  At that time, the target date for submission of the management 
brochure was by the end of July.  The Department had still not received 
the management brochure by mid- September and sent a letter to AgrEvo 
USA Company, dated September 21, 1995, stating that AgrEvo USA Company 
had 45 calendar days from the receipt of the letter to submit the 
brochure.  AgrEvo USA Company did not respond to the letter.  The 
Department sent another letter, dated November 24, 1995, which proposed 
to deny the application for registration of Rely Herbicide and Finale 
Herbicide effective 30 days from the receipt of the letter.  AgrEvo USA 
Company received this letter on November 29, 1995.
The Department received the first draft water quality management 
brochure on January 3, 1996.  The Department sent a letter to AgrEvo USA 
Company, dated February 29, 1996, with various comments and suggestions 
for the water quality management brochure.  The letter gave AgrEvo USA 
Company 30 days from receipt of the letter to respond.  The Department 
received the revised draft water quality management brochure on April 3, 
1996.
The use of glufosinate-ammonium in New York State is not likely to cause 
harm to fish and wildlife. Glufosinate-ammonium is a water soluble, 
broad-spectrum herbicide that is applied to the leaves and foliage of 
growing plants.  This herbicide is not toxic to birds or mammals when 
applied at the labeled rate.  It is not toxic to aquatic life at levels 
that are likely to occur following runoff events.
Glufosinate-ammonium produced a number of effects in laboratory animals 
at relatively low doses.  In an oncogenicity study in rats, glufosinate-
ammonium caused an increased incidence of combined benign and malignant 
adrenal medullary tumors in males at the highest dose tested and a 
significant trend was also reported for these tumors in males.  However, 
the tumor incidence was reported to be within the range of historical 
controls.  No oncogenic effects were reported in a chronic mouse feeding 
study.  The EPA Reference Dose Review Committee determined that the 
mouse study was adequate for evaluating carcinogenicity, but maintained 
that the rat study was not.  A repeat rat oncogenicity study is required 
as a condition of federal registration for Rely Herbicide, which is 
labeled for agriculture use, and is currently in progress according to 
the registrant.  Negative results were reported for glufosinate-ammonium 
in tests of genotoxicity.
Glufosinate-ammonium and degradates have properties which indicate that 
they may leach through soil and contaminate groundwater, despite the 
evidence that it can degrade quickly under optimal field conditions.  
The concerns regarding leaching potential are reflected in the 
Environmental Hazards label statement on the Rely Herbicide and Finale 
Herbicide labels which states "Glufosinate-ammonium and its degradates 
have those properties normally associated with pesticides that have been 
detected in groundwater.  Use of this product in areas with coarse soils 
and high water tables may result in groundwater contamination."  The 
labeled uses of Rely Herbicide (apple and tree nut orchards and 
vineyards) and Finale Herbicide (nurseries, recreational and public 
areas, farmsteads) allow treatment over a considerable area which 
increases the risk of groundwater contamination.
The concerns regarding groundwater contamination lead to the Department 
requiring the submittal of updated labels, which would prohibit the use 
of Rely Herbicide and Finale Herbicide in Nassau and Suffolk Counties, 
and the production of brochures, which discuss guidelines for the proper 
use of the products in order to protect water quality in New York State, 
before registration of Rely Herbicide and Finale Herbicide.
Groundwater contamination concerns were not raised during the review for 
the registration of the other three products, Glufosinate-Ammonium Grass 
& Weed Killer Super Concentrate, Glufosinate-Ammonium Grass & Weed 
Killer Ready-to-Use, and Glufosinate-Ammonium Grass & Weed Killer 
Concentrate, which were registered in New York State on June 27, l99S. 
The three products are labeled for use primarily as residential spot 
treatments and edging, and do not pose the same threat to groundwater as 
does Rely Herbicide and Finale Herbicide.
There are no chemical-specific federal or New York State drinking 
water/groundwater standards for glufosinate-ammonium.  Based on its 
chemical structure, glufosinate-ammonium would fall under the 50 
micrograms/liter (ug/L) New York State drinking water standard for an 
"unspecified organic contaminant" (10 NYCRR Part 5 - Public Water 
Systems).  This value of 50 ug/L should also be considered a potential 
State groundwater standard.
The Department was concerned as to how AgrEvo USA Company was to assure 
that the brochures would be readily available to users of Rely Herbicide 
and Finale Herbicide in New York State.  The Department suggested that 
AgrEvo USA Company revise the final product label for Rely Herbicide and 
Finale Herbicide to add a reference to the water quality management 
brochure.  AgrEvo USA Company stated that if a reference to the brochure 
was added to the product label, then the brochure would actually become 
part of the product label and be subject to a possibly lengthy EPA 
review before approval.
Therefore, as an alternative to revising the product labels,  AgrEvo USA 
Company has proposed the following procedures that will be instituted 
upon registration of Rely Herbicide and Finale Herbicide in New York 
State in order to assure that the brochure will be provided to both the 
potential and actual users of the products:
     1.  AgrEvo USA Company will issue a press release to the trade 
press announcing the registration approvals. The release will include a 
reference to the management brochures and will state that copies are 
available free of charge upon request by calling or writing AgrEvo.
     2.  AgrEvo USA Company will institute a direct mail campaign to 
introduce each product to the respective communities. They will include 
a copy of the appropriate management brochure in each direct mail
piece. AgrEvo USA Company will provide a copy of the mailing lists to 
the Department upon request.
     3.  When AgrEvo USA Company advertises the products in New York 
newsletters, they will also include the reference to the management 
brochures in the ads as well as their availability free of charge upon 
request by calling or writing AgrEvo USA Company.
     4.  AgrEvo USA Company currently has a system in place which sends 
out a Material Safety Data Sheet (MSDS) with each product ordered by a 
distributor.  They will modify the system to include an equivalent 
number of brochures for each container of product that is shipped.  The 
brochures would be mailed to all AgrEvo USA Company distributors located 
in New York and nearby states who are likely to resell the products in 
New York State.  The brochures would be accompanied by an instruction 
sheet that would direct the distributor to provide the appropriate 
number of brochures for each container of product resold in New York 
State. AgrEvo USA Company will provide a list of the distributors who 
have received the brochures to the Department upon request.
     5.  AgrEvo USA Company and its distributors will have the brochures 
available in the exhibition booths for dissemination to all prospective 
buyers at various trade shows exhibiting turf and crop protection 
products in New York State and educational meetings, such as the Cornell 
Turf Day.
     6.  AgrEvo USA Company will provide to the Department at no charge 
a reasonable number of the brochures for dissemination to the public 
through our own channels.
     7.  AgrEvo USA Company will provide a report to the Department, on 
an annual basis for the next five years, which summarizes the 
implementation of all of the above-mentioned procedures by the end of 
AgrEvo USA Company's fiscal year.
Therefore, the Department hereby accepts for general use registration, 
not for use in Nassau and Suffolk Counties, Rely Herbicide (EPA Reg. No. 
45639-187) and Finale Herbicide (EPA Reg. No. 45639-187).  The products 
are registered with the understanding that if AgrEvo USA Company does 
not adhere to their above-outlined procedures for assuring that the 
brochures will be provided to both the potential and actual users of the 
products, the Department will require the revision of the final product 
labels in order to maintain the registration of Rely Herbicide and 
Finale Herbicide in New York State.
Enclosed are your New York State stamped "ACCEPTED" labels and water 
quality management brochures, and a copy of the Certificate of 
Registration.
Please contact Ms. Maureen Serafini, Supervisor of our Pesticide Product 
Registration Section, at (518) 457-7446, if you have any questions.
Sincerely,
Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous
Materials
Enclosures
cc:  w/enc. - N. Kim/A. Grey - NYS Dept. of Health
     N. Rudgers/R. Mungari - NYS Dept. of Agriculture and Markets
     D. Rutz/W. Smith - Cornell University