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fipronil
NYS DEC Letter - Packaging Approval 12/97

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
50 Wolf Road, Albany, New York 12233-7250
Phone 518-457-6934 FAX 518-457-0629

December 18, 1997

VIA FAX AND MAIL

Mr. Stephen Smith
Regulatory Specialist
Clorox Services Company
P.O. Box 493
Pleasanton, CA 94566-0803

Dear Mr. Smith:

Re: Approval of "Improved Smear Welded" Packaging for Combat Quick Kill Formula 2 (EPA Reg.
    No. 64240-34) and Maxforce FC professional Insect Control Large Roach Bait Stations
    (EPA Reg. No. 64248-12)

This letter amends our letter dated September 12, 1997 to allow use of "improved smear
welded" packaging for the referenced pesticide products in New York State. The September 12,
1997 letter approved the referenced two products, along with seven other similar products,
for use in New York State only if contained in "index welded" bait stations.

We have determined that the use of "improved smear welded" packaging for the referenced two
products should not pose unreasonable public health risks in New York State. In your September
25, 1997 letter to Mr. Marion Johnson of the United States Environmental Protection Agency
(USEPA) regarding the referenced products, received by this Department via facsimile on
September 25, 1997, the Clorox Services Company reports: "Production will be made with
improved smear welding through end of 1st quarter 1998 (40% of 1998 production). After that
time, the product will use index welding." As such, this approval is granted only until the
transition to index welded packaging is completed.

The referenced products contain the active ingredient fipronil enclosed in a bait station and
are labeled to control cockroaches indoors and outdoors. These two products, along with seven
other fipronil-containing bait station products (Combat Quick Kill Formula 3; EPA Reg. No.
64240-30; Combat Outdoor Ant Stakes, EPA Reg. No. 64240-30; Combat Quick Kill Formula l, EPA
Reg. No. 64240-33; Combat Quick Kill Formula 1 Roach Baits, EPA Reg. No. 64240-33; Maxforce
FC Professional Insect Control Ant Bait Stations, EPA Reg. No. 64248-10; and Maxforce FC
Professional Insect Control Roach Bait Stations, EPA Reg. No. 64248-11), were reviewed and

approved for use In New York State. The Combat® and Maxforce® product labels allow a number
of bait stations to be placed In close proximity to building occupants, presenting a potential
poisoning hazard to children and pets. We determined that effective child-resistant packaging
should reduce the risk of poisoning for these occupants. The child-resistant packaging study
for the index welded bait station indicated that no children tested were able to open the
stations. Based on information provided to us by representatives of Clorox, and the data
provided In the submitted child-resistance studies, we approved only those products packaged
In index welded bait stations for use In New York State (ref. letter from N. Nosenchuck
to S. Smith, dated September 12, 1997).

 Following this registration, we received a request on September 16, 1997 to approve
alternate packaging for the reference large roach bait stations because Clorox was
experiencing manufacturing delays with implementing the index welding for the large roach
bait stations. Clorox proposed to manufacture the referenced large roach bait products with
an improved smear welded bait station until the index-welded bait stations can be made.
(We were informed that Clorox expects to start producing the index welded bait stations for
the large roach products by the second quarter of 1998.) Because the performance of the bait
stations In child-resistance testing was an integral factor In the original registration of
these products, we concluded that any changes In the packaging of these products would have
to be reviewed for public health risks.

To support the packaging change, Clorox submitted a	-resistant packaging study for the
improved smear welded bait stations. In this study, 50 children were tested to determine
how many could gain access to the bait formulation (no actual bait was present In the
stations at the time of testing) when given 12 bait stations each and tested for a period
of ten minutes. Of the 50 children, two accessed one bait station each for an overall
child-resistant packaging effectiveness of 96 percent. This effectiveness exceeds the United
States Environmental Protection Agency's criteria for effective child-resistant packaging.
Based on the previously submitted data on the toxicity of fipronil and the concentration of
fipronil In the bait stations (0.03 to 0.05 percent), adverse effects would not be expected
from a child ingesting the bait from one station.

Given the adequate performance of the improved smear welded bait station In the
child-resistant packaging test, we are granting approval of the use of the improved smear
welded packaging to Combat Quick Kill Formula 2 and Maxforce FC Professional Insect Control
Large Roach Bait Stations In New York State. We expect Clorox to begin manufacturing the
index welded bait stations for the referenced large roach bait stations by the second quarter
of 1998 as stated. All bait stations manufactured after the second quarter of 1998 should be
contained In index welded bait stations. Please Note: You must notify this Department of any
changes to the packaging implementation schedule set forth above.

If you have any questions, please contact Maureen Serafini, Supervisor of our Pesticide
Product Registration Section, at (518) 457-7446.

Sincerely,

Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous Materials

cc: D. Rutz/W. Smith, Cornell U, PMEP
N. Kim/D. Luttinger, NYSDOH