[Federal Register Volume 60, Number 65 (Wednesday, April 5, 1995)]
[Notices]
[Pages 17357-17359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8344]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-66209; FRL-4943-4]
Mevinphos; Amendment to Cancellation Order and FIFRA Section 6(g)
Notification
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of issuance of amended cancellation order.
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SUMMARY: On June 30, 1994, Amvac Chemical Corporation (Amvac) of Los
Angeles, California, requested voluntary cancellation of all
registrations containing mevinphos (2-carbomethoxy-1-methylvinyl
dimethyl phosphate, alpha and beta isomers, trade name Phosdrin).
Pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA canceled all mevinphos registrations on
July 1, 1994. The Cancellation Order contained certain limitations upon
the distribution, sale, and use of existing stocks of canceled
pesticide products containing mevinphos. EPA has modified the existing
stocks provision of the Cancellation Order to extend the period for
sale, distribution, and use of existing stocks of certain canceled
products containing mevinphos through November 30, 1995. At the end of
this period, all product in the channels-of-trade, including product in
the hands of growers, will be subject to a recall which has some
provisions for reimbursement. Product sold after February 27, 1995,
will be labelled with additional protective requirements. This notice
also amends the timeframe for reporting the possession of canceled
mevinphos products as required under section 6(g) of FIFRA.
DATES: The amended cancellation order became effective January 13,
1995.
FOR FURTHER INFORMATION CONTACT: By mail: Richard Dumas, Special Review
Branch, Special Review and Reregistration Division (7508W),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Special Review Branch, 3rd floor,
2800 Crystal Drive, Arlington, VA, (703) 308-8015.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Background
On June 30, 1994, Amvac requested voluntary cancellation of all
pesticide product registrations containing mevinphos as an active
ingredient. On July 1, 1994, EPA issued a Cancellation Order for all
mevinphos registrations pursuant to FIFRA section 6(f)(1). In the
Federal Register of August 1, 1994 (59 FR 38973), EPA issued a Notice
announcing receipt of the request for cancellation, the Cancellation
Order, and the FIFRA section 6(g) notification requirements. The
Cancellation Order prohibited the distribution and sale of existing
stocks of canceled pesticide products containing mevinphos after
December 31, 1994, and prohibited the use of existing stocks after
February 28, 1995. Existing stocks refer to those stocks of previously-
registered mevinphos products which were in the United States and were
packaged, labeled, and released for shipment prior to the cancellation
on July 1, 1994. Also, the Order required Amvac to develop and
implement an acceptable Recall Plan for the recall of mevinphos
products that were in the hands of dealers and distributors after
December 31, 1994.
On December 28, 1994, EPA amended the Cancellation Order by
extending distribution and sale of existing stocks of canceled
mevinphos products through January 14, 1995, to facilitate work on a
pending agreement between EPA and Amvac. On January 13, 1995, EPA
entered into an agreement with Amvac and issued a new amendment to the
Cancellation Order which changed the existing stocks provisions in the
amended Cancellation Order by extending the period for distribution,
sale, and use of mevinphos, established new use restrictions, and
ordered the recall of mevinphos products. [[Page 17358]]
The EPA registration numbers canceled by the Cancellation Order
are: 5481-113, 5481-114, 5481-161, 5481-248, 5481-411, 5481-412, 5481-
425, CA80001800, CA81000300, CA86006300, CA86007300 and any
supplemental registrations of the registrations listed above.
B. Restrictions on Distribution, Sale, and Use
The Cancellation Order, as amended on December 28, 1994, provided
that no person may distribute or sell mevinphos products after January
14, 1995, and that no person may use mevinphos products after February
28, 1995. The Amended Cancellation Order and Recall Order, issued
January 13, 1995, prohibits all distribution, sale, and use of
mevinphos products after November 30, 1995. The extension of the date
for use, sale, and distribution does not affect the registration of
mevinphos products in any way. All mevinphos registrations remain
canceled, and will not be considered for registration. Moreover, all
production of mevinphos products for use in the United States ceased
July 1, 1994.
C. Relabeling Requirements and Additional Restrictions on Use of
Mevinphos Products
Because of the risks that mevinphos poses to workers, the
Cancellation Order as amended requires Amvac to relabel mevinphos
products in the hands of dealers and distributors to reflect additional
use restrictions. The additional required use restrictions are as
follows: (1) Use of hand-held application equipment and air blast
sprayers is prohibited; (2) applicators and other handlers must wear a
respirator with either an organic vapor removing (O/V) cartridge with a
prefilter approved for pesticides (MSHA/NIOSH) approval number prefix
(TC-230), or a canister with a prefilter approved for pesticides (MSHA/
NIOSH) approval number prefix (TC-14G); (3) applicators and other
handlers must use protective eyewear; (4) applicators and other
handlers must wear: coverall over long shirt and long pants; chemical-
resistant apron (for mixing/loading and cleaning equipment); chemical-
resistant gloves, such as Barrier Laminate, Butyl Rubber, Nitrile,
Neoprene Rubber, Polyvinyl Chloride, or Viton; chemical-resistant
footwear plus socks; and chemical-resistant headgear for overhead
exposure; (5) use of protective measures described in 2, 3, and 4 apply
even when a closed loading system is used; and (6) all applications in
greenhouses and on grapes are prohibited.
New labelling also must contain information on the recall and last
legal date for distribution, sale, and use. The specific language
required on new labelling is as follows:
This product may not be sold, distributed, or used after
November 30, l995. Any product remaining after that date may be
returned to Amvac Chemical Corporation which will arrange for
storage and transportation. You may obtain reimbursement for the
purchase price of any unopened containers in accordance with the
terms of the Recall Plan. To obtain information on storage, return,
and the reimbursement process, call 1-800-205-5330. If you dispose
of this product, you must comply with applicable requirements for
hazardous waste under federal and state law.
The additional use restrictions, recall information, and the
November 30, 1995 deadline for legal distribution, sale, and use are
contained in a Notice that will become a part of labelling for all
mevinphos product sold or distributed after February 27, 1995. All
mevinphos products sold and distributed after February 27, 1995, must
have a one-inch-by-two-inch sticker affixed to each container directing
users to read the Notice containing new labelling requirements. The
Notice must accompany each container sold after February 27, 1995.
Amvac is relabeling at its own cost. Amvac reports that it initiated
the restickering program immediately after reaching agreement with the
Agency and that the program is now completed.
D. Recall
When the Agency reached its agreement with Amvac on June 30, 1994,
Amvac agreed to develop and implement an acceptable recall plan
covering existing stocks of mevinphos in the hands of dealers and
distributors. As part of the agreement between Amvac and EPA reached on
January 13, 1995, Amvac submitted to EPA a proposed recall plan for the
recall of existing stocks of mevinphos product. EPA has accepted
Amvac's proposed plan and has ordered Amvac to begin implementing the
recall plan on December 1, 1995. Amvac's recall plan, which is
exemplary, includes provisions for recall of all mevinphos products
down through the end-user, including opened and partially filled
containers. Additionally, holders of unopened containers of Amvac
product or those products that are supplemental registrations of Amvac
products will be reimbursed for the purchase price. Reimbursement will
go through the distribution chain, where dealers reimburse end-users,
distributors reimburse dealers, and Amvac reimburses distributors.
Reimbursement to all holders provides a strong incentive to return
mevinphos products. Finally, Amvac is assuming all costs associated
with transportation, collection, and storage of mevinphos products that
are being recalled.
The mevinphos registrations subject to the recall and reimbursement
are: 5481-113, 5481-114, 5481-161, 5481-248, 5481-411, 5481-412, 5481-
425, CA80001800, CA81000300, CA86006300, CA86007300, and supplemental
registrations 5481-161-34704, 5481-114-34704, and 5481-412-34704.
Mevinphos products that are not Amvac products or its supplemental
registrations are subject to this recall, but they are not eligible for
reimbursement. For example, products produced by Shell, Dupont, and
Helena may not be eligible for reimbursement, but are subject to the
recall.
E. Modified Reporting Schedule Under Section 6(g)
In the July 1, 1994 Cancellation Order, any person holding canceled
mevinphos product was required to report holdings under section 6(g) of
FIFRA. Producers, exporters, applicants for a registration, applicants
or holders of an experimental use permit, dealers, distributors, and
retailers were to report by January 31, 1995. Commercial applicators
were to report by March 28, 1995. All persons must now report by
December 31, 1995.
II. Agency Rationale for Amendment
On July 1, 1994, when the Agency accepted the voluntary
cancellation and allowed the use of existing stocks through February
28, 1995, there were many reasons to accept the voluntary cancellation
rather than issuing a notice of intent to suspend notice as the Agency
was prepared to do to resolve the risks posed by mevinphos. Had the
Agency issued the suspension and Amvac contested the suspension and
requested an administrative hearing, production and distribution could
have continued throughout the legal proceedings. This outcome could
have resulted in significantly greater use and almost certainly a
larger volume of potential hazardous waste at all levels of the
channels-of-trade (particularly, at the grower level) than would have
occurred had the Agency not agreed to a voluntary cancellation that
allowed existing stocks. Mevinphos would have become a hazardous waste
only when it was intended for disposal and not when it would be
returned under the recall program. Moreover, even if the Agency had
prevailed in an administrative hearing, Amvac could have appealed
[[Page 17359]] the decision and further production and use might have
been allowed during the appeal process. In addition, Amvac had agreed
to conduct a recall of mevinphos products in the hands of dealers and
distributors. If the Agency had to mandate a recall rather than utilize
a voluntary recall, it would have had to do so through a rulemaking
process which can take more time to implement than the voluntary
program agreed to by Amvac. Finally, the Agency anticipated that a
safer alternative, NTN, would be registered by end of 1994 that would
have mitigated the economic impact on growers from the loss of
mevinphos. Weighing the risk and benefit outlined above, the Agency
believed that it was in the public's interest to enter into the
agreement with Amvac that is reflected in the July 1, 1994 Cancellation
Order.
On June 29, 1994, California imposed some additional restrictions
on mevinphos use. The specific restrictions were not known to the
Agency at the time it came to agreement with Amvac. It is now the
Agency's understanding that these restrictions possibly along with
other factors such as low pest pressure lead to significantly less use
of mevinphos during the rest of 1994. Consequently, there was
significantly more mevinphos product in the hands of growers, dealers,
and distributors than originally anticipated by the Agency on July 1,
1994. Because of the quantity of existing stocks in the channels-of-
trade, Amvac indicated there were substantial difficulties and costs
associated with the recall program and it expressed reluctance to
undertake such an extensive recall. If the product was not recalled in
a timely manner pursuant to a voluntary recall, then the potential for
illegal use and risk associated with possession of a potential
hazardous waste would be greater than expected. In addition, the safer
alternative that the Agency expected to be available by the end of 1994
has yet to be registered. Consequently, the economic impact of
enforcing the existing stocks provisions of the July 1, 1994
Cancellation Order would have been greater than originally anticipated.
The potential for greater existing stocks at all levels in the
channels-of-trade for a longer time and greater potential economic
impacts than originally anticipated were considerations for the Agency
extending the last date for distribution, sale, and use of existing
stocks on January 13, 1995.
In addition to extending the use of existing stocks, the Agency
also required that additional protective measures for the use of
mevinphos, a relabelling program, and an expanded recall of mevinphos
products be carried out by Amvac. The protective measures are intended
to reduce exposure during the extended use period. Product in the hands
of dealers and distributors will be relabelled to include the new
protective measures, information on the recall, including an 800
number, and the last legal use date. Amvac has agreed to recall and
reimburse any person possessing any unopened mevinphos product produced
by Amvac or by supplemental registrants, even stocks held by growers,
to accept mevinphos products produced by other companies including
Dupont, Shell, and Helena and to accept opened containers of mevinphos
product. A voluntary recall that includes opened and partially filled
containers and goes down through the end-user is unprecedented. Because
of the recall which includes reimbursement provisions, growers are less
likely to have a potential hazardous waste for an extended period. This
plan reduces potential accidental poisonings and the opportunity for
illegal use in the future. The minimization of the holding of hazardous
waste, accidental poisonings, and illegal use along with the imposition
of additional protective measures for workers were important benefits
contributing to the Agency's decision.
The Agency believes that the amount of mevinphos product used by
November 30, 1995, will likely be no more than the amount originally
anticipated when the Agency entered into the agreement with Amvac on
July 1, 1994. This level of use combined with the requirement for
additional protective measures for those using the product during the
extended use period leads the Agency to believe that exposure to
agricultural workers from the continued use of mevinphos will be no
greater, and likely less, than the Agency anticipated in July of 1994.
An additional benefit associated with the new arrangement is that
it allows the Agency to avoid the uncertainty associated with
litigation over the cancellation and recall.
The Agency has considered the risks and benefits of extending the
distribution, sale, and use of existing stocks of products containing
mevinphos. When the risk of continued use through November 30, 1995, is
weighed against the benefits, both economic and in terms of risk
reduction, the Agency believes that the agreement signed on January 13,
1995, was in the best interest of the public.
Dated: March 27, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 95-8344 Filed 4-4-95; 8:45 am]
BILLING CODE 6560-50-F