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Inert Ingredients No Longer Used in Pesticide Products
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: June 11, 1999 (Volume 64, Number 112)]
[Notices]
[Page 31575-31576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jn99-65]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-36193; FRL-6070-5]
Inert Ingredients No Longer Used in Pesticide Products
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA has removed certain chemicals from its list of pesticide
product inert ingredients that are not currently used in pesticide
products. Future use of these chemicals as inert ingredients in
pesticide products will not be permitted unless a petitioner or
registrant satisfies all data requirements as identified by the Agency,
and the Agency is able to make a determination that the use of the
inert ingredient will not pose unreasonable risk to human health or the
environment. This notice is the result of ongoing evaluation of
pesticide inert ingredients.
FOR FURTHER INFORMATION CONTACT: By mail: Vera Soltero, Minor Use,
Inerts, and Emergency Response Branch (MUIERB), Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location, telephone, and
e-mail address: 1921 Jefferson Davis Highway, Room 707C, Arlington, VA,
(703) 308-8373, e-mail: soltero.vera@epa.gov.
SUPPLEMENTARY INFORMATION:
I. How Can I Get Additional Information or Copies of Support
Documents?
1. Electronically. You may obtain electronic copies of this
document and various support documents are available from the EPA Home
page at the Federal Register- Environmental Documents entry for this
document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr).
2. In person. The official record for this notice, as well as the
public version, has been established under docket control number [OPP-
36193], including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of any electronic comments, which does not include any
information claimed as CBI, is available for inspection in Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
II. Background
On April 22, 1987, EPA announced certain policies designed to
reduce the potential for adverse effects from the use of pesticide
products containing toxic inert ingredients (52 FR 13305). In
developing the policy, the Agency reviewed the available data on
chemicals used as inert ingredients, and concluded that some inert
ingredients had potentially significant long-term health and
environmental hazards associated with their use in pesticide products.
The 1987 notice categorized all inert ingredients into four lists,
according to toxicity, as follows: List 1 inert ingredients, described
as ``inerts of toxicological concern,'' were so categorized on the
basis of toxicological or adverse ecological effects which had been
documented in studies subject to peer review. The criteria used for
placement of inert ingredients on List 1 were discussed in detail in
the November 22, 1989 Federal Register notice (54 FR 58314). In
summary, the criteria for inclusion on List 1 included carcinogenicity,
adverse reproductive effects, neurotoxicity or other chronic effects,
developmental toxicity (birth defects), adverse ecological effects or
the potential for bioaccumulation. List 2 inert ingredients,
``potentially toxic inerts/high priority for testing,'' are
structurally similar to chemicals known to be toxic and may have data
suggesting a basis for concern. List 3 inert ingredients, ``inerts of
unknown toxicity,'' do not have data supporting their inclusion on
Lists 1 or 2 (or 4; see below). List 4 inert ingredients, ``minimal
hazard or risk inerts,'' consists of ingredients which are generally
regarded as innocuous. In a subsequent Federal Register notice (54 FR
48314, November 22, 1989), EPA further revised List 4, creating two
subcategories: (1) List 4A, ``inerts generally regarded as safe'' and
(2) List 4B, ``inerts for which EPA has sufficient information to
reasonably conclude that the current use pattern in pesticide products
will not adversely affect public health or the environment''.
The Agency further revised List 4A in 1994 (59 FR 49400, September
28, 1994)(FRL-4872-5), and continues to evaluate the toxicity of inert
ingredients. EPA's designation of inert ingredients according to list
has been published as the ``List of Pesticide Product Inert
Ingredients'' ( May 17, 1995), and is available through the Office of
Pesticide Program's Public Information and Record Integrity Branch at
the address given above.
On June 24, 1998, the Agency delisted 249 inert ingredients from
List 1, List 2 and List 3 (63 FR 34384)(FRL-5792-3). Many of the
delisted List 1 inert ingredients were removed from pesticide products
after EPA issued data call-in notices (DCIs) under section 3(c)(2)(B)
of FIFRA. In response to the issuance of DCIs for List 1 inert
ingredients, most registrants of products containing List 1 inert
ingredients chose to cancel the registration or reformulate the product
to remove the List 1 inert ingredient. According to Agency records,
none of the delisted chemicals had been used in any registered
pesticide product for over two years, and in most cases, had not been
used as inert ingredients in registered pesticide products for over 5
years.
III. Inert Ingredients no Longer Used in Pesticide Products
The Agency has identified certain additional List 2 and List 3
inert ingredients that are no longer used in pesticide products. All of
these chemicals are on the Toxics Release Inventory (TRI) published by
the Agency as a source of information about toxic chemicals that are
being used, manufactured, treated, transported, or released into the
environment. The purpose of the TRI is to provide citizens with
accurate information about potentially hazardous chemicals. Facilities
meeting certain criteria are required to report releases of the
approximately 600 TRI chemicals into the air, water and land, as well
as reporting off-site transfers. They are also required to report on
pollution prevention activities and chemical recycling.
List 2 inert ingredients which are no longer used in pesticide
products are identified as follows (with chemical name and Chemical
Abstracts Service (CAS) Registry Numbers:
[[Page 31576]]
List 2--Inert Ingredients No Longer Used In Pesticide Products
------------------------------------------------------------------------
CAS
Chemical Name Registry
No.
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Chloroethane............................................... 75-00-3
m-Cresol................................................... 108-39-4
p-Cresol................................................... 106-44-5
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The chemicals p-cresol and m-cresol were included in List 2 when it
was originally published as part of the Inerts Strategy in 1987. They
were not delisted in June 24, 1998, but were inadvertently omitted from
the updated List 2.
List 3 inert ingredients which are no longer used in pesticide
products are identified as follows (with chemical name and Chemical
Abstracts Service (CAS) Registry Numbers):
List 3--Inert Ingredients No Longer Used In Pesticide Products
------------------------------------------------------------------------
CAS Registry
Chemical Name No.
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Dicyclopentadiene....................................... 77-73-6
4,4-Isopropylidenediphenol.............................. 80-05-7
Manganese chloride...................................... 7773-01-5
Nitrocellulose.......................................... 9004-70-0
Potassium bromide....................................... 7758-01-2
Safrole................................................. 94-59-7
Zinc carbonate.......................................... 3486-35-9
Zinc dodecylbenzene sulfonate........................... 12068-16-5
Zinc sulfide............................................ 1314-98-3
------------------------------------------------------------------------
According to Agency records, none of the above chemicals is
currently used in pesticide products. If a registrant disputes the
Agency's determination concerning inert ingredients that are no longer
used in pesticide products and still has an active registration for a
pesticide product containing one of the chemicals identified as no
longer used in pesticide products, the registrant should immediately
notify the Agency as detailed in the ``ADDRESSES'' section of this
notice. The registrant should include the inert ingredient name, CAS
Registry No. for the inert ingredient in question and the EPA
Registration Number of the pesticide product containing the inert
ingredient.
IV. Future Use of Chemicals that are No Longer Permitted for Use as
Inert Ingredients
Because of the toxicological and other concerns associated with
List 1 and List 2 ingredients, and the fact that the EPA does not have
adequate data to show that these chemicals do not result in
unreasonable adverse effects on human health and the environment, the
Agency does not expect to approve future applications involving the use
of any of the above List 2 chemicals as ingredients. Data requirements
for any such future requests will be determined by the Agency on a
case-by-case basis. Use of any of the above List 3 chemicals will be
considered by the Agency under the same procedures that apply to new
inert ingredients specified in the April 22, 1987, Inert Ingredient
Policy Statement.
V. Process for Future Removal of Inert Ingredients that are No
Longer Used as Inert Ingredients
As a part of its ongoing inerts strategy, the Agency will continue
to perform future reviews of List 1, List 2, and List 3 inert
ingredients to identify those inert ingredients which are no longer
used. The Agency will issue future Federal Register notices removing
those chemicals from its list of inert ingredients. Any associated
exemptions from the requirement of a tolerance for such chemicals when
used as inert ingredients will also be revoked. The Agency will not
remove any List 4A or 4B inert ingredients from its list of inert
ingredients, since sufficient data have been presented to establish
that the use of these chemicals as inert ingredients will not present a
hazard to public health or the environment.
In an effort to identify inert ingredients which are no longer
used, the Agency may contact registrants of pesticide products or
manufacturers/suppliers of substances which are used as inert
ingredients in pesticide formulations. This action may be necessary to
verify the information currently contained in the Agency's database
relative to product formulation information.
The Agency considers all alternate formulations valid for purposes
of registration unless a registrant provides specific written notice to
the Agency that a particular formulation will no longer be used.
Therefore, the Agency encourages registrants as part of their pesticide
product stewardship program to provide the Agency with written notice
identifying specific formulations that are no longer used as part of
the pesticide product registration and amendment process. This action
will assist the Agency in better identifying those inert ingredients
that are no longer used in pesticide products as well as improving the
overall accuracy of the Agency's product formulation information.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 2, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 99-14759 Filed 6-10-99; 8:45 am]
BILLING CODE 6560-50-F