[Federal Register Volume 64, Number 112 (Friday, June 11, 1999)]
[Notices]
[Pages 31575-31576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14759]


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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: [email protected].
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
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                                                                 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
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                                                           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