Inert Ingredients No Longer Used in Pesticide Products

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'' (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:

List 2--Inert Ingredients No Longer Used In Pesticide Products ------------------------------------------------------------------------ CAS Chemical Name Registry No. ------------------------------------------------------------------------ Chloroethane............................................... 75-00-3 m-Cresol................................................... 108-39-4 p-Cresol................................................... 106-44-5 ------------------------------------------------------------------------

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. ------------------------------------------------------------------------ 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