Document ID: EPA-HQ-OPP-2011-0961-0001
Agency: epa
Document Type: Notice
Title: Results from Inert Ingredient Test Orders Issued under EPAs Endocrine Disruptor Screening Program: New Data Compensation Claims; Potential Disapproval of Inert Uses Pending Public Comment
Posted Date: 2012-03-14T04:00Z

[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Notices]
[Pages 15101-15104]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6164]

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ENVIRONMENTAL PROTECTION AGENCY

 [EPA-HQ-OPP-2011-0961; FRL-9332-2]

Results From Inert Ingredient Test Orders Issued Under EPA's 
Endocrine Disruptor Screening Program: New Data Compensation Claims; 
Potential Disapproval of Inert Uses Pending Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In January and February of 2010, EPA issued test orders (Data 
Call-Ins) to companies that manufacture or import any of the following 
nine chemicals currently used as inert ingredients in pesticide 
products: Acetone, isophorone, di-sec-octyl phthalate, toluene, methyl 
ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl 
phthalate, and dimethyl phthalate. The test orders required recipients 
to submit specific screening data on hormonal effects under EPA's 
Endocrine Disruptor Screening Program (EDSP) and the Federal Food, 
Drug, and Cosmetic Act (FFDCA). In response to the test orders, 
companies have agreed to develop data and have asserted data 
compensation rights for two inert ingredients, acetone and isophorone. 
No companies are developing data for the remaining seven inert 
ingredients. For di-sec-octyl phthalate and toluene, EPA plans to issue 
new test orders as both chemicals meet the selection criteria for 
endocrine testing under the Safe Drinking Water Act (SDWA). EPA has no 
plans to issue further test orders for methyl ethyl ketone, butyl 
benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl 
phthalate, but plans to no longer approve their use as inert 
ingredients in pesticide products. EPA is, however, offering an 
opportunity for interested parties to comment or commit to submitting 
the required data.

DATES: Comments must be received on or before May 14, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0961, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.

[[Page 15102]]

     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0961. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or 
email. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to EPA without going through regulations.gov, your 
email address will be automatically captured and included as part of 
the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Anthony Britten, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8179; fax number: (703) 605-0781; email address: 
Britten.Anthony@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer; or 
if you manufacture or import chemical substances that are used in 
pesticides. Potentially affected entities may include, but are not 
limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
     Chemical manufacturers, importers and processors (NAICS 
code 325).
     Pesticide, fertilizer, and other agricultural chemical 
manufacturing (NAICS code 3253).
     Scientific research and development services (NAICS code 
5417), e.g., persons who conduct testing of chemical substances for 
endocrine effects.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

    EPA began issuing test orders (Data Call-Ins) on January 14, 2010, 
to companies that manufacture or import the following pesticide inert 
ingredients: Acetone, isophorone, di-sec-octyl phthalate, toluene, 
methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl 
phthalate, and dimethyl phthalate. These inert ingredients were 
selected for initial testing based solely on their potential for broad 
public exposure. The test

[[Page 15103]]

orders required recipients to generate data that would allow the Agency 
to screen these chemicals for their potential to interact with the 
estrogen, androgen or thyroid hormonal systems. Extensive background on 
the Agency's endocrine program is available at http://www.epa.gov/endo.
    Based on responses to the test orders, EPA is announcing that 
consortia are developing data for two of these inert ingredients, 
acetone and isophorone, and have asserted data compensation rights. EPA 
has determined that the data protection rights as given in FIFRA 
section 3(c)(1)(F) and FFDCA 408(i) apply for all data submitted in 
support of the EDSP test orders. The other inert ingredients that were 
subject to EDSP test orders are unsupported; no one is developing 
required data. EPA plans to issue new test orders for di-sec-octyl 
phthalate and toluene under the Safe Drinking Water Act (SDWA) because 
the chemicals meet the selection criteria. EPA has no plans to issue 
further test orders for the remaining five inert ingredients (methyl 
ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl 
phthalate, and dimethyl phthalate), but plans to stop approving their 
use in pesticide products as inert ingredients on a timeline described 
later in this notice. EPA is, however, offering an opportunity for 
interested parties to comment or commit to submitting the required 
data.
    The following table lists the inert ingredients subject to EDSP 
test orders by chemical name and Chemical Abstract Service Registry 
Number (CAS Reg. No.), and identifies whether consortia are generating 
data or EPA is issuing new test orders. For information on which 
companies received test orders and their individual responses, see 
http://www.epa.gov/scipoly/oscpendo/pubs/edsp_orders_status.pdf.

    Table of Inert Ingredients Subject to EDSP Test Orders for Tier 1
                             Screening Data
------------------------------------------------------------------------
                                                        Are consortia
Inert ingredients subject to test                    generating data, or
  orders: chemical name and CAS       Date test      will EPA issue new
             Reg. No.               orders issued     test orders under
                                                            SDWA?
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Acetone (67-64-1)................        2/4/2010   Consortium is
                                                     developing data.
Butyl benzyl phthalate (85-68-7).       1/21/2010   No.
Dibutyl phthalate (84-74-2)......       1/21/2010   No.
Diethyl phthalate (84-66-2)......       1/21/2010   No.
Dimethyl phthalate (131-11-3)....       1/21/2010   No.
Di-sec-octyl phthalate (117-81-7)       1/21/2010   New test orders
                                                     planned.
Isophorone (78-59-1).............       1/14/2010   Consortium is
                                                     developing data.
Methyl ethyl ketone (78-93-3)....       1/28/2010   No.
Toluene (108-88-3)...............       2/25/2010   New test orders
                                                     planned.
------------------------------------------------------------------------

    The following list identifies the screening data that EPA required 
in the test orders for potential effects on the thyroid, estrogen and 
androgen systems, and the estimated number of months needed to develop 
the data. If screening data were to identify endocrine activity, 
additional testing might be required to establish dose-levels for 
adverse effects.
Required Tier 1 endocrine screening data and estimated time (months) to 
develop
    Amphibian Metamorphosis (Frog): 15.
    Androgen Receptor Binding (Rat Prostate): 6.
    Aromatase (Human Recombinant): 6.
    Estrogen Receptor Binding: 6.
    Estrogen Receptor Transcriptional Activation (Human Cell Line 
(HeLa-9903)): 6.
    Fish Short-term Reproduction: 12.
    Hershberger (Rat): 9.
    Female Pubertal (Rat): 15.
    Male Pubertal (Rat): 15.
    Steroidogenesis (Human Cell Line--H295R): 6.
    Uterotrophic (Rat): 9.
    EPA has included a sample test order in the docket for reference. 
If after reading this notice and the test order requirements, you 
intend to submit data, indicate this clearly in your comments.
    1. Supported inert ingredients subject to data compensation. 
Company consortia for isophorone (CAS Reg. No. 78-59-1) and acetone 
(CAS Reg. No. 67-64-1) are conducting all eleven Tier 1 endocrine 
assays to screen for potential effects on the thyroid, estrogen and 
androgen systems. These data are due January 21, 2012, for isophorone 
and February 7, 2013, for acetone. Data protection rights as given in 
FIFRA section 3(c)(1)(F) and FFDCA 408(i) apply for all data submitted 
in support of the EDSP test orders. Registrants of products containing 
acetone or isophorone must identify the source of these chemicals on 
their Confidential Statements of Formula (CSF). If a CSF lists a source 
of isophorone or acetone other than a consortia member, EPA intends to 
take appropriate action to ensure that the registrant takes one of the 
following actions: (i) Changes the source to a consortia member; (ii) 
submits proof of an offer to pay the consortia to use their data; (iii) 
submits a commitment to generate the required data; (iv) reformulates; 
or (v) cancels. If necessary, EPA will issue a Data Call-In or a 
product-specific test order to ensure one of these actions is taken. A 
Federal Register notice, ``Endocrine Disruptor Screening Program; 
Policies and Procedures for Initial Screening,'' (April 15, 2009, 74 FR 
17559) (FRL-8399-9), addresses data compensation in more detail. http://www.gpo.gov/fdsys/pkg/FR-2009-04-15/pdf/E9-8706.pdf. The acetone and 
isophorone consortia are managed by and reachable through the American 
Chemistry Council (http://www.americanchemistry.com).
    2. Unsupported inert ingredients subject to new test orders. EPA 
plans to issue new test orders for di-sec-octyl phthalate (CAS Reg. No. 
117-81-7) and toluene (CAS Reg. No. 108-88-3) to require Tier 1 
endocrine screening data because these chemicals also meet the criteria 
under SDWA. EPA plans to wait until the SDWA test orders are issued and 
the responses are received before taking further action on these two 
chemicals. For more information about SDWA test orders, see the Federal 
Register notice, ``Endocrine Disruptor Screening Program; Draft 
Policies and Procedures for Screening Safe Drinking Water Act 
Chemicals'' (November 17, 2010; 75 FR 70558) (FRL-8848-9). http://www.gpo.gov/fdsys/pkg/FR-2010-11-17/pdf/2010-28812.pdf#page=1.
    3. Unsupported inert ingredients subject to disapproval pending 
public comment. Importers and manufacturers of the following chemicals 
declined to develop data in response to test orders: Methyl ethyl 
ketone (CAS Reg. No. 78-93-3); butyl benzyl phthalate (CAS Reg. No. 85-
68-7); dibutyl phthalate (CAS Reg. No. 84-74-2); diethyl phthalate (CAS 
Reg. No. 84-66-2); and dimethyl phthalate (CAS Reg. No. 131-11-3). 
Rather, all elected to ``opt out'' of the

[[Page 15104]]

pesticide market rather than conduct testing, and, under the ``opt-
out'' provision, were required to cease, within 6 months of EPA issuing 
the test order, all sales and distribution of their chemical for use in 
pesticide formulations.
    EPA is not pursuing further test orders at this time for these 
chemicals. None meet the criteria for new test orders under SDWA, and 
dialogue with pesticide trade associations indicates that member 
companies are unlikely to develop data in response to further FFDCA 
test orders. Instead, EPA intends to no longer approve the use of these 
inert ingredients in pesticide registration applications or 
reformulations unless a commenter commits to submitting required data. 
The effective date for this action would be the same effective date 
that EPA has proposed for revoking the tolerance exemptions for methyl 
ethyl ketone and diethyl phthalate; that is, 6 months after the date 
EPA publishes the tolerance revocation final rule. You can find the 
proposed rule in this issue of the Federal Register. For products 
already in the marketplace, EPA intends to take appropriate action to 
ensure registrants either reformulate or cancel those products. If 
necessary, EPA will issue test orders (product-specific Data Call-Ins). 
EPA also is reminding registrants that current regulations require them 
to amend any pesticide product registrations before selling a pesticide 
product with a composition different from that listed on the approved 
Confidential Statement of Formula.
    EPA believes its proposed timeline for no longer approving use of 
these chemicals as inert ingredients gives registrants sufficient time 
to take appropriate action. Under the EDSP test orders, the 
manufacturers and importers that ``opted out'' of testing had to cease 
all sales and distribution to the pesticide market within 6 months of 
EPA issuing the test order. EPA issued the last test orders for these 
chemicals on January 28, 2010, so all sales and distribution of methyl 
ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl 
phthalate, and dimethyl phthalate for use in pesticide formulations 
were to have ceased as of July 28, 2010. EPA has also been performing 
outreach to trade groups to inform them about the potential loss of 
these chemicals as inert ingredients. This Federal Register document 
provides further notice.
    To help companies avoid formulating new product with methyl ethyl 
ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, 
and dimethyl phthalate, EPA plans to remove them from its lists of 
approved inert ingredients. These lists, now consolidated in a web-
searchable database called ``InertFinder'' (http://www.epa.gov/pesticides/inertfinder), are informational only. Adding or removing a 
chemical from these lists is not a regulatory action. InertFinder 
points users to the Code of Federal Regulations as the legal record for 
uses that require a tolerance or tolerance exemption for residues on 
raw agricultural commodities or processed food. For inert ingredient 
uses that do not require a tolerance or exemption (such as nonfood- 
only uses), InertFinder helps formulators find chemicals that EPA has 
previously approved for use as inert ingredients in pesticide products.

B. What is the agency's authority for taking this action?

    The statutory authority for the Endocrine Disruptor Screening 
Program is described in detail in a companion document in this issue of 
the Federal Register which proposes to revoke the tolerance exemptions 
for methyl ethyl ketone and diethyl phthalate, and in a Federal 
Register notice titled, ``Endocrine Disruptor Screening Program; 
Policies and Procedures for Initial Screening,'' (74 FR 17560), http://www.gpo.gov/fdsys/pkg/FR-2009-04-15/pdf/E9-8706.pdf.

List of Subjects

    Environmental protection, Endocrine disruptors, Pesticides and 
pests.

    Dated: February 17, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-6164 Filed 3-13-12; 8:45 am]
BILLING CODE 6560-50-P