Revocation of Tolerance Exemptions for Diethyl Phthalate and Methyl Ethyl Ketone; No Data Being Developed as Required by Test Orders (Data Call-Ins) Under EPA's Endocrine Disruptor Screening Program, 15015-15019 [2012-6210]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Proposed Rules]
[Pages 15015-15019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6210]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0964; FRL-9332-3]


Revocation of Tolerance Exemptions for Diethyl Phthalate and 
Methyl Ethyl Ketone; No Data Being Developed as Required by Test Orders 
(Data Call-Ins) Under EPA's Endocrine Disruptor Screening Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes, under section 408(e)(1) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), to revoke the existing exemptions 
from the requirement of a tolerance (tolerance exemptions) for residues 
of diethyl phthalate and methyl ethyl ketone when used as inert 
ingredients in pesticide products because there are insufficient data 
to make the determination of safety required by FFDCA. No manufacturer 
or importer of these chemicals has committed to conduct testing and

[[Page 15016]]

submit data required by test orders that EPA issued under the Endocrine 
Disruptor Screening Program (EDSP). 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-2011-0964, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     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-
2011-0964. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://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 https://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 https://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.

[[Page 15017]]

C. What can I do if I wish EPA to maintain a tolerance or tolerance 
exemption that the agency proposes to revoke?

    This proposed rule provides a comment period of 60 days for any 
person to state an interest in retaining a tolerance exemption proposed 
for revocation. If EPA receives a comment within the 60-day period to 
that effect, EPA will not proceed to revoke the tolerance exemption 
immediately. However, EPA will take steps to ensure the submission of 
any needed supporting data and will either issue an order under 
sections 3(c)(2)(B) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) and section 408(p)(5) of FFDCA if the commenter 
is a registrant or manufacturer, or will issue an order in the Federal 
Register under FFDCA section 408(f) if the interested party is neither 
a registrant nor manufacturer.
    EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. Comments should be limited 
only to the inert ingredients and tolerance exemptions subject to this 
proposed rule. After considering comments, EPA will issue a final 
regulation determining whether revocation of the tolerance exemptions 
is appropriate and making a final finding on whether these tolerance 
exemptions are ``safe'' within the meaning of section 408(b)(2)(A)(ii).
    In addition to submitting comments in response to this proposal, 
you may also submit an objection at the time of the final rule pursuant 
to section 408(g) (21 U.S.C. 346a(g)). If you anticipate that you may 
wish to file objections to the final rule, you must raise those issues 
in your comments on this proposal. EPA will treat as waived any issues 
raised in objections that could reasonably have been, but were not, 
presented in comments on this proposal. Similarly, if you fail to file 
an objection to the final rule within the time period specified, you 
will have waived the right to raise any issues resolved in the final 
rule. After the specified time, issues resolved in the final rule 
cannot be raised again in any subsequent proceedings.

II. Background

A. What action is the agency taking?

    EPA, under section 408(e)(1) of FFDCA, is proposing to revoke 
tolerance exemptions for residues of diethyl phthalate and methyl ethyl 
ketone in or on raw agricultural commodities and processed foods when 
these chemicals are used as inert ingredients in pesticide products. 
These revocations would be effective 6 months after the final rule is 
published in the Federal Register.
    EPA issued test orders to manufacturers and importers of diethyl 
phthalate and methyl ethyl ketone on January 21, 2010 and January 28, 
2010, respectively. The test 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 consistent with EPA's Endocrine Disruptor Screening Program 
(EDSP), developed in accordance with section 408(p) of FFDCA.
    Section 408(p)(3) of FFDCA requires screening of ``all pesticide 
chemicals,'' including by definition inert ingredients in pesticide 
products, to determine their potential to disrupt the endocrine system. 
21 U.S.C. 345a(p)(3). The statute also ties the availability of these 
or other data ``on whether the pesticide chemical may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen or other endocrine effects'' to the safety finding that EPA 
must make in order to allow a tolerance or exemption to remain. 21 
U.S.C. 346a(b)(2)(D).
    No company which received a test order has committed to submit the 
required data to support the continued use of these chemicals as 
pesticide inert ingredients. Rather, all elected to ``opt out'' of the 
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's outreach to trade associations suggests that registrants of 
pesticide products will also decline to conduct required testing in 
order to continue using these chemicals as inert ingredients. EPA 
therefore is not issuing further test orders at this time. Rather, this 
proposed rule offers a final opportunity for any interested parties to 
commit to develop these data, which FFDCA makes necessary to support a 
tolerance or exemption. A companion notice in this issue of the Federal 
Register provides background on all the inert ingredient test orders 
issued and the responses EPA has received to date.
    In sum, because no one has committed to generate these data, and 
because EPA has no other data on which it could rely to evaluate the 
endocrine disruption potential of these inert ingredients, EPA is 
proposing to revoke the tolerance exemption under 40 CFR 180.930 for 
diethyl phthalate and the tolerance exemption under 40 CFR 180.920 for 
methyl ethyl ketone. In the absence of any data bearing on the 
endocrine disruption potential of these chemicals, EPA cannot find that 
these chemicals continue to meet the required safety standard under 
FFDCA section 408(b)(2). Through this proposed rule, the Agency is 
inviting individuals who need these exemptions to identify themselves 
and the tolerance exemptions that are needed. If during the comment 
period for this proposal no one either submits or commits to generate 
data required by the test orders, EPA will revoke these tolerance 
exemptions. The following list identifies the data EPA required in the 
test orders to screen for potential effects on the thyroid, estrogen 
and androgen systems, and the estimated time to generate the data. If 
screening data were to identify endocrine activity, additional testing 
might be required to establish dose-levels for adverse effects.
Required Data and Estimated Number of 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 loaded a sample test order in the docket for reference. If 
after reading this proposed rule and the test order requirements, you 
intend to submit data, indicate this clearly in your comments.

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

    This proposed rule is issued pursuant to section 408(e)(1)(B) of 
FFDCA (21 U.S.C. 346a(e)(1)(B)). A ``tolerance'' represents the maximum 
level for residues of pesticide chemicals legally allowed in or on raw 
agricultural commodities and processed foods. Section 408 of FFDCA, 21 
U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 
(FQPA), Public Law 104-170, authorizes the establishment of tolerances, 
exemptions from tolerance requirements, modifications in tolerances, 
and revocation of tolerances for residues of pesticide chemicals in or 
on raw agricultural commodities and processed foods. Without a 
tolerance or exemption, food containing pesticide residues is 
considered to be unsafe and

[[Page 15018]]

therefore ``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 
342(a). Such food may not be distributed in interstate commerce (21 
U.S.C. 331(a)).
    Section 408(b)(2)(A)(i) of the FFDCA requires EPA to modify or 
revoke a tolerance if EPA determines that the tolerance is not 
``safe.'' 21 U.S.C. 346a(b)(2)(A)(ii). Section 408(b)(2)(A)(ii) of the 
FFDCA defines ``safe'' to mean that ``there is a reasonable certainty 
that no harm will result from aggregate exposure to the pesticide 
chemical residue, including all anticipated dietary exposures and all 
other exposures for which there is reliable information.'' Among those 
factors that EPA is directed to consider in establishing, modifying, 
leaving in effect, or revoking a tolerance or exemption for a pesticide 
chemical residue is ``such information as the Administrator may require 
on whether the pesticide chemical may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen or 
other endocrine effects; * * *.'' 21 U.S.C. 346a(b)(2)(D)(viii).
    FFDCA section 408(p)(1) requires EPA ``to develop a screening 
program, using appropriate validated test systems and other 
scientifically relevant information to determine whether certain 
substances may have an effect in humans that is similar to an effect 
produced by a naturally occurring estrogen, or such other effects as 
[EPA] may designate.'' 21 U.S.C. 346a(p). FFDCA section 408(p)(3) 
expressly requires that EPA ``shall provide for the testing of all 
pesticide chemicals.'' FFDCA section 201 defines ``pesticide chemical'' 
as ``any substance that is a pesticide within the meaning of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including 
all active and pesticide inert ingredients of such pesticide.'' 21 
U.S.C. 231(q)(1). FFDCA section 408(e)(1)(B) provides that the 
Administrator may issue a regulation ``establishing, modifying, 
suspending under section (l)(3), or revoking an exemption of a 
pesticide chemical residue from the requirement of a tolerance.'' 21 
U.S.C. 346a(e)(1)(B).

C. When would this action become effective?

    EPA is proposing to revoke the tolerance exemptions for diethyl 
phthalate and methyl ethyl ketone effective 6 months after the date the 
final rule publishes in the Federal Register. EPA believes its proposed 
timeline gives registrants sufficient time to take appropriate action. 
Under the EDSP test orders, manufacturers and importers that ``opted 
out'' of testing had to cease all sales and distribution of the 
chemical to the pesticide market for use in formulating pesticide 
products 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 diethyl phthalate and methyl ethyl ketone for use 
in formulating pesticide products 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.
    Any commodities treated with pesticide products containing the 
inert ingredients diethyl phthalate and methyl ethyl ketone and in the 
channels of trade following the tolerance revocations, shall be subject 
to FFDCA section 408(1)(5), as established by FQPA. Under this section, 
any residues of these pesticide chemicals in or on such food shall not 
render the food adulterated so long as it is shown to the satisfaction 
of FDA that:
    i. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA.
    ii. The residue does not exceed the level that was authorized, at 
the time of the application or use, to be present on the food under a 
tolerance or exemption from a tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates when the 
pesticide was applied to such food.

III. Statutory and Executive Order Reviews

    EPA is proposing to revoke the exemptions from the requirement of a 
tolerance for diethyl phthalate and methyl ethyl ketone. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this proposed rule has 
been exempted from review under Executive Order 12866 due to its lack 
of significance, this proposed rule is not subject to Executive Order 
13211, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 
This proposed rule does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 
et seq., or impose any enforceable duty or contain any unfunded mandate 
as described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under section 408(d) of the 
FFDCA, such as the tolerance in this proposed rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. The Agency 
hereby certifies that this proposed action will not have a significant 
negative economic impact on a substantial number of small entities. In 
addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This proposed rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this proposed rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November

[[Page 15019]]

9, 2000). Executive Order 13175 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This proposed rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Endocrine disruptors, Pesticides and pests, 
Reporting and recordkeeping requirements.

    Dated: February 17, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for 40 CFR part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


Sec.  180.920  [Amended]

    2. In Sec.  180.920, the table is amended by removing the entire 
entry for ``Methyl ethyl ketone.''


Sec.  180.930  [Amended]

    3. In Sec.  180.930, the table is amended by removing the entire 
entry for ``Diethylphthalate.''

[FR Doc. 2012-6210 Filed 3-13-12; 8:45 am]
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