Inert Ingredient; Revocation of the Tolerance Exemption for Mono- and Bis-(1H, 45408-45411 [E6-12541]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45408-45411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12541]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0253; FRL-8082-3]


Inert Ingredient; Revocation of the Tolerance Exemption for Mono- 
and Bis-(1H, 1H, 2H, 2H-perfluoroalkyl) Phosphates Where the Alkyl 
Group is Even Numbered and in the C6-C12 Range

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) section 408(e)(1), the existing exemption from the 
requirement of a tolerance for residues of the inert ingredient ``Mono- 
and bis-(1H, 1H, 2H, 2H-perfluoroalkyl) phosphates where the alkyl 
group is even numbered and in the C6-C12 range'' 
under 40 CFR 180.920. The regulatory action contributes toward the 
Agency's tolerance reassessment requirements under FFDCA section 
408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. 
By law, EPA is required by August 2006 to reassess the tolerances that 
were in existence on August 2, 1996. This regulatory action counts as a 
tolerance reassessment toward the August 2006 review deadline.

DATES: This rule is effective February 9, 2008.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0253. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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 Docket Facility is open 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: Karen Angulo, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; e-mail address: angulo.karen@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. 
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).
    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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II. 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0253 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before October 10, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0253, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    In evaluating the tolerance exemption under 40 CFR 180.920 for 
``Mono- and

[[Page 45409]]

bis-(1H, 1H, 2H, 2H-perfluoroalkyl) phosphates where the alkyl group is 
even numbered and in the C6-C12 range,'' EPA 
determined that there were potential risks of concern associated with 
the use of these perfluoroalkyl phosphates. EPA concluded that it was 
unable to determine that the tolerance exemption met the safety 
requirements of FFDCA section 408(c)(2) and proposed the revocation of 
the tolerance exemption in the Federal Register on April 19, 2006 (71 
FR 20048) (FRL-8058-3).
    EPA received comments on the proposed rule from Bayer CropScience 
and Mason Chemical Company. Neither commentor challenged EPA's 
conclusions on the chemical described under the current tolerance 
exemption. Therefore, this final rule revokes the tolerance exemption 
under 40 CFR 180.920 for ``Mono- and bis-(1H, 1H, 2H, 2H-
perfluoroalkyl) phosphates where the alkyl group is even numbered and 
in the C6-C12 range'' 18 months after the 
publication date of this final rule in the Federal Register. EPA's 
response to the comments received is found in the following section.

B. EPA's Responses to Comments

    1. Does the tolerance exemption name the wrong chemical? Mason 
Chemical Company claims that the current tolerance exemption describes 
the wrong chemical, and this error reaches back to the establishment of 
the exemption. They assert that the tolerance exemption actually should 
encompass certain perfluoroalkylphosphinic and phosphonic acid 
compounds instead of the perfluoroalkyl phosphate compound described by 
the tolerance exemption.
    The Agency disagrees. The current inert ingredient tolerance 
exemption under 40 CFR 180.920 for ``Mono- and bis-(1H, 1H, 2H, 2H-
perfluoroalkyl) phosphates where the alkyl group is even numbered and 
in the C6-C12 range'' was established on January 
23, 1985 by a final rule published in the Federal Register (50 FR 
2983). The Agency established this tolerance exemption in response to a 
petition from the American Hoechst Corporation. The petitioner 
requested that the new tolerance exemption limit the use of the 
compound in pesticide products to a defoaming agent used only on 
growing crops at no more than 0.5% of the pesticide formulation. No 
comments were received on the proposed rule. From the time of the 
establishment of the current tolerance exemption in 1985 until now, the 
Agency has received no petitions to modify the current tolerance 
exemption. The Agency concludes that the tolerance exemption is not in 
error as the commentors assert, rather, it describes the chemical 
compound that the original petitioner requested. If commodities are 
sold or distributed containing pesticide residues that are not within 
the tolerance expression, and for which there is no existing tolerance 
or exemption, those commodities may be deemed adulterated for purposes 
of FFDCA.
    2. Reassess the compounds. Mason Chemical Company asserts that EPA 
must reassess the perfluoroalkylphosphinic and phosphonic acid 
compounds because the current tolerance exemption should have included 
these chemicals all along.
    FFDCA as amended by FQPA requires EPA to reassess all inert 
ingredient tolerance exemptions established prior to August 3, 1996. No 
inert ingredient tolerance exemption that includes the 
perfluoroalkylphosphinic and phosphonic acid compounds described by 
Mason Chemical Company was in existence prior to 1996, nor is one in 
existence now. EPA cannot reassess a tolerance exemption that does not 
exist.
    3. Permit use of the compounds. Bayer CropScience requests that the 
Agency allow the use of the perfluoroalkylphosphonic and 
perfluoroalkylphosphinic acid compounds under the current exemption for 
two years. Bayer CropScience requested use of the compounds only for 
two years because ``insufficient data exist for 
perfluoroalkylphosphonic and perfluoroalkylphosphinic acid to allow the 
Agency to make a safety finding according to FFDCA section 408(b)(2).'' 
Bayer CropScience indicated an interest in generating data to support a 
new tolerance exemption for these compounds.
    FFDCA requires a tolerance or tolerance exemption for all chemicals 
used in pesticide products. As of July 5, 2006, EPA has not received a 
petition for a tolerance or tolerance exemption for the 
perfluoroalkylphosphonic and perfluoroalkylphosphinic acid compounds, 
and data sufficient for evaluating these compounds have not been 
submitted to the Agency. As stated in the proposed rule, the Agency has 
identified human health and environmental risks of concern for the 
perfluoroalkyl phosphate chemical described by the current exemption 
under 40 CFR 180.920, and the FFDCA safety finding cannot be made. A 
party or parties may choose to petition the Agency for a tolerance or 
tolerance exemption for the perfluoroalkylphosphonic and 
perfluoroalkylphosphinic acid compounds. The very limited information 
available to the Agency indicates that there may be serious human 
health and environmental risk issues associated with these compounds. 
It is likely that petitioner(s) will have to support their petition 
with a robust dataset.

C. What is the Agency's Authority for Taking this Action?

    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 FQPA of 1996, 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 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)). 
For a food-use pesticide to be sold and distributed, the pesticide must 
not only have appropriate tolerances under FFDCA, but also must be 
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not 
registered in the United States must have tolerances in order for 
commodities treated with those pesticides to be imported into the 
United States.

D. When Do These Actions Become Effective?

    This action becomes effective 18 months after the publication date 
of this final rule in the Federal Register. Any commodities listed in 
the regulatory text of this document that are treated with the 
pesticide chemical subject to this final rule, and that are in the 
channels of trade following the tolerance exemption revocations, shall 
be subject to FFDCA section 408(1)(5), as established by the FQPA. 
Under this section, any residue of the pesticide chemical in or on such 
food shall not render the food adulterated so long as it is shown to 
the satisfaction of the Food and Drug Administration that:
     The residue is present as the result of an application or 
use of the pesticide chemical at a time and in a manner that was lawful 
under FIFRA.
     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 
an exemption from tolerance. Evidence to show that food

[[Page 45410]]

was lawfully treated may include records that verify the dates that the 
pesticide chemical was applied to such food.

E. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006, to reassess the tolerances 
and exemptions from tolerances that were in existence on August 2, 
1996. This document revokes one inert ingredient tolerance exemption 
which is counted as a tolerance reassessment toward the August 2006, 
review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

III. Statutory and Executive Order Reviews

    In this final rule, EPA is revoking a tolerance exemption 
established under section 408(d) of FFDCA. The Office of Management and 
Budget (OMB) has exempted this type of action from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993). Because this rule has been exempted from 
review under Executive Order 12866 due to its lack of significance, 
this final rule is not subject to Executive Order 13211, Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final 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). 
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency previously assessed whether revocations of tolerances 
might significantly impact a substantial number of small entities and 
concluded that, as a general matter, these actions do not impose a 
significant economic impact on a substantial number of small entities. 
This analysis was published on December 17, 1997 (62 FR 66020), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration. Taking into account this analysis, and available 
information concerning the pesticide listed in this rule, the Agency 
hereby certifies that this final action will not have a significant 
economic impact on a substantial number of small entities. In a 
memorandum dated May 25, 2001, EPA determined that eight conditions 
must all be satisfied in order for an import tolerance or tolerance 
exemption revocation to adversely affect a significant number of small 
entity importers, and that there is a negligible joint probability of 
all eight conditions holding simultaneously with respect to any 
particular revocation (this Agency document is available in the docket 
of this final rule). Furthermore, for the pesticide named in this final 
rule, the Agency knows of no extraordinary circumstances that exist as 
to the present revocations that would change the EPA's previous 
analysis (note also that revocation of these tolerances does not affect 
entities selling or distributing commodities containing only pesticide 
residues that are not subject to these tolerances). 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 final 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 final 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 6, 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 final 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 final rule.

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: July 26, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:


[[Page 45411]]


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

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2. In Sec.  180.920, the table is amended by revising the following 
inert ingredient to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Mono- and bis-(1H, 1H, 2H, 2H-    Not more than 0.5%  Surfactant,
 perfluoroalkyl) phosphates        of pesticide        related adjvants
 where the alkyl group is even     formulation.        of surfactants
 numbered and in the C6-C12        Expires February
 range.                            9, 2008.
                                * * * * *
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[FR Doc. E6-12541 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S