Document ID: EPA-HQ-OPP-2006-0495-0001
Agency: epa
Document Type: Proposed Rule
Title: Food-Contact Surface Sanitizing Solutions; Proposed Revocation of Tolerance Exemptions for Sanitizers with No Food-Contact Uses in Registered Pesticide Products and with Insufficient Data for Reassessment
Posted Date: 2006-06-09T12:54:34Z

[Federal Register: June 9, 2006 (Volume 71, Number 111)]
[Proposed Rules]               
[Page 33416-33419]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn06-9]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0495; FRL-8072-8]

 
Food-Contact Surface Sanitizing Solutions; Proposed Revocation of 
Tolerance Exemptions for Sanitizers with No Food-Contact Uses in 
Registered Pesticide Products and with Insufficient Data for 
Reassessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes under section 408(e)(1) of the Federal 
Food, Drug and Cosmetic Act (FFDCA) to revoke the existing exemption 
from the requirement of a tolerance for the food-contact surface 
sanitizing solution use of certain antimicrobial pesticides because the 
Agency has determined that the tolerance exemption corresponds to the 
food-contact sanitizing use for which there are no longer registered 
pesticide products, and because there are insufficient data to make the 
determination of safety required by FFDCA section 408(b)(2). The 
regulatory actions proposed in this document will contribute toward the 
Agency's tolerance reassessment requirements under the 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.

DATES: Comments must be received on or before July 10, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0495, by one of the following methods:
     Federal eRulemaking Portal: http://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 telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0495. 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 e-
mail. The Federal regulations.gov website 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 e-mail comment directly to EPA without going through 
regulations.gov, your e-mail 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. 
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 
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Bailey, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone 
number: (703) 308-6212; e-mail address: bailey.laura@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).

[[Page 33417]]

     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.A. 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 e-mail. 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.

C. What Can I do if I Wish the Agency to Maintain a Tolerance that the 
Agency Proposes to Revoke?

    This proposed rule provides a comment period of 30 days for any 
person to state an interest in retaining a tolerance proposed for 
revocation. If EPA receives a comment within the 30-day period to that 
effect, EPA will not proceed to revoke the tolerance immediately. 
However, EPA will take steps to ensure the submission of any needed 
supporting data and will issue an order in the Federal Register under 
FFDCA section 408(f) if needed.
    EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. In addition to submitting 
comments in response to this proposal, you may also submit an objection 
to the final rule. 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 is proposing to revoke several food-contact surface sanitizing 
solutions tolerance exemptions in 40 CFR 180.940, because these 
specific tolerance exemptions correspond to uses no longer current or 
registered in the United States under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), and because there are 
insufficient data to make the determination of safety required by 
FFDCA. It is EPA's general practice to propose revocation of those 
tolerances for residues of pesticide active or inert ingredients on 
crops for which there are no active registrations under FIFRA, unless 
any person in comments on the proposal indicates a need for the 
tolerance to cover residues in or on imported commodities or domestic 
commodities legally treated. In addition, the safety finding required 
by FFDCA section 408(b)(2) cannot be made for certain antimicrobial 
ingredient tolerance exemptions because there are insufficient data.
    The specific tolerance exemptions proposed for revocation in 40 CFR 
180.940 are as follows:
    1. The entry for Potassium Permanganate; CAS Reg. No. 7722-64-7; is 
proposed to be removed from the tables in paragraphs (a) and (c).
    2. The entry for Sodium mono- and didodecylphenoxy-
benzenedisulfonate; CAS Reg. No. None; is proposed to be removed from 
the tables in paragraphs (b) and (c).
    3. The entry for Alkyl (C12-C15) monoether of 
mixed (ethylene-propylene) polyalkylene glycol, cloud point of 70-77 
[deg]C in 1% aqueous solution, average molecular weight (in amu), 807; 
CAS Reg. No. None; is proposed to be removed from the table in 
paragraph (c).
    4. The entry for Benzensulfonamide, N-chloro-4-methyl, sodium salt; 
CAS Reg. No. 127-65-1; is proposed to be removed from the table in 
paragraph (c).
    5. The entry for Benzenesulfonic acid, oxybis[dodecyl-; CAS Reg. 
No. 30260-73-2; is proposed to be removed from the table in paragraph 
(c).
    6. The entry for Calcium bromide; CAS Reg. No. 7789-41-5; is 
proposed to be removed from the table in paragraph (c).
    7. The entry for Oxirane, methyl-, polymer with oxirane, ether with 
(1,2-ethanediyldinitrilo)tetrakis [propanol] (4:1); CAS No. 11111-34-5; 
is proposed to be removed from the tables in paragraphs (b) and (c).

B. 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 the 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 the 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.

[[Page 33418]]

    EPA's general practice is to propose revocation of tolerances for 
residues of pesticide active or inert ingredients on crops for which 
FIFRA registrations no longer exist and on which the pesticide may 
therefore no longer be used in the United States. EPA has historically 
been concerned that retention of tolerances or exemptions that are not 
necessary to cover residues in or on legally treated foods may 
encourage misuse of pesticides within the United States. Nonetheless, 
EPA will establish and maintain tolerances or exemptions even when 
corresponding domestic uses are canceled if the tolerances or 
exemptions are necessary to allow importation into the United States of 
food containing such pesticide residues. However, where there are no 
imported commodities that require these import tolerances, the Agency 
believes it is appropriate to revoke tolerances for unregistered 
pesticides in order to prevent potential misuse.
    Furthermore, as a general matter, the Agency believes that 
retention of import tolerances or exemptions not needed to cover any 
imported food may result in unnecessary restriction on trade of 
pesticides and foods. Under section 408 of the FFDCA, a tolerance or 
exemption may only be established or maintained if EPA determines that 
the tolerance is safe based on a number of factors, including an 
assessment of the aggregate exposure to the pesticide and an assessment 
of the cumulative effects of such pesticide and other substances that 
have a common mechanism of toxicity. In doing so, EPA must consider 
potential contributions to such exposure from all tolerances and 
exemptions. If the cumulative risk is such that the tolerances or 
exemptions in aggregate are not safe, then every one of these 
tolerances and/or exemptions is potentially vulnerable to revocation. 
Furthermore, if unneeded tolerances or exemptions are included in the 
aggregate and cumulative risk assessments, the estimated exposure to 
the pesticide would be inflated. Consequently, it may be more difficult 
for others to obtain needed tolerances or exemptions or to register 
needed new uses. To avoid potential trade restrictions, the Agency is 
proposing to revoke tolerances or exemptions for residues on crops for 
which FIFRA registrations no longer exist, unless someone expresses a 
need for such tolerances or exemptions. Through this proposed rule, the 
Agency is inviting individuals who need these import tolerances or 
exemptions to identify themselves and the tolerances or exemptions that 
are needed to cover imported commodities.
    Parties interested in retention of the exemptions in this proposal 
should be aware that additional data are needed to support retention. 
The data needed include: A set of basic toxicity studies, chemistry 
studies and exposure studies. Especially important to reassessment is 
an acceptable repeat-dose study. In the absence of this data, EPA 
cannot make the required reasonable certainty of no harm finding. If 
the needed data is not submitted during the comment period on this 
proposal, these tolerances will be revoked on this ground as well.

C. When do These Actions Become Effective?

    EPA is proposing that revocation of these exemptions become 
effective 90 days following publication of a final rule in the Federal 
Register to ensure that all affected parties receive notice of EPA's 
actions. For this rule, the proposed revocations will affect exemptions 
for active or inert ingredients which have not been used in registered 
products, in some cases, for many years. The Agency believes that 
existing stocks of pesticide products containing active or inert 
ingredients covered by the exemptions proposed for revocation have been 
completely exhausted and that treated commodities have had sufficient 
time for passage through the channels of trade. However, if EPA is 
presented with information that existing stocks would still be 
available and that information is verified, the Agency will consider 
extending the expiration date of the exemption. If you have comments 
regarding existing stocks and whether the effective date allows 
sufficient time for treated commodities to clear the channels of trade, 
please submit comments as described under SUPPLEMENTARY INFORMATION.
    Any commodities treated with the pesticides subject to this 
proposal, and in the channels of trade following the exemption 
revocations, shall be subject to FFDCA section 408(1)(5), as 
established by FQPA. Under this section, any residues of these 
pesticides 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:
    1. 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, 
and
    2. 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 tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates when the 
pesticide was applied to such food.

D. Length of Comment Period

    Pursuant to section 408(e)(2) EPA concludes that there is good 
cause for providing a comment period of 30, as opposed to 60, days. The 
lack of use of the pesticides covered by this proposal in pesticide 
products indicates a lack of interest in these particular pesticides. 
Should any person need additional time to comment on this proposal, a 
request for a comment extension should be filed with EPA well before 
the expiration of the 30-day comment period.

III. Are the Proposed Actions Consistent with International 
Obligations?

    The exemption revocations in this proposal are not discriminatory 
and are designed to ensure that both domestically-produced and imported 
foods meet the food safety standard established by the FFDCA. The same 
food safety standards apply to domestically produced and imported 
foods.
    EPA is working to ensure that the U.S. tolerance and exemption 
reassessment program under FQPA does not disrupt international trade. 
EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. 
tolerances and exemptions and in reassessing them. MRLs are established 
by the Codex Committee on Pesticide Residues, a committee within the 
Codex Alimentarius Commission, an international organization formed to 
promote the coordination of international food standards. It is EPA's 
policy to harmonize U.S. tolerances and exemptions with Codex MRLs to 
the extent possible, provided that the MRLs achieve the level of 
protection required under FFDCA. EPA's effort to harmonize with Codex 
MRLs is summarized in the tolerance and exemption reassessment section 
of individual Reregistration Eligibility Decision documents. EPA has 
developed guidance concerning submissions for tolerances or exemptions 
pertaining to imported foods (65 FR 35069, June 1, 2000) (FRL-6559-3). 
This guidance will be made available to interested persons. Electronic 
copies are available on the internet at http://www.epa.gov/. On the 

Home Page select ``Laws, Regulations, and Dockets,'' then select 
Regulations and Proposed Rules and then look up the entry for this 
document under ``Federal Register--Environmental Documents.'' You can 
also go directly to

[[Page 33419]]

the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific 
tolerance exemptions established under FFDCA section 408. The Office of 
Management and Budget (OMB) has exempted this type of action (e.g., 
tolerance revocation for which extraordinary circumstances do not 
exist) 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, 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 as required by 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 other 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 
or exemptions 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 pesticides listed in this proposed 
rule, the Agency hereby certifies that this proposed action will not 
have a significant negative economic impact on a substantial number of 
small entities. Specifically, as per the 1997 notice, EPA has reviewed 
its available data on imports and foreign pesticide usage and concludes 
that there is a reasonable international supply of food not treated 
with canceled pesticides. Furthermore, for the pesticides named in this 
proposed rule, the Agency knows of no extraordinary circumstances that 
exist as to the present proposal that would change the EPA's previous 
analysis. Any comments about the Agency's determination should be 
submitted to the EPA along with comments on the proposal, and will be 
addressed prior to issuing a final rule. 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 the 
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 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 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, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 2, 2006.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

Sec.  180.940  [Amended]

    2. Section 180.940 is amended as follows:
    i. In the tables to paragraphs (a) and (c) by removing the entry 
for``Potassium Permanganate'' (CAS Reg. No.7722-64-7).
    ii. In the tables to paragraphs (b) and (c) by removing the entries 
for ``Sodium mono-and didodecylphenoxy-benzenedisulfonate'' (CAS Reg. 
No. None); and ``Oxirane, methyl-, polymer with oxirane, ether with 
(1,2-ethanediyldinitrilo)tetrakis [propanol] (4:1)'' (CAS Reg. No. 
11111-34-5).
    iii. In the table to paragraph (c) by removing the entries for 
``Alkyl (C12-C15) monoether of mixed (ethylene-
propylene) polyalkylene glycol, cloud point of 70-77 [deg]C in 1% 
aqueous solution, average molecular weight (in amu), 807;'' (CAS Reg. 
No. None); ``Benzensulfonamide, N-chloro-4-methyl, sodium salt;'' (CAS 
Reg. No. 127-65-1); ``Benzenesulfonic acid, oxybis[dodecyl-'' (CAS Reg. 
No. 30260-73-2); and ``Calcium bromide'' (CAS Reg. No. 7789-41-5)

[FR Doc. E6-8928 Filed 6-8-06; 8:45 am]

BILLING CODE 6560-50-S