Document ID: EPA-HQ-OPP-2007-0220-0001
Agency: epa
Document Type: Rule
Title: Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8); Exemption from the Requirement of a Tolerance
Posted Date: 2007-08-15T04:00Z

[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Rules and Regulations]               
[Page 45653-45656]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au07-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0220; FRL-8122-3]

 
Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane 
chloride (CAS Reg. No. 51229-78-8); Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of cis-isomer of 1-(3-chloroallyl)-3,5,7-
triaza-1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8) under 40 
CFR 180.920 (growing crops) when used as an inert ingredient as a 
preservative at 0.14% by weight (wt) or less of pesticide formulations. 
Dow Chemical Company submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA), requesting an exemption from the 
requirement of a tolerance.

DATES: This regulation is effective August 15, 2007. Objections and 
requests for hearings must be received on or before October 15, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0220. To access the

[[Page 45654]]

electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. 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 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 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. 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 http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://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 http://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-2007-0220 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 15, 2007.
    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-2007-0220, 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.

II. Background and Statutory Findings

    In the Federal Register of December 17, 2003 (67 FR 70251) (FRL-
7336-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 3E6656) by Dow Chemical Company, 
Building 1803, Midland, Michigan 48674. The petition requested that 40 
CFR 180.920 be amended by establishing an exemption from the 
requirement of a tolerance for residues of cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride. That notice 
included a summary of the petition prepared by the petitioner. Dow 
Chemical Company requested the use of cis-isomer of 1-(3-chloroallyl)-
3,5,7-triaza-1-azoniaadamantane chloride as a preservative at 0.14% by 
weight or less in pesticide formulations. No comments were received in 
response to the notice of filing.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(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.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....'' These provisions were added to the FFDCA by the 
Food Quality Protection Act (FQPA) of 1996.

III. Risk Characterization and Conclusion.

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity,

[[Page 45655]]

completeness and reliability and the relationship of this information 
to human risk. EPA has also considered available information concerning 
the variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children. The nature of the toxic 
effects caused by cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride are discussed in this unit. EPA has 
sufficient data to assess the hazards of and make a determination on 
aggregate exposure for the chemical.The following provides a brief 
summary of the risk assessment and conclusions for the Agency's review 
of cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane 
chloride. The full decision document for this action is available on 
EPA's Electronic Docket at http://www.regulations.gov/ under docket 

number EPA-HQ-OPP-2007-0220.

A. Human Health

    The Agency reviewed the available information on cis-isomer of 1-
(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride submitted by 
the petitioner as well as additional information available to EPA and 
the data evaluated in the 1995 Dowicil[reg]CTAC RED. The toxicity 
database is sufficient for cis-isomer of 1-(3-chloroallyl)-3,5,7-
triaza-1-azoniaadamantane chloride. In laboratory animal studies 
measuring acute toxicity, cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-
1-azoniaadamantane chloride is slightly toxic in acute inhalation and 
oral toxicity studies. Dermal effects were observed in rabbits at close 
to the limit dose (no observed adverse effect level of 1,000 milligram/
kilogram/day (mg/kg/day)) in a subchronic study, and in a dermal acute 
toxicity study the LD50 was determined to be 923 mg/day. The 
chemical was mutagenic in the in vitro Chinese hamster ovary cell HGPRT 
(Hypoxanthine guanine phophoribosyl transferase)forward mutation assay 
with activation, but was nonmutagenic without activation. It was 
negative in two other mutagenicity studies. Developmental effects were 
observed at or above the level of maternal toxicity (optic 
malformations may be linked to genetic issues rather than exposure to 
the chemical). Chronic toxicity studies are not available, 
nevertheless, sufficient information is available in sub-chronic and 
developmental toxicity studies.

B. Exposure Assessment

    The potential for exposure to residues of cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride is adequately 
characterized based on the chemical's non-persistent nature and ready 
dissipation in the environment and the low use rate. Exposures from 
residues in food and drinking water are expected to be minimal. 
Residential exposure (inhalation and dermal) is also expected to be 
minimal from the use of the chemical in pesticides considering the low 
application rate. Residential exposures from non-pesticides uses are 
not anticipated to be of concern considering the low dermal toxicity 
findings. The Agency concludes dietary and residential exposures of 
concern are not anticipated from the inert ingredient use of cis-isomer 
of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride 
considering its non-persistent nature in the environment, low toxicity, 
and the limitations imposed on its proposed use under 40 CFR 180.920 as 
a preservative at 0.14% by weight (wt) or less of the pesticide 
formulation.

C. Safety Factor for Infants and Children

    Section 408 of the FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. The toxicity database is 
sufficient for cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride and potential exposure is adequately 
characterized based on the low use rate. In terms of hazard, there are 
low concerns and no residual uncertainties regarding prenatal and/or 
postnatal toxicity.

D. Cumulative Exposure

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride and any other substances, and the chemical 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

E. Other Considerations

    1. Analytical methods. Adequate enforcement methodology is 
available to enforce the tolerance exemption expression. The method may 
be requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov. 
Residues are not expected because of the chemical's ready degradation 
in the environment and the low amount that will be permitted in the 
pesticide formulation (limited to 0.14% by weight (wt) or less).
    2. International tolerances. The Agency is not aware of any country 
requiring a tolerance for cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-
1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8) nor have any 
CODEX Maximum Residue Levels (MRLs) been established for any food crops 
at this time.

F. Determination of Safety and Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm to the general population, 
including infants and children, from aggregate exposure to residues of 
cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane 
chloride. Accordingly, EPA finds that exempting cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride from the 
requirement of a tolerance will be safe. EPA is establishing a 
tolerance exemption in 40 CFR 180.920 for cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride when it is used 
as an inert ingredient as a preservative at 0.14% by weight or less in 
pesticide formulations.

[[Page 45656]]

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a petition submitted to the Agency. 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 rule 
has been exempted from review under Executive Order 12866, this 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) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final 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.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not 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).
    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).

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 final rule in the Federal 
Register. This final 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: August 3, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.920, is amended by adding alphabetically the 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
------------------------------------------------------------------------
                              * * * * * * *
 Cis-isomer of 1-(3-chloroallyl)- Maximum of 0.14%    Preservative
 3,5,7-triaza-1-azoniaadamantane   by weight of
 chloride (CAS Reg. No. 51229-78-  formulation
 8)
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E7-16055 Filed 8-14-07; 8:45 am]

BILLING CODE 6560-50-S