Document ID: EPA-HQ-OPP-2006-0791-0003
Agency: epa
Document Type: Rule
Title: Inert Ingredient: Exemption From the Requirement of a Tolerance for amylopectin, acid-hydrolyzed, 1-octenylbutanedioate and for amylopectin, hydrogen 1-octadecenylbutanedioate
Posted Date: 2008-09-17T04:00Z

[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Rules and Regulations]               
[Page 53721-53725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se08-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0791; FRL-8374-1]

 
Inert Ingredient: Exemption From the Requirement of a Tolerance 
for amylopectin, acid-hydrolyzed, 1-octenylbutanedioate and for 
amylopectin, hydrogen 1-octadecenylbutanedioate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of amylopectin, acid-hydrolyzed, 1-
octenylbutanedioate (CAS Reg. No. 113894-85-2) and for amylopectin, 
hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) when used 
in antimicrobial formulations (food-contact surface sanitizing 
solutions) under 40 CFR 180.940(a), and when used in accordance with 
good agricultural or manufacturing practice under 40 CFR 180.950. The 
petitioner, Lewis & Harrison, LLC, on behalf of Alco Chemical, 
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. 
This

[[Page 53722]]

regulation eliminates the need to establish a maximum permissible level 
for residues of amylopectin, acid-hydrolyzed, 1-octenylbutanedioate and 
amylopectin, hydrogen 1-octadecenylbutanedioate.

DATES: This regulation is effective September 17, 2008. Objections and 
requests for hearings must be received on or before November 17, 2008, 
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-2006-0791. To access the 
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 website 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 Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.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 FFDCA, as amended by 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-2006-0791 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 November 17, 2008.
    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-2006-0791, 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 
Bldg.), 2777 S. Crystal Dr., 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

    In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-
8104-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 6E7083) by Lewis & Harrison, LLC, on 
behalf of Alco Chemical, 122 C St., NW., Suite 740, Washington, DC 
20001. The petition requested that 40 CFR 180.940(a) and 40 CFR 180.950 
be amended by establishing exemptions from the requirement of a 
tolerance for residues of amylopectin, acid-hydrolyzed, 1-
octenylbutanedioate (CAS Reg. No. 113894-85-2) and amylopectin, 
hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) when used 
in antimicrobial formulations (food-contact surface sanitizing 
solutions) under 40 CFR 180.940(a) and when used in accordance with 
good agricultural or manufacturing practice under 40 CFR 180.950. That 
notice included a summary of the petition prepared by the petitioner. 
There were no comments received in response to the notice of filing. 
For ease of reading in this document amylopectin, acid-hydrolyzed, 1-
octenylbutanedioate (CAS Reg. No. 113894-85-2) and amylopectin, 
hydrogen 1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1) are 
referred to as starch octenylsuccinates.
    Section 408(b)(2)(A)(i) of 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.''

[[Page 53723]]

Section 408(b)(2)(A)(ii) of 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 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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, 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 starch 
octenylsuccinates are discussed in this unit.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of starch octenylsuccinates. The 
Agency's full decision document for this action is available in EPA's 
Electronic Docket at http://www.regulations.gov, under docket number 
EPA-HQ-OPP-2006-0791.
    The toxicity database is sufficient for starch octenylsuccinates. 
In terms of hazard, there are low concerns (practically non-toxic). In 
subchronic and chronic toxicity feeding studies in rats, the results 
show that the compound does not produce compound-related effects at 
dietary concentrations as high as 30% of the diet (equivalent to 15 
gram/kilogram/day (g/kg/day)). While no neurotoxicity studies where 
submitted, neurotoxicity was not observed in the dietary studies at 
concentrations as high as 30% (15 g/day) of the test material. The 
compound does not suggest increased toxicity in young rats and all the 
mutagenicity testing results were negative. The metabolism data showed 
that with oral dosing in dogs, 14C-octenylsuccinate was 
absorbed and eliminated via the urine and feces. The major route of 
elimination was via urine (62-72% of the administered radioactivity). 
No developmental toxicity studies are available in the data base. 
However, in the dietary study conducted in rats fed octenylsuccinate 
modified starch during gestation through post-natal day 90 at doses up 
to 30% (15 g/day), there was no systemic toxicity in female rats and 
their offspring.
    Furthermore, it should be noted that starch octenylsuccinate 
anhydride is currently permitted by the U.S. Food and Drug 
Administration (FDA) as a direct food additive under 21 CFR 172.892.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    For dietary exposures, application of starch octenylsuccinates to 
food (including crops, meats, and fish) as inert ingredients in 
pesticide products is not expected to result in significant human 
exposure to starch octenylsuccinates residues considering their rapid 
biodegradation in soil and water and lack of persistence in the 
environment. For the same reason, significant drinking water exposures 
from the use of these chemicals as inert ingredients in pesticide 
formulations are not anticipated.
    In evaluating the potential for exposure from the use of starch 
octenylsuccinates in residential pesticide products, inhalation 
exposures are not anticipated since the compounds are not likely to 
volatize and are not expected to be absorbed via inhalation due to 
their large particle size. It is expected that dermal exposure is the 
primary route of exposure; however, based on their molecular weight, 
these chemicals are not likely to be absorbed via the dermal route. 
Therefore, there is no concern for dermal exposure.
    Starch octenylsuccinates are widely used in a variety of consumer 
products. An aggregate assessment for starch octenylsuccinates was not 
conducted because the exposures to the chemicals by non-pesticide 
consumer products are not likely to result in significant residues of 
concern. Furthermore, starch octenylsuccinates are used as food 
additives and are normal constituents of the human diet.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of 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 
starch octenylsuccinates and any other substances and, these materials 
do not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that starch octenylsuccinates have 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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.

VI. 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 starch octenylsuccinates and potential exposure is 
adequately characterized given the low toxicity of starch 
octenylsuccinates. In terms of hazard, there are low concerns 
(practically non-toxic) and no residual

[[Page 53724]]

uncertainties regarding prenatal and/or postnatal toxicity. No 
developmental toxicity studies are available in the data base. However, 
in the dietary study conducted in rats fed octenylsuccinate modified 
starch during gestation through post-natal day 90 at doses up to 30% 
(15 g/day), there was no systemic toxicity in female rats and their 
offspring. Based on lack of any systemic toxicity at doses up to 15 g/
day in rats, lack of any apparent developmental effects, and lack of 
any systemic toxicity in weanlings at doses up to 15 g/day, EPA 
concluded that there is no evidence of increased susceptibility to 
infants and children. Given the low toxicity of starch 
octenylsuccinates, a safety factor analysis has not been used to assess 
risk. For similar reasons, including the lack of any concern regarding 
increased sensitivity in the young, the additional 10X FQPA safety 
factor for protection of infants and children is not necessary.

VII. Determination of Safety

    The toxicity database is sufficient for the risk assessment of 
starch octenylsuccinates as specified. In terms of hazard, there are 
low concerns (practically non-toxic). The toxicity database does not 
indicate susceptibility in fetuses, thus there is no concern at this 
time for increased sensitivity to infants and children to starch 
octenylsuccinates when used as ingredients in pesticide formulations.
    Dietary (food and drinking water) exposures of concern are not 
anticipated from the use of starch octenylsuccinate as inert 
ingredients in pesticide and non-pesticide products, considering their 
rapid biodegradation in soil and water and lack of persistence in the 
environment. Inhalation and dermal exposures of concern from the use of 
these chemicals as inert ingredients in pesticide products in 
residential settings are not anticipated because these compounds are 
not likely to volatize and are not expected to be absorbed due to their 
large particle size.
    Considering their low toxicity (practically non-toxic), ready 
biodegradation in soil and water, and lack of persistence in the 
environment, it is unlikely that dietary and residential exposures of 
concern would result from the use of starch octenylsuccinates as 
ingredients in pesticides. An aggregate assessment for starch 
octenylsuccinates was not conducted because the exposures to the 
chemicals by non-pesticide consumer products are not likely to result 
in significant residues of concern.
    Based on this information, EPA concludes that starch 
octenylsuccinates do not pose a risk to the general population, or to 
infants and children, under reasonably foreseeable circumstances. 
Therefore, EPA finds that the exemptions from the requirement of a 
tolerance for amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS 
Reg. No. 113894-85-2) and for amylopectin, hydrogen 1-
octadecenylbutanedioate (CAS Reg. No. 125109-81-1) when used in 
antimicrobial formulations (food-contact surface sanitizing solutions) 
under 40 CFR 180.940(a), and when used in accordance with good 
agricultural or manufacturing practice under 40 CFR 180.950 will be 
safe under section 408(c) of FFDCA and is granting the requested 
tolerance exemptions.

VIII. Other Considerations

A. Analytical Method

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
amylopectin, acid-hydrolyzed, 1-octenylbutanedioate (CAS Reg. No. 
113894-85-2) and for amylopectin, hydrogen 1-octadecenylbutanedioate 
(CAS Reg. No. 125109-81-1) nor have any CODEX Maximum Residue Levels 
(MRLs) been established for any food crops at this time.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 final rule has been 
exempted from review under Executive Order 12866, 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) 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 9, 2000) do not apply to this final rule. In addition, 
this final 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).

X. 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).

[[Page 53725]]

List of Subjects in 40 CFR Part 180

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

    Dated: September 4, 2008.
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 180.940 is amended by alphabetically adding entries to the 
table in paragraph (a) to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                      Pesticide Chemical                              CAS Reg. No.                Limits
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
Amylopectin, acid-hydrolyzed, 1-oxtenylbutanedioate...........              113894-85-2                     none
Amylopectin, hydrogen 1-octadecenylbutanedioate...............              125109-81-1                     none
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
3. Section 180.950 is amended by alphabetically adding entries to the 
table in paragraph (e) to read as follows:

Sec.  180.950  Tolerance exemptions for minimal risk active and inert 
ingredients.

* * * * *
    (e) * * *

------------------------------------------------------------------------
                       Chemical                             CAS No.
------------------------------------------------------------------------
                                * * * * *
Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate..        113894-85-2
Amylopectin, hydrogen 1-octadecenylbutanedioate......        125109-81-1
                                * * * * *
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[FR Doc. E8-21737 Filed 9-16-08; 8:45 am]

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