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