[Federal Register Volume 74, Number 240 (Wednesday, December 16, 2009)]
[Rules and Regulations]
[Pages 66574-66580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29897]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0802; FRL-8798-5]
2,6-Diisopropylnaphthalene (2,6-DIPN); Time-Limited Pesticide
Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of 2,6-diisopropylnaphthalene (2,6-DIPN), including its
metabolites and degradates, resulting from post-harvest applications to
potatoes, in or on various commodities. Loveland Products, Incorporated
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA). The tolerances will expire on May 18, 2012.
DATES: This regulation is effective December 16, 2009. Objections and
requests for hearings must be received on or before February 16, 2010,
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-2009-0802. All documents in the
docket are listed in the docket index available at http://www.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 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: Leonard Cole, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-5412; e-mail
address: [email protected].
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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr.
[[Page 66575]]
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0802 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 February 16, 2010.
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-2009-0802, 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 Facility'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 October 21, 2009 (74 FR 54043) (FRL-
8795-7), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 9F7626) by Loveland Products, Inc., 7251 W. 4th Street,
Greeley, CO 80634. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the biochemical
pesticide 2,6-DIPN in or on the following food commodities: Cattle, fat
at 0.8 ppm; cattle, liver at 0.3 ppm; cattle, meat at 0.1 ppm; cattle,
meat byproducts at 0.1 ppm; goat, fat at 0.8 ppm; goat, liver at 0.3
ppm; goat, meat at 0.1 ppm; goat, meat byproducts at 0.1 ppm; hog, fat
at 0.8 ppm; hog, liver at 0.3 ppm; hog, meat at 0.1 ppm; hog, meat
byproducts at 0.1 ppm; horse, fat at 0.8 ppm; horse, liver at 0.3 ppm;
horse, meat at 0.1 ppm; horse, meat byproducts at 0.1 ppm; milk at 0.1
ppm; potato at 2.0 ppm; potato, wet peel at 6.0 ppm; sheep, fat at 0.8
ppm; sheep, liver at 0.3 ppm; sheep, meat at 0.1 ppm; and sheep, meat
byproducts at 0.1 ppm. The proposed tolerance levels were based on
results of studies on the magnitude of 2,6-DIPN in potatoes and
processed potatoes and in livestock edible commodities.
The Agency failed to include a summary of the petition prepared by
Loveland Products, Incorporated, the petitioner, in the docket;
therefore, the Agency placed the summary of the petition in the docket
and reopened the comment period (74 FR 57467; November 6, 2009) (FRL-
8798-4).
One comment was received in response to the October 21, 2009
notice. In general, a private citizen expressed opposition to the
establishment of the numeric tolerances sought by the petitioner.
Comment: The commenter objected to the manufacture, sale, and use
of pesticide products containing 2,6-DIPN in the United States (U.S.)
and asserted that EPA does not possess sufficient data to ascertain
whether 2,6-DIPN products are truly harmful to human health.
Furthermore, the commenter articulated the following opinions: ``It is
also clear that our waters are being deluged with toxic chemicals
courtesy of this Agency approving 100% of all toxic chemicals that come
before it. This Agency is harmfully impacting the people of the United
States and this Agency needs to have fired many of its employees. Bush
put lobbyists in charge of it and those guys just sank down to their
knees for toxic chemical polluters. The situation is bad and
desperately needs correction.''
EPA Response: The toxicity of 2,6-DIPN has been examined thoroughly
by the Agency, and the data show that when 2,6-DIPN is used in
accordance with EPA-approved labeling and good agricultural practices,
there is a reasonable certainty of no harm to human health. Given the
available data, the Agency has established numeric tolerances for 2,6-
DIPN that are safe.
Based upon review of the data supporting the petition, EPA has
increased the petitioned-for tolerance levels for all of the livestock
commodities and added two new tolerances for ``milk, fat'' and
``potatoes, granules/flakes.'' EPA also revised commodity terms, as
necessary, to agree with the Agency's Food and Feed Commodity
Vocabulary. The Agency is also issuing time-limited tolerances at this
time instead of permanent tolerances. The reasons for these changes are
explained in Unit IV.E.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(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. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
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. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for time-limited tolerances for residues of 2,6-
DIPN, including its metabolites and degradates, in or on cattle, fat at
1.0 ppm; cattle, liver at 0.5 ppm; cattle, meat at 0.2 ppm; cattle,
meat byproducts (except liver) at 0.4 ppm; goat, fat at 1.0 ppm; goat,
liver at 0.5 ppm; goat, meat at 0.2 ppm; goat, meat byproducts (except
liver) at 0.4 ppm; hog, fat at 1.0 ppm; hog, liver at 0.5 ppm; hog,
meat at 0.2 ppm; hog, meat byproducts (except liver) at 0.4
[[Page 66576]]
ppm; horse, fat at 1.0 ppm; horse, liver at 0.5 ppm; horse, meat at 0.2
ppm; horse, meat byproducts (except liver) at 0.4 ppm; milk at 0.2 ppm;
milk, fat at 0.5 ppm; potato at 2.0 ppm; potato, wet peel at 6.0 ppm;
potato, granules/flakes at 5.5 ppm; sheep, fat at 1.0 ppm; sheep, liver
at 0.5 ppm; sheep, meat at 0.2 ppm; and sheep, meat byproducts (except
liver) at 0.4 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the time-limited tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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 2,6-DIPN are
discussed in this unit.
Time-limited tolerances for 2,6-DIPN expired on August 1, 2009 (40
CFR 180.590). To evaluate the tolerances requested in the subject
petition, EPA reviewed data unavailable for the previous, time-limited
tolerances. In support of this rule, EPA is providing a discussion of
the toxicity of 2,6-DIPN in light of the newly submitted data.
Evaluation of these data indicates that the toxicity profile of 2,6-
DIPN has not been affected. Based on this finding, the Agency can make
a determination of reasonable certainty of no harm to human health when
residues of 2,6-DIPN, including its metabolites and degradates, within
the tolerance levels established by this final rule are consumed from
the aforementioned commodities.
2,6-DIPN is classified as a biochemical-like active ingredient,
primarily based upon its structural and functional similarities to the
following naturally occurring plant growth regulators: 1-Isopropyl-4,6-
dimethylnaphthalene; 1-methyl-7-isopropylnaphthalene; and 4-isopropyl-
1,6-dimethylnaphthalene. 2,6-DIPN behaves as a sprout inhibitor;
therefore, the Agency considers this mode of action to be non-toxic.
With regard to the toxicity of 2,6-DIPN to humans (including infants
and children), as a result of consumption of potatoes treated with this
active ingredient after harvest, the Agency has, since 2,6-DIPN's
initial registration in 2003, continued to evaluate this active
ingredient for its toxicity and safety to the general population. EPA's
discussion and analysis of the toxicological profile of 2,6-DIPN can be
found in the Federal Register of September 1, 2006 (71 FR 52003) (FRL-
8081-9), and August 8, 2003 (68 FR 47246) (FRL-7321-6).
In support of these current time-limited tolerances, EPA did not
assess any new toxicity data on 2,6-DIPN. EPA has previously conducted
comprehensive evaluations of the potential human health and dietary
toxicity of 2,6-DIPN. As mentioned above (see Unit III.A.2.), EPA
reviewed newly submitted nature of residue data conducted on plants and
livestock (For a detailed discussion of these data, see Unit IV.A.).
These data are required by the Agency to demonstrate the fate and
distribution of the active ingredient and its metabolites in plants and
livestock. These data enable the Agency to better understand if any
metabolites of the active ingredient contribute to the toxicity of the
active ingredient being evaluated and require an increase or decrease
in proposed tolerance levels. Moreover, this information ultimately may
or may not impact the Agency's risk assessment. In the case of the
evaluation of these newly submitted data in support of these time-
limited tolerances and a reevaluation of field trial data on file
(Master Record Identification Number (MRID No.) 451632-02), the Agency
has concluded that the toxicity profile of 2,6-DIPN has not changed,
nor does the original risk assessment for this active ingredient
change. In further support of this assertion, the Agency also
considered potato processing data, which demonstrates that residues of
2,6-DIPN were found not to concentrate in baked potatoes, boiled
potatoes, and french fries (MRID No. 448660-01). In consideration of
all of the previously explained information, EPA concludes that
residues of 2,6-DIPN, including its metabolites and degradates within
the tolerance limits established by this final rule will present no
harm to human health when used in accordance with EPA-approved labeling
and good agricultural practices. Included in this document is a summary
of the toxicity findings to date from both acute and chronic
perspectives (see Unit III.B.).
Additionally, EPA concludes that the analytical methods submitted
to enforce the time-limited tolerance levels established for 2,6-DIPN
residues in potato and potato peels (MRID Nos. 464749-01 and 464749-02,
respectively) are adequate for the purpose of establishing these
tolerances for 2,6-DIPN. But, a revised analytical method for the
analysis of 2,6-DIPN and its metabolites in livestock commodities
remains inadequate. Data reviewed in support of these time-limited
tolerances support validation of the analytical method for the parent
compound in livestock commodities only, while an independent laboratory
validation demonstrating the suitability of the analytical method for
the metabolites and degradates in livestock commodities and a
radiovalidation are still required. The need for these data will be set
as conditions of registration.
B. Toxicological Endpoints
1. Acute toxicity. While EPA's discussion and analysis of acute
toxicity of 2,6-DIPN can be found in the Federal Register of August 8,
2003 (68 FR 47246), in summary, 2,6-DIPN is classified as Toxicity
Category IV for the oral route of exposure (lethal dose
(LD)50 >5,000 milligrams/kilogram (mg/kg)).
2. Short- and intermediate-term toxicity. While EPA's complete
discussion and analysis of short- and intermediate-term toxicity of
2,6-DIPN can be found in the Federal Register of August 8, 2003 (68 FR
47246), a summary is provided here. The subchronic toxicity study
submitted and reviewed suggests the endpoint selection (value/dose at
which an effect was observed) is the 104 milligrams/kilogram/day (mg/
kg/day) no observable adverse effects level (NOAEL) based on reduced
body weight, weight gain, and food consumption. Although the
developmental toxicity study indicated a lower NOAEL (50 mg/kg/day) for
the same toxicity, the maternal lowest observable adverse effects level
(LOAEL) of 150 mg/kg/day is between the subchronic NOAEL of 104-121 mg/
kg/day and the LOAEL of 208-245 mg/kg/day. The NOAEL of 50 mg/kg/day
may have been appropriate for use in characterization of risks for the
subpopulation of women of childbearing age; however, the response at 50
mg/kg/day in the developmental study was minimal and the observations
for toxic effects were more thoroughly documented in the subchronic
study.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for 2,6-DIPN at 1 mg/kg/day. This RfD is based on results from the
subchronic and developmental toxicity studies described in the Federal
Register of September 1, 2006 (71 FR 52003) (FRL-8081-9). In support of
these tolerances, the RfD remains unchanged.
4. Carcinogenicity. No new study results suggest that 2,6-DIPN is
carcinogenic. See EPA's discussion and analysis in the Federal Register
of August 8, 2003 (68 FR 47246).
[[Page 66577]]
C. Exposures and Risks
1. From food and feed uses. The Agency is establishing time-limited
tolerances for the residues of 2,6-DIPN, including its metabolites and
degradates, in or on cattle, fat at 1.0 ppm; cattle, liver at 0.5 ppm;
cattle, meat at 0.2 ppm; cattle, meat byproducts (except liver) at 0.4
ppm; goat, fat at 1.0 ppm; goat, liver at 0.5 ppm; goat, meat at 0.2
ppm; goat, meat byproducts (except liver) at 0.4 ppm; hog, fat at 1.0
ppm; hog liver at 0.5 ppm; hog, meat at 0.2 ppm; hog, meat byproducts
(except liver) at 0.4 ppm; horse, fat at 1.0 ppm; horse, liver at 0.5
ppm; horse, meat at 0.2 ppm; horse, meat byproducts (except liver) at
0.4 ppm; milk at 0.2 ppm; milk, fat at 0.5 ppm; potato at 2.0 ppm;
potato, granules/flakes at 5.5 ppm; potato, wet peel at 6.0 ppm; sheep,
fat at 1.0 ppm; sheep, liver at 0.5 ppm; sheep, meat at 0.2 ppm; and
sheep, meat byproducts (except liver) at 0.4 ppm.
Acute dietary risk assessments are performed for a food-use
pesticide if a toxicological study has indicated the possibility of an
effect of concern occurring as a result of a 1-day or single exposure.
In the case of 2,6-DIPN, the toxicity data base did not indicate an
acute endpoint, but the 100 mg/kg/day NOAEL from the subchronic
toxicity study (rounded from 104 mg/kg/day) was used to evaluate
potential acute dietary exposure as a conservative basis for risk
characterization. Also, if the 50 mg/kg/day NOAEL from the
developmental toxicity study had been used to establish an acute RfD,
this choice would have been inconsistent with the use of the 100 mg/kg/
day NOAEL since it implies that exposure to repeated daily doses at 100
mg/kg/day is potentially less hazardous than a single dose at 50 mg/kg/
day. Given the minimal nature of the responses in the subchronic and
developmental toxicity studies, and the fact that the NOAEL from the
developmental study is only appropriate to the subgroup of females 13-
49 years of age, using the 100 mg/kg/day RfD for the acute and chronic
dietary assessments is more appropriate for assessing risk for other
subgroups and the general population. Therefore, a conservative
interpretation of these endpoints indicated the need for an acute
dietary exposure assessment. The 100 mg/kg/day endpoint was also
interpreted as requiring a chronic dietary exposure assessment.
Acute and chronic dietary exposure assessments for 2,6-DIPN were
conducted using the Dietary Exposure Evaluation Model software
(DEEM\TM\ version 1.30), which incorporates consumption data from the
United States Department of Agriculture's Continuing Surveys of Food
Intakes by Individuals (CSFII, 1994-1996/1998).
For acute exposure assessments, individual 1-day food consumption
data define an exposure distribution, which is expressed as a
percentage of the acute population adjusted dose (aPAD) (for 2,6-DIPN,
aPAD = 0.1 mg/kg/day). For chronic exposure and risk assessment, an
estimate of the residue level in each food or food-form (e.g., orange
or orange juice) on the commodity residue list is multiplied by the
average daily consumption estimate for the food or food-form. The
resulting residue consumption estimate for each food or food-form is
summed with the residue consumption estimate for all other food or
food-forms on the commodity residue list to arrive at the total
estimated exposure. Exposure estimates are expressed as mg/kg body
weight/day and as a percent of the 2,6-DIPN chronic population adjusted
dose (cPAD) (0.1 mg/kg/day). These procedures are performed for each
population subgroup.
2. From drinking water. Because 2,6-DIPN treatment of stored (i.e.,
post-harvest) potato occurs inside (in warehouses, for example), no
concern from exposure through water is expected regarding acute and
chronic dietary risk assessment. For this reason, the dietary risk
assessment did not include drinking water values.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). 2,6-DIPN is not
registered for use on any sites that would result in residential
exposure. Furthermore, because the registered use involves applications
via a closed system, no exposure of consequence is expected to mixers
or loaders.
4. Cumulative effects from substances with a common mechanism of
toxicity. 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 2,6-DIPN and any other
substances. In this case, 2,6-DIPN, as well as the three functionally
and structurally similar substances, all act as plant regulators by a
``mode of action'' that is specific to plants, and therefore, their
common mode of action is unlikely to be relevant to a mechanism of
toxicity in animals or humans. The comparison of 2,6-DIPN with three
naturally occurring, alkyl-substituted naphthalenes is made to
demonstrate biological activity (plant regulation, in this case), which
the Agency has characterized as a non-toxic mode of action with respect
to pesticidal activity. For the purposes of this tolerance action,
therefore, EPA has not assumed that 2,6-DIPN 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 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.
D. Aggregate Risks and Determination of Safety for U.S. Population and
for Infants and Children
1. Acute risk. Acute dietary exposure estimates were based on the
tolerances (i.e., the tolerance levels as established in this final
rule supported by the residue trial results) and worst-case
assumptions.
As reported in the Federal Register of August 8, 2003 (68 FR
47246), EPA established a RfD of 1 mg/kg/day, and an aPAD and cPAD of
0.1 mg/kg/day.
The Acute Dietary Exposure Analysis was based on the following
tolerance levels for the residues of 2,6-DIPN, including its
metabolites and degradates: in or on cattle, fat at 1.0 ppm; cattle,
liver at 0.5 ppm; cattle, meat at 0.2 ppm; cattle, meat byproducts
(except liver) at 0.4 ppm; goat, fat at 1.0 ppm; goat, liver at 0.5
ppm; goat, meat at 0.2 ppm; goat, meat byproducts (except liver) at 0.4
ppm; hog, fat at 1.0 ppm; hog, liver at 0.5 ppm; hog, meat at 0.2 ppm;
hog, meat byproducts (except liver) at 0.4 ppm; horse, fat at 1.0 ppm;
horse, liver at 0.5 ppm; horse, meat at 0.2 ppm; horse, meat byproducts
(except liver) at 0.4 ppm; milk at 0.2 ppm; milk, fat at 0.5 ppm;
potato at 2.0 ppm; potato, granules/flakes at 5.5 ppm; potato, wet peel
at 6.0 ppm; sheep, fat at 1.0 ppm; sheep, liver at 0.5 ppm; sheep, meat
at 0.2 ppm; and sheep, meat byproducts (except liver) at 0.4 ppm;
For the U.S. population, acute dietary exposure was estimated to be
0.011459 mg/kg/day. This value represented
[[Page 66578]]
11.46% of the aPAD. The subpopulation with the highest acute dietary
exposure estimate was children 1-2 years old (0.029362 mg/kg/day,
29.36% of the aPAD). Therefore, the acute dietary exposures to all the
subpopulations in the analysis did not exceed EPA's level of concern
(i.e., they did not exceed 100% of the aPAD).
2. Chronic risk. The chronic dietary risk estimates do not exceed
EPA's level of concern (i.e., they do not exceed 100% of the cPAD). For
the U.S. population, chronic dietary exposure was estimated to be
0.003516 mg/kg/day. This value represented 3.5% of the cPAD. The
subpopulation with the highest chronic dietary exposure estimate was
children 1-2 years old (0.012173 mg/kg/day, 12.2% of the cPAD).
3. Determination of safety. Based on these risk assessments and in
consideration of new residue data, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
2,6-DIPN and its metabolites and degradates within the established
tolerance limits resulting from post-harvest applications, undertaken
in accordance with good agricultural practices and EPA-approved
labeling, to potatoes. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. In
arriving at this conclusion, the Agency has retained the tenfold margin
of safety in order to adequately account for potential pre- and post-
natal toxicity and completeness of the data with respect to exposure
and toxicity to infants and children, pursuant to FFDCA section
408(b)(2)(C).
IV. Other Considerations
A. Metabolism in Plants and Animals
The metabolism study for stored potatoes treated with [\14\C-]-DIPN
is ACCEPTABLE. The results indicate that significant amounts of [\14\C-
]-DIPN were lost during storage. Total Radioactive Residues (TRR) of
2,6-DIPN decreased from 94.1% to 26.3% in whole potatoes from day 0 to
178 days. The percentages of the TRR identified in the whole potato
samples ranged from 70.2% to 95.3% (70.6% to 95.3% for potato peels).
The four metabolites detected, which reached or exceeded 10% of the
TRR in potato peels and whole potatoes, were M29, M22, M19, and M18.
The metabolic pathway of 2,6-DIPN in potatoes demonstrates that these
four metabolites are adequately understood. M29, a monohydroxy
derivative of 2,6-DIPN, appeared first as a significant residue. The
other major metabolites (M22, M19, and M18) were formed by metabolism
of M29, which indicated that M29 was formed continuously throughout the
study. However, based on residue declined data, these metabolites (M29,
M22, M19, and M18) will not be included in tolerance setting because
they showed an insignificant amount at day 0.
The nature of the residue study in a lactating goat indicated that
residues of 2,6-DIPN and its metabolites were distributed in muscle
loin, muscle flank, fat renal, fat omental, fat subcutaneous, liver,
kidney, blood, skim milk, and milk fat. The Agency has considered this
information in evaluating the levels of 2,6-DIPN in livestock
commodities and has incorporated residues of metabolites that exceed
10% of the TRR in its risk assessment.
The qualitative nature of the 2,6-DIPN residues in livestock
commodities is adequately understood, based on a metabolism study. The
four major metabolites (i.e., M14, M19, M27, and M29) were identified
by high performance liquid chromatography/mass spectrometry (HPLC/MS)
from samples of milk, muscles, fat, liver, and kidney.
B. Analytical Enforcement Methodology
Loveland Products, Incorporated has proposed a liquid
chromatographic/ultraviolet (LC/UV) detection analytical method for
enforcement of tolerances for residues of 2,6-DIPN in potatoes and
potato peels. The method (entitled, ``Liquid Chromatographic Analysis
for the Determination of 2,6-Diisopropylnaphthalene (DIPN) in Potatoes
and ``Liquid Chromatographic Analysis for the Determination of 2,6-
Diisopropylnaphthalene (DIPN) in Potato Peels'' (Platte Report Number
CARDC-1298-DIPN)) was used for the determination of residues of 2,6-
DIPN in potatoes and potato peels.
The method includes instructions and chromatograms for analysis of
samples of potatoes and potato peels. Briefly, samples are extracted
with acetonitrile. The extracts are partitioned with hexane. The
acetonitrile part is discarded. The hexane part is roto-evaporated to
dryness. The residues are reconstituted in hexane and purified using a
Florisil column. The residues are roto-evaporated to dryness and
reconstituted in acetonitrile. The samples are filtered through
Acrodisc[reg] LC polyvinylidene difluoride (PVDF) 0.45 micrometer
([mu]m) filters and analyzed by high performance liquid chromatography
(HPLC) with ultraviolet (UV) detection at 254 nanometers (nm) using a
Zorbax ODS column.
The validated limit of quantitation (LOQ) is 0.01 ppm for 2,6-DIPN
in potatoes and 0.02 ppm in potato peels. The reported limits of
detection (LODs) were 0.001 ppm for 2,6-DIPN in potatoes and potato
peels. The method does not include instructions for confirmatory
analysis. Method validation data for the LC/UV method demonstrated
adequate method recoveries of residues of 2,6-DIPN. Potato samples were
fortified with 2,6-DIPN at levels of 0.01 ppm, 0.02 ppm, 0.05 ppm, and
50 ppm. Samples were analyzed at the limit of quantitation of 0.01 ppm.
Overall, recovery ranges (and CVs) from these matrices were 77.9-123.2
(13.9%) for 2,6-DIPN. Potato peel samples were fortified with 2,6-DIPN
at levels of 0.02 ppm, 0.05 ppm, and 0.2 ppm. Samples were analyzed at
the limit of quantitation of 0.02 ppm. Overall, recovery ranges (and
CVs) from these matrices were 83.2-96.1 (5.3%) for 2,6-DIPN.
Acceptable independent laboratory validation is available for this
method using potato and potato peel samples.
As described above, an adequate enforcement methodology (liquid
chromatographic/ultraviolet detection analytical method) is available
to enforce the tolerance expression for potatoes and potato peels only.
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:
[email protected]. As conditions of registration, the Agency is
requesting a revised analytical method for the analysis of the
metabolites of 2,6-DIPN in livestock commodities, an associated
independent laboratory validation, and radiovalidation of this method.
As stated Unit III.A., the Agency is requesting these data since the
study analyzed the parent compound only.
C. International Residue Limits
There are currently no established Codex Alimentarius Commission,
Canadian, or Mexican Maximum Residue Levels (MRLs) for residues of 2,6-
DIPN in/on plant or livestock commodities. Therefore, no compatibility
issues exist with regard to the proposed U.S. tolerances.
D. Rotational Crop Restrictions
The rotational crop restrictions are not applicable for this
petition because the commodity is for stored potatoes.
[[Page 66579]]
E. Revisions to the Requested Tolerances
Based upon review of the data supporting the petition, EPA has
slightly increased the tolerance levels requested in the petition for
all of the livestock commodities and added two new tolerances for
``milk, fat'' and ``potatoes, granules/flakes.'' EPA also revised
commodity terms, as necessary, to agree with the Agency's Food and Feed
Commodity Vocabulary.
In light of review of the submitted nature of the residue data
(lactating goat), the Agency slightly increased all of the livestock
commodity tolerance levels to fully account for metabolites that
exceeded 10% of the TRR. Additionally, EPA has set tolerance levels for
milk, fat and potatoes, granules/flakes because residues of 2,6-DIPN
would normally be expected to be present in these byproducts.
While the petitioner requested permanent tolerances for residues of
2,6 DIPN in or on the food commodities listed in this document, the
Agency has determined that time-limited tolerances with an expiration
date is appropriate in the absence of an analytical method for
metabolites of 2,6-DIPN in livestock.
V. Conclusion
Therefore, time-limited tolerances are established for residues of
2,6-DIPN, including its metabolites and degradates, when applied post-
harvest to potatoes, in or on cattle, fat at 1.0 ppm; cattle, liver at
0.5 ppm; cattle, meat at 0.2 ppm; cattle, meat byproducts (except
liver) at 0.4 ppm; goat, fat at 1.0 ppm; goat, liver at 0.5 ppm; goat,
meat at 0.2 ppm; goat, meat byproducts (except liver) at 0.4 ppm; hog,
fat at 1.0 ppm; hog, liver at 0.5 ppm; hog, meat at 0.2 ppm; hog, meat
byproducts (except liver) at 0.4 ppm; horse, fat at 1.0 ppm; horse,
liver at 0.5 ppm; horse, meat at 0.2 ppm; horse, meat byproducts
(except liver) at 0.4 ppm; milk at 0.2 ppm; milk, fat at 0.5 ppm;
potato at 2.0 ppm; potato, granules/flakes at 5.5 ppm; potato, wet peel
at 6.0 ppm; sheep, fat at 1.0 ppm; sheep, liver at 0.5 ppm; sheep, meat
at 0.2 ppm; and sheep, meat byproducts (except liver) at 0.4 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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, entitled 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).
VII. 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: November 18, 2009.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution Prevention 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 180.590 is amended by revising paragraph (a) to read as
follows:
Sec. 180.590 2,6-Diisopropylnaphthalene (2,6-DIPN); tolerances for
residues.
(a) General. (1) Time-limited tolerances are established for
combined residues of 2,6-DIPN, including its metabolites and
degradates, in or on the commodities in the table below as a result of
the post-harvest application of 2,6-DIPN to potatoes, when 2,6-DIPN is
used in accordance with good agricultural practices. Compliance with
the tolerance levels specified below is to be determined by measuring
only 2,6-DIPN in or on the commodities.
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Potato, granules/flakes....................... 5.5 5/18/12
Potato, wet peel.............................. 6.0 5/18/12
Potato, whole................................. 2.0 5/18/12
------------------------------------------------------------------------
(2) Time-limited tolerances are established for combined residues
of 2,6-DIPN, including its metabolites and degradates, in or on the
commodities in
[[Page 66580]]
the table below as a result of the post-harvest application of 2,6-DIPN
to potatoes, when 2,6-DIPN is used in accordance with good agricultural
practices. Compliance with the tolerance levels specified below is to
be determined by measuring only 2,6-DIPN and the metabolites M14, M19,
M27, and M29 in or on the commodities.
------------------------------------------------------------------------
Revocation/
Commodity Parts per expiration
million date
------------------------------------------------------------------------
Cattle, fat................................... 1.0 5/18/12
Cattle, liver................................. 0.5 5/18/12
Cattle, meat.................................. 0.2 5/18/12
Cattle, meat byproducts....................... 0.4 5/18/12
Goat, fat..................................... 1.0 5/18/12
Goat, liver................................... 0.5 5/18/12
Goat, meat.................................... 0.2 5/18/12
Goat, meat byproducts......................... 0.4 5/18/12
Hog, fat...................................... 1.0 5/18/12
Hog, liver.................................... 0.5 5/18/12
Hog, meat..................................... 0.2 5/18/12
Hog, meat byproducts.......................... 0.4 5/18/12
Horse, fat.................................... 1.0 5/18/12
Horse, liver.................................. 0.5 5/18/12
Horse, meat................................... 0.2 5/18/12
Horse, meat byproducts........................ 0.4 5/18/12
Milk, fat..................................... 0.5 5/18/12
Sheep, fat.................................... 1.0 5/18/12
Sheep, liver.................................. 0.5 5/18/12
Sheep, meat................................... 0.2 5/18/12
Sheep, meat byproducts........................ 0.4 5/18/12
------------------------------------------------------------------------
* * * * *
[FR Doc. E9-29897 Filed 12-15-09; 8:45 am]
BILLING CODE 6560-50-S