[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Rules and Regulations]
[Pages 68692-68697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27809]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-1029; FRL-9368-2]
1,4-Dimethylnaphthalene; Amendment to an Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the existing exemption from the
requirement of a tolerance for residues of the plant growth regulator,
1,4-dimethylnaphthalene (1,4-DMN) by expanding the current exemption to
include all sprouting root and tuber vegetables (EPA Crop Group 01) and
all bulb vegetables (EPA Crop Group 03). On behalf of D-I-1-4, Inc., a
division of 1,4Group, Inc., Technology Sciences Group, Inc. (TSG)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting that EPA amend the existing exemption from the
requirement of a tolerance for 1,4-DMN. This regulation eliminates the
need to establish a maximum permissible level for residues of 1,4-DMN
under the FFDCA.
DATES: This regulation is effective November 16, 2012. Objections and
requests for hearings must be received on or before January 15, 2013,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-1029, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Colin G. Walsh, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0298; email
address: walsh.colin@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
To access the OCSPP test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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. 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-2011-1029 in the subject line on
[[Page 68693]]
the first page of your submission. All objections and requests for a
hearing must be in writing, and must be received by the Hearing Clerk
on or before January 15, 2013. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any CBI) for inclusion in the public docket.
Information not marked confidential pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior notice. Submit the non-CBI copy
of your objection or hearing request, identified by docket ID number
EPA-HQ-OPP-2011-1029, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
1F7920) by TSG, Agent, 712 Fifth Street, Suite A, Davis, CA 95616, on
behalf of D-I-1-4, Inc., a division of 1,4Group, Inc., P.O. Box 860,
Meridian, ID 83680. The petition requested that 40 CFR 180.1142 be
amended by expanding the current exemption to include all sprouting
root, tuber, and bulb crops, thus establishing an exemption from the
requirement of a tolerance for residues of the plant growth regulator,
1,4-DMN, when applied postharvest to all sprouting root, tuber, and
bulb crops in accordance with good agricultural practices. This notice
referenced a summary of the petition prepared by the petitioner TSG, on
behalf of D-I-1-4, Inc., a division of 1,4Group, Inc., which is
available in the docket via http://www.regulations.gov. There were no
comments received in response to the notice of filing.
Section 408(c)(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 exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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 * *
*.'' Additionally, FFDCA section 408(b)(2)(D) requires that 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.''
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 FFDCA section 408(b)(2)(D), 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.
EPA established a tolerance exemption for 1,4-DMN in a Final Rule
published in the Federal Register on February 8, 1995, (60 FR 7456-
7457) (FRL-4932-4), which supported the plant growth regulator
postharvest use on potatoes. The toxicological data submitted to
support the previous tolerance exemption included the following: Acute
(six-pack) toxicity, three mutagenicity studies, and a report of no
hypersensitivity incidents for 1,4-DMN. The mutagenicity studies
included an Ames test, an in vitro test for unscheduled DNA synthesis,
and an in vivo micronucleus assay. All of the studies/information
submitted to support the previous tolerance exemption indicated a lack
of toxicity hazards for mammals, and EPA concluded that there is a
reasonable certainty of no harm to humans, including infants and
children, from the proposed food uses of 1,4-DMN. This amendment
proposes to expand the tolerance exemption when applied postharvest to
all sprouting root, tuber, and bulb crops in accordance with good
agricultural practices. In support of this expansion of the tolerance
exemption, new data have been generated by the petitioner and reviewed
by EPA to address the developmental toxicity (OCSPP Guideline No.
870.3700) data requirement (the study was not submitted for the
previous tolerance exemption). In addition, the petitioner submitted
the following studies that were not required by EPA for this expansion
of the tolerance exemption: In vivo unscheduled DNA synthesis, in vitro
skin absorption, dermal sensitization, one-generation reproductive
toxicity, and a combined chronic toxicity/carcinogenicity (OCSPP
Guideline Nos. 870.5550, 870.7600, 870.2600, 870.3800, and 870.4300,
respectively). The developmental data are required when the use of the
substance under widespread and commonly recognized practices may
reasonably be expected to result in significant exposure to humans,
specifically females of child-bearing age. The rest of the
toxicological profile as stated in the February 8, 1995 issue of the
Federal Register, and referenced herein, has not changed. The data
submitted for the previous tolerance exemption include the acute
toxicity (six-pack) studies, three mutagenicity studies, and a report
of no hypersensitivity incidents for 1,4-DMN. A copy of the February 8,
1995 final rule document (60 FR 7456-7457) and risk assessments cited
herein (Refs. 1 and 2) are located under docket ID number EPA-HQ-OPP-
2011-1029.
As discussed in the Federal Register of February 8, 1995 (60 FR
7456) and risk assessments (Refs. 1 and 2), 1,4-DMN is naturally
occurring and has a nontoxic mode of action. 1,4-DMN is
[[Page 68694]]
found naturally occurring in potatoes (60 FR 7456) and detected in
various other crops including cocoa, coffee, apples, corn, raisins,
tomatoes, apricots, peaches, pear juice, eggplants, green peppers, star
fruit, tea, radishes, oranges, cinnamon, poppies, and red beans (Ref.
1). When conditions are right for sprouting, the potato metabolizes
1,4-DMN to a low enough level so that sprouting can occur. 1,4-DMN is
applied to postharvest sprouting root, tuber, and bulb stored crops at
a level, generally 20 parts per million (ppm) up to 4 applications
during a storage season, to continue to inhibit sprouting.
As stated previously in this Unit, new toxicity data have been
submitted in support of the request by the petitioner to expand the
current tolerance exemption to cover all sprouting root, tuber, and
bulb crops. These data include: (1) A prenatal developmental toxicity
study and (2) additional data not required by EPA, but used to further
support the developmental data and this expansion of the tolerance
exemption. All new data, coupled with the data submitted to support the
previous tolerance exemption (60 FR 7456), confirm the minimal human
health hazard effects, as reported in the original assessment of the
tolerance exemption, associated with dietary exposures of 1,4-DMN and
fully demonstrate the lack of mammalian toxicity. Summaries of the new
toxicological data submitted in support of the expansion of the
tolerance exemption follow.
A. Developmental Toxicity
A new developmental study (Master Record Identification (MRID)
Number 48590905) was performed for 1,4-DMN to support the expansion of
the tolerance exemption. 1,4-DMN was administered by oral gavage to
female rabbits at the dose levels of 0, 25, 80, or 250 milligrams/per/
day (mg/kg/day) (23 rabbits per test group) over gestation days 6
through 28. No treatment-related clinical signs were noted during the
study, and gross necropsy findings were limited to those rabbits that
underwent abortion (Ref. 1). The gross necropsy findings consisted of
changes in the gastrointestinal tract (dilatation of stomach and/or
intestines) and were likely related to the lack of eating prior to and
during the abortion. Mean food consumption was significantly reduced in
the 250 mg/kg/day treated doses shortly after treatment initiation
(over gestation days 6 to 9 and 9 to 12). This reduction in food
consumption was likely treatment-related. Corollary reductions in mean
body weight gain were observed in the 250 mg/kg/day treated group over
gestation days 6 to 9. Alterations in uterus weight were not observed,
nor were changes seen in maternal body weight or body weight gain when
corrected for uterus weight. As such, the changes seen early on in
gestational body weight gain were considered to be solely associated
with maternal toxicity. Therefore, the lowest observed adverse effect
level (LOAEL) for maternal toxicity of 1,4-DMN in rats is 250 mg/kg/day
based on reduced food consumption and reduced body weight gain. The no
observed adverse effect level (NOAEL) for maternal toxicity is 80 mg/
kg/day based on no effects observed at this dose.
For developmental toxicity, no treatment-related differences in
litter viability were detected at any dose level tested. The number of
male, female, and total fetuses (sexes combined) were similar across
the treatment and control groups and average fetal weights were
unaffected. No structural alterations, including gross external,
visceral, skeletal, and cephalic, were evident from the fetal
examinations; as such, 1,4-DMN did not produce any frank malformations
and was not teratogenic. Based on no effects observed for developmental
toxicity at any doses tested, the NOAEL for developmental toxicity is
greater than 250 mg/kg/day (highest dose tested). The LOAEL was not
identified for developmental toxicity, suggesting that the test animals
could have tolerated a higher dose.
Based on the developmental toxicity data submitted for this
expansion to the tolerance exemption, which showed no adverse effects
at the highest dose tested, 250 mg/kg/day, there are sufficient data
and information to confirm that 1,4-DMN is not a developmental
toxicant. Therefore, the consumption of food commodities that have been
treated with 1,4-DMN when used as a pesticide is safe and will not
result in any harm to human health, specifically women of child-bearing
age, from dietary exposure.
B. Additional Toxicity Data
Additional toxicity data for 1,4-DMN that were not required by EPA
to support this expansion of the tolerance exemption were submitted by
the petitioner. The additional data include the following: Unscheduled
DNA synthesis (mutagenicity), in vitro skin absorption, dermal
sensitization, one-generation reproductive toxicity, and a combined
chronic toxicity/carcinogenicity study (OCSPP Guideline Nos. 870.5550,
870.7600, 870.2600, 870.3800, and 870.4300, respectively). Although the
developmental data submitted were sufficient to support this expansion
of the tolerance exemption, EPA has used this data, along with the
required data submitted to support the previous tolerance exemption (60
FR 7456), to confirm that the consumption of food commodities that have
been treated with 1,4-DMN when used as a pesticide is safe and will not
result in any harm to human health from dietary exposure.
1. An in vivo unscheduled DNA synthesis in rats (MRID 48590902)
showed no genotoxicity activity in rat livers when given a single dose
of 1,4-DMN up to the limit dose of 1,000 mg/kg (Ref. 1). These results,
combined with the lack of mutagenic and genotoxic effects observed in
the bacterial reverse mutation (Ames) test, in vitro unscheduled DNA
synthesis in mammalian cells, and in vivo mammalian erythrocyte
micronucleus test submitted to support the previous tolerance exemption
(60 FR 7456), confirm that 1,4-DMN is not a mutagen.
2. An in vitro precutaneous absorption test (MRID 48590903) in
humans showed that the mean total dermal absorption of 1,4-DMN was 2.5%
of the dose applied (Ref. 1). Based on the relatively low absorption of
1,4-DMN and the data submitted to support the previous tolerance
exemption (60 FR 7456), which included an acute dermal toxicity study
that showed a low acute dermal toxicity (median lethal dose
(LD)50 > 2,000 mg/kg), 1,4-DMN is not considered a dermal
toxicant.
3. A dermal sensitization test (MRID 48590904) utilizing the Local
Lymph Node Assay (LLNA) method showed that 1,4-DMN is not a dermal
sensitizer (Ref. 1). The dermal sensitization test utilizing the
Buehler method submitted to support the previous tolerance exemption
(60 FR 7456) also showed that 1,4-DMN is not a dermal sensitizer.
4. A one-generation reproductive toxicity study (MRID 48590906) was
conducted on rats to assess systemic, developmental, and reproductive
toxicity. 1,4-DMN was administered in the diet at the dose
concentrations of 0, 500, 2,000, and 7,500 ppm with each dose group
consisting of 24 males and 24 female rats. The results of the study
showed that the NOAEL for systemic toxicity was 2,000 ppm (equivalent
to 121 to 207 mg/kg/day in parental male and female rats and 184 to 213
mg/kg/day in F1 males and females, respectively) and the
LOAEL was 7,500 ppm based on a single histological change in the kidney
of one, 7,500 ppm treated rat (Ref. 1). The NOAEL and LOAEL for
developmental toxicity were also 2,000 ppm and 7,500 ppm, respectively,
based on delayed vaginal
[[Page 68695]]
patency and preputial separation in the 7,500 ppm group; although, the
delay in development was considered secondary to body weight effects
that were attributed to reduced food consumption. The NOAEL for
reproductive toxicity was 7,500 ppm (equivalent to 441 to 591 mg/kg/day
in parental male and female rats and 776 to 839 mg/kg/day in
F1 males and females, respectively) based on the lack of
change in reproductive endpoints such as mating performance, fertility,
fecundity, litter survival, sperm morphology/vaginal cytology as well
as the lack of histological change in the reproductive organs. The
LOAEL was not identified for reproductive toxicity, suggesting that the
test animals could have tolerated a higher dose.
Based on the reproductive toxicity data submitted for this
expansion to the tolerance exemption, which showed no adverse
reproductive effects at the highest dose tested, 7,500 ppm (equivalent
to 441 to 591 mg/kg/day in parental male and female rats and 776 to 839
mg/kg/day in F1 males and females, respectively), there are
sufficient data and information to confirm that 1,4-DMN is not a
reproductive toxicant, and that consumption of food commodities that
have been treated with this substance when used as a pesticide is safe
and will not result in any harm to human health from dietary exposure.
5. A combined chronic toxicity and carcinogenicity study (MRID
48590907) was conducted on rats (65 rats/sex/group for carcinogenicity
and 20 rats/sex/group for chronic toxicity) to assess the chronic
toxicity and carcinogenicity potential for 1,4-DMN. 1,4-DMN was
administered in the diet of rats 7 days/week for a minimum of 52 weeks
(chronic toxicity phase) or 104 weeks (carcinogenicity phase), at the
dose concentrations of 0, 150, 500, and 3,750 ppm, equivalent to the
dose concentrations of 0, 10, 33, and 250 mg/kg/day. For the chronic
study, decreased food consumption with concurrent decreases in body
weight and body weight gain were noted in the 250 mg/kg/day dose group.
Minimal to moderate histologic test material-related effects in the
kidney (proteinosis, papillary necrosis and karyomegaly) were noted in
male rats at 250 mg/kg/day, while minimal to mild karyomegaly was noted
in the kidney of female rats administered 1,4-DMN at dosages of 33 or
250 mg/kg/day. Based on the results of the chronic toxicity study, the
NOAEL for chronic toxicity was 33 mg/kg/day for males and 10 mg/kg/day
for females. For the carcinogenicity study, no incidences of
carcinogenicity were noted in rats in any of the dose concentrations
after the 97 weeks and 104 weeks of treatment for female and male rats,
respectively.
Based on the results of the carcinogenicity data submitted for this
expansion to the tolerance exemption, which showed that there was no
evidence of carcinogenicity at the highest dose tested, 3,750 ppm
(equivalent to 250 mg/kg/day), there are sufficient data and
information to confirm that 1,4-DMN is not a carcinogen, and that
consumption of food commodities that have been treated with this
substance when used as a pesticide is safe and will not result in any
harm to human health from dietary exposure.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 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).
A. Dietary Exposure
Dietary risks to humans are considered negligible based on the lack
of significant dietary toxicological endpoints for 1,4-DMN, its non-
toxic mode of action, and the fact that it is applied to postharvest
root, tuber, and bulb crops at the relatively low application rate of
20 ppm up to four applications during the storage season. No
significant acute, subchronic, mutagenic, developmental, chronic, or
carcinogenicity dietary toxicity hazards were identified in the studies
submitted to support this expansion of the tolerance exemption or the
previous tolerance exemption (60 FR 7456). The submitted data and
information for this expansion of the tolerance exemption show that any
residues of 1,4-DMN found in or on the sprouting root, tuber, and bulb
crops are far below any toxicological endpoints identified in this
expansion of the tolerance exemption or in the previous tolerance
exemption (60 FR 7456) and confirm 1,4-DMN's lack of dietary toxicity
hazards for mammals (Ref. 2).
1. Food. The petitioner submitted a scientific literature summary
of the natural occurrence of 1,4-DMN in food crops (MRID 48653101) to
support the expansion of the tolerance exemption from postharvest use
on potatoes only, which are found in EPA Crop Group 01, to include all
other sprouting root and tuber vegetables in the same EPA Crop Group 01
and all bulb vegetables (EPA Crop Group 03). Bulb vegetables include
garlic, leek, onion, rakkyo, and shallot. As stated in the summary,
1,4-DMN has been detected in various crops including cocoa, coffee,
apples, corn, raisins, tomatoes, apricots, peaches, pear juice,
eggplants, green peppers, star fruit, tea, radishes (EPA Crop Group
01), oranges, cinnamon, poppies, and red beans (Ref. 1). It is likely
that 1,4-DMN occurs naturally in other crops not listed in the
literature summary, including crops in EPA Crop Group 01 (besides the
already listed potatoes and radishes), and bulb crops in EPA Crop Group
03. The literature summary also indicated that the isomers of
dimethylnaphthalene were shown to be present in various crops; however,
the research indicates that it is extremely difficult to measure the
amounts of the natural occurrence due to the volatility of the
dimethylnaphthalene isomers, and any amounts reported are most likely
an underestimation of the actual amount naturally present in the crop.
As stated in Unit III of this final rule, the previous tolerance
exemption (60 FR 7456) indicated that 1,4-DMN is found naturally
occurring in potatoes. When conditions are right for sprouting, the
potato metabolizes 1,4-DMN to a low enough level so that sprouting can
occur. 1,4-DMN is applied to postharvest potatoes at a level, generally
20 ppm up to four applications during a storage season, to maintain
1,4-DMN at a sufficient concentration in the potato to continue to
inhibit sprouting.
Based on the submitted data and information for this expansion of
the tolerance exemption, any residues of 1,4-DMN found in or on the
sprouting root, tuber, and bulb crops are far below any toxicological
endpoints identified in this expansion of the tolerance exemption or in
the previous tolerance exemption (60 FR 7456). These toxicological
endpoints identified in Unit III of this final rule include: Maternal
toxicity NOAEL of 80 mg/kg/day, developmental toxicity NOAEL greater
than 250 mg/kg/day, reproductive toxicity NOAEL of 7,500 ppm
(equivalent to 441 to 591 mg/kg/day in parental male and female rats
and 776 to 839 mg/kg/day in F1 males and females,
respectively), and chronic toxicity NOAEL of 33 mg/kg/day (500 ppm) for
males and 10 mg/kg/day (150 ppm) for females. The previous tolerance
exemption showed an acute oral toxicity LD50 of 2,730 mg/kg/
day. In addition, under the conditions of the respective studies, there
were no signs of mutagenicity or carcinogenicity for 1,4-DMN. In
summary, the toxicity data
[[Page 68696]]
submitted for 1,4-DMN, the natural occurrence of the substance in the
various crops listed in this section, the nontoxic mode of action, the
volatility of the isomers of dimethylnaphthalene, and the fact that it
is applied to postharvest root, tuber, and bulb crops at the relatively
low application rate of 20 ppm up to four applications during the
storage season, demonstrate a lack of aggregate dietary risk that is
sufficient to support this expansion of the tolerance exemption.
2. Drinking water exposure. No new drinking water exposure is
expected to result from the new food uses of 1,4-DMN. Exposure of
humans to 1,4-DMN in drinking water is highly unlikely since the
products are labeled for postharvest application to sprouting root,
tuber, and bulb crops stored in indoor facilities and are not applied
directly to crops in the field. The data and information demonstrate a
lack of aggregate dietary risk via drinking water and is sufficient to
support this expansion of the tolerance exemption.
B. Other Non-Occupational Exposure
No new non-occupational exposure is expected to result from the new
food uses of 1,4-DMN. No health risks are expected from any non-
occupational exposure to 1,4-DMN based on the data submitted for the
previous tolerance exemption (60 FR 7456) and for this expansion of the
tolerance exemption.
1. Dermal exposure. No new non-occupational dermal exposure is
expected to result from the new food uses of 1,4-DMN resulting from
this expansion of the tolerance exemption. Any new dermal exposure
associated with this expansion of the tolerance exemption is expected
to be occupational in nature.
2. Inhalation exposure. No new non-occupational inhalation exposure
is expected to result from the new food uses of 1,4-DMN resulting from
this expansion of the tolerance exemption. Any new inhalation exposure
associated with this expansion of the tolerance exemption is expected
to be occupational in nature.
V. Cumulative Effects from Substances With a Common Mechanism of
Toxicity
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.''
EPA has not found 1,4-DMN to share a common mechanism of toxicity
with any other substances, and 1,4-DMN does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that 1,4-DMN does not 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) 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 unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments
either directly or through the use of a margin of exposure analysis, or
by using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk.
Relevant data and information submitted for the previous tolerance
exemption (60 FR 7456) and for this expansion of the tolerance
exemption indicate that 1,4-DMN has negligible acute, subchronic,
mutagenic, developmental, chronic, or carcinogenicity toxicity hazards.
Moreover, 1,4-DMN has a nontoxic mode of action and naturally occurs in
various crops as listed in Unit IV.A.1. Therefore, the Agency 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 the residues of 1,4-DMN. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. EPA has arrived at this conclusion because the data and
information available on 1,4-DMN do not demonstrate significant toxic
potential to mammals. Thus, there are no threshold effects of concern
and, as a result, an additional margin of safety is not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes for
the reasons stated above, and because EPA is establishing an exemption
from the requirement of a tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for 1,4-DMN.
VIII. Conclusions
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 1,4-DMN. Therefore, the existing
exemption from the requirement of a tolerance for residues of the plant
growth regulator, 1,4-DMN, when applied postharvest to potatoes is
amended by establishing the exemption from the requirement of a
tolerance for residues of the plant growth regulator, 1,4-DMN, when
applied postharvest to sprouting root, tuber, and bulb crops in
accordance with good agricultural practices.
IX. References
The following references used in this document and the previous
Final Rule published in the Federal Register on February 8, 1995, (60
FR 7456) (FRL-4932-4) are in the OPP docket listed under docket ID EPA-
HQ-OPP-2011-1029 and may be seen by accessing the www.regulations.gov
Web site.
1. U.S. EPA. 2012. Memorandum from Gina M. Burnett to Colin Walsh.
Science Review of Tolerance Petition 1F7920,
[[Page 68697]]
Intended to Expand the Use of 1,4-Dimethylnaphthalene to Include Use on
All Root and Tuber Vegetables (Crop Group 01) and Bulb Vegetables (Crop
Group 03); Label Amendments for 67727-1, -3 and -4 Upon Tolerance
Amendment Approval. U.S. Environmental Protection Agency, Office of
Pesticide Programs. March 16, 2012.
2. U.S. EPA. 2012. Memorandum from Russell S. Jones, Ph.D., to
Colin Walsh. Science Review of Registrant's Response to Deficiencies in
Tolerance Petition 1F7920, Intended to Expand the Use of 1,4-
Dimethylnaphthalene to Include Use on All Root and Tuber Vegetables
(Crop Group 01) and Bulb Vegetables (Crop Group 03); Label Amendments
for 67727-1, -3 and -4 Upon Tolerance Amendment Approval. U.S.
Environmental Protection Agency, Office of Pesticide Programs. June 21,
2012.
X. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) 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 FFDCA section 408(d), such as the tolerance
exemption 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: October 26, 2012.
Keith A. Mathews,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
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. Revise Sec. 180.1142 to read as follows:
Sec. 180.1142 1,4-Dimethylnaphthalene; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established for
the residues of the plant growth regulator, 1,4-dimethylnaphthalene
(1,4-DMN), when applied postharvest to all sprouting root, tuber, and
bulb crops in accordance with good agricultural practices.
[FR Doc. 2012-27809 Filed 11-15-12; 8:45 am]
BILLING CODE 6560-50-P