Methyl Jasmonate; Exemption From the Requirement of a Tolerance, 22789-22794 [2013-08829]
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Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations
The corrections do not involve
changes to the technical standards
related to test methods or monitoring
methods; thus, the requirements of
section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272) do not
apply.
The corrections also do not involve
special consideration of environmental
justice-related issues as required by EO
12898, Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA),
generally provides that before a rule
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promulgating the rule must submit a
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a report containing this rule and other
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List of Subjects in 40 CFR Part 80
Environmental protection,
Administrative practice and procedure,
Agriculture, Air pollution control,
Confidential business information,
Diesel fuel, Energy, Forest and forest
products, Fuel additives, Gasoline,
Imports, Labeling, Motor vehicle
pollution, Penalties, Petroleum,
Reporting and recordkeeping
requirements.
Dated: April 8, 2013.
Gina McCarthy,
Assistant Administrator, Office of Air and
Radiation.
40 CFR part 80 is amended as follows:
PART 80—[AMENDED]
1. The authority citation for part 80
continues to read as follows:
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Authority: 42 U.S.C. 7414, 7521(1) and
7601(a).
§ 80.1454 What are the recordkeeping
requirements under the RFS program?
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[FR Doc. 2013–09068 Filed 4–16–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0134; FRL–9382–6]
Methyl Jasmonate; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of the biochemical
methyl jasmonate in or on all food
commodities when applied pre-harvest.
Becker Underwood, Inc. submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA)
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of methyl jasmonate when
applied pre-harvest.
DATES: This regulation is effective April
17, 2013. Objections and requests for
hearings must be received on or before
June 17, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0134, is
available at https://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
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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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–0031; email address:
pfeifer.chris@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
ADDRESSES:
2. Section 80.1454 (k)(1) introductory
text and (k)(2) introductory text are
revised to read as follows:
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(k)(1) Biogas and electricity in
pathways involving feedstocks other
than grain sorghum. A renewable fuel
producer that generates RINs for biogas
or electricity produced from renewable
biomass (renewable electricity) for fuels
that are used for transportation pursuant
to § 80.1426(f)(10) and (11), or that uses
process heat from biogas to generate
RINs for renewable fuel pursuant to
§ 80.1426(f)(12) shall keep all of the
following additional records:
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(2) Biogas and electricity in pathways
involving grain sorghum as feedstock. A
renewable fuel producer that produces
fuel pursuant to a pathway that uses
grain sorghum as a feedstock shall keep
all of the following additional records,
as appropriate:
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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 https://www.ecfr.
gov/cgi-bin/text-idx?&c=ecfr&tpl=/
ecfrbrowse/Title40/40tab_02.tpl. To
access the OCSPP test guidelines
referenced in this document
electronically, please go to https://
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
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proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2012–0134 in the subject line on
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 June 17, 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 Confidential Business Information
(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–
2012–0134, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be 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 https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background and Statutory Findings
In the Federal Register of May 2, 2012
(77 FR 25957) (FRL–9346–1), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 1F7941) by
Becker Underwood, Inc.; 801 Dayton
Avenue, Ames, IA 50010. The petition
requested that 40 CFR part 180 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of methyl jasmonate. That
document referenced a summary of the
petition prepared by the petitioner
Becker Underwood, Inc., which is
available in the docket, https://
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
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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.
Methyl jasmonate is a biochemical
pesticide active ingredient intended for
use as a systemic acquired resistance
(SAR) inducer on a variety of
agricultural crops. It is applied preharvest as a seed treatment and an infurrow soil treatment. Methyl jasmonate
is a naturally occurring biochemical
hormone found in most plants. It acts by
eliciting plant defense responses in
vulnerable seedlings. Methyl jasmonate
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is the principal compound of a class of
plant hormones known as jasmonates,
which are common to most plants but
particularly concentrated in jasmine and
honeysuckle. As a group, jasmonates are
known to trigger plant responses to a
variety of stresses. Methyl jasmonate, in
particular, is known to bolster plant
defenses against extreme temperature
changes and attacks by insects, fungi
and bacteria. It has a non-toxic mode of
action and is present in most fruits, with
especially high concentrations in apples
and strawberries. As such, it is already
a normal part of the human diet.
With regard to dietary risks related to
pesticidal use, EPA has determined that
the information submitted by the
applicant satisfies the required human
health assessment data requirements
and demonstrates that any potential
residues of methyl jasmonate in or on
foods do not pose a toxicological risk.
First, methyl jasmonate is a ubiquitous
and naturally occurring plant hormone
that is already regarded as a safe and
natural part of the human diet through
such commonly consumed fruits as
apples and strawberries (Memorandum
from Miachel Rexrode, Ph.D., July 19,
2012). Data demonstrate that humans,
including infants, regularly ingest
methyl jasmonate in fruits and plants at
much higher levels than what can be
expected to be ingested from the
pesticidal use of this active ingredient
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Second, the
toxicity data demonstrate that methyl
jasmonate is virtually non-toxic to
humans and other non-target organisms,
through all routes of exposure,
including oral (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012).
Third, methyl jasmonate has been
assessed and approved by Food and
Agriculture Organization/World Health
Organization (FAO/WHO) as a food
additive (JECFA, 2005). Their robust
assessment concluded that methyl
jasmonate was non-toxic as a food
additive, establishing a threshold of 540
microgram/day (ug/day), far above the
maximum anticipated pesticidal
residues of 373 ug ai/kg of seed (JECFA,
2005). Fourth, no toxicological
endpoints have been identified for
methyl jasmonate through any route of
exposure (Memorandum from Miachel
Rexrode, Ph.D., July 19, 2012). Fifth,
methyl jasmonate’s non-toxic mode of
action has been well established
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Further, methyl
jasmonate biodegrades readily within
four weeks (Memorandum from Miachel
Rexrode, Ph.D., July 19, 2012). Because
applications necessarily occur early in
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the growing season due to its mode of
action as a SAR inducer on seeds and
seedlings, no significant pesticidal
residues are anticipated for any
harvested foods. Data show that any
potential exposures are expected to be
well within the range of exposures that
would occur naturally, and are therefore
not of concern (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012).
For all of the foregoing reasons, EPA
finds that methyl jasmonate is virtually
non-toxic and poses no dietary risks to
humans.
Summaries of the toxicological data
submitted in support of this exemption
from the requirement of a tolerance
follow:
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A. Acute Toxicity
Acute toxicity studies, submitted to
support the registration of the products
containing methyl jasmonate, confirm a
virtually non-toxic profile and support
the finding that this active ingredient
poses no significant human health risk
with regard to new food uses. The acute
toxicity data show virtual non-toxicity
for all routes of exposure and suggest
that any dietary risks associated with
this naturally occurring plant hormone
would be inconsequential.
1. The acute oral median lethal doses
(LD50s) in rats were greater than 3,129
milligrams per kilogram (mg/kg) and
confirmed virtual non-toxicity through
the oral route of exposure. There were
no observed toxicological effects on the
test subjects in the acute oral study
submitted (Master Record Identification
Number (MRID No.) 48653901). Methyl
jasmonate is Toxicity Category III for
acute oral toxicity.
2. The acute dermal median lethal
dose (LD50) in rats was greater than
5,050 mg/kg. There were no clinical
signs of toxicity or dermal irritation
throughout the study. The data
substantiate methyl jasmonate’s virtual
non-toxicity through the dermal route of
exposure. (MRID No. 48653902). Methyl
jasmonate is Toxicity Category IV for
acute dermal toxicity.
3. The acute inhalation median lethal
concentration (LC50) was greater than
2.23 milligrams per liter (mg/L) in rats
and showed no consequential inhalation
toxicity (MRID No. 48653903). Methyl
jasmonate is Toxicity Category III for
acute inhalation toxicity.
4. A skin irritation study on rabbits
indicated that methyl jasmonate was not
irritating to the skin (MRID No.
48653905). Methyl jasmonate is Toxicity
Category IV for dermal irritation.
5. Data indicated methyl jasmonate is
not a dermal sensitizer (MRID No.
48653906).
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Data indicate that methyl jasmonate is
not acutely toxic. No toxic endpoints
were established in any of the acute
toxicity studies, and no significant
toxicological effects were observed in
any of the acute toxicity studies.
B. Subchronic Toxicity
Based on its biodegradation
properties, residues of methyl jasmonate
are not expected to result in significant
dietary exposure beyond the levels
expected in background dietary
exposures. Sufficient information (MRID
No. 48653908) on methyl jasmonate was
submitted to satisfy requirements for
subchronic toxicity testing [i.e., 90-day
Oral (OCSPP 870.3100), 90-day
Inhalation (OCSPP 870.3465), and 90day Dermal (OCSPP 870.3250)]. The
information submitted was found
acceptable based on the toxicological
and exposure profile of methyl
jasmonate, summarized below.
Methyl jasmonate is a naturally
occurring compound found in fruits and
other plants and is already consumed in
the human diet. This compound has a
history of safe dietary exposure
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). The proposed use
pattern of this active ingredient results
in exposure levels that are lower than
the current estimated dietary exposure
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Oral exposure of
children and adults to methyl jasmonate
calculated from food consumption
information from the U.S. EPA Exposure
Factors Handbook (U.S. EPA, 2009)
were found to be less than the residues
resulting from a maximum application.
Methyl jasmonate was reviewed by the
Joint FAO/WHO Expert Committee on
Food Additives (JECFA, 2005) and was
identified as a non-toxic flavoring agent.
Methyl jasmonate is not known or
expected to be metabolized differently
following exposure by the dermal route
than the oral route, and a literature
search yielded no reports of subchronic
dermal toxicity effects in rodents or
humans from methyl jasmonate
exposure (Memorandum from Miachel
Rexrode, Ph.D., July 19, 2012).
Prolonged dermal exposure is not
expected because the product is not
purposely applied to the skin and
because handlers and applicators are
required to wear appropriate personal
protective equipment (PPE). There is a
long history of safe inhalation exposure
to methyl jasmonate because it is a
naturally occurring volatile component
of common plants. The potential
inhalation exposure concentration from
use of products containing methyl
jasmonate will be less than or equal to
naturally occurring concentrations from
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22791
crops and other plants (Memorandum
from Miachel Rexrode, Ph.D., July 19,
2012). Significant exposure to humans
is not anticipated based on low
application rates and, more importantly,
rapid degradation in the environment
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012).
C. Developmental Toxicity and
Mutagenicity
The applicant provided adequate
information (MRID No. 48653908) to
fulfill the developmental toxicity and
mutagenicity data requirements [i.e.,
Prenatal Development (OCSPP
870.3700), Bacterial Reverse Mutation
Test (OCSPP 870.5100), In vitro
Mammalian Chromosome Aberration
(OCSPP 870.5375), and In vitro
Mammalian Cell Assay (OCSPP
870.5300)]. The submitted information
is sufficient to confirm that there are no
expected dietary or non-occupational
risks of mutagenicity with regard to new
food uses. The information submitted
was found acceptable based on the
toxicological and exposure profile of
methyl jasmonate, summarized below.
There is a long history of safe dietary
exposure to methyl jasmonate because it
naturally occurs in apples, strawberries
and mangos (Lalel et al., 2003), fruits
that are part of the normal diet. The
potential oral exposure to methyl
jasmonate from the proposed uses of
methyl jasmonate is well below the
average exposure for women of childbearing age from the consumption of
fruits that naturally contain methyl
jasmonate, and also well below the Joint
FAO/WHO Expert Committee on Food
Additives (JECFA) human exposure
threshold (Munro, 1999). Methyl
jasmonate has been evaluated for safety
by the FAO and determined to be
metabolized to innocuous end products
that are eliminated in the urine (Lalel et
al., 2003). A literature search yields no
reports of genotoxicity in laboratory
studies on methyl jasmonate
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Significant
exposure to child-bearing women is not
anticipated based on low application
rates, appropriate PPE requirements on
the label, and rapid degradation in the
environment.
D. Effects on Endocrine Systems
There is no available evidence
demonstrating that methyl jasmonate is
an endocrine disruptor in humans. As a
result, the Agency is not requiring
information on the endocrine effects of
methyl jasmonate at this time. However,
the Endocrine Disruption Screening
Program (EDSP) has established a
protocol which guides the Agency in
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selecting suspect ingredients for review,
and the Agency reserves the right to
require new information should the
program require it. Presently, based on
the lack of exposure and the virtually
non-toxic profile of methyl jasmonate,
no adverse effects to the endocrine are
known or expected. Overall, the lack of
evidence of endocrine disruption is
consistent with methyl jasmonate’s
negligible toxicity profile and supports
this exemption from the requirement of
a tolerance.
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IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in or on food and all other nonoccupational 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
Because of methyl jasmonate’s ability
to biodegrade quickly relative to the
time it is to be applied on seeds or to
soil near planting, the Agency does not
anticipate significant residues being
present in or on food at the time of
consumption. Moreover, any residues
that are present in or on food at the time
of consumption as a result of pesticide
use are likely to be indistinguishable
from naturally occurring methyl
jasmonate due to its ubiquitous
presence in plants. Finally, the Agency
believes that it is unlikely that any
exposure to the residues of methyl
jasmonate will result in dietary risks
because of the non-toxic mode of action
as a SAR inducer and the pesticide’s
virtually non-toxic profile.
1. Food. Exposure to residues of
methyl jasmonate on foods is expected
to be negligible. The application of
methyl jasmonate is made directly to
seeds through a contained seedtreatment or through in-furrow or soil
drench applications. This application
scenario prevents drift and minimizes
exposure to humans. Although
applications will result in minimal
exposure, the Agency has calculated
that exposures associated with
maximum application rates are still
lower than the current estimated dietary
exposure for regular fruit consumption
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Further, the data
indicate that methyl jasmonate is
readily biodegradable within four weeks
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Because
applications necessarily occur early in
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the growing season due to its mode of
action as a SAR inducer on seeds and
seedlings, no significant pesticidal
residues are anticipated for any
harvested foods. However, in the event
of exposure to residues of methyl
jasmonate, no dietary risks are
anticipated. As described in Unit III,
acute, subchronic, mutagenic and
developmental studies and information
support its nontoxic profile.
Furthermore, it is already present in the
human fruit and vegetable diet without
any known detrimental effects. There is
no information in the public literature
suggesting any health issues to either
animals or plants relative to this
compound. It is estimated that humans
consume at least .348 ug/day on
average, based on EPA models for apple
and strawberry consumption
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Finally, the
dietary use of methyl jasmonate as a
food additive was approved by the Joint
FAO/WHO Expert Committee on Food
Additives, which found methyl
jasmonate to be non-toxic at a
conservative threshold of 540 ug/day.
(JECFA, 2005). By comparison,
maximum residues have been calculated
to be 373 ug ai/kg of seed
(Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). In sum, minimal
dietary exposure is expected; however,
any potential dietary exposures would
not be expected to pose any
consequential risk, mainly due to
methyl jasmonate’s virtually non-toxic
profile.
2. Drinking water exposure. Residues
of methyl jasmonate are not expected to
be present in drinking water because
applications of methyl jasmonate are
made directly to seeds, seedlings and
soil. Methyl jasmonate residues are not
expected to percolate through the soil
because residues are not expected to
persist beyond the time it would
typically take for any residues to
percolate into the groundwater.
Nonetheless, given methyl jasmonate’s
virtually non-toxic profile as described
in Unit III, risks from aquatic exposure
would be negligible.
B. Other Non-Occupational Exposure
Non-occupational exposure is not
expected because methyl jasmonate is
intended for commercial use. The active
ingredient is applied directly to seeds or
agricultural furrows, and it degrades
rapidly. Further, health risks are not
expected from any pesticidal exposure
to this active ingredient, no matter the
circumstances. A February, 2013
Agency risk assessment of methyl
jasmonate establishes that even a worst
case exposure scenario involving
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prolonged and regular occupational
exposures, which are not associated
with this active ingredient, would pose
negligible risks (Methyl Jasmonate
BRAD, February 28, 2013). Methyl
jasmonate is characterized by its
biodegradability; low toxicity profile;
nontoxic, SAR-inducing mode of action;
and demonstrable lack of dietary effects.
1. Dermal exposure. Nonoccupational dermal exposures to
methyl jasmonate are expected to be
negligible because of its directed
agricultural use. Even in the event of
dermal exposure to residues, the
nontoxic profile of methyl jasmonate (as
described in Unit III) is not expected to
result in any risks through this route of
exposure.
2. Inhalation exposure. Nonoccupational inhalation exposures are
not expected to result from the
agricultural uses of methyl jasmonate.
Any inhalation exposure associated
with this new agricultural and
commercial use pattern 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 methyl jasmonate
to share a common mechanism of
toxicity with any other substances, and
methyl jasmonate does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that methyl jasmonate 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
https://www.epa.gov/pesticides/
cumulative.
VI. Determination of Safety for U.S.
Population, Infants and Children
Health risks to humans, including
infants and children, are considered
negligible with regard to the pesticidal
use of methyl jasmonate. As illustrated
in Unit III, acute toxicity studies
indicate that methyl jasmonate is
virtually non-toxic. It is ubiquitous in
nature and present in fruits and
vegetables. There is no history of any
toxicological incident involving its
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Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations
consumption, and its use in food
supplements is already allowed by the
United States Food and Drug
Administration. For all of these reasons,
the Agency has determined that this
food use of methyl jasmonate poses no
foreseeable risks to human health or the
environment. Thus, there is a reasonable
certainty of no harm to the general U.S.
population, including infants and
children, from exposure to this active
ingredient.
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A. U.S. Population
The Agency has determined that there
is a reasonable certainty that no harm
will result from aggregate exposure to
residues of methyl jasmonate to the U.S.
population. This includes all
anticipated dietary exposures and other
non-occupational exposures for which
there is reliable information. The
Agency arrived at this conclusion based
on the low levels of mammalian dietary
toxicity associated with methyl
jasmonate, the natural ubiquity of
methyl jasmonate in food, and
information suggesting that the
pesticidal use of methyl jasmonate will
not result in significant exposure. For
these reasons, the Agency has
determined that methyl jasmonate
residues in and on all food commodities
will be safe, and that there is a
reasonable certainty that no harm will
result from aggregate exposure to
residues of methyl jasmonate.
B. 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
exposure (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 the EPA determines that
a different margin of exposure (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.
Based on all the information
evaluated for methyl jasmonate, the
Agency concludes that there are no
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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 since the
Agency 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 methyl jasmonate.
VIII. Conclusions
Therefore, an exemption is
established for residues of methyl
jasmonate in or on all food commodities
when applied preharvest.
IX. References
Complete citations to the references
used in this document are set forth in
Appendix C to the document captioned
‘‘Methyl Jasmonate BRAD (Biopesticides
Registration Action Document) Methyl
Jasmonate PC Code: 028100’’ (document
ID number EPA–HQ–OPP–2012–0134–
0006), found in the OPP docket listed
under docket ID number EPA–HQ–
OPP–2012–0134, and may be seen by
accessing the www.regulations.gov Web
site.
X. Statutory and Executive Order
Reviews
This final rule establishes 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,
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
22793
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 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).
E:\FR\FM\17APR1.SGM
17APR1
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Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations
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: March 22, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1320 is added to
subpart D to read as follows:
■
§ 180.1320 Methyl jasmonate; exemption
from the requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of methyl jasmonate in or on all food
commodities when methyl jasmonate is
applied pre-harvest.
[FR Doc. 2013–08829 Filed 4–16–13; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
World Trade Center Health Program;
Certification of Breast Cancer in WTC
Responders and Survivors Exposed to
PCBs
Centers for Disease Control and
Prevention, HHS.
ACTION: Change in certification
requirements.
AGENCY:
On September 12, 2012, HHS
published a final rule in the Federal
Register adding certain types of cancer
to the List of World Trade Center
(WTC)-Related Health Conditions (List)
established in the WTC Health Program
regulation. Breast cancer was included
on the List, although only individuals
erowe on DSK2VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:11 Apr 16, 2013
Jkt 229001
experiencing nighttime sleep disruption
as a result of response and cleanup
activities involving shiftwork are
currently considered to have
experienced exposure relevant for
certification. A recent publication in
The Lancet Oncology by the
International Agency for Research on
Cancer (IARC) concludes that there is
limited evidence that polychlorinated
biphenyls (PCBs) cause breast cancer in
humans. As described below, the WTC
Program Administrator (Administrator)
has found that PCBs were present in
WTC dust in the New York City disaster
area and, accordingly, the Program will
now certify breast cancer in eligible
WTC responders and survivors who
were exposed to either shiftwork/
nighttime sleep disruption or PCBs as a
result of the 9/11 attacks.
DATES: This change in certification
requirements is effective April 17, 2013.
FOR FURTHER INFORMATION CONTACT: Paul
Middendorf, Senior Health Scientist,
1600 Clifton Rd. NE., MS: E–20, Atlanta,
GA 30329; telephone (404)498–2500
(this is not a toll-free number); email
pmiddendorf@cdc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
On September 7, 2011, the
Administrator received a written
petition to add cancers to the List of
WTC-Related Health Conditions in 42
CFR 88.1 (Petition 001). On October 5,
2011, the Administrator formally
exercised his option to request a
recommendation from the WTC Health
Program Scientific/Technical Advisory
Committee (STAC) regarding the
petition.1 The Administrator requested
that the STAC ‘‘review the available
information on cancer outcomes
associated with the exposures resulting
from the September 11, 2001, terrorist
attacks, and provide advice on whether
to add cancer, or a certain type of
cancer, to the List specified in the
Zadroga Act.’’ Following three public
meetings where the Committee
deliberated on the issues, the STAC
submitted its recommendation on
Petition 001 to the Administrator on
April 2, 2012. After considering the
STAC’s recommendation, the
Administrator issued a notice of
proposed rulemaking on June 13, 2012
[77 FR 35574]. On September 12, 2012,
HHS published a final rule in the
Federal Register adding certain types of
cancer to the List of WTC-Related
Health Conditions in 42 CFR 88.1 [77
FR 56138]. On October 12, 2012, HHS
published a Federal Register notice to
1 See
PO 00000
42 CFR 88.17(a)(2)(i).
Frm 00028
Fmt 4700
Sfmt 4700
correct errors in Table 1 of the final rule
(the list of cancers covered by the
Program) [77 FR 62167].
B. Administrator’s Determination on
the Inclusion of Female Breast Cancer
In the final rule, the Administrator
established a four-pronged Methodology
for evaluating whether to add certain
types of cancer to the List:
Epidemiologic Studies of September 11,
2001 Exposed Populations (Method 1);
Established Causal Associations
(Method 2); Review of Evaluations of
Carcinogenicity in Humans, requiring
both Published Exposure Assessment
Information, and Evaluation of
Carcinogenicity in Humans from
Scientific Studies (Method 3, including
criteria 3A and 3B); and Review of
Information Provided by the WTC
Health Program Scientific/Technical
Advisory Committee (Method 4). A full
narrative description and graphic of the
Methodology were published in the
final rule [77 FR 56138, 56142–56143
(September 12, 2012)].
At the time of the Administrator’s
deliberation, breast cancer was
determined to meet Method 4 (the STAC
had provided a reasonable basis for its
inclusion on the List). In its April 2,
2012 recommendation, the STAC had
reported that:
There is evidence of PCB [polychlorinated
biphenyl] exposures to WTC responders and
survivors based on air samples, window film
samples and one biomonitoring study.
Studies have linked total and congenerspecific PCB levels in serum and adipose
tissue with breast cancer, although evidence
has been conflicting. PCBs and some other
substances at the WTC site are endocrine
disruptors. Breast cancer risks are highly
related to hormonal factors, including
endogenous and exogenous estrogens, and
could plausibly be affected by endocrine
disruptors. A recent study found that PCBs
enhanced the metastatic properties of breast
cancer cells by activating rho-associated
kinase. Shiftwork involving circadian rhythm
disruption has been classified by IARC as
probably carcinogenic to humans, based in
part on epidemiologic studies associating
shiftwork with increased risks of breast
cancer. Both shiftwork and long shifts were
common for workers involved in rescue,
recovery, clean up, restoration and other
activities at the WTC site.2 [references
omitted]
Although the STAC specified that
PCBs might be causally associated with
breast cancer, the Committee provided
stronger evidence (IARC classification
as a carcinogen) that shiftwork
2 STAC [World Trade Center Health Program
Scientific/Technical Advisory Committee) [2012].
Letter from Elizabeth Ward, Chair to John Howard,
MD, Administrator. This letter is included in
NIOSH Docket 257, https://www.cdc.gov/niosh/
docket/archive/docket257.html.
E:\FR\FM\17APR1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Rules and Regulations]
[Pages 22789-22794]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08829]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0134; FRL-9382-6]
Methyl Jasmonate; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the biochemical methyl jasmonate in or
on all food commodities when applied pre-harvest. Becker Underwood,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA) requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of methyl jasmonate when applied pre-
harvest.
DATES: This regulation is effective April 17, 2013. Objections and
requests for hearings must be received on or before June 17, 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-2012-0134, is available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0031; email
address: pfeifer.chris@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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document
electronically, please go to https://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
[[Page 22790]]
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2012-0134 in the subject line on 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 June 17, 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 Confidential Business Information (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-2012-0134, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be 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 https://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of May 2, 2012 (77 FR 25957) (FRL-9346-1),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
1F7941) by Becker Underwood, Inc.; 801 Dayton Avenue, Ames, IA 50010.
The petition requested that 40 CFR part 180 be amended by establishing
an exemption from the requirement of a tolerance for residues of methyl
jasmonate. That document referenced a summary of the petition prepared
by the petitioner Becker Underwood, Inc., which is available in the
docket, https://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.
Methyl jasmonate is a biochemical pesticide active ingredient
intended for use as a systemic acquired resistance (SAR) inducer on a
variety of agricultural crops. It is applied pre-harvest as a seed
treatment and an in-furrow soil treatment. Methyl jasmonate is a
naturally occurring biochemical hormone found in most plants. It acts
by eliciting plant defense responses in vulnerable seedlings. Methyl
jasmonate is the principal compound of a class of plant hormones known
as jasmonates, which are common to most plants but particularly
concentrated in jasmine and honeysuckle. As a group, jasmonates are
known to trigger plant responses to a variety of stresses. Methyl
jasmonate, in particular, is known to bolster plant defenses against
extreme temperature changes and attacks by insects, fungi and bacteria.
It has a non-toxic mode of action and is present in most fruits, with
especially high concentrations in apples and strawberries. As such, it
is already a normal part of the human diet.
With regard to dietary risks related to pesticidal use, EPA has
determined that the information submitted by the applicant satisfies
the required human health assessment data requirements and demonstrates
that any potential residues of methyl jasmonate in or on foods do not
pose a toxicological risk. First, methyl jasmonate is a ubiquitous and
naturally occurring plant hormone that is already regarded as a safe
and natural part of the human diet through such commonly consumed
fruits as apples and strawberries (Memorandum from Miachel Rexrode,
Ph.D., July 19, 2012). Data demonstrate that humans, including infants,
regularly ingest methyl jasmonate in fruits and plants at much higher
levels than what can be expected to be ingested from the pesticidal use
of this active ingredient (Memorandum from Miachel Rexrode, Ph.D., July
19, 2012). Second, the toxicity data demonstrate that methyl jasmonate
is virtually non-toxic to humans and other non-target organisms,
through all routes of exposure, including oral (Memorandum from Miachel
Rexrode, Ph.D., July 19, 2012). Third, methyl jasmonate has been
assessed and approved by Food and Agriculture Organization/World Health
Organization (FAO/WHO) as a food additive (JECFA, 2005). Their robust
assessment concluded that methyl jasmonate was non-toxic as a food
additive, establishing a threshold of 540 microgram/day (ug/day), far
above the maximum anticipated pesticidal residues of 373 ug ai/kg of
seed (JECFA, 2005). Fourth, no toxicological endpoints have been
identified for methyl jasmonate through any route of exposure
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Fifth, methyl
jasmonate's non-toxic mode of action has been well established
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Further,
methyl jasmonate biodegrades readily within four weeks (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012). Because applications
necessarily occur early in
[[Page 22791]]
the growing season due to its mode of action as a SAR inducer on seeds
and seedlings, no significant pesticidal residues are anticipated for
any harvested foods. Data show that any potential exposures are
expected to be well within the range of exposures that would occur
naturally, and are therefore not of concern (Memorandum from Miachel
Rexrode, Ph.D., July 19, 2012). For all of the foregoing reasons, EPA
finds that methyl jasmonate is virtually non-toxic and poses no dietary
risks to humans.
Summaries of the toxicological data submitted in support of this
exemption from the requirement of a tolerance follow:
A. Acute Toxicity
Acute toxicity studies, submitted to support the registration of
the products containing methyl jasmonate, confirm a virtually non-toxic
profile and support the finding that this active ingredient poses no
significant human health risk with regard to new food uses. The acute
toxicity data show virtual non-toxicity for all routes of exposure and
suggest that any dietary risks associated with this naturally occurring
plant hormone would be inconsequential.
1. The acute oral median lethal doses (LD50s) in rats
were greater than 3,129 milligrams per kilogram (mg/kg) and confirmed
virtual non-toxicity through the oral route of exposure. There were no
observed toxicological effects on the test subjects in the acute oral
study submitted (Master Record Identification Number (MRID No.)
48653901). Methyl jasmonate is Toxicity Category III for acute oral
toxicity.
2. The acute dermal median lethal dose (LD50) in rats
was greater than 5,050 mg/kg. There were no clinical signs of toxicity
or dermal irritation throughout the study. The data substantiate methyl
jasmonate's virtual non-toxicity through the dermal route of exposure.
(MRID No. 48653902). Methyl jasmonate is Toxicity Category IV for acute
dermal toxicity.
3. The acute inhalation median lethal concentration
(LC50) was greater than 2.23 milligrams per liter (mg/L) in
rats and showed no consequential inhalation toxicity (MRID No.
48653903). Methyl jasmonate is Toxicity Category III for acute
inhalation toxicity.
4. A skin irritation study on rabbits indicated that methyl
jasmonate was not irritating to the skin (MRID No. 48653905). Methyl
jasmonate is Toxicity Category IV for dermal irritation.
5. Data indicated methyl jasmonate is not a dermal sensitizer (MRID
No. 48653906).
Data indicate that methyl jasmonate is not acutely toxic. No toxic
endpoints were established in any of the acute toxicity studies, and no
significant toxicological effects were observed in any of the acute
toxicity studies.
B. Subchronic Toxicity
Based on its biodegradation properties, residues of methyl
jasmonate are not expected to result in significant dietary exposure
beyond the levels expected in background dietary exposures. Sufficient
information (MRID No. 48653908) on methyl jasmonate was submitted to
satisfy requirements for subchronic toxicity testing [i.e., 90-day Oral
(OCSPP 870.3100), 90-day Inhalation (OCSPP 870.3465), and 90-day Dermal
(OCSPP 870.3250)]. The information submitted was found acceptable based
on the toxicological and exposure profile of methyl jasmonate,
summarized below.
Methyl jasmonate is a naturally occurring compound found in fruits
and other plants and is already consumed in the human diet. This
compound has a history of safe dietary exposure (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012). The proposed use pattern of
this active ingredient results in exposure levels that are lower than
the current estimated dietary exposure (Memorandum from Miachel
Rexrode, Ph.D., July 19, 2012). Oral exposure of children and adults to
methyl jasmonate calculated from food consumption information from the
U.S. EPA Exposure Factors Handbook (U.S. EPA, 2009) were found to be
less than the residues resulting from a maximum application. Methyl
jasmonate was reviewed by the Joint FAO/WHO Expert Committee on Food
Additives (JECFA, 2005) and was identified as a non-toxic flavoring
agent. Methyl jasmonate is not known or expected to be metabolized
differently following exposure by the dermal route than the oral route,
and a literature search yielded no reports of subchronic dermal
toxicity effects in rodents or humans from methyl jasmonate exposure
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Prolonged
dermal exposure is not expected because the product is not purposely
applied to the skin and because handlers and applicators are required
to wear appropriate personal protective equipment (PPE). There is a
long history of safe inhalation exposure to methyl jasmonate because it
is a naturally occurring volatile component of common plants. The
potential inhalation exposure concentration from use of products
containing methyl jasmonate will be less than or equal to naturally
occurring concentrations from crops and other plants (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012). Significant exposure to humans
is not anticipated based on low application rates and, more
importantly, rapid degradation in the environment (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012).
C. Developmental Toxicity and Mutagenicity
The applicant provided adequate information (MRID No. 48653908) to
fulfill the developmental toxicity and mutagenicity data requirements
[i.e., Prenatal Development (OCSPP 870.3700), Bacterial Reverse
Mutation Test (OCSPP 870.5100), In vitro Mammalian Chromosome
Aberration (OCSPP 870.5375), and In vitro Mammalian Cell Assay (OCSPP
870.5300)]. The submitted information is sufficient to confirm that
there are no expected dietary or non-occupational risks of mutagenicity
with regard to new food uses. The information submitted was found
acceptable based on the toxicological and exposure profile of methyl
jasmonate, summarized below.
There is a long history of safe dietary exposure to methyl
jasmonate because it naturally occurs in apples, strawberries and
mangos (Lalel et al., 2003), fruits that are part of the normal diet.
The potential oral exposure to methyl jasmonate from the proposed uses
of methyl jasmonate is well below the average exposure for women of
child-bearing age from the consumption of fruits that naturally contain
methyl jasmonate, and also well below the Joint FAO/WHO Expert
Committee on Food Additives (JECFA) human exposure threshold (Munro,
1999). Methyl jasmonate has been evaluated for safety by the FAO and
determined to be metabolized to innocuous end products that are
eliminated in the urine (Lalel et al., 2003). A literature search
yields no reports of genotoxicity in laboratory studies on methyl
jasmonate (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012).
Significant exposure to child-bearing women is not anticipated based on
low application rates, appropriate PPE requirements on the label, and
rapid degradation in the environment.
D. Effects on Endocrine Systems
There is no available evidence demonstrating that methyl jasmonate
is an endocrine disruptor in humans. As a result, the Agency is not
requiring information on the endocrine effects of methyl jasmonate at
this time. However, the Endocrine Disruption Screening Program (EDSP)
has established a protocol which guides the Agency in
[[Page 22792]]
selecting suspect ingredients for review, and the Agency reserves the
right to require new information should the program require it.
Presently, based on the lack of exposure and the virtually non-toxic
profile of methyl jasmonate, no adverse effects to the endocrine are
known or expected. Overall, the lack of evidence of endocrine
disruption is consistent with methyl jasmonate's negligible toxicity
profile and supports this exemption from the requirement of a
tolerance.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in or on 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
Because of methyl jasmonate's ability to biodegrade quickly
relative to the time it is to be applied on seeds or to soil near
planting, the Agency does not anticipate significant residues being
present in or on food at the time of consumption. Moreover, any
residues that are present in or on food at the time of consumption as a
result of pesticide use are likely to be indistinguishable from
naturally occurring methyl jasmonate due to its ubiquitous presence in
plants. Finally, the Agency believes that it is unlikely that any
exposure to the residues of methyl jasmonate will result in dietary
risks because of the non-toxic mode of action as a SAR inducer and the
pesticide's virtually non-toxic profile.
1. Food. Exposure to residues of methyl jasmonate on foods is
expected to be negligible. The application of methyl jasmonate is made
directly to seeds through a contained seed-treatment or through in-
furrow or soil drench applications. This application scenario prevents
drift and minimizes exposure to humans. Although applications will
result in minimal exposure, the Agency has calculated that exposures
associated with maximum application rates are still lower than the
current estimated dietary exposure for regular fruit consumption
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Further, the
data indicate that methyl jasmonate is readily biodegradable within
four weeks (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012).
Because applications necessarily occur early in the growing season due
to its mode of action as a SAR inducer on seeds and seedlings, no
significant pesticidal residues are anticipated for any harvested
foods. However, in the event of exposure to residues of methyl
jasmonate, no dietary risks are anticipated. As described in Unit III,
acute, subchronic, mutagenic and developmental studies and information
support its nontoxic profile. Furthermore, it is already present in the
human fruit and vegetable diet without any known detrimental effects.
There is no information in the public literature suggesting any health
issues to either animals or plants relative to this compound. It is
estimated that humans consume at least .348 ug/day on average, based on
EPA models for apple and strawberry consumption (Memorandum from
Miachel Rexrode, Ph.D., July 19, 2012). Finally, the dietary use of
methyl jasmonate as a food additive was approved by the Joint FAO/WHO
Expert Committee on Food Additives, which found methyl jasmonate to be
non-toxic at a conservative threshold of 540 ug/day. (JECFA, 2005). By
comparison, maximum residues have been calculated to be 373 ug ai/kg of
seed (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). In sum,
minimal dietary exposure is expected; however, any potential dietary
exposures would not be expected to pose any consequential risk, mainly
due to methyl jasmonate's virtually non-toxic profile.
2. Drinking water exposure. Residues of methyl jasmonate are not
expected to be present in drinking water because applications of methyl
jasmonate are made directly to seeds, seedlings and soil. Methyl
jasmonate residues are not expected to percolate through the soil
because residues are not expected to persist beyond the time it would
typically take for any residues to percolate into the groundwater.
Nonetheless, given methyl jasmonate's virtually non-toxic profile as
described in Unit III, risks from aquatic exposure would be negligible.
B. Other Non-Occupational Exposure
Non-occupational exposure is not expected because methyl jasmonate
is intended for commercial use. The active ingredient is applied
directly to seeds or agricultural furrows, and it degrades rapidly.
Further, health risks are not expected from any pesticidal exposure to
this active ingredient, no matter the circumstances. A February, 2013
Agency risk assessment of methyl jasmonate establishes that even a
worst case exposure scenario involving prolonged and regular
occupational exposures, which are not associated with this active
ingredient, would pose negligible risks (Methyl Jasmonate BRAD,
February 28, 2013). Methyl jasmonate is characterized by its
biodegradability; low toxicity profile; nontoxic, SAR-inducing mode of
action; and demonstrable lack of dietary effects.
1. Dermal exposure. Non-occupational dermal exposures to methyl
jasmonate are expected to be negligible because of its directed
agricultural use. Even in the event of dermal exposure to residues, the
nontoxic profile of methyl jasmonate (as described in Unit III) is not
expected to result in any risks through this route of exposure.
2. Inhalation exposure. Non-occupational inhalation exposures are
not expected to result from the agricultural uses of methyl jasmonate.
Any inhalation exposure associated with this new agricultural and
commercial use pattern 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 methyl jasmonate to share a common mechanism of
toxicity with any other substances, and methyl jasmonate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
methyl jasmonate 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 https://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
Health risks to humans, including infants and children, are
considered negligible with regard to the pesticidal use of methyl
jasmonate. As illustrated in Unit III, acute toxicity studies indicate
that methyl jasmonate is virtually non-toxic. It is ubiquitous in
nature and present in fruits and vegetables. There is no history of any
toxicological incident involving its
[[Page 22793]]
consumption, and its use in food supplements is already allowed by the
United States Food and Drug Administration. For all of these reasons,
the Agency has determined that this food use of methyl jasmonate poses
no foreseeable risks to human health or the environment. Thus, there is
a reasonable certainty of no harm to the general U.S. population,
including infants and children, from exposure to this active
ingredient.
A. U.S. Population
The Agency has determined that there is a reasonable certainty that
no harm will result from aggregate exposure to residues of methyl
jasmonate to the U.S. population. This includes all anticipated dietary
exposures and other non-occupational exposures for which there is
reliable information. The Agency arrived at this conclusion based on
the low levels of mammalian dietary toxicity associated with methyl
jasmonate, the natural ubiquity of methyl jasmonate in food, and
information suggesting that the pesticidal use of methyl jasmonate will
not result in significant exposure. For these reasons, the Agency has
determined that methyl jasmonate residues in and on all food
commodities will be safe, and that there is a reasonable certainty that
no harm will result from aggregate exposure to residues of methyl
jasmonate.
B. 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 exposure (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 the EPA determines that a different margin of exposure (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.
Based on all the information evaluated for methyl jasmonate, the
Agency concludes that 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 since
the Agency 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 methyl jasmonate.
VIII. Conclusions
Therefore, an exemption is established for residues of methyl
jasmonate in or on all food commodities when applied preharvest.
IX. References
Complete citations to the references used in this document are set
forth in Appendix C to the document captioned ``Methyl Jasmonate BRAD
(Biopesticides Registration Action Document) Methyl Jasmonate PC Code:
028100'' (document ID number EPA-HQ-OPP-2012-0134-0006), found in the
OPP docket listed under docket ID number EPA-HQ-OPP-2012-0134, and may
be seen by accessing the www.regulations.gov Web site.
X. Statutory and Executive Order Reviews
This final rule establishes 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 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).
[[Page 22794]]
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: March 22, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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 180.1320 is added to subpart D to read as follows:
Sec. 180.1320 Methyl jasmonate; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of methyl jasmonate in or on all food commodities when methyl
jasmonate is applied pre-harvest.
[FR Doc. 2013-08829 Filed 4-16-13; 8:45 am]
BILLING CODE 6560-50-P
