[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61635-61639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30251]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300557; FRL-5746-1]
Methyl Salicylate; Establishment of an Exemption from Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of the insecticide methyl salicylate in or on
food, when used as an insect repellent in food packaging and animal
feed packaging at an application rate that does not exceed 0.2 mg of
methyl salicylate per square inch of packaging materials.
EFFECTIVE DATE: November 19, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300557/PP 7F4818], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections and
hearing requests shall be labeled ``Tolerance Petition Fees'' and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk should be
identified by the docket control number [OPP-300557] and submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7506C), Office of Pesticide Programs,
Environmental protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring copy of objections and hearing requests to: Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1 file format or ASCII file format. All copies
of electronic objections and hearing requests must be identified by the
docket control number [OPP-300557]. No Confidential Business
Information (CBI) should be submitted through e-mail. Copies of
electronic objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Sheryl K. Reilly,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, U.S. Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460, Office location and telephone number: Room
CS15-W31, 2800 Jefferson Davis Hwy., Arlington, VA, (703/308-8265); e-
mail: [email protected].
SUPPLEMENTARY INFORMATION: Tenneco Packaging, 1603 Orrington Ave.,
Evanston, IL, 60201, requested in pesticide petition PP 7F4818 the
establishment of an exemption from the requirement of a tolerance for
residues of the insecticide methyl salicylate on food, when used as a
insect repellent in food packaging and animal feed packaging materials
alone or in conjunction with inert components which conform to the
requirements of regulations issued by the Food and Drug Administration
under section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
A notice of filing (FRL-5721-6) was published in the Federal Register
(62 FR 32331) on June 13, 1997, and the notice announced that the
comment period would end on July 13, 1997; no comments were received.
The data submitted in the petition and all other relevant material
have been evaluated. Following is a summary of EPA's findings regarding
this petition as required by section 408(d) of the FFDCA, as recently
amended by the Food Quality Protection Act.
I. Risk Assessment and Statutory Findings
New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe''. Section 408(c)(2)(A)(ii) 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 an in residential settings, but does not include
occupational exposure. Section 408(c)(2)(B) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue... .'' EPA performs a number of analyses to determine the risks
from aggregate exposure to pesticide residues. First, EPA determines
the toxicity of pesticides. Second, EPA examines exposure to the
pesticide through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Additionally, section 408(b)(2)(D)(v) 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.'' Methyl salicylate (CAS
Registry Number 119-36-8) is the primary chemical component of a
naturally occurring fragrant oil, oil of wintergreen. If present at
all, residues of methyl salicylate that may be found in foods in
contact with treated packaging materials is expected to be minimal and
considerably below the levels expected in existing GRAS uses of the
active ingredient as a direct food flavoring ingredient.
The toxicity of methyl salicylate has been extensively studied in
animal bioassays of acute, subchronic, and chronic duration. Studies
include assessments of the mutagenicity, developmental toxicity, and
reproductive effects of methyl salicylate. The petitioner submitted
data from the scientific literature to support all toxicology studies
typically required for registration of biochemical pesticides.
1. Acute toxicity . The acute oral LD50 for methyl
salicylate in the rat ranges
[[Page 61636]]
from 887-1,250 mg/kg. Acute dermal toxicity (LD50) has been
reported to be > 5 g/kg in the rabbit.
2. Skin and eye irritation. Methyl salicylate has been reported to
be a severe eye irritant. Methyl salicylate has been reported to
produce mild dermal irritation in rabbits at a concentration of 1%.
Moderate to severe irritation is produced in rabbits and guinea pigs at
concentrations above 1%. Applied full strength to intact or abraded
rabbit skin for 24 hours under occlusion, methyl salicylate was
moderately irritating. However, tested at 8% in petrolatum, it produced
no irritation after a 48 hour closed-patch test on human subjects.
3. Mutagenicity. No evidence for genotoxicity was observed in two
studies with prokaryotic test systems; no data on genotoxicity in
mammalian test systems are available.
4. Subchronic toxicity. Studies of subchronic duration with
administration by the oral route have been conducted in both rats and
dogs. In rats, no adverse effects were seen at a dose of 50 mg/kg/day
in the diet. In dogs, doses 250 mg/kg/day did not result in
any adverse effects, however, the liver appeared to be the target organ
of toxicity at doses above this level. No toxicity was observed when
rats were exposed to methyl salicylate via inhalation of saturated air
(approx. 700 mg/m3) after twenty 7-hour exposures.
5. Developmental toxicity. Methyl salicylate has been tested for
developmental effects in hamsters, rats and mice by the oral and dermal
routes. In hamsters, oral or dermal doses of methyl salicylate at doses
of 1,750 mg/kg/day induced maternal toxicity and increased the
incidence of neural tube defects. In rats given methyl salicylate at up
to 6,000 mg/kg/day in petroleum based grease by the dermal route, no
developmental effects were observed. However, undiluted methyl
salicylate applied to the skin of pregnant rats caused total litter
resorptions at 1,000 mg/kg/day (a dose that was reduced from 2,000 mg/
kg/day because of excessive maternal toxicity). The results of a
continuous breeding study in mice were consistent with findings in the
developmental studies because of the decreased numbers of litters per
pair, reduced average number of pups per litter, decreased proportion
of pups born alive in each litter, and reduced mean pup weights in mice
given 500 mg/kg/day. The no-observed-adverse-effect level (NOAEL) for
these effects was 250 mg/kg/day.
6. Chronic toxicity. Toxicity resulting from chronic exposure has
been evaluated in studies of two-years' duration as well as studies
initially intended to evaluate multi-generational reproductive and
developmental effects. In mice, the NOAEL for reproductive parameters
and the other toxic endpoints examined has been reported as 250 mg/kg/
day. When rats were exposed to methyl salicylate in the diet for two
years, no adverse effects were noted at levels of 0.1% (approx. 50 mg/
kg/day); pituitary lesions were increased in animals exposed to 0.5%
(approx. 250 mg/kg/day). In dogs orally exposed to methyl salicylate
for two years, no adverse effects were observed at 50 mg/kg/day; the
LOAEL (liver effects) was reported as 150 mg/kg/day.
7. Carcinogenicity. No studies have been performed with the primary
purpose of determining the oncogenicity of methyl salicylate; however,
chronic exposure studies with two-year exposure durations that included
extensive pathology did not indicate any increases in incidences of
benign or malignant tumors.
8. Toxicology data waivers. Waivers for acute inhalation toxicity,
dermal sensitization, and immune response studies were accepted by the
Agency, based on the long history of use of methyl salicylate by humans
without any indication of deleterious effects. Besides its use as a
flavoring agent in foods (see GRAS Assessment, below), methyl
salicylate has been used in mouthwash, suntan lotions, and in U.S.
Pharmocopeia (U.S.P.) preparations as a counterirritant and analgesic
for painful muscles or joints, in liniments, ointments, and other
preparations. In addition, the manufacturing use product is a liquid,
which is not expected to result in the release of appreciable
quantities of inhalable methyl salicylate during the manufacturing
process, and worker exposure via the dermal route will be minimized
through the use of rubber gloves and splash proof goggles and/or face
shields. In the end-use formulation, methyl salicylate will be
incorporated into a solid matrix in the packaging materials, and the
release of vapors at a very low rate over extended periods of time will
not result in significant worker or consumer dermal and inhalation
exposure.
9. GRAS assessment. The Flavoring Extract Manufacturer's
Association (FEMA) has determined GRAS levels of methyl salicylate and
oil of wintergreen in foods and beverages as indicated in the table
below.
Table 1- FEMA GRAS Levels in Food (ppm)
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Methyl Oil of
Food Salicylate Wintergreen
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Beverages..................................... 59 56
Ice cream..................................... 27 44
Candy......................................... 840 260
Baked goods................................... 54 1,500
Chewing gum................................... 8,400 3,900
Syrups........................................ 200 ---
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GRAS food levels in Table 1 are above both the maximum food residue
concentration (approx. 16 ppm) and the maximum dietary exposure
concentration (approx. 4.7 ppm) estimated by the Petitioner for the
proposed use pattern for methyl salicylate. These estimates used highly
conservative assumptions for migration of methyl salicylate from
packaging and food consumption. Petitioner has shown that even under
worst-case exposure conditions (i.e., assuming 30% of all food consumed
is in contact with packaging containing methyl salicylate, and 100% of
the methyl salicylate migrates to food) exposure to methyl salicylate
from use in packaging materials would be less than that received by
chewing one stick of chewing gum at the GRAS-approved level. Residue
data requirements were thus waived by the Agency.
III. 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 groundwater or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
There is no established Maximum Contaminant Level (MCL) for
residues of methyl salicylate in drinking water under the Safe Drinking
Water Act.
There are five currently registered pesticide products that contain
methyl salicylate as an active ingredient. These products include
impregnated materials and pellets to be used as vertebrate repellents,
and disinfectants/germicides registered for use in household,
institutional, hospital, and eating establishment premises. In
addition, methyl salicylate has many non-pesticidal uses, such as
liniments, lotions, and other products listed above.
With regard to dietary exposure, as noted above in Table 1, methyl
salicylate is used as a flavoring in many food products.
[[Page 61637]]
Aggregate exposure to methyl salicylate from all these sources is
difficult to determine, largely because of its use in a wide variety of
food products. While it is difficult to develop a precise estimate of
total human exposure to methyl salicylate, EPA believes that its
history of safe use as a flavoring additive and its low toxicity at
relatively high doses indicate that current exposures are likely to be
significantly below levels that may result in adverse health effects.
The likely dietary exposures from the pesticidal use in food packaging
would be indirect (i.e., resulting from food contact with a treated
surface) and therefore unlikely to add significantly to existing
exposures. However, because studies evaluated by the Agency indicate
that methyl salicylate is toxic to humans at certain high levels, EPA
believes it is appropriate to place some limitation on the amount of
methyl salicylate that may be applied to packaging material for the
purposes of repelling insects to ensure that large quantities of the
substance are not used in food packaging. The limitation of 0.2 mg per
square inch of packaging materials established by this regulation is
based on the lowest GRAS level (27 ppm for ice cream) and a worst-case
scenario, which assumes 100% transfer of the active ingredient from the
packaging material to food contained within, without consideration of
the physical and chemical barriers between the chemical and the food.
Using the lowest GRAS level is a conservative step that ties the
potential exposure to what is already likely to be in the food supply.
The limit, therefore, ensures that any increased human exposure
resulting from the pesticidal use of methyl salicylate in packaging
material would add very little to the existing exposures -- exposures
which EPA believes to be safe. Therefore, EPA concludes that there is a
reasonable certainty of no harm from aggregate dietary exposure under
this exemption.
A. Dietary Exposure
Dietary exposure of methyl salicylate via food or water is
difficult to estimate due to the use of methyl salicylate as a
flavoring in many food products. However, based upon its long history
of safe use as an additive in food and beverages and its low toxicity
at relatively high doses, the Agency believes that current dietary
exposure is likely to be significantly below levels that may cause
adverse health effects. The likely dietary exposures from the
registered products would be indirect (i.e., resulting from food
contact with a treated surface) and therefore add very little to
existing exposures. Therefore, EPA concludes that there is a reasonable
certainty of no harm from aggregate dietary exposure under this
exemption.
B. Non-dietary, Non-occupational Exposure
There are five currently registered pesticide products that contain
methyl salicylate as an active ingredient. These products include
impregnated materials and pellets to be used as vertebrate repellents,
and disinfectants/germicides registered for use in household,
institutional, hospital, and eating establishment premises. In
addition, methyl salicylate is already widely used in liniments,
lotions, and other products listed above. The Agency considers the
toxicology data base available to support non-pesticidal uses and
exposures adequate to support a conclusion of insignificant increase in
non-dietary, non-occupational exposure and toxicity from the pesticidal
use in food and feed packaging materials.
IV. Cumulative Exposure
The Agency has considered the potential for cumulative toxicity
effects of pesticidal uses of methyl salicylate and other substances
that may have a common mechanism of toxicity. The Agency concluded that
consideration of a common mechanism of toxicity is not appropriate
because there is no information in the publicly available literature
that indicates there are other substances that share a common mechanism
of toxicity with methyl salicylate. Thus, only the potential risks of
methyl salicylate were considered in this exemption from the
requirement of a tolerance.
V. Safety Factors
A. U.S. Population
Methyl salicylate is the major component of a naturally occurring
fragrant oil. FEMA has listed methyl salicylate on its GRAS list for
use as a flavoring ingredient in foods and beverages. An FDA Advisory
Review Panel has concluded that methyl salicylate is safe for use up to
a concentration of 0.4% in the form of a rinse or mouthwash. The
compound is extensively used in foods, beverages, pharmaceuticals,
lotions and perfumes and has wide distribution in commerce with no
reports of adverse outcomes associated with intended uses. The toxicity
of methyl salicylate has been adequately and reliably characterized; it
is summarized in this submission.
Based on this information, EPA concludes that there is reasonable
certainty of no harm from aggregate exposures to pesticidal uses of
methyl salicylate over a lifetime, and that no significant human health
risks will result from such exposures.
B. Infants and Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and postnatal toxicity and the
completeness of the data base unless EPA concludes that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through the use of a margin of exposure analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans.
Due to the low expected toxicity of this compound, EPA has not used
a safety factor analysis in assessing the risk of these compounds. For
the same reasons the additional safety factor is unnecessary.
VI. Determination of Safety for U.S. Population, Infants and
Children
Based on its long history of use by humans without any indication
of deleterious effects, there is reasonable certainty that no harm will
result from aggregate exposure to the United States population,
including infants and children, to residues of methyl salicylate. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. As a result, EPA establishes an
exemption from the requirement of a tolerance pursuant to FFDCA section
408(j)(3) for methyl salicylate, on the condition that Methyl
salicylate be used in accordance with the following provisions:
Tenneco Packaging must immediately notify the EPA of any findings
that have a bearing on safety. The company must also keep records of
production, distribution, and performance and on request make the
records available to any authorized officer or employee of the EPA or
the Food and Drug Administration.
This exemption from the requirement of a tolerance may be revoked
if any experience with or scientific data on this pesticide indicate
that the tolerance is not safe.
VII. Other Considerations
A. Endocrine Disrupters
Methyl salicylate has been studied in several tests of reproductive
and developmental effects, including multigenerational studies. In
addition,
[[Page 61638]]
the pathology of endocrine-sensitive tissues and organs has been
evaluated following repeated (i.e., subchronic) and long-term (i.e.,
chronic) exposures. No such effects were reported in any of these
studies. The Agency has no information to suggest that methyl
salicylate will have an effect on the immune and endocrine systems. The
Agency is not requiring information on the endocrine effects of this
biochemical pesticide at this time; Congress has allowed 3 years after
August 3, 1996, for the Agency to implement a screening program with
respect to endocrine effects.
B. Analytical Method
The Agency proposes to establish an exemption from the requirement
of a tolerance with a numerical limitation. Therefore, for enforcement
purposes, quantitative analysis of the active ingredient methyl
salicylate may be performed by a gas chromatographic method using flame
ionization detection as described by the Association of Official
Analytical Chemists (Method 969.13, AOAC Official Methods of Analysis,
1990, pages 754-755).
VIII. Codex Maximum Residue Level
No known maximum residue limits (MRLs) have been established for
methyl salicylate by the Codex Alimentarius Commission.
IX. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance exemption regulation issued by
EPA under new section 408(e) as was provided in the old section 408.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which govern the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can be made, EPA will continue to use those procedural
regulations with appropriate adjustments to reflect the new law.
Any person adversely affected by this regulation may, January 20,
1998, file written objections to the regulation and may also request a
hearing on those objections. Objections and hearing requests must be
filed with the Hearing Clerk, at the address given above (40 CFR
178.20). A copy of the objections and/or hearing requests filed with
the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25) Each objection must be accompanied by the fee prescribed by
40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issue(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is genuine and
substantial issue of fact; there is reasonable possibility that
available evidence identified by the requestor would, if established,
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as CBI. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. A copy
of the information that does not contain CBI must be submitted for
inclusion in the public record. Information not marked confidential may
be disclosed publicly by EPA without prior notice.
X. Public Docket
A record has been established for this rulemaking under the docket
number [OPP-300557]. A public version of this record, which does not
include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
XI. Regulatory Assessment Requirements
The Office of Management and Budget has exempted this notice from
the requirement of section 3 of Executive Order 12866.
This action does not impose any enforceable duty or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Because tolerances established on the basis of a petition under
section 408(d) of FFDCA do not require issuance of a proposed rule, the
regulatory flexibility analysis requirements of the Regulatory
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the
recent amendment of the FFDCA, EPA had treated such rulemakings as
subject to the RFA; however, the amendments to the FFDCA clarify that
no proposal is required for such rulemakings and hence that the RFA is
inapplicable. Nonetheless, the Agency has previously assessed whether
establishing tolerances or exemptions from tolerance, raising tolerance
levels, or expanding exemptions adversely impact small entities and
concluded, as a generic matter, that there is no adverse impact. (46 FR
24950) (May 4, 1981).
XII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), EPA submitted 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 General
Accounting Office prior to publication in today's Federal Register.
This rule is not a major rule as defined by 5 U.S.C. 804(a).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, pesticides and pests, Reporting and record
keeping requirements.
Dated: November 5, 1997.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
[[Page 61639]]
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1189 is added to read as follows:
Sec. 180.1189 Methyl salicylate; exemption from the requirement of a
tolerance.
The biochemical pesticide methyl salicylate is exempt from the
requirement of a tolerance for residues in or on food or feed when used
as an insect repellent in food packaging and animal feed packaging at
an application rate that does not exceed 0.2 mg of methyl salicylate
per square inch of packaging materials.
[FR Doc. 97-30251 Filed 11-18-97; 8:45am]
BILLING CODE 6560-50-F