[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: <a href="/cdn-cgi/l/email-protection#214e51510c454e424a4455614451404c40484d0f4451400f464e57"><span class="__cf_email__" data-cfemail="553a252578313a363e30211530253438343c397b3025347b323a23">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#5624333f3a3a2f78253e33242f3a163326373b373f3a7833263778313920"><span class="__cf_email__" data-cfemail="c2b0a7abaeaebbecb1aaa7b0bbae82a7b2a3afa3abaeeca7b2a3eca5adb4">[email protected]</span></a>.

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 LD<INF>50</INF> for methyl 
salicylate in the rat ranges

[[Page 61636]]

from 887-1,250 mg/kg. Acute dermal toxicity (LD<INF>50</INF>) 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 <ls-thn-eq>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)                 
------------------------------------------------------------------------
                                                   Methyl       Oil of  
                     Food                        Salicylate  Wintergreen
------------------------------------------------------------------------
Beverages.....................................           59           56
Ice cream.....................................           27           44
Candy.........................................          840          260
Baked goods...................................           54        1,500
Chewing gum...................................        8,400        3,900
Syrups........................................          200          ---
------------------------------------------------------------------------

    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


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