[Federal Register Volume 66, Number 139 (Thursday, July 19, 2001)]
[Notices]
[Pages 37677-37681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18098]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1033; FRL-6793-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1033, must be 
received on or before August 20, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1033 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dan Peacock, Insecticide-
Rodenticide Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5407; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                        Examples of
             Categories              NAICS codes   potentially affected
                                                         entities
------------------------------------------------------------------------
Industry                                     111  Crop production
                                             112  Animal production
                                             311  Food manufacturing
                                           32532  Pesticide
                                                   manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations.'' ``Regulation and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1033. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall

[[Page 37678]]

#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1033 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1033. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated:July 2, 2001
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summaries of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Syngenta Crop Protection, Inc.

PP 8F4984, 8F5031, 0F6141

    EPA has received pesticide petitions (8F4984, 8F5031, 0F6141) from 
Syngenta Crop Protection, Inc., PO Box 18300 Greensboro, NC 27419-8300 
proposing, pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by 
establishing a tolerance for residues of pymetrozine in or on the raw 
agricultural commodities cotton gin byproducts at 3.0 parts per million 
(ppm), cottonseed at 0.4 ppm, cucurbit vegetables at 0.1 ppm, hops at 
5.0 ppm, fruiting vegetables at 0.2 ppm, leafy vegetables (except 
Brassica) at 6.0 ppm, head and stem Brassica vegetables at 2.0 ppm, 
leafy Brassica greens at 5.0 ppm and pecans at 0.02 ppm. EPA has 
determined that the petition contains data or information regarding the 
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of pymetrozine in plants is 
understood for the purposes of the proposed tolerances. Studies in 
rice, tomatoes, cotton and potatoes gave similar results. The metabolic 
pathways have demonstrated that pymetrozine, per se, is the residue of 
concern for tolerance setting purposes.
    2. Analytical method. Syngenta has submitted an analytical method 
(AG-643) for the determination of pymetrozine in crop substrates. The 
limit of detection (LOD) for the analytical method is 1.0 ng and the 
limit of quantification (LOQ) is 0.02 ppm. Samples are extracted, 
purified with solid-phase and liquid-liquid partitions and analyzed by 
high performance liquid chromotography (HPLC). Analytical method has 
undergone independent laboratory validation. The

[[Page 37679]]

pymetrozine Analytical Method AG-643 is proposed as the tolerance 
enforcement method. Syngenta has also submitted an analytical method 
(AG-647) for the determination of the major crop metabolite of 
pymetrozine, GS-23199. GS-23199 is considered a marker for metabolite 
residues. This metabolite is not proposed as part of the tolerance 
expression. Samples are extracted, purified with solid-phase and/or 
liquid-liquid partitions and analyzed by HPLC.
    3. Magnitude of residues. Residue data were generated for 
pymetrozine for tolerance setting and dietary exposure estimates. Data 
were also generated for a major metabolite, GS-23199. Adequate residue 
trials were performed for pymetrozine on the uses proposed in this 
notice of filing.

B. Toxicological Profile

    1. Acute toxicity. Pymetrozine has low acute toxicity. The oral 
LD50 in rats is > 5,820 milligrams/kilogram(mg/kg) for males 
and females, combined. The rat dermal LD50 is > 2,000 mg/kg 
and the rat inhalation LC50 is > 1.8 milligrams/liter(mg/L) 
air. Pymetrozine is not a skin sensitizer in guinea pigs and does not 
produce dermal irritation in rabbits. It produces minimal eye 
irritation in rabbits. End-use water-dispersible granule formulations 
of pymetrozine have similar low acute toxicity profiles.
    2. Genotoxicity. Pymetrozine did not induce point mutations in 
bacteria (Ames assay in Salmonella typhimurium and Escherichia coli) or 
in cultured mammalian cells (Chinese hamster V79) and was not genotoxic 
in an in vitro unscheduled DNA synthesis assay in rat hepatocytes. 
Chromosome aberrations were not observed in an in vitro test using 
Chinese hamster ovary cells and there were no clastogenic or aneugenic 
effects on mouse bone marrow cells in an in vivo mouse micronucleus 
test. These studies show that pymetrozine is not mutagenic or 
genotoxic.
    3. Reproductive and developmental toxicity. In a teratology study 
in rats, pymetrozine caused decreased body weights and food consumption 
in females given 100 and 300 mg/kg/day during gestation. This maternal 
toxicity was accompanied by fetal skeletal anomalies and variations 
consistent with delayed ossification. The no-observed-adverse-effect 
level (NOAEL) for maternal and fetal effects in rats was 30 mg/kg/day. 
In a rabbit teratology study, maternal death, reduced body weight gain 
and food consumption were observed at 125 mg/kg/day (highest dose 
tested). Embryo- and feto-toxicity (abortion in one female and total 
resorptions in two females) accompanied maternal toxicity. Body weight 
and food consumption decreases, early resorptions and postimplantation 
losses were also observed in maternal rabbits given 75 mg/kg/day. There 
was an increased incidence of fetal skeletal anomalies and variations 
at these maternally toxic doses. The NOAEL for maternal and fetal 
effects in rabbits was 10 mg/kg/day. Pymetrozine is not teratogenic in 
rats or rabbits. In a two generation reproduction study in rats, 
parental body weights and food consumption were decreased, liver and 
spleen weights were reduced and histopathological changes in liver, 
spleen and pituitary were observed at approximately 110-440 mg/kg/day 
(highest dose tested). Liver hypertrophy was observed in a few parental 
males at approximately 10-40 mg/kg/day. Reproductive parameters were 
not affected by treatment with pymetrozine. The NOAEL for reproductive 
toxicity is approximately 110-440 mg/kg/day. The NOAEL for toxicity to 
adults and pups is approximately 1-4 mg/kg/day.
    4. Subchronic toxicity. Pymetrozine was evaluated in 13-week 
subchronic toxicity studies in rats, dogs and mice. Liver, kidneys, 
thymus and spleen were identified as target organs. The NOAEL was 33 
mg/kg/day in rats and 3 mg/kg/day in dogs. In mice, increased liver 
weights and microscopical changes in the liver were observed at all 
doses tested. The NOAEL in mice was <198 mg/kg/day. No dermal 
irritation or systemic toxicity occurred in a 28-day repeated dose 
dermal toxicity study with pymetrozine in rats given 1,000 mg/kg/day. 
Minimum direct dermal absorption (1.1%) of pymetrozine was detected in 
rats over a 21 hour period of dermal exposure. Maximum radioactivity 
left on or in the skin at the application site and considered for 
potential absorption was 11.9%.
    5. Chronic toxicity. Based on chronic toxicity studies in the dog 
and rat, a reference dose (RfD) of 0.0057 mg/kg/day is proposed for 
pymetrozine. This RfD is based on a NOAEL of 0.57 mg/kg/day established 
in the chronic dog study and an uncertainty factor of 100 to account 
for interspecies extrapolation and interspecies variability. Minor 
changes in blood chemistry parameters, including higher plasma 
cholesterol and phospholipid levels, were observed in the dog at the 
lowest-observed-adverse-effect level (LOAEL) of 5.3 mg/kg/day. The 
NOAEL established in the rat chronic toxicity study was 3.7 mg/kg/day 
and was based on reduced body weight gain and food consumption, 
hematology and blood chemistry changes, liver pathology and biliary 
cysts.
    The carcinogenic potential of pymetrozine has been evaluated in 
rats and mice. A liver tumor response was observed in male and female 
mice and female rats at high doses exceeding the maximum tolerated 
dose. These liver tumors correlated with reversible biochemical 
(induction of liver metabolizing enzymes) and morphological (hepatocyte 
and smooth endoplasmic reticulum proliferation) changes and a 
reversible saturation of metabolic processes. EPA has assigned a cancer 
classification of ``likely'' to pymetrozine and calculated a Q1* value. 
However, Syngenta believes that the mechanism of action leading to 
liver tumors at maximum tolerated doses is a non-genotoxic threshold 
event and should be regulated as such.
    6. Animal metabolism. The metabolism of pymetrozine in the rat is 
well understood. Metabolism involves oxidation of substituent groups of 
the triazine ring yielding ketones and carboxylic acids. Hydrolysis of 
the enamino bridge between rings results in products that are further 
metabolized. The metabolic pathways in animals and plants are similar.
    7. Metabolite toxicology. The residue of concern for tolerance 
setting purposes is the parent compound. Metabolites of pymetrozine are 
considered to be of equal or lesser toxicity than the parent.
    8. Endocrine disruption. Pymetrozine does not belong to a class of 
chemicals known or suspected of having adverse effects on the endocrine 
system. There is no evidence that pymetrozine has any effect on 
endocrine function in developmental and reproduction studies. 
Furthermore, histological investigation of endocrine organs in chronic 
dog, rat and mouse studies did not indicate that the endocrine system 
is targeted by pymetrozine.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. A tier 3 chronic analysis was 
conducted for pymetrozine using average (mean) field trial residues for 
the following crops and crop groups: cotton, pecans, hops, cucurbits, 
fruiting vegetables, tuberous and corm, Brassica leafy vegetables and 
leafy vegetables. The average field trial values were adjusted for the 
percent of crop-treated and residue values for processed commodities 
were calculated by applying processing factors (either default or 
empirically-derived) to average field trial values of the raw 
agricultural commodity. Secondary residues in animal commodities were 
not included in the exposure assessment since a three-level dairy 
feeding study

[[Page 37680]]

in lactating livestock showed no residues at any of the feeding levels 
and the highest feeding level (10 ppm) was at least 10-fold higher than 
what would be expected in treated feed. Exposure was evaluated using 
the Dietary Exposure Evaluation Model (DEEM) and food 
consumption information from USDA's 1994-96 Continuing Survey of Food 
Intake by Individuals (CSFII). Dietary exposure for the general 
population was 0.5% of the chronic reference dose (cRfD) of 0.0038 mg/
kg/day based on a no-observed-adverse-effect level (NOAEL) of 0.38 mg/
kg/day from a chronic feeding study in rats and a 100X uncertainty 
factor. Exposure to the U.S. population for each season, each region 
and for all ethnic groups in the DEEM were also compared to 
the cRfD of 0.0038 mg/kg/day and ranged from 0.4-0.9%. Exposure to all 
male subpopulations and seniors (55+ years old) ranged between 0.4-0.5% 
of the cRfD (0.0038 mg/kg/day). Chronic dietary exposure to females, 
infants and children was compared to a chronic population adjusted dose 
(cPAD) of 0.0013 mg/kg/day based on the NOAEL of 0.38 mg/kg/day 
(described above) and a 300X uncertainty factor. The chronic dietary 
exposure results for the most sensitive female population subgroup, 
females (13+ years and nursing), was 2.2% of the cPAD. The most 
sensitive population containing children exclusively was children (1-6 
years old) with an exposure of 2.5% of the cPAD. Lifetime cancer risk 
to pymetrozine was evaluated by comparing exposure to a Q* value of 
0.0119. The assessment was conducted as for the chronic assessment 
described above. Lifetime risk for the U.S. population was 2.24 x 
10-7. The most sensitive adult population was females (13+, 
nursing) with a lifetime risk of 3.46 x 10-7. These exposure 
estimates are conservative since field trial residues were utilized and 
do not reflect residue reductions expected in normal food commerce, 
storage or food preparation. Therefore, these results show that there 
is more than a reasonable certainty of no harm resulting from chronic 
exposure through the consumption of pymetrozine-treated commodities.
    A tier 3 probabilistic acute dietary analysis was conducted with a 
full distribution of residues for each commodity described above. Each 
residue distribution was adjusted for percent of crop treated by adding 
zeroes to the distribution to account for the percent of crop not 
treated. This acute assessment was conducted using the DEEM 
software and food consumption information from USDA's 1994-96 CSFII. 
Processing factors were used to adjust average field trial values for 
processed (blended) commodities and were obtained either empirically or 
from default values. EPA has required that exposure to females (13+ 
years old) be compared to a NOAEL of 10 mg/kg/day based on a rabbit 
developmental study and a 300X uncertainty factor. Acute exposure to 
the most sensitive female subpopulation, females (13-50 years old), was 
1.61% of the acute population adjusted-dose (aPAD) of 0.033 mg/kg/day 
(300X uncertainty factor). For the U.S. population and infants and 
children, exposures were compared to a lowest-observed-adverse-effect 
level (LOAEL) of 125 mg/kg/day from an acute neurotoxicity study in 
rats. Uncertainty factors of 300X and 900X were applied to the LOAEL 
for the general population and infants and children subgroups, 
respectively. Acute exposure for the U.S. population was 0.13% of the 
aPAD of 0.42 mg/kg body weight/day (300X uncertainty factor). For the 
infants and children populations, the most sensitive population 
subgroup was non-nursing infants with an exposure of 1.77% of the aPAD 
of 0.14 mg/kg/day (900X-uncertainty factor). These results show a very 
large margin of safety associated with the consumption of pymetrozine-
treated commodities and even under conservative assumptions all 
populations receive less than 2% of the acute population adjusted dose.
    ii. Drinking water. The acute drinking water exposure to 
pymetrozine was evaluated based on the crops above using EPA's surface 
water Tier 1 model (GENEEC). Hops with 3 applications at 0.1875 lb ai/
acre was the highest contributor at 4.27 ppb. Using the current aPAD of 
0.033 mg/kg for females 13+, the margin of exposure percent (MOE%) of 
risk cup anticipated is 0.43%. For children the aPAD of 0.14 mg/kg 
yields an MOE% of risk cup of 0.30%.
    Hops was also the highest contributor to surface water exposure at 
0.31 ppb. Using the current cPAD of 0.0013 mg/kg/day (for females and 
children) the surface water exposure results in an MOE% of risk cup of 
2.38% for children. Using a Q* of 0.0119 the risk to a typical 70 kg 
adult drinking 2 liters of water per day would be estimated at 1.05 x 
10-7.
    2. Non-dietary exposure. Pymetrozine is registered on ornamentals 
and exposure could occur through post-application re-entry to treated 
plants. Syngenta believes that risks due to short-term, intermediate-
term or chronic exposure are either not applicable or insignificant.

D. Cumulative Effects

    The potential for cumulative effects of pymetrozine and other 
substances that have a common mechanism of toxicity has also been 
considered. Pymetrozine belongs to a new chemical class known as 
pyridine azomethines and exhibits a unique mode of action. There is no 
reliable information to indicate that toxic effects produced by 
pymetrozine would be cumulative with those of any other chemical 
including another pesticide. Therefore, Syngenta believes it is 
appropriate to consider only the potential risks of pymetrozine in an 
aggregate risk assessment.

E. Safety Determination

    1. U.S. population. Using the exposure assumptions and the proposed 
RfD described above, the aggregate exposure to pymetrozine will utilize 
0.5% of the RfD for the U.S. population. The RfD represents the level 
at or below which daily aggregate exposure over a lifetime will not 
pose appreciable risks to human health. EPA generally has no concern 
for exposures below 100 percent of the RfD. In addition, Lifetime 
cancer risk for the U.S. population was 2.24 x 10-7, which 
is below the level of EPA concern. Therefore, Syngenta concludes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to pymetrozine residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of pymetrozine, data 
from developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat have been considered.
    In a teratology study in rats, developmental toxicity anomalies and 
variations associated were observed only at maternally toxic doses. 
Similarly, in a rabbit teratology study, effects were observed only at 
maternally toxic doses. The NOAELs in the rat and rabbit teratology 
studies were 30 and 10 mg/kg/day, respectively. In the two-generation 
rat reproduction study, there were no effects on reproductive 
parameters. Offspring body weights were slightly reduced and eye 
opening was slightly delayed at dose levels producing parental 
toxicity. The NOAEL for parental and offspring toxicity was 
approximately 1-4 mg/kg/day.
    FFDCA section 408 provides that EPA shall apply an additional 10-
fold margin of safety for infants and children in the case of threshold 
effects to account for prenatal and postnatal toxicity and the 
completeness of the database unless EPA determines that a

[[Page 37681]]

different margin of safety will be safe for infants and children. EPA 
has added an additional 3-fold factor to the acute dietary risk 
assessment for infants and children due to the lack of a NOAEL in the 
critical study. An additional 3-fold factor is also needed due to the 
uncertainty resulting from the data gap for the developmental 
neurotoxicity study in rats. This latter safety factor is applicable to 
the following subgroup populations: Females 13-50; infants, children 
(1-6 years old), and children (7-12 years old) for all risk assessment 
scenarios for acute and chronic dietary and residential scenarios. No 
greater additional factor is needed because, using the exposure 
assumptions described above, the percent of the pymetrozine chronic PAD 
that will be utilized by the most exposed sub-population (children, 1-6 
years old) is 2.5%. Therefore, based on the completeness and 
reliability of the toxicity database, Syngenta concludes that there is 
reasonable certainty that no harm will result to infants and children 
from exposure to pymetrozine residues.

F. International Tolerances

    There are no established European (CODEX), Canadian, or Mexican 
Maximum Residue Limits (MRLs) for pymetrozine. There are provisional 
MRLs in Germany for hops (10 ppm) and potatoes (0.02 ppm). The European 
Union is currently evaluating a proposed tolerance of 5 ppm on hops. At 
this time, international harmonization of residue levels is not an 
issue.

[FR Doc. 01-18098 Filed 7-18-01; 8:45 a.m.]
BILLING CODE 6560-50-S