[Federal Register Volume 67, Number 60 (Thursday, March 28, 2002)]
[Notices]
[Pages 14944-14947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7497]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1077; FRL-6829-1]


Notice of Filing Pesticide Petitions to Establish a Tolerance for 
Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the amendment of a pesticide petitions 
proposing the establishment of regulations for residues of certain 
pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-1077, must be 
received on or before April 29, 2002.

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-1077 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja Brothers, Registration 
Division (7511C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number (703) 308-3194; and 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
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Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing

[[Page 14945]]

 
                                  32532               Pesticide
                                                       manufacturing
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    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'' 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-1077. 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 #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-1077 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-1077. 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 listed 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 an amended pesticide petition as follows proposing 
the establishment and/or amendment of regulations for residues of 
certain pesticide chemicals in or on various food commodities under 
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a. EPA has determined that these petitions contain 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: March 15, 2002.
Richard P. Keigwin, Jr.,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioner and represent the views of 
the petitioner. The petition summary announces the availability of

[[Page 14946]]

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.

Interregional Research Project Number 4 (IR-4)

PP 2E6355, 2E6367, 2E6368

    EPA has received pesticide petitions (2E6355, 2E6367, 2E6368) from 
the Interregional Research Project Number 4 (IR-4), 681 US Highway #1 
South, North Brunswick, NJ 08902-3390 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 180.371 by establishing tolerances for 
combined residues of thiophanate-methyl, (dimethyl [(1,2-phenylene)-
bis(iminocarbonothioyl)] bis[carbamate]), its oxygen analogue dimethyl-
4,4-o-phenylenebis(allophonate), and its benzimidazole-containing 
metabolites (calculated as thiophanate-methyl) in or on the following 
raw agricultural commodities:
    1. Pesticide Petition (PP) 2E6355 proposes a tolerance for 
pistachio at 0.2 parts per million (ppm).
    2. PP 2E6367 proposes a tolerance for potato at 0.05 ppm.
    3. PP 2E6368 proposes a tolerance for canola at 0.1 ppm.
    This notice includes a summary of the petition prepared by 
Cerexagri, Inc., 2000 Market Street, Philadelphia, PA 19103. EPA has 
determined that the petitions contain 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 support granting of the petitions. Additional data 
may be needed before EPA rules on the petitions.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of thiophanate-methyl in plants 
is well understood.
    2. Analytical method. An adequate method for purposes of 
enforcement of the proposed thiophanate-methyl tolerances is available. 
The method uses a HPLC system employing column-switching capabilities. 
It consists of reverse phase HPLC with UV detection, and is capable of 
analyzing for residues of thiophanate-methyl and its metabolite, MBC.
    3. Magnitude of residues. The magnitude of residues for pistachio, 
potato, and canola are adequately understood for the proposed 
tolerances.

B. Toxicological Profile

    1. Acute toxicity. Technical thiophanate-methyl is practically non-
toxic (Toxicity Category III) after administration by the oral, dermal 
and respiratory routes. Thiophanate-methyl is a skin sensitizer.
    2. Genotoxicity. Thiophanate-methyl has been tested in the 
Salmonella typhimurium reverse mutation assay with and without 
activation, the Chinese hamster V79 gene mutation assay with and 
without activation, the Chinese hamster ovary cell chromosomal 
aberration assay with and without activation, a primary rat hepatocyte 
unscheduled DNA synthesis assay, and a mouse dominant lethal assay. All 
these tests were negative. Thiophanate-methyl is not genotoxic.
    3. Reproductive and developmental toxicity. At non-maternally toxic 
doses, thiophanate-methyl induced no teratogenic or fetotoxic effects 
in rats or rabbits. Even at doses well above maternally toxic levels, 
thiophanate-methyl caused only minor reversible effects in fetuses and 
even these effects may not have been compound related. In addition, 
thiophanate-methyl showed no developmental effects. In rat 
developmental studies, no abnormalities were observed at gavage doses 
up to 1,000 mg/kg/day or in a dietary study of doses up to 163 mg/kg/
day. Furthermore, increased offspring sensitivity was not observed in 
the reproductive toxicity studies at doses up to 172 mg/kg/day.
    4. Subchronic toxicity. Thiophanate-methyl was administered 
dermally to male and female New Zealand white rabbits 6/hours/day, 5 
days/week for 21 days at 100, 300, and 1,000 mg/kg/day. Slight dermal 
irritation was noted in all the treatment groups during the second week 
of the study. Decreased food consumption was observed in males at 1,000 
mg/kg/day. A systemic NOAEL of 100 mg/kg/day was established. A 
systemic LOAEL of 300 mg/kg/day was established based on significant 
decreases in food consumption in female rabbits.
    Thiophanate-methyl was evaluated in a 90 day rat feeding study. The 
effects of treatment were anemia, follicular hyperplasia and 
hypertrophy of the thyroid, hepatocellular swelling and lipofuscin, 
fatty degeneration of the adrenal cortex and glomerulonephrosis. The 
LOAEL was 2,200 ppm (155 mg/kg/day). Based on these results, a NOAEL of 
200 ppm (15.7 mg/kg/day) was established for both males and females.
    Dogs were fed thiophanate-methyl for 90 days. Based on the 
occurrence of follicular hypertrophy of the thyroid gland in both sexes 
and decreased serum glutamic pyruvic transaminase (SGPT) activity in 
females the LOAEL was determined to be 50 mg/kg/day. No NOAEL was 
established. ( The NOAEL for the one year chronic study was 8 mg/kg/
day.)
    5. Chronic toxicity. Thiophanate-methyl was administered by capsule 
to beagle dogs for 1 year. Based on the decreased body weight gain in 
both sexes, decreased T4 levels in males and increased thyroid-to-body 
weight ratio and hypertrophic histologic changes in the thyroid gland 
in both sexes, the LOAEL for thiophanate-methyl is 40 mg/kg/day and the 
NOAEL is 8 mg/kg/day.
    A combined chronic/carcinogenicity feeding study was performed in 
rats at dosages of 0, 75, 200, 1,200 and 6,000 ppm thiophanate-methyl 
for two years. No clinical signs attributable to thiophanate-methyl 
were noted in the first 52 weeks. It was concluded that the effects of 
the treatment with thiophanate-methyl included growth depression, 
anemia, morphological and functional changes in the thyroid and 
pituitary, hepatocellular hypertrophy with lipofuscin, accelerated 
nephropathy and lipidosis of the adrenal cortex. The maximally 
tolerated dose (MTD) was determined to be 1,200 ppm for both males and 
females. At 6,000 ppm, approximately five times the MTD, an increase in 
thyroid follicular cell adenomas was observed in males. Thyroid 
hyperplasia and hypertrophy were observed only at or above the MTD. 
These effects are considered to be related to the treatment related 
changes in hormonal homeostasis of the pituitary-thyroid axis. The 
NOAEL is 200 ppm (8.8 mg/kg/day in males and 10.2 mg/kg/day in females) 
when fed for 104 weeks.
    In a 2-year feeding study in F344 rats, females receiving up to 
334.7 mg/kg/day thiophanate-methyl showed no increase in carcinomas but 
did show a slight increase in benign adenomas at the highest dose. Male 
rats showed a dose related increase in benign adenomas and three 
animals at the highest dose (281 mg/kg/day) had carcinomas. However, 
the MTD was exceeded for both male and female rats at the highest dose 
tested. In males, the MTD was exceeded, as demonstrated by the severity 
of toxicity seen in various organs and excessive mortality (2/55 
survivors at study end vs. 37/50 controls). In the highest dose 
females, net body weight gain was only 69% (p <0.001) of the control 
value at the end of the study.
    In an 18-month feeding study in CD-1 mice, males receiving 3,000 
ppm (468

[[Page 14947]]

mg/kg/day) showed an increased incidence of hepatocellular hypertrophy 
and a small, but statistically significant, decrease in body weight 
(<8%). Transient increases in serum thyroid stimulating hormone (TSH) 
and in absolute and relative thyroid weights were also observed in 
males. At the highest dose tested (7,000 ppm) both males and females 
showed increased mortality and increased liver weight at both weeks 39 
and 78. Females at 7,000 ppm (1329 mg/kg/day) showed a statistically 
significant decrease in body weight (<8%), decreased serum thyroxine 
(T4) at week 39, and increased heart weight at weeks 39 and 78. A dose-
related statistically significant increase in the incidence of 
hepatocellular adenomas was observed in both sexes at 3,000 and 7,000 
ppm. Two hepatocarcinomas and one hepatoblastoma were found. The 
systemic NOAEL is 150 ppm (23.7 mg/kg/day in males and 28.7 mg/kg/day 
in females). The LOAEL is 640 ppm based on an increased incidence of 
hepatocellular hypertrophy in females.
    6. Animal metabolism. The metabolism of thiophanate-methyl in 
animals is well understood.
    7. Metabolite toxicology. There are two primary metabolites of 
thiophanate-methyl: MBC and 2-AB. The metabolite that has been 
extensively evaluated for toxicity is MBC. The toxicity of MBC is well 
understood and documented in the report of the International Programme 
on Chemical Safety (Environmental Health Criteria 149).
    8. Endocrine disruption. No effects were observed that would 
indicate that the endocrine system is disrupted with regard to the 
reproductive system (i.e., is anti-estrogenic, estrogenic, androgenic, 
or anti-androgenic). Thiophanate-methyl does alter thyroid function 
through the thyroid stimulating hormone.

C. Aggregate Exposure

    1. Dietary exposure. Dietary exposure is the primary route of 
exposure to thiophanate-methyl. Tolerances have been established for 
the residues of thiophanate-methyl in or on a variety of raw 
agricultural commodities.
    i. Food. For the purposes of assessing the potential dietary 
exposure for these existing and pending tolerances, Cerexagri, Inc. 
conducted exposure estimates using the Lifeline software version 1.1 
from The Lifeline Group, results from field trials and processing 
studies, monitoring data, consumption data from the 1994-1996, 1998 
USDA Continuing Surveys of Food Intakes by Individuals (CSFII), and 
information on the percentages of the crops treated (where available) 
with thiophanate-methyl were utilized.
    ii. Drinking water. Thiophanate-methyl is not expected to be found 
in water. The half-life of thiophanate-methyl is very short in soil and 
water. When metabolized or chemically converted to MBC, none is 
expected to leave the soil. In dissipation studies neither thiophanate-
methyl nor MBC was found below the top layer of the soil (0-8 cm or 0-6 
inches). Little to no thiophanate-methyl exposure is expected in 
drinking water.
    2. Non-dietary exposure. Thiophanate-methyl has turf use patterns. 
The primary use is commercial (golf course, turf sale). Based on the 
limited use of the product on golf courses, and the low dermal 
toxicity, little to no contribution to the thiophanate-methyl risk cup 
is expected through non-occupational exposure.

D. Cumulative Effects

    Benomyl (marketed until recently), MBC, thiabendazole, and 
thiophanate-methyl have been evaluated for similar toxicity patterns 
because of the potential structure-activity relationship. Thiophanate-
methyl, although displaying some similarities to each of the other 
benzimidazoles, is also very different. These benzimidazoles do not 
share a toxicity profile that would indicate there is common mode of 
action. The difference in toxicity patterns is apparent in the recent 
HED Revised Preliminary Risk Assessment for thiophanate-methyl. In this 
assessment, none of the NOAELs for thiophanate-methyl are based on 
liver effects, while both subchronic and chronic NOAELs for MBC are 
based on liver effects. In acute studies, MBC has testicular effects, 
while thiophanate-methyl induce tremors at high doses. The main overlap 
in toxicity profiles between thiophanate-methyl and MBC are non-
specific effects such as reduced food consumption and body weights in 
dietary studies.
    In addition, for subchronic and chronic exposures, thiophanate-
methyl toxicity primarily involves the thyroid. In contrast, no 
disruption of the thyroid-pituitary-liver axis is documented in either 
the carbendazim or the benomyl studies. Secondary effects on the liver 
could be seen in common, but these too are very different. If driven by 
MBC alone, thiophanate-methyl should have a dose effect much higher 
than MBC. In fact, it is two to three times higher. Reproductive, 
developmental and genetic toxicity are also different between 
thiophanate-methyl and MBC. Likewise, thiabendazole is different than 
thiophanate-methyl. It does not metabolize to MBC and shows significant 
differences from thiophanate-methyl in the type of toxicities observed. 
Therefore, there is no scientific basis for aggregating this class of 
fungicides, due to a lack of common mechanisms of toxicity.

E. Safety Determination

    1. U.S. population. For both the general population and all 
specific sub-populations, there is a reasonable certainty of no harm 
associated with all exposure assessments. Non-cancer and cancer risks 
are lower than have been previously calculated by EPA because: (i) PDP 
data were used where appropriate rather than field trial data, (ii) 
updated usage data lowered the estimates of the percent of crop treated 
for some key commodities, such as stone fruit, and (iii) a consumer 
washing factor of 0.07 was used for smooth skinned fruits (apples, 
blueberries, and strawberries). Note that two separate Lifeline 
analyses were conducted and submitted to EPA, one on October 3, 2001, 
and a second on October 19, 2001. The second analysis used actual MBC 
residues to calculate MBC and 2-AB residues, rather than estimating 
them based on thiophanate-methyl residues. The use of actual MBC data 
provided a more accurate assessment of exposure.
    2. Infants and children. The rabbit study indicated that even at 
twice the maternal LOAEL, thiophanate-methyl induced only two effects 
of questionable significance, increase in supernumerary ribs (a 
reversible condition) and a reduction in fetal weight that was not 
statistically significant and was likely related to maternal toxicity. 
The rat developmental study showed no teratogenic or fetotoxic effects 
at any dose tested.
    The thiophanate-methyl 2-generation reproduction study showed 
thyroid and liver effects in both the parental and first generation 
pups. The effects were greater in the parental animals than in 
subsequent generations. This would indicate that there is no greater 
sensitivity for infants and children to thiophanate-methyl than the 
general population.

F. International Tolerances

    There are no Codex Alimentarius Commission tolerances for canola, 
pistachios, or potatoes. The European Union tolerances for each of the 
three commodities is 0.1 ppm (lower limit of analytical determination).

[FR Doc. 02-7497 Filed 3-27-02; 8:45 a.m.]
BILLING CODE 6560-50-S