[Federal Register Volume 64, Number 179 (Thursday, September 16, 1999)]
[Notices]
[Pages 50280-50283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24168]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-890; FRL-6098-3]


Notice of Filing a Pesticide Petition 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 initial filing of a pesticide 
petition 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-890, must be 
received on or before October 1, 1999.

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'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number PF-890 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Jim Tompkins, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460; telephone number: (703) 305-5697; and e-mail address: 
[email protected].


[[Page 50281]]


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            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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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-890. 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-890 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, 401 M St., SW., 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 5.1/
6.1 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-890. 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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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 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 supports 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

[[Page 50282]]

and pests, Reporting and recordkeeping requirements.

    Dated: September 7, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary 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 views of the 
petitioner. 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.

 Zeneca Ag. Products

 PP5F4554

    EPA has received a pesticide petition [PP 5F4554] from Zeneca Ag. 
Products, 1800 Concord Pike, P. O. Box 15458, Wilmington, DE 19850-5458 
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 sulfosate (the 
trimethylsulfonium (TMS) salt of glyphosate, also known as glyphosate-
trimesium in or on the raw agricultural commodity (RAC) wheat grain at 
10 parts per million (ppm) (of which no more than 2.5 ppm is TMS); 
wheat hay at 1 ppm (of which no more than 0.5 ppm is TMS); wheat straw 
at 90 ppm (of which no more than 40 ppm is TMS); wheat bran at 30 ppm 
(of which no more than 6 ppm is TMS); and wheat shorts at 20 ppm (of 
which no more than 5 ppm is TMS); and to increase the tolerance in 
poultry meat by-products to 0.5 ppm and in milk to 2 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 sulfosate has been studied 
in corn, grapes, and soybeans. EPA has concluded that the nature of the 
residue is adequately understood and that the only residues of concern 
are the parent ions N-(phosphonomethyl)-glycine anion (PMG) and 
trimethylsulfonium cation.
    2. Analytical method. Gas chromatography/mass selective (GC/MS) 
detector methods have been developed for PMG analysis in crops, animal 
tissues, milk, and eggs. GC detection methods have been developed for 
TMS in crops, animal tissues, milk, and eggs.
    3. Magnitude of residues in crops-- Wheat. Residue data are 
available for sulfosate in a total of 20 trials conducted in 8 EPA 
regions. The proposed tolerance of 1 ppm (of which no more than 0.5 ppm 
is TMS) for wheat hay; the proposed tolerance of 10 ppm (of which no 
more than 2.5 ppm is TMS) for wheat grain; and the proposed tolerance 
of 90 ppm (of which no more than 40 ppm is TMS) for wheat straw will 
accommodate any residue resulting from the proposed use pattern.
    Wheat seed for processing were obtained and samples were processed. 
Analysis of the treated samples showed that residue of PMG and TMS 
concentrated in wheat bran, wheat shorts, and aspirated grain 
fractions. The proposed tolerance for wheat bran of 30 ppm (of which no 
more than 6 ppm is TMS) and the proposed tolerance for wheat shorts of 
20 ppm (of which no more than 5 ppm is TMS) is adequate to accommodate 
any residues arising from this use pattern in wheat. No tolerances are 
required for wheat middlings or patent flour. Aspirated grain fractions 
(AGF) were also collected. Analysis of the treated samples showed that 
residue of both TMS and PMG concentrated in AGF, but the combined 
levels are less than the existing tolerance in 40 CFR 180.489 for AGF. 
No change in the existing tolerance is required.
    4. Magnitude of residue in animals--i. Ruminants. The maximum 
dietary burden in dairy cows results from a diet comprised of 20% AGF, 
60% wheat forage, 15% sweet corn stover, and 5% cotton gin byproducts 
for a total dietary burden of 427 ppm. The maximum dietary burden in 
beef cows results from a diet comprised of 20% AGF, 25% sweet corn 
stover, 25% sorghum grain, 25% wheat forage, and 5% cotton gin 
byproducts for a total dietary burden of 438 ppm. Comparison to a 
ruminant feeding study at a dosing level of 1,000 ppm indicates that 
the appropriate tolerance levels resulting from proposed additional 
uses are covered by existing tolerances in 40 CFR 180.489, except milk. 
The appropriate tolerance for milk is 2 ppm.
    ii. Poultry. The maximum dietary burden in poultry results from a 
diet comprised of 80% sorghum grain and 20% soybean hulls for a total 
dietary burden of 43 ppm. Comparison to a poultry feeding study at a 
dosing level of 50 ppm indicates that the appropriate tolerance levels 
are covered by existing tolerances in 40 CFR 180.489, except poultry 
meat by-products. The appropriate tolerance for poultry meat by-product 
is 0.5 ppm.

B. Toxicological Profile

    1. Acute toxicity. Several acute toxicology studies have been 
conducted placing technical grade sulfosate in Toxicity Category III 
and IV.
    2. Genotoxicty. The toxicological endpoints for sulfosate are 
discussed in Unit 3.B. of the Federal Register notice of April 8, 1999 
(64 FR 17171) (FRL 6071-2).
    3. Reproductive and developmental toxicity. The toxicological 
endpoints for sulfosate are discussed in Unit 3.B. of the Federal 
Register notice of April 8, 1999 (FR 17171).
    4. Subchronic toxicity. The toxicological endpoints for sulfosate 
are discussed in Unit 3.B. of the Federal Register notice of April 8, 
1999 (64 FR 17171).
    5. Chronic toxicity. The toxicological endpoints for sulfosate are 
discussed in Unit 3.B. of the Federal Register notice of April 8, 1999 
(FR 17171).
    6. Animal metabolism. The metabolism of sulfosate has been studied 
in animals. The residues of concern for sulfosate in meat, milk, and 
eggs are the parent ions PMG and TMS only.
    7. Metabolite toxicology. There are no metabolites of toxicological 
concern. Only the parent ions, PMG and TMS are of toxicological 
concern.
    8. Endocrine disruption. Current data suggest that sulfosate is not 
an endocrine disruptor.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. For the purposes of assessing the 
potential dietary exposure, Zeneca has utilized the tolerance level for 
all existing and pending tolerances; and the proposed maximum 
permissible levels of 10 ppm for wheat grain (of which no more than 2.5 
ppm is TMS); 1 ppm for wheat hay (of which no more than 0.5 ppm is 
TMS); 90 ppm for wheat straw (of which no more than 40 ppm is TMS); 30 
ppm for wheat bran (of which no more than 6 ppm is TMS); and 20 ppm for 
wheat shorts (of which no more than 5 ppm is TMS) and 100% crop treated 
acreage for all commodities. Assuming that 100% of foods, meat, eggs, 
and milk products

[[Page 50283]]

will contain sulfosate residues and those residues will be at the level 
of the tolerance results is an overestimate of human exposure. This is 
a very conservative approach to exposure assessment.
    a. Chronic exposure. For all existing and pending tolerances; and 
the proposed maximum permissible levels proposed in this notice of 
filing, the potential exposure for the U.S. population is 0.04 
milligrams/kilograms bodyweight/day (mg/kg bwt/day) (17.6% of reference 
dose (RfD). Potential exposure for children's population subgroups 
range from 0.02 mg/kg bwt/day (7.8% of RfD for nursing infants (< 1 
year old) to 0.12 mg/kg/ bwt/day (47.8%) for children 1-6 years old. 
The chronic dietary risk due to food does not exceed the level of 
concern (100%).
    b. Acute exposure. The exposure to the most sensitive population 
subgroup, non-nursing infants, is 23.5% of the acute RfD at the 95th 
percentile. The acute dietary risk due to food does not exceed the 
level of concern (100%).
    ii. Drinking water. Results from computer modeling indicate that 
sulfosate in ground water will not contribute significant residues in 
drinking water as a result of sulfosate use at the recommended maximum 
annual application rate (8.00 lbs a.i./acre). The computer model uses 
conservative numbers, therefore it is unlikely that ground water 
concentrations would exceed the estimated concentration of 0.014 parts 
per billion (ppb), and sulfosate should not pose a threat to ground 
water.
    The surface water estimates are based on an exposure modeling 
procedure called GENEEC (Generic Expected Environmental Concentration). 
The assumptions of two applications of 4.00 lbs a.i./acre resulted in 
calculated estimated maximum concentrations of 58 ppb (acute, based on 
the highest 56-day value) and 10 ppb (chronic, average). GENEEC 
modeling procedures assumed that sulfosate was applied to a 10-hectare 
field that drained into a 1-hectare pond, 2-meters deep with no outlet.
    As a conservative assumption, because sulfosate residues in 
groundwater are expected to be insignificant compared to surface water, 
it has been assumed that 100% of drinking water consumed was derived 
from surface water in all drinking water exposure and risk 
calculations. To calculate the maximum acceptable acute and chronic 
exposures to sulfosate in drinking water, the dietary food exposure 
(acute or chronic) was subtracted from the appropriate (acute or 
chronic) RfD. Drinking Water Levels of Concern (DWLOCs) were then 
calculated using the maximum acceptable acute or chronic exposure, 
default body weights (70 kg - adult, 10 kg - child), and drinking water 
consumption figures (2 liters - adult, 1 liter - child).
    The maximum concentration of sulfosate in surface water is 58 ppb. 
The acute DWLOCs for sulfosate in surface water were all greater than 
5,400 ppb. The estimated average concentration of sulfosate in surface 
water is 10 ppb which is much less than the calculated levels of 
concern (> 1,300 ppb) in drinking water as a contribution to chronic 
aggregate exposure. Therefore, for current and proposed uses of 
sulfosate, Zeneca concludes with reasonable certainty that residues of 
sulfosate in drinking water would not result in unacceptable levels of 
aggregate human health risk.
    2. Non-dietary exposure. Sulfosate is currently not registered for 
use on any residential non-food sites. Therefore, residential exposure 
to sulfosate residues will be through dietary exposure only.

D. Cumulative Effects

    There is no information to indicate that toxic effects produced by 
sulfosate are cumulative with those of any other chemical compound.

E. Safety Determination

    1. U.S. population--i. Acute risk. Since there are no residential 
uses for sulfosate, the acute aggregate exposure only includes food and 
water. Using the conservative assumptions of 100% of all crops treated 
and assuming all residues are at the tolerance level for all 
established and proposed tolerances, the aggregate exposure to 
sulfosate will utilize 12.3% of the acute RfD at the 95th percentile 
for the U.S. population. The estimated peak concentrations of sulfosate 
in surface and ground water are less than DWLOCs for sulfosate in 
drinking water as a contribution to acute aggregate exposure. Residues 
of sulfosate in drinking water do not contribute significantly to the 
aggregate acute human health risk considering the present uses and uses 
proposed in this action.
    ii. Chronic risk. Using the conservative exposure assumptions 
described above, the aggregate exposure to sulfosate from food will 
utilize 17.6% of the chronic RfD for the U.S. population. The estimated 
average concentrations of sulfosate in surface and ground water are 
less than DWLOCs for sulfosate in drinking water as a contribution to 
chronic aggregate exposure. Residues of sulfosate in drinking water do 
not contribute significantly to the aggregate chronic human health risk 
considering the present uses and uses proposed in this action.
    2. Infants and children. The data base on sulfosate relative to 
prenatal and postnatal toxicity is complete. Because the developmental 
and reproductive effects occurred in the presence of parental 
(systemic) toxicity, these data do not suggest an increased prenatal or 
postnatal sensitivity of children and infants to sulfosate exposure. 
Therefore, Zeneca concludes, upon the basis of reliable data, that a 
100-fold uncertainty factor is adequate to protect the safety of 
infants and children and an additional safety factor is unwarranted.
    i. Acute risk. Using the conservative exposure assumptions 
described above, the aggregate exposure to sulfosate from food will 
utilize 23.5% of the acute RfD at the 95th percentile for the most 
highly exposed group, children (1-6 years). The estimated peak 
concentrations of sulfosate in surface and ground water are less than 
DWLOCs for sulfosate in drinking water as a contribution to acute 
aggregate exposure. Residues of sulfosate in drinking water do not 
contribute significantly to the aggregate acute human health risk 
considering the present uses and uses proposed in this action.
    ii. Chronic risk. Using the conservative exposure assumptions 
described above, we conclude that the percent of the RfD that will be 
utilized by aggregate exposure to residues of sulfosate is 47.8% for 
children (1-6 years), the most highly exposed group. The estimated 
average concentrations of sulfosate in surface and ground water are 
less than DWLOCs for sulfosate in drinking water as a contribution to 
chronic aggregate exposure. Residues of sulfosate in drinking water do 
not contribute significantly to the aggregate chronic human health risk 
considering the present uses and uses proposed in this action.

F. International Tolerances

    There are no Codex Maximum Residue Levels established for 
sulfosate.
[FR Doc. 99-24168 Filed 9-15-99; 8:45 am]
BILLING CODE 6560-50-F