[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:
tompkins.jim@epa.gov.
[[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
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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 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: opp-docket@epa.gov,'' 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
