[Federal Register Volume 65, Number 76 (Wednesday, April 19, 2000)]
[Notices]
[Pages 20968-20971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9665]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-923; FRL-6495-7]


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

[[Page 20969]]

pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-923, must be 
received on or before May 19, 2000.

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-923 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Marshall Swindell, PM 33 
Regulatory Management Branch I, Antimicrobials Division (7510C), Office 
of Pesticide Programs, Environmental Protection Agency, Ariel Rios 
Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (703) 308-6341; 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'' 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-923. 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-923 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, Ariel Rios Bldg., 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-923. 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

[[Page 20970]]

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 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 and pests, Reporting and recordkeeping 
requirements.

    Dated: May 11, 2000.
Frank Sanders,
Director, Antimicrobials 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 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.

Milliken Chemical

8F5007

    EPA has received a supplement to a pesticide petition (8F5007) from 
Milliken Chemical, P.O. Box 1927, Spartanburg, SC 29304-1927, 
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 to 
establish an exemption from the requirement of a tolerance for silver 
sodium hydrogen zirconium phosphate, when used as an antimicrobial 
agent at levels up to 2% by weight, in or on polymers used for food-
contact surfaces, for the following applications: containers, tubing, 
utensils, hardware, filters, appliances, food preparation, or 
processing surfaces, food storage devices, coverings, film, packaging 
(other than food packaging regulated exclusively by the Food, and Drug 
Administration (FDA)), fabrics, equipment, conveyance, and transport 
items, and tools. 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. Silver sodium hydrogen zirconium phosphate 
will not be used on growing plants. Plant metabolism studies are 
therefore not necessary.
    2. Analytical method. Silver sodium hydrogen zirconium phosphate 
and its potential migration products, silver and zirconium, have been 
determined to be at such low levels that there is no need for an 
established method for quantitating levels of such residues in or on 
food.
    3. Magnitude of residues. The proposed use of silver sodium 
hydrogen zirconium phosphate is at levels up to 2% by weight in or on 
substances such as polymers. Migration studies estimate the maximum 
amounts of silver and zirconium that might migrate from a polymer 
impregnated with silver sodium hydrogen zirconium phosphate are less 
than the limits of detection (i.e., 10 parts per billion (ppb) for 
silver, and 20 ppb for zirconium). The levels of anticipated residues 
of silver and zirconium that might migrate from contact substances into 
or onto food are expected to be negligible.

B. Toxicological Profile

    1. Acute toxicity. The acute toxicity data for silver sodium 
hydrogen zirconium phosphate are the following: (i) The acute median 
lethal oral dose in rats is greater than 5 g/kg body weight (Toxicity 
Category IV); (ii) the acute median lethal dermal dose in rats is 
greater than 2 g/kg body weight (Toxicity Category III); (3) the acute 
inhalation median lethal concentration is greater than 5.18 milligram 
liter (mg/L) in rats with nose only exposure (Toxicity Category IV); 
(iv) eye irritation and opacity is reversible within 72 hours in 
rabbits (Toxicity Category III); (v) no dermal irritation is induced 
when applied at 0.5 g under occlusion to rabbits (Toxicity Category 
IV); and (vi) no evidence of dermal sensitization is produced in guinea 
pigs.
    2. Genotoxicity. Mutagenicity tests for silver sodium hydrogen 
zirconium phosphate are negative in the Ames Salmonella typhimurium, 
and Escherichia coli (wp2 uvrA) assays with and without activation, and 
are negative in the forward mutation mouse lymphoma assay with and 
without activation. Silver sodium hydrogen zirconium phosphate shows no 
evidence for chromosome-damaging activity in the mouse micronucleus 
test.
    3. Reproductive and developmental toxicity. Doses up to 1,000 
milligrams/kilograms/day (mg/kg/day) of silver sodium hydrogen 
zirconium phosphate showed no evidence for maternal toxicity and no 
statistically significant test material-related effects on the growth 
and development of offspring. Visceral and skeletal anomalies were 
proportional in fetuses from control and treated rats. The maternal 
(systemic) no observed adverse effect level (NOAEL) was 1,000 mg/kg/
day, and the developmental (fetal) NOAEL was 1,000 mg/kg/day.
    4. Subchronic toxicity--i. Palatability study. Doses up to 1,000 
mg/kg/day of silver sodium hydrogen zirconium phosphate in the diet of 
male and female rats for 14 days caused no deaths, no abnormal clinical 
signs, no effects on body weights, and no palatability problems.
    ii. Ninety-day oral toxicity. Male and female rats were 
administered silver sodium hydrogen zirconium phosphate in the diet for 
13 weeks at concentrations up to 1,000 mg/kg/day. Increases in 
cholesterol in males and in alkaline phosphatase in females were 
observed but were not biologically significant. The NOAEL was 1,000 mg/
kg/day, and the NOAEL was 30 mg/kg/day.
    5. Chronic toxicity. No chronic exposure to silver sodium hydrogen 
zirconium phosphate is expected, therefore, no chronic toxicity studies 
are needed. Five chronic toxicity studies failed to show effects when 
silver was administered in the drinking water of rats.
    6. Carcinogenicity. No chemical carcinogenicity is expected from 
silver sodium hydrogen zirconium phosphate. This is based on the 
absence of significant adverse toxicological effects in the subchronic 
study, and negative genotoxicity data. Negligible exposure to migrant 
silver is expected from the proposed uses of silver sodium hydrogen 
zirconium, based on migration studies. The levels of silver found in 
the normal human diet are greater than could potentially arise from 
migration. EPA classifies silver as a Group D carcinogen.

[[Page 20971]]

    7. Metabolite toxicology. The principal migration products from 
silver sodium hydrogen zirconium phosphate are silver and zirconium. 
Silver has an EPA reference dose (RfD) of 0.005 mg/kg/day and does not 
occur normally in animal or human tissues. The major effect of 
excessive absorption of silver is local or generalized impregnation of 
the tissue with silver, a condition called argyria. Argyria is not 
associated with any adverse health effects. Silver is absorbed from the 
lungs and in small amounts from the gastrointestinal (GI) tract, and 
form complexes with albumin. The GI tract is the major route of 
excretion of silver (90 to 99% in 2 days).
    Zirconium is extensive in the human diet with the daily uptake up 
to 125 mg. The toxicity level for this ubiquitous element is 
negligible. Zirconium is present and retained in high quantities in 
biological systems, but has not been associated with any specific 
metabolic function. The average body burden is 250 mg.
    8. Endocrine disruption. Silver sodium hydrogen zirconium 
phosphate, silver, and zirconium are not chemically or structurally 
similar to natural hormones, and are not expected to disrupt, block, 
enhance, mimic, or otherwise interfere with normal endocrine system 
functions.

C. Aggregate Exposure

    1. Dietary exposure. Based on the toxicity data, an aggregate risk, 
or likelihood of the occurrence of an adverse health effect resulting 
from all routes of exposure to silver sodium hydrogen zirconium 
phosphate is not anticipated. Used in polymeric food contact 
substances, dietary exposures to migrant silver and zirconium are 
estimated in migration studies to be below 10 ppb for silver, and 20 
ppb for zirconium. These levels are much less than in a normal human 
diet. For the migration studies, silver sodium hydrogen zirconium 
phosphate was embedded in a polymer, and migrant silver and zirconium 
were extracted into ethanol for quantitation by atomic absorption 
(silver) and UV/VIS absorption (zirconium). The Estimated Dietary 
Intakes (EDIs) that might be expected to enter the diet as a result of 
the proposed use of the silver sodium hydrogen zirconium phosphate were 
12 g/day (silver), and 24 g/day (zirconium). These 
levels are not expected to induce toxicity.
    i. Food. Silver sodium hydrogen zirconium phosphate will be 
incorporated into polymeric food contact substances, will not be 
introduced intentionally into food, and is not expected to induce acute 
or chronic toxicological concerns. The calculated RfD for silver sodium 
hydrogen zirconium phosphate is 0.003 mg/kg/day and is based on the 
subchronic toxicity (NOAEL=30 mg/kg/day) and accepted uncertainty 
factors that account for extrapolation from the subchronic NOAEL, 
extrapolation from animals to humans, variation among the human 
population, and a worst case modifying factor. EPA RfD for silver is 
0.005 mg/kg/day.
    ii. Drinking water. Silver sodium hydrogen zirconium phosphate will 
be incorporated into polymeric food contact substances and will not be 
introduced intentionally into the environment or the drinking water. If 
a drinking water exposure of 1 mg were assumed, the lifetime daily 
exposure level would be 1.0  x  10-6 mg/kg/day and would not 
cause toxic responses.
    2. Non-dietary exposure. The proposed uses of silver sodium 
hydrogen zirconium phosphate are not expected to result in any 
significant non-dietary exposure for the general population.

D. Cumulative Effects

    The cumulative exposure assessment provides an estimate of the 
extent to which a defined population is exposed to two or more 
chemicals which share a common mechanism of toxicity by all relevant 
routes and from all relevant sources. There are no data to suggest that 
silver or zirconium are synergistic or antagonistic of each other, or 
of silver sodium hydrogen zirconium phosphate.

E. Safety Determination

    1. U.S. population. The toxicology data provided to establish an 
exemption from the requirement of a tolerance for silver sodium 
hydrogen zirconium phosphate demonstrate that this substance is of a 
very low order of toxicity. The EDIs for the silver and zirconium 
migrants from the pesticide chemical are 12 g/day (4 ppb) for 
silver, and 24 g/day (8 ppb) for zirconium. These exposure 
levels are not significant health or safety concerns. The RfD for 
silver sodium hydrogen zirconium phosphate is 0.003 mg/kg/day and is 
comparable to the RfD of 0.005 mg/kg/day for silver. For zirconium, 
neither an RfD nor an ADI have been established due to the absence of 
toxicological concern for this ubiquitous element. Zirconium is present 
at high levels in foods; the average daily intake is estimated to be 
4.2 mg/kg/day. This level far exceeds the maximum contribution of 
zirconium anticipated from silver sodium hydrogen zirconium phosphate 
in polymeric food-contact materials.
    For drinking water, EPA has established a Secondary Maximum 
Contaminant Level (SMCL) for silver of 0.1 mg/L, and the FDA bottled 
drinking water standard is 50 g/L. These standards far exceed 
the anticipated drinking water exposure levels of 0.039 g/kg 
calculated for silver sodium hydrogen zirconium phosphate.
    2. Infants and children. The potential for additional sensitivity 
of infants and children was assessed from a developmental toxicity 
study in rats. Doses up to 1,000 mg/kg/day elicited no maternal 
toxicity and no significant effects on the growth and development of 
offspring (fetal NOAEL = 1,000 mg/kg/day).
    Based on migration data with silver sodium hydrogen zirconium 
phosphate, consumption patterns of infants and children (i.e., a 10 kg 
child consumes 1 kg of food), and the assumption that 80% of the diet 
comes into contact with polymeric packaging material containing the 
pesticide chemical, the expected dietary exposure to silver and 
zirconium are calculated as:

    Silver: 0.80  x  5 ppb = 4 ppb (4 ppb of 1,000 g daily diet = 4 
g/person/day).
    Zirconium: 0.80  x  10 ppb = 8 ppb (8 ppb of 1,000 g daily diet 
= 8 g/person/day).

    These exposure levels are not expected to cause toxicological 
responses.
    There is no evidence that infants and children would: (1) consume 
disproportionately high levels of food containing residues of sodium 
hydrogen zirconium phosphate, silver or zirconium; (2) be more 
susceptible to silver sodium hydrogen zirconium phosphate, silver or 
zirconium; (3) be susceptible to growth and development defects or 
neurological effects induced by silver sodium hydrogen zirconium 
phosphate; or (4) experience harm from cumulative or aggregate 
exposures to silver sodium hydrogen zirconium phosphate or to silver 
and zirconium.

F. International Tolerances

    There are no international tolerances for silver sodium hydrogen 
zirconium phosphate. There are no U.S. EPA, CODEX (international), 
Canadian or Mexican tolerances for silver.

[FR Doc. 00-9665 Filed 4-18-00; 8:45 am]
BILLING CODE 6560-50-F