[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20545-20549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7330]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0076; FRL-7703-9]


Aluminum-magnesium Hydroxy Carbonate; Notice of Filing a 
Pesticide Petition for Exemption from Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition

[[Page 20546]]

proposing the establishment of regulations for residues of a certain 
pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0076, must be received on or before May 20, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-2857; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2005-0076. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your

[[Page 20547]]

comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0076. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2005-0076. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0076.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0076. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket 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 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA 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 30, 2005
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
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. EPA has not fully evaluated the merits of this 
pesticide petition. The summary may have been edited by EPA if the 
terminology used was unclear, the summary contained extraneous 
material, or the summary unintentionally made the reader conclude that 
the findings reflected EPA's position and not the position of the 
petitioner.

Keller & Heckman LLP

PP 5E6907

    EPA has received a pesticide petition (5E6907) from Keller & 
Heckman LLP, 1001 G St., NW., Suite 500, Washington, DC 20001, 
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 
aluminum-magnesium hydroxy carbonate (CAS No. 85585-93-9) when used in 
the formulation process for antimicrobial pesticides used on food-
contact surfaces and in water that contacts raw agricultural 
commodities postharvest. EPA has determined that the petition contains 
data or information regarding the elements set forth in section 
408(d)(2) of FFDCA; 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.

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A. Residue Chemistry

    An analytical method for residues is not applicable, as this 
petition proposes an exemption from the requirement of a tolerance.

B. Toxicological Profile

    Hydrated aluminum oxide and magnesium oxide (MgO) are the principal 
components of aluminum-magnesium hydroxy carbonate. Both of these 
materials have been reviewed by EPA, and are exempt from the 
requirement of a tolerance without limitation at 40 CFR 180.910 when 
used in pesticide formulations that are applied to growing crops, or to 
postharvest raw agricultural commodities. Additionally, EPA has 
exempted a similar substance, magnesium carbonate, from the requirement 
of a tolerance at 40 CFR 180.910. The stability of aluminum-magnesium 
hydroxy carbonate (insoluble except in strong acids) indicates that it 
does not present a greater potential for exposure to the components 
used in its preparation, and the uses proposed for it are identical to 
uses that are currently cleared by EPA for the starting materials (flow 
agent and solid diluent).
    1. Acute toxicity. To assess the acute toxicity, the composition of 
aluminum-magnesium hydroxy carbonate was compared to aluminum oxides 
and hydroxides, to magnesium oxides and hydroxides, and to other 
components used to produce the finished product. When manufactured, 
aluminum-magnesium hydroxy carbonate forms a layered lattice, similar 
to that of clay minerals. It may be further formed into shapes, or used 
as a loose powder to absorb moisture in dry formulations. Magnesium 
oxide and aluminum hydroxide are used in antacids sold over the counter 
in the United States. No acute toxicity data were identified for oxides 
or hydroxides of magnesium or aluminum. However, the salts of these 
metals have been assessed in acute toxicity studies.
    An acute toxicity study of magnesium chloride (MgCl2) 
administered intravenously in ICR (ICR refers to a strain of mice) mice 
identified an LD50 (lethal dose that causes death to half 
the test animals) of 14.4 mg/kg bw. However, MgCl2 
administered via the oral route resulted in an LD50 of 
>2,500 mg/kg bw. In reports of human exposure to magnesium compounds, 
large doses (unspecified) can cause metabolic alkalosis, diarrhea, 
dehydration, and cardiac arrest. Exposure to MgO fumes has been 
associated with leukocytosis and fever.
    Male mice were administered aluminum sulfate 
(Al(SO4)3) or aluminum chloride 
(AlCl3) via oral gavage. The LD50 was reported as 
980 milligrams aluminum/kilograms body weight (mg aluminum/kg bw,) and 
the LD50 of AlCl3 as 770 mg aluminum/kg bw.
    An acute inhalation study of aluminum dust was completed in male 
Fischer rats. Rats were exposed to nominal chamber concentrations of 
10, 50, 100, 200 and 1,000 mg/m\3\ for four hours (mean geometric 
particle diameter of 2.82 [mu]m). The acute inhalation LC50 
(lethal concentration of the test substance to half the animals) of 
aluminum metal is reported as greater than 1,000 mg aluminum/m\3\, as 
no animal fatalities occurred during the study.
    2. Genotoxicity. The mutagenic potential of AlCl3 in 
Salmonella typhimurium strain TA102 was studied at doses of 10, 30, 
100, 300 and 1,000 nM per plate. No base-pair substitutions or frame 
shift mutations were observed at up to 1,000 nM/plate.
    A mouse lymphoma mutagenicity assay was completed with several 
metal salts, including MgCl2 and AlCl3. Exposure 
of cells to MgCl2 from 22,000 to 32,000 [mu]g/mL resulted in 
no increase in mutations over the negative control. Exposure to 
AlCl3 from 570 to 625 [mu]g/mL resulted in a two-fold 
increase in mutations over the negative control, but was not considered 
to be related to exposure to AlCl3, since survival was not 
related to dose.
    Male albino rats, 8 weeks old, were administered (by gavage) 
Al2(SO4)3 [middot]18 H2O 
suspended in deionized water; 15 animals/dose received 212, 265, 353, 
530, 1,060 or 2,120 mg/kg bw for 21 days. Prolonged treatment of rats 
with aluminum sulfate caused a dose-dependent inhibition of dividing 
cells (bone marrow) and an increase in chromosomal aberrations.
    3. Reproductive and developmental toxicity. Magnesium is an 
essential mineral in animals, and its deficiency has been linked to 
reduced viability, increased resorptions, skeletal malformations, and 
heart and lung anomalies in rats. No adverse developmental effects of 
excessive intake of magnesium were identified.
    The reproductive and developmental toxicity of aluminum is unclear, 
based on two separate studies reported by a particular investigator. 
Pregnant Wistar rats were administered 0, 192, 384, or 768 mg 
Al(OH)3/kg bw/day through gestation day 20, sacrificed, and 
maternal and fetal effects recorded. There were no maternal or 
developmental effects in any of the treatment groups that differed from 
those of the control group of rats. A no-observed-effects-level (NOEL) 
of 768 mg/kg/day was reported. Pregnant Sprague-Dawley rats were 
administered Al(OH)3 (384 mg/kg), Al(OH)3 plus 
citric acid (384 mg/kg and 62 mg/kg, respectively), or aluminum citrate 
(1,064 mg/kg) by gavage on gestation days 6 to 15. All animals were 
sacrificed on gestation day 20, and maternal and fetal effects 
recorded. Maternal body weights were significantly reduced in the 
aluminum hydroxide/citric acid treatment group. Fetal body weights were 
significantly lower in the aluminum hydroxide/citric acid treatment 
group, and the incidence of fetal skeletal development defects was 
significantly increased.
    4. Subchronic toxicity. Male Sprague-Dawley rats were administered 
aluminum hydroxide (302 mg aluminum/kg), sodium aluminum phosphate (141 
mg aluminum/kg), or dibasic sodium aluminum phosphate (67 or 288 mg 
aluminum/kg) in the diet for 28 days. No treatment-related effects were 
reported at any dose in any of the treatment groups, when compared to 
the control. Male and female beagle dogs were administered sodium 
aluminum phosphate for six months; mean dietary concentrations were 0, 
118, 317, and 1,034 mg/kg/day in male dogs, and 112, 361, and 1,087 mg/
kg/day in female dogs. No treatment-related effects were reported, 
except for a sporadic decrease in food intake in females of all 
treatment groups, without a corresponding decrease in body weight. A 
NOEL of 1,034 mg/kg bw/day was reported.
    5. Chronic toxicity. Several studies suggest that aluminum is not 
carcinogenic, and that it may induce a protective immune response to 
implanted tumors. Both reviews suggest that results of epidemiological 
studies linking aluminum compounds to cancers are questionable.
    Male Syrian golden hamsters received 2 mg MgO, aluminum oxide 
(Al2O3), or carbon in 0.9% sodium chloride (NaCl) 
solution by intratracheal instillation once per week for 30 weeks. 
Negative and positive controls were 0.9% NaCl solution and 
diethylnitrosamine, respectively. No tumors were identified in hamsters 
in the Al2O3 treatment group, although lung 
fibrosis, macrophages, and multinucleated giant cells were observed. 
The MgO treatment group had a significantly higher incidence of 
histiocytic lymphomas than the negative control. Interestingly, 
hamsters treated simultaneously with diethylnitrosamine (subcutaneous 
injection) and MgO did not develop similar lymphomas.

[[Page 20549]]

    6. Animal metabolism. Magnesium is an essential mineral in animals. 
It is used therapeutically to treat hypertension, myocardial 
infarction, and cardiac arrhythmia. Large doses of magnesium salts are 
administered orally to cleanse the colon prior to endoscopic 
procedures. Normal human serum contains 2 to 5 mg magnesium/dL. 
Magnesium salts are poorly absorbed from the intestines, and cause 
osmotic withdrawal of water into the intestinal lumen; it is ultimately 
excreted in the feces.
    Aluminum metabolism is compound-dependent, but is generally very 
low. Approximately 0.01% of aluminum hydroxide is absorbed when 
administered via the oral route. Consequently, the majority is excreted 
in the feces, and the remainder is excreted in the urine. Distribution 
of aluminum compounds is not well understood, due to the levels that 
occur naturally in and outside the body. Aluminum that is absorbed is 
generally sequestered in bone tissue, and gradually accumulates over 
time.
    7. Endocrine disruption. No evidence of endocrine disruption from 
magnesium compounds or aluminum compounds was identified.

C. Aggregate Exposure

    1. Dietary exposure -- i.Food. Exposure to aluminum-magnesium 
hydroxy carbonate from food is not anticipated, due to its insolubility 
(except in strong acids) and the lack of potential for contact with 
food or food-contact surfaces under the proposed conditions of use. 
Additionally, the components in aluminum-magnesium hydroxy carbonate 
(Al2O3, magnesium carbonate, and MgO) are all 
exempt from the requirement of a tolerance at 40 CFR 180.910 without 
limitation. EPA has already assessed the dietary risks of these 
substances, and determined that limitations on their use in pesticides 
are not warranted when they are used individually or in combination in 
pesticide formulations that are applied to growing crops or to 
postharvest raw agricultural commodities.
    ii. Drinking water. Both aluminum and magnesium compounds are 
present in natural water that may be used for drinking. EPA has not 
established a maximum contaminant level (MCL) for magnesium. The EPA 
National Secondary Drinking Water Standard for aluminum in drinking 
water is 0.05 to 0.2 mg/L. The use of aluminum-magnesium hydroxy 
carbonate as an inert ingredient is not expected to result in 
additional exposure to aluminum compounds in drinking water, as it is 
insoluble when used as intended, as described above.
    2. Nondietary exposure. There is no anticipated worker exposure to 
aluminum-magnesium hydroxy carbonate from application of the pesticides 
in which it will be used. Nondietary exposures to aluminum-magnesium 
hydroxy carbonate may result from its use as a stabilizer in polyvinyl 
chloride, and its use as a catalyst to polymerize propylene oxide. 
These reactions occur in contained vessels, and no exposure to 
aluminum-magnesium hydroxy carbonate would occur except during loading 
of the reactants. Similarly, during manufacture of pesticides to which 
aluminum-magnesium hydroxy carbonate is added, the components are mixed 
in closed vessels, and limited exposure to workers is anticipated.

D. Cumulative Effects

    No cumulative effects from a common mechanism of toxicity is 
expected to result from the use of aluminum-magnesium hydroxy carbonate 
in pesticide formulations.

E. Safety Determination

    Based on the information available, the petitioner believes that 
there is no expectation that the U.S. population, including infants and 
children, will be at increased risk from potential exposure to residues 
of aluminum-magnesium hydroxy carbonate. It is insoluble except in 
strong acids, and the components used to manufacture the finished inert 
ingredient have been individually evaluated and granted exemptions from 
the requirement of a tolerance at 40 CFR 180.910.

F. International Tolerances

    No international tolerances are known to exist for residues of 
aluminum-magnesium hydroxy carbonate.

[FR Doc. 05-7330 Filed 4-19-05; 8:45 am]
BILLING CODE 6560-50-S