Pesticide, food, and feed additive petitions: Keller & Heckman LLP,

[Federal Register: April 20, 2005 (Volume 70, Number 75)]

[Notices]

[Page 20545-20549]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr20ap05-57]

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.

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

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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: martin.kathleen@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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.

   2. 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.

   3. 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

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         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 opp-docket@epa.gov, 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.

   4. 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.

   5. 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.

2. 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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   1. Residue Chemistry

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

   2. 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 LD50of >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 LD50was reported as 980 milligrams aluminum/kilograms body weight (mg aluminum/kg bw,) and the LD50of AlCl3as 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 AlCl3in 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 MgCl2and AlCl3. Exposure of cells to MgCl2from 22,000 to 32,000 [mu]g/mL resulted in no increase in mutations over the negative control. Exposure to AlCl3from 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)3plus 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 Al2O3treatment 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.

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      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.

   3. 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.

   4. 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.

   5. 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.

   6. 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