Gellan Gum; 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.

SUMMARY:

This notice announces the initial filing of a pesticide petition 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-2003-0235, must be received on or before August 15, 2003.

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:

Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6304; e-mail address: boyle.kathryn@epa.gov.

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 code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 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-2003-0235. 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, 1921 Jefferson Davis Hwy., 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 EPA's 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. 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 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-2003-0235. 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-2003-0235. 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-2003-0235.

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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0235. 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

Summary of Petition

The petitioner's 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 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. 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.

CP Kelco

PP 3E6567

A. Residue Chemistry

1. Plant metabolism. As a polysaccharide polymer, gellan gum is non-systemic and therefore no metabolism of gellan gum in raw agricultural commodities or processed commodities is expected.

2. Analytical method. Analytical methods for determination of the polysaccharide polymer, gellan gum are available. Gellan gum is determined by the dissolution of gellan gum containing gels by heating and cooling in the presence of a dilute sequestrant solution (e.g. 0.1% w/v sodium hexametaphosphate). The gellan gum assay is based upon the presence of the 6-deoxyhexose rhamnose which can be determined using the cysteine-sulfuric acid procedure, originally developed by Dische and Shettles and modified by Graham.

3. Magnitude of residues. Gellan gum is applied as a minor component of pesticidal formulations. Gellan gum degrades into simple non-toxic sugars and their salts.

B. Toxicological Profile

1. Acute toxicity. The acute toxicity of gellan gum was studied using male and female rats via the oral and inhalation routes. In the acute oral toxicity study, the lethal dose (LD)₅₀ for both males and females was established at >5,000 milligrams/kilogram body weight (mg/kg bwt). For the acute inhalation toxicity study, the LD₅₀ for both males and females was established at >5.09 milligrams/Liter (mg/L). Gellan gum is practically non-toxic to rats when administered as a single large dose (5 g/kg bwt) in diet or via gavage.

2. Genotoxicity. Gellan gum was shown to be non-genotoxic in a battery of standard short-term tests. The Ames test, involving S. typhimurium at 10, 30, 100, 300, and 1,000 μg/plate resulted in a negative response. A deoxyribonucleic acid (DNA) repair test using the rat hepatocyte as a test subject at 3, 5, 10, and 20 milligrams/liter (mg/L) resulted in a negative response. For the V-79/hypoxanthine guanine phophoribosyl transferase/(HGPRT) study, involving the Chinese hamster lung fibroblasts, doses at 3, 5, 10, and 20 mg/mL resulted in a negative response.

3. Reproductive and developmental toxicity. Groups of 26 male and female CD (Sprague-Dawley) rats were administered gellan gum in their diets at doses of 0, 2.5, 3.8, or 5.0%. Males were treated for 70 days prior to mating and for 3 weeks after mating. Females were treated for 14 days prior to mating and throughout mating, gestation, and lactation. Selection was made for the pups (F₁) of this mating and they were allowed to mature and were mated to form the F₂ generation. There was no treatment-related effect of mating or fertility index, conception rate, length of gestation, length or parturition, number of live pups, number of dead pups, post-implantation loss index, survival index on day 4, 7, 14, or 21 or lactation index for any of the generations.

For teratology studies, gellan gum was fed to groups of 25 pregnant female Sprague-Dawley rats at dietary levels of 0, 2.5, 3.8, or 5.0% during days 6-15 of gestation. Gellan gum has no fetotoxic or teratogenic effects on rats when ingested in the diet at levels up to 5.0%. In the reproduction and teratogenic studies in rats in which gellan gum was given at doses up to 50 g/kg in the diet, there was no evidence of interference with the reproductive process, and no embryotoxic or developmental effects were observed.

4. Subchronic toxicity. For short-term studies, male and female Sprague-Dawley rats (20/sex/group) were fed dietary levels of gellan gum ranging from 0-6% for 13 weeks. Although the animals on this study experienced symptoms of a sialodacryoadenitis viral infection, all animals survived treatment and there were no adverse effects associated with the feeding of gellan gum at levels up to 60 gram/kilogram (g/kg). Also, prepubertal rhesus monkeys (2/sex/group) were dosed by oral gavage with gellan gum at levels of 0, 1, 2, or 3 g/kg/day for 28 days. There were no overt signs of toxicity reported at levels up to 50 g/kg in the diet.

5. Chronic toxicity. Groups of 50 male and female Swiss Crl mice were fed gellan gum admixed in the diet at 0, 1.0, 2.0, and 3.0% for 96 and 98 weeks for males and females, respectively. All animals were examined twice daily for mortality and morbidity. Physical examination for the presence of palpable masses was initiated on a weekly basis starting in week 26. Body weights and food consumption were measured for 7-day periods on a weekly basis for the first 26 weeks of treatment and every 2 weeks thereafter. At necropsy, a complete gross pathological examination was performed on the animals from the control and 3.0% groups. Only the liver, kidneys, ovaries, testes, adrenals, pituitary, lungs, and heart were examined for animals of the 1.0 and 2.0% groups. There were no effects attributable to the feeding of gellan gum on either body weight gain or food consumption. There were no neoplastic or non-neoplastic changes which were associated with the feeding of gellan gum.

For the rat, groups of 50 F₁ generation Sprague-Dawley rats of each sex were exposed to gellan gum in utero and continued on gellan gum diets for approximately 104 weeks. The dietary levels of gellan gum were 0, 2.5, 3.8, and 5.0%. The rats were observed daily for the first 4 weeks of treatment and weekly thereafter for clinical signs of toxicity. Individual bodyweights and food consumption were measured on a weekly basis for the first 26 weeks of treatment and every 2 weeks thereafter. Fundoscopic and biomicroscopic examinations were conducted on the control and 5% groups during weeks 1, 13, 26, 52, 78, and 103. Clinical chemistry and haematological samples were collected at weeks 13, 25, 39, and 51. After 104 weeks, ophthalmoscopic examinations, haematology, clinical chemistries and organ weight data revealed no changes which could be attributed to the feeding of gellan gum. Survival of male treated rats was poor when compared to controls whereas female treated rats exhibited better survival than their concurrent controls. Male rats, fed gellan gum at the 3.8 and 5.0% dietary levels, exhibited lower body weights after 76 weeks. The initial bodyweights were 5.2 and 3.4% lower than the control values for the 3.8 and 5.0% dietary levels, respectively. It was concluded that in spite of the initial body weight deficit, the growth pattern for these treated groups was identical to that of the control. In addition, this effect was not seen in either the females or any other species tested. There is no basis to suggest that the lower body weights, observed in the male rats, are indicative of toxicity. Organs and tissues as those listed in the mouse study were examined for histopathological changes at study termination. There were no neoplastic or non-neoplastic changes that could be associated with the feeding of gellan gum. The authors concluded that gellan gum is non-carcinogenic to Sprague-Dawley rats.

For chronic toxicity study on dogs, diets containing 0, 3, 4.5, and 6% gellan gum were fed to groups of 5 Beagle dogs per sex for a period of 52 weeks. The dogs were observed daily for clinical signs of toxicity and were measured for body weights and food consumption. Ophthalmoscopic examinations were performed during pretreatment and after 12, 24, 29, and 51 weeks. Hematology and clinical chemistry were measured during pretreatment and after 6, 13, 25, 39, and 50 weeks. After 52 weeks all animals were killed and grossly examined. All animals survived treatment. Food intake was higher in the treated groups compared to the controls. There were no adverse effects associated with the feeding of gellan gum to beagle dogs for a period 1-year.

6. Animal metabolism. The adsorption, distribution, and excretion of gellan gum was studied using a dually radiolabeled (³ H and¹⁴ C) preparation. The use of dual labeling allowed simultaneous quantitation of both polysaccharide and “protein” fractions of gellan gum.

One male and one female Sprague-Dawley rat were gavaged with single doses of the³ H/¹⁴ C-gellan gum (ca. 960 mg/kg; ca. 4 μCi). Expired air was collected 24 hours after dosing. Less than 0.55% of the given radioactivity was detected as¹⁴ C.

Four male and three female Sprague-Dawley rats were dosed with single gavage dose of³ H/¹⁴ C-gellan gum (ca. 870 mg/kg; 2.9 - 4.1 μCi¹⁴ C; 0.7 - 0.9 μCi³ H). Urine and feces were collected for 7 days, at which time the animals were sacrificed and their tissues analyzed for residual radioactivity. Females excreted 86.8% and 1.9% of the given¹⁴ C in the feces and urine, respectively. Males excreted 86% of the dosed¹⁴ C in the feces and 3.3% in the urine. Females excreted 4.1% of the dosed³ H in their urine and 100.1% in their feces, while males excreted 3.6% of the total³ H in their urine and 99.6% in their feces. In all animals, the activities of³ H in tissues (blood, brain, liver, kidney, lung, muscle, skin, heart, and carcass) were too low to be quantitated accurately. Tissue and carcass radioactivity for¹⁴ C averaged 3.8% of dose for male rats and 3.0% of dose for female rats. A male and four female Sprague-Dawley rats were gavaged with about 1 g/kg of radiolabeled gellan gum and blood samples collected from the tail vein at different time intervals over a 7-day period. Data were reported as¹⁴ C dmp/mL blood (³ H dmp/mL blood was not reported). The peak level of radioactivity, which amounted to about 0.4% of the administered radioactivity, occurred about 5 hours after dosing.

Gellan gum was shown to be poorly absorbed and did not cause any deaths in rats which received a single large dose (5 g/kg bwt) in the diet or by gavage.

7. Metabolite toxicology. Gellan gum is a polysaccharide polymer composed of D-mannopyranose with D-glucopyranose and 6-deoxy-L-mannopyronose, calcium, potassium, and sodium salt. Gellan gum metabolizes into simple non-toxic sugars and their salts.

8. Endocrine disruption. Gellan gum does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. There is no evidence that gellan gum has any effect on endocrine function in developmental or reproduction studies. Furthermore, histological investigation of endocrine organs in chronic dog, rat, and mouse studies did not indicate that the endocrine system is targeted by gellan gum.

C. Aggregate Exposure

1. Dietary exposure. As a minor formulation component, there is no reasonable expectation that gellan gum will appear in diet.

i. Food. Gellan gum is approved in the U.S. under 21 CFR 172.665 as a food additive, stabilizer, and thickener in batters, breadings, coatings, glazes, gravies, and sauces for meat and poultry products. As a minor formulation component, there is no reasonable expectation that gellan gum will appear in food from pesticide uses.

ii. Drinking water. As a minor formulation component, there is no reasonable expectation that gellan gum will appear in water.

2. Non-dietary exposure. The only non-dietary exposure to gellan gum will be exposure through treating and handling of treated seeds and application of formulations containing gellan gum.

D. Cumulative Effects

The potential for cumulative effects of gellan gum and other substances that have a common mechanism of toxicity has also been considered. Gellan gum is a high-molecular-weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Sphingomonas elodea. There is no reliable information to indicate that toxic effects produced by gellan gum would be cumulative with those of any other chemical including another pesticide. Therefore, CP Kelco believes it is appropriate to consider only the potential risks of gellan gum in an aggregate risk assessment.

E. Safety Determination

1. U.S. population. The occupational exposure to gellan gum in pesticide formulations during distribution and storage will be limited to: Workers involved in the transportation of gellan gum to customers; and those involved in the loading and off-loading of the product containers from commercial carriers and during opening of drums containing gellan gum. However, the potential for worker exposure is expected to be well controlled and limited if worker-safety procedures are routinely practiced. The potential opportunity for human exposure to gellan gum is expected to be limited to clean-up activities during routine maintenance, or following an accidental spill or release. Exposures occurring during these activities would typically be minimized by the accommodations made in equipment design and employee work practices. As long as the recommended practices for worker protection during use are respected, the risk of worker exposure to gellan gum in an occupational setting is expected to be of minimal significance.

2. Infants and children. The exposure to gellan gum in pesticide formulations is limited to formulators and applicators. Dietary exposure to infants and children does not differ from the general population.

F. International Tolerances

Gellan gum is approved, registered, or filed as a food additive in the countries of Argentina, Brazil, Canada, Chile, Columbia, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, Venezuela, Egypt, Hungary, Israel, Jordan, Morocco, Norway, Pakistan, Poland, South Africa, Switzerland, Tunisia, Turkey, Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Malta, New Zealand, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, the Philippines, and Vietnam. In the European community, gellan gum has approval (E-418) as a food additive. Purity criteria are established by JECFA (Joint Expert Committee on Food Additives).