EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDE RAL REGISTER E PA Biopesticides and Pollution Prevention Division contact: [Linda Holli s , Branch C hi ef Bio Pes ticid es & Pollution Prevention Division (BPPD) 703-347 -8496] 

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NST R UCT IO NS: Please utilize thi s outline in preparin g the pe sticid e petition. In cases where the outline element doc s not apply , plea se in sert "NA-Removc " and maintain the outline . Please do not change the margins, font , or format in your pesticid e p etition. Simply replace the in struction s that appear in green , i . e. , " [insert compan y nam e] ," with the information specific to your action . 

### TEMPL A TE: [C H Biotech R&D C o . , LTD . ]] [4F 8280] I · P \has rcccin:!d a pesticide petition ( [4 F8280]) lrom [C H Biotech R&D Co. , L T O . , No. 121 , Xian ' an Rd., Xianxi Town ship , C han ghua C oun ty 50741 , Taiwan (R . O .C.)], requesting. pursuant to section .f08(d) ofthc federal! ood. Drug. and Cosmetic .\ct (ffDCA). 21 LJ.S
. C. 3.f6a(d). to amend .fO CI"R pan 180. I he addition of a request for an exemption l'rom the requirement of a tolerance for C H Bio T ech R & D Betain e EU P and Betain e T echnical a s an active ingredient l{>r usc on pre- & post-han ·est emergent and post-hancst [growing crops or in products to treat animals] at Iunder 40 CFR 180.] . EPA has determined that the petition contains data or information regarding the dements set forth in section 408 (d) (2) or FDDCA: however. EPA has not rull) e\aluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition . Additional data may be needed berorc EPA rules on the petition. 2
. l3iochemical pesticide [Betaine, C AS Reg. No . 107-432-7 , or N, N, NT rimeth ylglys ine ,] Pursuant to section 408(d)(2)(A)(i) of FFDCA. as amended. [CH Biotech R&D Co . , LTO. , ] has submitted the follo\\ ·ing sum

**mar~** of information. data. and arguments in support of their pesticide petition. This summar) "as prepared

**b~** [CH Biotech R&D Co . , LTD. ,] and EP :\ has not fully c\"aluated the merits or the pesticide petition. The -;ummat") ma) ha' e been edited b) EPA if the tcrminolog) used \\aS unclear. the

**summar~** contained extraneous material. or the summary

**unintentional!~** made the reader conclude that the findings reflected EPA· s position and not the position of the petitioner. I. fC H Biotech R&D C o. , LTD. , ] Petition Summar) [4F8280l2 A. Product Name and Proposed Use Practices [Betaine EUP and Betaine Technical, PGR] B. Product ldentity ! Chemisll:r I
. Identity ofthe pesticide and corresponding residues. [Betaine , CAS Reg . No . 107

- 432

-7, or N, N, N

-Trimethylglysine, it is a s mall N

- trimethylated amino acid, ex isting in zwitterionic form at neutral pH. ) 2 . Magnitude**(~(residues** at the time**~fharwsl** and method used to determine the residue . [Based on the use pattern and natural occurrence of the product a waiver for the residue ha s been requested . ] 3 . A statement**(~(why** an analytical metlwd**(~{detecting** and measuring the le,•els**~{the** pesticide residue are not needed. (CH BioTech R&D believes that the lOX standard safety factor i s unnecessary for Betaine EUP and Betaine Technical a compound u sed as an additive in baby formula as a food supplement. There was no increased susceptibility demonstrated in the developmental toxicity and reproduction studies . ] C. Mammalian Toxicological**Pr~file** [The animal metabolism of this chemistry has not been investigated and metabolites have not been identified. However, based on the plausible metabolic pathways, no metabolites of toxicological concern are expected. ] D. Aggregate Exposure 1. Dietary exposure. [In examining aggregate exposure , section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and a ll other non-occupational exposures , including drinking water from gro und water or surface water and expos ure through pesticide use in gardens, lawn s , or buildings (residential and other indoor uses] i
. Food [In evaluating dietary exposure to Betaine EUP and Betaine Technical based on its use in food, feed, cosmetics, drugs, and in plants CH BioTech R & D believes there is no risk from any increase in exposure from the use as a PGR in food or feed crops . ] ii
. Drinking \\'Oter . [In evalu ating environmental exposure to Betaine EUP and Betaine Technical based on its consumption in drinking water and irrigating plants , CH Bio Tech R & D believes there is no risk from any increase in exposure from the use as a PGR in drinking water. ] 2
. Non-dieU/1) ' exposure. E. Cw111dath ·e Effects3 [We have not found a common mechanism of toxicity finding as to Betaine EUP and Betaine Technical do not appear to produce a toxic metabolite produced by other substances. For the purposes of this requested tolerance action Betaine EUP and Betaine Technical do not have a common mechanism of toxicity with other substances.] F. S'qf'ety Determination I . L'.S '. populo/ion [Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of Betaine EUP and Betaine Technical. ) 2 . ln/i.n71s and children . [Based on these risk assessments, CH Biotech R & D concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the lower weight Betaine EUP and Betaine Technical. CH BioTech R & D believes that a reliable data show that the safety of infants and children would be adequately protected and that the extra FQPA SF is unnecessary . That decision is based on the data presented with this petition the GRAS status of the chemical and the current long accepted uses for this natural sugar. ] G. Ef!'ects on the Immune and Endocrine Systems [FQPA requires EPA to develop a s creening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients) , " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen , or such other endocrine effect. " EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing the salts of Betaine and Glycine Betaine for endocrine effects may be required. The literature was searched for any information on the endocrine disruption of the salts of betaine . No information was located indicating any potential for endocrine disruption nor was any evidence observed in the studies supporting this petition . ] H. Existing Tolerances [Thi s petition is r e questing the establi shme nt of tolerance.] I. Infernalional Tolemnces [CH Bio Tech R & D is not aware of any country requiring a tolerance for Betaine EUP and Betaine Technical nor have any CODEX Maximum Residue Levels been established for any food crops at this time.]4