EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION 

COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN 

THE FEDERAL REGISTER 

EPA Biopesticides and Pollution Prevention Division contact: [Linda Hollis, Branch 

Chief Bio Pesticides & Pollution Prevention Division (BPPD) 703-347-8496] 

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element docs not apply, please insert "NA-Removc" and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., " [insert 

company name]," with the information specific to your action. 

TEMPLA TE: 

[CH Biotech R&D Co., LTD.]] 

[4F8280] 

I·P \has rcccin:!d a pesticide petition ([4F8280]) lrom [CH Biotech R&D Co., 

L TO., No.121, Xian' an Rd., Xianxi Township, Changhua County 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 

CH Bio Tech R & D Betaine EUP and Betaine Technical as 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, CAS Reg. No. 107-432-7, or N, N, NTrimethylglysine,] 

Pursuant to section 408(d)(2)(A)(i) of FFDCA. as amended. [CH Biotech R&D Co., 

L TO.,] 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 Co., LTD.,] Petition Summar) 

[4F8280l 
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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 small N-trimethylated amino acid, 

existing 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 has 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 is unnecessary for Betaine EUP and Betaine Technical a 

compound used 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 all other non-occupational exposures, including 

drinking water from ground water or surface water and exposure through pesticide 

use in gardens, lawns, 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 evaluating 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 Effects 
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[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 screening 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 

[This petition is requesting the establishment of tolerance.] 

I. Infernal ional 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.] 
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