L-Glutamic Acid (LGA) and Gamma-Aminobutyric Acid (GABA) EPA-HQ-OPP-2014-0I09 www.regulation s.gov



# L-GlutamicAcid (LGA) and Gamma-AminobutyricAcid (GABA) (PC Codes: 374350 and 030803)



# FinalWorkPlan Registration Review

Case Number 6025
March 2015

Approved by: Biopesticides and PollutionPrevention Division
Date:INTRODUCTION This is th e E n vironmenta l Protection Agency's (EPA or the Agency) Fi n a l Work Plan ( FWP) for th e regist r ation revi ew of L-glutamic acid (LGA) and gamma-aminobutyric acid (GABA). T his work plan addresses updates, additional data needs, and public comments received concerning the Preliminary Work Plan (PWP), which was posted in the L-glutamic acid (LGA) and garnmaaminobutyric acid (GABA) regist ra tio n review docket (E P A -HQ-OPP-2 0 1 4 - 0 109 ) on September 24, 2014. Two products containing LGA and GABA are currently registered for use as plant growth regulators. The Agency is im p l ementing the re g i stration review program pur suant to Sect i on 3(g) of the

Fe deral I nsectic id e, Fungici d e, and Rodenti cide Act (FIFRA), and will rev i ew each re gistered pe s ticid e e v e ry 15 years to determine wh e th er it con tinues to meet th e F I FRA s tandard for

r egis trati o n. C h anges in scie n ce, publi c policy, and pesticide u se practices occur over time. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory s tand ard. The public phase of regist r atio n review beg i ns whe n the initial docket is opened for each case. Informati o n on this p r ogram is provided on th e Agency's website. 1 T h e FWP begins with any update s s inc e the PWP was i ssued. Next is a summary of substantive comme nt s re ce i ved during the publ ic comment period for th e PWP concern in g anticipated d ata n ee ds , ex p e ct ed risk assess ments , or th e estimated t imeline identifi e d in t h e PWP , and a sum mary of th e Agency's responses to those comments. This section is followed by registration review planned data needs, risk assessments expected to be cond u cted, and the p r o jected r egistrat i o n rev i ew timel in e for LGA and GABA. Lastly , there is a discussion of next steps. UP DAT ES SINCE THE PWP WAS ISS UED Since the PWP for LGA and GA B A was issued , CP Bio GABA Technical was registered on Decembe r 17, 20 14 , con t a ining i ts active in gredient, Gamma-aminobutyric ac id (GABA), at 99%. The product i s intended for formula t i o n i n to e nd-use - product s (EPs) to b e used as plant

gro wth re gu lat o r s (PGRs) to increase yi e ld s in growing crops, turf, and agric ultural and

o rnam en t al trees. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comme nt period on the LGA and GABA PWP , w hi ch ope ned on Septem b er 24, 2014 , and closed on November 24, 20 14 , the Agency received one ( 1 ) comment concerning this case. 2 The comment was s ubmitt ed by the Center for Biological Diversity. The

comment stated that EPA must consult with U.S. Fish and Wildlife Serv i ce and the National Marine Fi s heri es under Sec tion 7 of th e Endangered Species Act to insure that LGA and GABA do no t jeopardize the continue d exis tenc e of any li sted species or result in adverse modification or destruction of critical habitat.

1 http: // www2 . epa.gov / pe s ticide-reevaluation/ 2 Federa l R e gister , Volume 79, I ssue No. 185 pp. 57092 - 57095 (issue d Wed. September 24, 2014) . 2Summarizedbelow is the public comment and the Agency's response. The public comment is available inthe entirety inthe docket, EPA-HQ-OPP-2014-0109. Comment submitted by Center for Biological Diversity in EPA-HQ- OPP-2014-0109. 

### 1. Comment: a). "EPA hasan independent duty under the EndangeredSpeciesAct to Consult with the US. Fish and Wildlife Service andN ationalMarine Fisheries on the Reregistration of LGA andGABA
. b). 

### The EPA mustmake a defensible "NotLikely toAdverselyAffect" and "Likely toAdverselyAffect"Determination as a Prerequisite for Defensible "Jeopardy" and "No Jeopardy" Determinations. c). EPA andthe Services mustassess theAdverse impacts of LGA andGABA in CriticalHabitat. d). EPA hasan independent Duty under the Endangered SpeciesActto Consult with the US. Fish and Wildlife Service andNationalMarine Fisheries Service on the Approval of AllLGA and GABA end-useproduct labels. " Response: As indicated 

### in the PWP, the Agency concluded that the risks to nontarget species, including federally listed threatened or endangered species (listed species) and/or their designated critical habitat, from the use ofLGA and GABA as PGRs are negligible, and will have "no effect" on listed species and/or their designated critical habitat, based upon the low toxicity of LGA and GABA demonstrated in the mammalian acute toxicity studies (U.S. EPA 2014) and the nontarget freshwater invertebrate and fish studies, their ubiquity in living organisms, and the low application rates as PGRs. EPAanticipates conducting no further analysis ofpotential risks to endangered or threatened species, unless data or information are obtained during the registration review process that would indicate such an assessment would be needed to inform the Agency's decision. The data requirements for nontarget birds (avian acute oral and dietary toxicity studies), plants, and insects were waived, based upon the low acute toxicity ofLGA and GABA in mammalian species, their natural occurrence, their biodegradability in the environment 3and the presence ofthese substances in virtually all living plants and animals, including humans
. From the submitted studies, the 96 hour LCso in freshwater fish (species tested was the rainbow trout, 

### Oncorhynchus mykiss) and the 48 hour ECso value for the freshwater invertebrate, 

### Daphnia magna , are > 100 mg/L. The No Observed Ef fect Concentration (NOEC) value was determined to be 100 mg/L, based upon no mortality at the highest concentration tested in these studies, which classifies LGA and GABA as practically nontoxic to these organisms (U.S. EPA, 2014). PLANNED DATA NEEDS The PWP stated that there were no anticipated data needs for the LOA and GABA registration review. Thathas not changed
.

3 Half

-life in water = 8.7 days; in soil = 17.3 days- Level III Fugacity Model, generated using USEPA's "EP!SuiteTM" http://www.chemspider.com/Chemicai-Structure.ll6.html 

### 3RISK ASSESSMENTS FOR REGISTRATION REVIEW Since pu b lic atio n of the PWP, the agency has comp l eted a comprehensive risk assessment (U.S. EPA, 2014) for GABA, in s upport o f a new m anufac turing

- use -product (MP) regis tration, C P

Bio GABA T echnical. The agency has concluded that th e r e ar e no data gaps for LGA or GABA and that there is no need to cond uc t a n ew risk assessme nt for these active ingredients during registration review. TIMELINE EPA has created the following estimated timeline for the completion of the LGA and GABA reg i stra ti on review in Table 1 , below. T hi s projected timeline has not changed si nc e the PWP. Registration Review for LGA and GABA- Projected Registration Review Ti meline Act ivities Estimate d Month/Year Op _ ening t he Docket Open Docket and 60-Day Public Comm ent Peri od for LGA and GABA Septem b er 2 014 C lo se Public Comment Period November 2014 Case Deve lopm e nt Issue Final Wo rk Plan March 2015 Issue Data Call-in N / A Data Submission N I A Open 30-Day Public Comment Period for Draft Risk Assessments N I A C l ose Pub lic C omment Period NIA Registration R e view Decision Open 60-Day Public Comme n t Period for Prop osed Registration Review December 2015 Decision Close Public Comment Period February 2016 Final Decision June 2016 *Estimated Total (years) 1 y ear and 9 months * This sc he dule is subject to r ev1sion should unforeseen 1ssues anse dunng the reg1strat1on rev1ew process . In the event an issue arises , such as the fa ilure to acquire an EDSP exe mp t i on , an amended Fi n a l Work Plan will be i ssued at t h at t im e. That Fina l Work Plan will i den t ify newly a n ticipate d data needs (if any) a nd set f orth a new time l ine. NEXT STEPS

The Agency plans to issue a Proposed Registration Review Decision for this case in De cember 2015. At that t ime, a 60-day pub lic comment period w ill be opened for the Proposed Deci s i on. 4

### U.S. Environmental ProtectionAgency RiskAssessment Memoranda U.S. EPA. 1997. Registration ofAuxiGro (EPA File Symbol 70810-R) and Exemption from the requirement ofa tolerance for GABA (pp#7F4843) and L-Glutamic Acid (PP#7F4842) on all RAWAgricultural Commodities (RACs). Review ofProduct Chemistry, MammalianToxicology and Eco

-Toxicity Studies. (Chemical Nos. 030802 and 374350); MRID Nos. 442962-01 to 07, 442964

-01 to 21; and 442962-01 to 442962-06). Memorandum from Freshteh Toghrol to Edward Allen. U.S. Environmental ProtectionAgency (U.S
. EPA). October06, 1997. U.S. EPA. 1998
. Review ofFreshwater Acute Toxicity Studies, Chemical No
. 030
. 802, 374350; MRID Nos. 444057-01 and 02. Memorandum from Edward Allento FreshtehToghrol. U.S. Environmental ProtectionAgency (U.S. EPA). April 13, 1998 U.S. EPA. 1998. GABAand L

-Glutamic Acid (030802, 374350)Technical Document. U.S. Environmental ProtectionAgency (U.S. EPA). Issued September, 1998. Available at: http:// www.epa.gov/oppOOOO 1/chem search/reg actions /registration/related PC-030802 1-Sep98.pdf U.S. EPA. 2004. GABAand L-GlutamicAcid (030802, 374350) Fact Sheet. Issued October 19, 2004. Available at: http://www.epa.gov/oppOOOOllchem search/reg actions/registrationlfs G132 19-0ct

-04.pdf U.S. EPA. 2014. L

-GlutamicAcid (LOA) and Gamma-Aminobutyric Acid (GABA) (PC Codes: 374350 and 030803). PreliminaryWork Plan and Summary Document. U.S. Environmental Protection



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