[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Page 39812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17117]





[[Page 39812]]



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DEPARTMENT OF AGRICULTURE



Animal and Plant Health Inspection Service



[Docket No. APHIS-2011-0080]




Scotts Miracle-Gro Co.; Regulatory Status of Kentucky Bluegrass 

Genetically Engineered for Herbicide Tolerance



AGENCY: Animal and Plant Health Inspection Service, USDA.



ACTION: Notice.



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SUMMARY: We are advising the public that the Animal and Plant Health 

Inspection Service (APHIS) has received a letter from the Scotts 

Miracle-Gro Company seeking confirmation that their Kentucky bluegrass, 

which has been genetically engineered for herbicide tolerance without 

the use of plant pest components, does not meet the definition of a 

regulated article under APHIS regulations for genetically engineered 

organisms. Based on the information provided in the letter, we agree 

that the Kentucky bluegrass does not meet the definition of a regulated 

article under APHIS regulations for genetically engineered organisms.



ADDRESSES: You may view the letter from Scotts and APHIS' response 

letter on the Internet at http://www.aphis.usda.gov/biotechnology/news.shtml.



FOR FURTHER INFORMATION CONTACT: Dr. Andrea Huberty, Branch Chief, 

Regulatory and Environmental Analysis Branch, Biotechnology Regulatory 

Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; 

(301) 734-0485, e-mail: andrea.f.huberty@aphis.usda.gov. To obtain 

copies of the letters, contact Ms. Cindy Eck at (301) 734-0667, e-mail: 

cynthia.a.eck@aphis.usda.gov.



SUPPLEMENTARY INFORMATION:



Background



    The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.), authorizes 

the Secretary of Agriculture to prohibit or restrict the importation, 

entry, exportation, or movement in interstate commerce of any plant, 

plant product, biological control organism, noxious weed, article, or 

means of conveyance if the Secretary determines that the prohibition or 

restriction is necessary to prevent the introduction of a plant pest or 

noxious weed into the United States or dissemination of a plant pest or 

noxious weed within the United States.

    In section 403 of the PPA, ``plant pest'' is defined as any living 

stage of any of the following that can directly or indirectly injure, 

cause damage to, or cause disease in any plant or plant product: A 

protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, 

a virus or viroid, an infectious agent or other pathogen, or any 

article similar to or allied with any of the foregoing.

    Under the plant pest authority of the PPA, the Animal and Plant 

Health Inspection Service (APHIS) administers the regulations in 7 CFR 

part 340, ``Introduction of Organisms and Products Altered or Produced 

Through Genetic Engineering Which Are Plant Pests or Which There Is 

Reason to Believe Are Plant Pests,'' which regulate, among other 

things, the introduction (importation, interstate movement, or release 

into the environment) of organisms and products altered or produced 

through genetic engineering that are plant pests or that there is 

reason to believe are plant pests. Such genetically engineered (GE) 

organisms and products are considered ``regulated articles.''

    In the past, APHIS has received letters from developers seeking 

clarification on the regulatory status of GE organisms that the 

developers believed did not meet the definition of a regulated article. 

These developers sought confirmation from APHIS that APHIS did not 

consider the organisms to be regulated under 7 CFR part 340. When APHIS 

receives such a request, we review the information provided. If APHIS 

agrees with the developer that the GE organism does not meet the 

definition of a regulated article, then the organism is not subject to 

regulation under 7 CFR part 340. If APHIS disagrees, the organism is 

subject to all of the requirements of 7 CFR part 340.

    On September 13, 2010, APHIS received a letter from the Scotts 

Miracle-Gro Company (Scotts) of Marysville, OH, seeking confirmation 

that their Kentucky bluegrass (Poa pratensis L.), which has been 

genetically engineered for herbicide tolerance, does not meet the 

definition of a regulated article under APHIS regulations. Scotts 

stated that the Kentucky bluegrass was genetically engineered without 

plant pest components and, therefore, should not be subject to APHIS' 

regulations in 7 CFR part 340, as it does not meet the definition of a 

regulated article in those regulations. No permits have been issued or 

notifications acknowledged by APHIS for the interstate movement or for 

field releases of Scotts' GE Kentucky bluegrass.

    As described in the letter, Scotts' GE Kentucky bluegrass has been 

genetically engineered to express an enzyme, 5-enolpyruvylshikimate-3-

phosphate synthase, from thale cress (Arabidopsis thaliana), which 

imparts tolerance to the herbicide glyphosate. Scotts' GE Kentucky 

bluegrass was also genetically engineered using genetic material from 

rice (Oryza sativa) and corn (Zea mays).

    We agree that, according to the description provided by Scotts, 

their GE Kentucky bluegrass does not meet the definition of a 

``regulated article'' and is not subject to the regulations in 7 CFR 

part 340. Kentucky bluegrass itself is not a plant pest, no organisms 

used as sources of the genetic material used to create Scotts' GE 

Kentucky bluegrass are plant pests, and the method used to genetically 

engineer Scotts' GE Kentucky bluegrass did not involve plant pests. 

Because no plant pests, unclassified organisms, or organisms whose 

classification is unknown were used to genetically engineer Scotts' GE 

Kentucky bluegrass, APHIS has no reason to believe it is a plant pest 

and therefore does not consider the Kentucky bluegrass described in the 

Scotts letter to be regulated under 7 CFR part 340.

    In addition to plant pests, APHIS regulates noxious weeds under the 

authority of the PPA. In a separate notice published in today's Federal 

Register, we are advising the public of our decision that Kentucky 

bluegrass that has been genetically engineered for tolerance to the 

herbicide glyphosate will not be regulated under APHIS regulations 

governing noxious weeds in 7 CFR part 360.



    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.3.



    Done in Washington, DC, this 1st day of July 2011.

Gregory L. Parham,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 2011-17117 Filed 7-6-11; 8:45 am]

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