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The USDA, for example, requires a "detailed description of the molecular biology of the system … used to produce the regulated article".
The regulatory status of such animals is unclear as the definition of a regulated article is not consistent among different regulatory agencies and organizations.
After an initial, naïve phone call to the agency, I was informed that administered stool would constitute a "biological product" as defined in Section 351(i) of the Public Health Service Act [42 U.S.C. 262(i ], in that stool is a "regulated article" applicable to the prevention, treatment or cure of a disease or condition of human beings.
As governed under the Plant Protection Act (PPA), APHIS was required by the National Environmental Policy Act (NEPA) to conduct an extensive and rigorous scientific analysis, an Environmental Impact Statement (EIS), on any regulated article that poses a risk of significant environmental harm before fully deregulating its use.
The decision that transgenic Kentucky bluegrass is not a regulated article is consistent with other APHIS regulatory determinations.
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A clinical study involving an FDA-regulated article can evoke certain requirements.
He added that the FBI explained in its letter that cell site simulator manufactures like the Harris Corporation have "classified their devices as regulated defense articles on the United States Munitions List".
down-regulated regulated.
Regulator-regulated gene associations.
This article investigates how regulated automakers and upstream component suppliers comply with "technology-forcing" regulations, or laws that set performance standards beyond their usual technological capabilities.
[Editors' note: further concerns were raised before acceptance.] Thank you for resubmitting your article entitled "MAF1-Regulated-Pol III-Mediated Activation of CDKN1A and Chromatin Looping" for further consideration by eLife.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com