N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 352-1.2

Current through Register Vol. 46, No. 45, November 2, 2024

Section 352-1.2 - Definitions

(a) 'Certified reference material' means a reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.

(b) 'Continuing Calibration Verification' means an assessment of an analytical instruments calibration drift and memory effects over the course of an analytical sequence.

(c) 'Correlation Coefficient' means the statistical relationship between two variables.

(d) 'Cosmetic product' means any article

(1) intended to be rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for beautifying, promoting attractiveness, or altering the appearance, and

(2) intended for use as a component of any such article. The term cosmetic product shall not include any personal care product as defined in this section for which a prescription is required for distribution or dispensation as provided in section 281 of the Public Health Law or section 6810 of the Education Law.

(e) 'Household cleansing product' means any product, including but not limited to, soaps and detergents, which contain a surfactant as a wetting or dirt emulsifying agent and are used primarily for domestic or commercial cleaning purposes, including but not limited to, the cleansing of fabrics, dishes, food utensils, automobiles, and household and commercial premises. Household cleansing product shall not mean:

(1) foods, drugs, and cosmetics, and personal care products as defined in this Subpart;

(2) products labeled, advertised, marketed, and distributed for use primarily as pesticides, as defined in article 33 of the Environmental Conservation Law; or

(3) cleansing products used primarily in industrial manufacturing, production and assembling processes.

(f) 'Initial Calibration' means a plot of instrument responses to an analyte versus known concentrations of analyte from certified reference materials. The initial calibration must cover a range containing the applicable limitation set forth in section 352-1.3 of this Part.

(g) 'Initial Calibration Verification' means an assessment of the reference materials used to calibrate an analytical instrument by analyzing certified reference materials obtained from a second source.

(h) 'Internal Standard' means a chemical substance that is similar, but not identical to, the analyte or analytes of interest that are added to a sample at a known concentration. An internal standard is used for quantitation of 1,4-dioxane and to account for matrix effects or variability in instrument response by normalizing the response of 1,4-dioxane, or both, thereby decreasing measurement bias to the extent that their behavior mimics that of 1,4-dioxane.

(i) 'Laboratory Control Sample or Laboratory Control Sample Duplicate' means a clean matrix prepared and analyzed in the same analytical batch and in exactly the same manner as the other routine samples. The laboratory control sample or laboratory control sample duplicate is used to assess general method performance based on the ability of the laboratory to successfully recover 1,4-dioxane from the matrix.

(j) 'Limit of Detection' means the minimum concentration of an analyte that can be reliably detected with a signal to noise ratio of 3:1 or greater.

(k) 'Limit of Quantitation' means the minimum concentration of an analyte that can be reliably quantitated with defined accuracy and precision, and a signal to noise ratio of 10:1 or greater.

(l) 'Manufacturer' means any person who (1) manufactures, produces or substantially produces any covered household cleansing product, personal care product or cosmetic product for sale in the State under its own brand name or under any other brand name for sale in the State; (2) sells in the State, under its own brand name, any covered household cleansing product, personal care product or cosmetic product; (3) owns a brand name that it licenses to another person for use on any covered household cleansing product, personal care product or cosmetic product sold in the State; (4) imports any covered household cleansing product, personal care product or cosmetic product for sale in the State; or (5) manufactures any covered household cleansing product for sale in the State without affixing a brand name.

(m) 'Matrix Spike or Matrix Spike Duplicate' means samples to which known concentrations of 1,4-dioxane have been added before extraction and analysis.

(n) 'Method Blank' means a clean matrix containing only the internal standard. The method blank is used to assess background interference or contamination that exists in the analytical system that might lead to the reporting of elevated concentration levels or false positive data. Results from tests of the method blank should be below the limit of quantitation.

(o) 'Multiple Reaction Monitoring' means a mass spectrometry scanning mode whereby a particular ion mass-to-charge is selected in the first stage, fragmented in a second stage, and specific product ions resulting from the fragmentation are detected in the third stage. Multiple reaction monitoring typically results in increased sensitivity of the instrumentation.

(p) 'Percent Recovery' means the amount of 1,4-dioxane analyzed relative to the known amount spiked, converted to percentage.

(q) 'Percent Relative Standard Deviation' means a statistical analysis that determines how measurements in a data set are scattered around the average. Percent relative standard deviation is defined as the standard deviation of the measurements in the data set divided by their average, converted to percentage.

(r) 'Person' means any individual, partnership, firm or corporation, or unincorporated association.

(s) 'Personal care product' means any product intended for cleaning or cleansing any part of the body, such as the skin and hair, and including, but not limited to, hair shampoo, hair conditioner, soap, bath gels, and other bath products. The term personal care product shall not include any product for which a prescription is required for distribution or dispensation as provided in section 281 of the Public Health Law or section 6810 of the Education Law.

(t) 'Relative Percent Difference' means a statistical analysis between two measurements defined as the absolute difference between the two measurements, divided by their average, then converted to percentage.

(u) 'Selected Ion Monitoring' means a mass spectrometry scanning mode in which only a limited mass-to-charge ratio range is transmitted/detected by the instrument. Select ion monitoring typically results in increased sensitivity of the instrumentation.

(v) 'Signal to Noise Ratio' means a measure that compares the level of a desired signal to the level of background noise.

(w) 'State' means the State of New York.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 352-1.2

Adopted New York State Register September 18, 2024/Volume XLVI, Issue 38, eff. 9/18/2024