1 Colo. Code Regs. § 212-3-7-7015

Current through Register Vol. 47, No. 20, October 25, 2024

Section 1 CCR 212-3-7-7015 - Certification Required

Basis and Purpose - 7015

The statutory authority for this rule includes but is not limited to sections 25-2.5-120, 44-50-202(1)(b), 44-50-203(1)(a), 44-50-203(1)(d), 44-50-203(1)(f), 44-50-203(1)(n), 44-50-203(2)(a), and 44-50-404(2), C.R.S. The purpose of this rule is to establish that a Natural Medicine Testing Facility is required to have both a License issued by the State Licensing Authority and a certification from the Colorado Department of Public Health and Environment before performing any tests on Regulated Natural Medicine or Regulated Natural Medicine Product. This rule further provides the requirements for a Natural Medicine Testing Facility if its certification is suspended or reissued.

A. All Natural Medicine Testing Facilities licensed by the State Licensing Authority must be certified by the Colorado Department of Public Health and Environment in each of the testing categories required by these Rules. See Part 4, Regulated Natural Medicine Testing Program. Natural Medicine Testing Facilities must be accredited to ISO/IEC 17025:2017 and have each test type the Natural Medicine Testing Facility performs included on that Facility's scope of accreditation. Accreditation must be performed by an accreditation body that conforms to ISO/IEC 17011:2017 and is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) for testing.

1. This Rule incorporates the ISO/IEC 17025:2017 standard effective as of August 9, 2024, and does not include any later amendments or editions to this ISO/IEC accreditation. The Division maintains a copy of ISO/IEC 17025:2017 at 1697 Cole Boulevard, Suite 200, Lakewood, Colorado, 80401, which is available to the public for inspection during the Division's regular business hours.

2. A Natural Medicine Testing Facility offering non-required testing services, for example, pesticide testing, in accordance with Rule 7005, must disclose to the requestor which test types the Licensee is certified to perform. The Licensee must notify each requestor any requested tests for which the Licensee is not certified to perform and that such test results have not been accredited, validated, or otherwise subject to regulatory oversight and disclose this on the certificate of analysis.

B. A Natural Medicine Testing Facility shall hold both a Natural Medicine Testing Facility License issued by the State Licensing Authority and a certification issued by the Colorado Department of Public Health and Environment for each required test type that it provides for any Natural Medicine Business. Failure to obtain or suspension or revocation of either the required Natural Medicine Testing Facility License or the certification prohibits the Natural Medicine Testing Facility from providing required testing services to any Natural Medicine Business.

C.Certification Suspension. If the Colorado Department of Public Health and Environment suspends a Natural Medicine Testing Facility's certification to conduct required Regulated Natural Medicine test(s), the Licensee must immediately notify the Division and cease conducting any tests for which the Licensee has lost certification.

1. Upon notification that a Natural Medicine Testing Facility has lost certification to conduct required test(s) or that the public health, safety, or welfare imperatively require emergency action, the State Licensing Authority may immediately suspend the Natural Medicine Testing Facility's License in accordance with Part 9 of these Rules.

D.Re-certification. A Natural Medicine Testing Facility must comply with Colorado Department of Public Health and Environment requirements to re-certify to conduct required testing. Upon re-certification, the Natural Medicine Testing Facility must notify the Division with written confirmation from the Department of Public Health and Environment that the Licensee is permitted to conduct required test(s) again.

1 CCR 212-3-7-7015

47 CR 17, September 10, 2024, effective 10/1/2024