Source: https://www.federalregister.gov/documents/2012/12/10/2012-29260/codification-of-animal-testing-policy
Timestamp: 2016-10-23 08:00:36
Document Index: 43226093

Matched Legal Cases: ['art 1500', '§\u20091500', '§\u20091500', '§\u20091500', 'art 1500', '§\u20091500', '§\u20091500', '§\u20091500', '§\u20091500', '§\u20091500', '§\u20091500', '§\u20091500', '§\u20091500', '§\u20091500']

:: Codification of Animal Testing Policy
https://www.federalregister.gov/d/2012-29260
In addition, on June 29, 2012, the Commission also proposed to codify its statement of policy on animal testing to reflect new methods accepted by the scientific community as replacements, reductions, or refinements to animal tests including recommendations of and test methods of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; http://iccvam.niehs.nih.gov/home.htm). 77 FR 38751. Codification at 16 CFR 1500.232 would make the ICCVAM recommendations and Commission's animal testing policy more accessible and transparent to interested parties. Although the Commission proposed to make the animal testing policy effective on the date of publication in the Federal Register, because the animal testing policy references sections of the animal testing regulations in 16 CFR part 1500, we will make the statement of policy effective on the same date, 30 days after publication of the policy in the Federal Register. The Commission has also established a Web page on the CPSC's Web site at http://www.cpsc.gov/library/animaltesting.html regarding the ICCVAM recommendations and new developments in test methods that replace, reduce, or refine animal testing. After consideration of the comments, the Commission codifies its final statement of policy on animal testing. B. Response to Comments on the Proposed Policy
Comment: One commenter states that alternative test methods approved for testing potentially hazardous substances were too limited as laid out in the Commission's proposal, and requests that the CPSC broaden its recommendations to in vitro and in silico tests beyond those already approved by the Commission through ICCVAM. Specifically, the commenter recommends adding methods that were already approved by other regulatory bodies, such as the Organisation for Economic Cooperation and Development (OECD) or the European Centre for the Validation of Alternative Methods (ECVAM EURL). The commenter further suggests that § 1500.232(b) should include any “scientifically acceptable” non-animal alternative that is “fit for the purpose,” not limited to those expressly approved by the Commission, nor to those that had undergone an official regulatory validation process.
Comment: One commenter requests that all details on in vivo testing procedures be deleted from § 1500.232, including the LD50/LC50 assays at 1500.232(b)(1)(i), the method of testing dermally toxic substances at 1500.232(b)(1)(ii), and the ocular irritation assay at 1500.232(b)(1)(iii).
Comment: One commenter requests that we reorder the paragraphs in § 1500.232(a) to ensure that manufacturers first consider the most human-relevant data and methods in determining appropriate labeling
1. The authority for part 1500 continues to read as follows: Authority:
2. Add § 1500.232 to read as follows: § 1500.232 Statement on animal testing policy.
(i) Acute toxicity. The traditional FHSA animal test for acute toxicity determines the median lethal dose (LD50) or lethal concentration (LC50), the dose or concentration that is expected to kill half the test animals. Procedures for determining the median LD50/LC50 are described in section 2(h)(1) of the Act and supplemented in § 1500.3(c)(1) and (2) and the test method outlined in § 1500.40. The Commission recommends in vitro alternatives over in vivo LD50/LC50 tests, or using modifications of the traditional LD50/LC50 test during toxicity testing that reduce the number of animals tested whenever possible. Data from in vitro or in silico test methods that have not been approved by the Commission may be submitted to the Commission for consideration of their acceptability. Commission-approved testing alternatives are identified on the Web site at: http://www.cpsc.gov/library/animaltesting.html and include:
(C) A sequential version of the traditional LD50/LC50 tests described in § 1500.3(c)(1) and (2) and the test method described in § 1500.40, in which dose groups are run successively rather than simultaneously;
(A) In a tiered in vivo dermal study, a single rabbit is tested initially. If the outcome is positive for corrosivity, testing is stopped, and the substance is labeled appropriately. If the substance is not corrosive, two more rabbits should be patch-tested to complete the assessment of skin irritation potential. (B) If a tiered test is not feasible, the Commission recommends the test method described in § 1500.41. Note that in any in vivo dermal irritation test method, the Commission recommends using a semiocclusive patch to cover the animal's test site and eliminating the use of stocks for restraint during the exposure period, thereby allowing the animal free mobility and access to food and water.
(B) If the dermal test strategy outlined in section paragraph (b)(1)(ii)(B) of this section leads to a conclusion of not corrosive, a tiered in vivo ocular irritation test should be performed, in which a single rabbit is exposed to the substance initially. If the outcome of this initial test is positive, testing is stopped, and the substance is labeled an eye irritant. If the outcome of this initial test is negative, one to two more rabbits are tested for ocular irritation, and the outcome of this test will determine the label. If a tiered test is not feasible, the Commission recommends the test method described in § 1500.42.
(C) When any ocular irritancy testing on animals is conducted, including the method described in § 1500.42, the Commission recommends a threefold plan to reduce animal suffering: The use of preemptive pain management, including topical anesthetics and systemic analgesics that eliminate or reduce suffering that may occur as a result of the application process or from the test substance itself (an example of a typical preemptive pain treatment is two applications of tetracaine ophthalmic anesthetic, 10-15 minutes apart, prior to instilling the test material to the eye); post-treatment with systemic analgesics for pain relief; and implementation of humane endpoints, including scheduled observations, monitoring, and recording of clinical signs of distress and pain, and recording the nature, severity, and progression of eye injuries. The specific techniques that have been approved by the Commission can be found at: http://www.cpsc.gov/library/animaltesting.html.