Someone's in the kitchen with OIRA
by Guest Blogger, 1/21/2005
What's cooking on the anti-regulatory front? Follow your nose... to the OIRA log of meetings with industry. These meetings have already begun in 2005:
Meeting with the International Dairy Foods Association about FDA rules on "Food Standards: General Principles and Food Standards Modernization"
About this pending rulemaking (RIN 0910-AC54):
In 1995, the FDA and FSIS reviewed their regulatory procedures and requirements for food standards to determine whether any were still needed, and if so, which ones should be modified or streamlined. To request public comment to assist them in their review of the need for food standards, both agencies published advance notices of proposed rulemaking (ANPRMs) on food standards in December, 1995 (60 FR 47453 and 60 FR 67492). These ANPRMs discussed the agencies' regulations and policy governing food standards, the history of food standards, and the possible need to revise the food standards. Several comments in response to the ANPRMs recommended that the agencies establish general principles or a fundamental philosophy for reviewing food standards and revising them. The agencies agreed with these comments and determined that it would be appropriate to develop general principles for reviewing and revising food standards regulations. The agencies also agreed with the comments that stated that the agencies should work in concert to develop consistent food standards regulations. FDA and FSIS are now proposing a set of general principles that define how modern food standards should be structured. If this proposed rule is adopted, FDA and FSIS will require that a citizen petition for establishing, revising, or eliminating a food standard in 21 CFR parts 130 to 169 and 7 CFR part 410 be submitted in accordance with the general principles. Conversely, the agencies may find deficient a petition to establish, revise, or eliminate a food standard that does not follow these general principles.
Meeting with GlaxoSmithKline on FDA rule: "Use of Ozone Depleting Substances; Removal of Essential Use Designations"
About this one (RIN 0910-AF18):
Under the Clean Air Act, the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services, in consultation with the Environmental Protection Agency, is required to determine whether an FDA-regulated product that releases an ozone-depleting substance (ODS) is essential. The two agencies have tentatively determined that the two currently marketed non-ODS metered-dose inhalers (MDIs) will be satisfactory alternatives to albuterol MDIs that contain ODS, and have proposed to remove the essential use designations for albuterol MDIs. If the essential use designation is removed, albuterol MDIs that contain an ODS could not be marketed after a suitable transition period. The proposed rule specifically asked for comments on which phase-out period length will best ensure a smooth transition and minimize any adverse affects on the public health.
