Extracted text

OCR Page 1 of 59
Page 54 S. 1530 NOVEMBER 21, 1997 VERSION: 1 THE ESTABLISHMENT OR AMENDMENT OF A HEALTH RISK MANAGEMENT STANDARD FOR A TOBACCO PRODUCT SHALL BE ACCOMPANIED BY A JUSTIFICATION OF THE PROPOSED ACTION AND SHALL- "(I) INVITE INTERESTED PERSONS TO SUBMIT TO THE SECRETARY, WITHIN 30 DAYS OF THE PUBLICATION OF THE NOTICE, REQUESTS FOR CHANGES IN THE STANDARD BASED ON NEW INFORMATION RELEVANT TO THE STANDARD; AND "(II) INVITE INTERESTED PERSONS TO SUBMIT AN EXISTING HEALTH RISK MANAGEMENT STANDARD FOR THE TOBACCO PRODUCT, INCLUDING A DRAFT OR PROPOSED HEALTH RISK MANAGEMENT STANDARD, FOR CONSIDERATION BY THE SECRETARY. (c) NOTICE OF REVOCATION.-A NOTICE OF PROPOSED RULEMAKING FOR THE REVOCATION OF A HEALTH RISK MANAGEMENT STANDARD SHALL SET FORTH A FINDING WITH SUPPORTING JUSTIFICATION THAT THE HEALTH RISK MANAGEMENT STANDARD IS NO LONGER NECESSARY WITH RESPECT TO THE TOBACCO PRODUCT. "(D) COMMENTS.-THE SECRETARY SHALL PROVIDE FOR A COMMENT PERIOD OF NOT LESS THAN 60 DAYS AFTER THE DATE ON WHICH A NOTICE HAS BEEN PUBLISHED UNDER THIS PARAGRAPH. (2) REQUEST FOR CHANGE.-IF, AFTER THE PUBLICATION OF A NOTICE IN ACCORDANCE WITH PARAGRAPH (1), THE SECRETARY RECEIVES A REQUEST FOR A CHANGE IN THE HEALTH RISK MANAGEMENT STANDARD FOR A TOBACCO PRODUCT, THE SECRETARY SHALL, WITHIN 60 DAYS OF THE PUBLICATION OF THE NOTICE, EITHER DENY THE REQUEST OR GIVE NOTICE OF AN INTENT TO INITIATE SUCH A CHANGE. "(3) REGULATION FOR ESTABLISHMENT.- '(A) IN GENERAL.-AFTER THE EXPIRATION OF THE PERIOD FOR COMMENT ON A NOTICE OF PROPOSED RULEMAKING PUBLISHED UNDER PARAGRAPH (1) WITH RESPECT TO A HEALTH RISK MANAGEMENT STANDARD, AND AFTER CONSIDERATION OF SUCH COMMENTS AND ANY REPORT FROM THE TOBACCO PRODUCTS ADVISORY COMMITTEE UNDER SECTION 907, THE SECRETARY SHALL- "(I) PROMULGATE A REGULATION ESTABLISHING A HEALTH RISK MANAGEMENT STANDARD AND PUBLISH IN THE FEDERAL REGISTER FINDINGS ON THE MATTERS REFERRED TO IN SUBSECTION (B); OR "(II) PUBLISH A NOTICE TERMINATING THE PROCEEDING FOR THE DEVELOPMENT OF THE STANDARD TOGETHER WITH THE REASONS FOR SUCH TERMINATION. (B) CONTENTS. -A REGULATION ESTABLISHING A HEALTH RISK MANAGEMENT STANDARD UNDER SUBPARAGRAPH (A) SHALL SET FORTH THE DATE OR DATES UPON WHICH THE STANDARD SHALL TAKE EFFECT, BUT NO SUCH REGULATION MAY TAKE EFFECT BEFORE THE EXPIRATION OF THE 1-YEAR PERIOD BEGINNING ON THE DATE OF ITS PUBLICATION UNLESS THE SECRETARY DETERMINES THAT AN EARLIER EFFECTIVE DATE IS NECESSARY FOR THE PROTECTION OF THE PUBLIC HEALTH. SUCH DATE OR DATES SHALL BE ESTABLISHED so AS TO MINIMIZE ECONOMIC LOSS To, AND DISRUPTION OR DISLOCATION OF, DOMESTIC AND INTERNATIONAL TRADE. '(4) AMENDING OR REVOKING OF STANDARDS.- (A) IN GENERAL.-THE SECRETARY, UPON THE INITIATIVE OF THE SECRETARY OR UPON PETITION OF AN INTERESTED PERSON, MAY BY REGULATION, PROMULGATED IN ACCORDANCE WITH THE REQUIREMENTS OF PARAGRAPHS (1), (2), AND (3), AMEND OR REVOKE A HEALTH RISK MANAGEMENT STANDARD FOR A TOBACCO PRODUCT. (B) EFFECTIVENESS OF AMENDMENT.-THE SECRETARY MAY DECLARE A