FOOD SAFETY ENFORCEMENT ENHANCEMENT ACT OF 1997 Release No. 0290.97 SECTION-BY-SECTION-ANALYSIS FOOD SAFETY ENFORCEMENT ENHANCEMENT ACT OF 1997 Section 1. Section 1 would provide that the Act may be cited as "The Food Safety Enforcement Enhancement Act of 1997". Section 2. Section 2 would amend the Federal Meat Inspection Act (FMIA) by redesignating the current section 411 as section 414 and adding three new enforcement provisions related to notification and recall of products, the refusal and withdrawal of inspection, and the assessment of civil penalties. Section 411, Notification and Recall, would require persons, firms, or corporations to notify the Secretary of the identity and location of adulterated and misbranded products. Further, section 411 would provide the Secretary with authority to issue orders to cease distribution of and to recall adulterated and misbranded products if there is a reasonable probability of a threat to public health. Section 411 would provide a mechanism to prevent such articles from reaching consumers. Section 411(a) would require any person, firm, or corporation which has a reasonable basis for believing that any carcasses, parts of carcasses, meat, or meat food products are adulterated or misbranded to immediately notify the Secretary of the identity and location of such articles. The immediate notification of the identity and location of articles believed to be adulterated or misbranded is necessary to provide the Secretary with the opportunity to limit the distribution of such articles, and possibly avoid human illness. The Secretary would prescribe by regulation the means and manner that notification is to be provided. Section 411(b) would provide that if the Secretary finds, through notification or otherwise, that (1) any carcasses, parts of carcasses, meat, or meat food products are adulterated or misbranded and (2) there is a reasonable probability that human consumption of such articles presents a threat to public health, the Secretary would provide the persons, firms, or corporations with an opportunity to (1) voluntarily cease distribution of such articles; (2) notify all persons, firms, and corporations transporting, storing, or distributing such articles or to which such articles were transported or sold, to immediately cease distribution of such articles; (3) to recall the articles; and (4) to provide, in consultation with the Secretary, notice to consumers to whom such articles were, or may have been, distributed. If the person, firm, or corporation refuses to or does not voluntarily cease distribution, make notification, recall the articles, and notify the public, within the time and in the manner prescribed by the Secretary, the Secretary would have the authority to issue an order requiring such person, firm, or corporation immediately (1) to cease distribution of the articles and (2) to notify all persons, firms, and corporations transporting or distributing the articles, or to which the articles were transported or sold, to immediately cease distribution. The Secretary shall, as he deems necessary, provide for notice to consumers to whom such articles were, or may have been, distributed. Section 411(c) would provide for an opportunity for an informal hearing, to be held as soon as possible but not later than two days after the issuance of the order, to allow the affected person, firm, or corporation the opportunity to contest the order. Further, the informal hearing would allow the affected person, firm or corporation an opportunity to present evidence as to why the articles should not be recalled. Section 411(d) would give the Secretary authority to require recall of the articles if, after opportunity for a hearing under subsection (c), the Secretary continues to find that there is a reasonable probability of a threat to public health. Upon this determination, the Secretary would, as he deems necessary, amend the order to require a recall. The order would specify a timetable for the recall, require periodic reports describing the progress of the recall, and provide for notice to consumers, to whom such articles were or may have been distributed. If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary would be required to vacate the order. Section 411(e) would provide that the remedies provided in section 411 are in addition to all other available remedies. Section 411 would enable the Secretary to better protect the public from receiving products that present a reasonable probability that human consumption of the product presents a threat to public health. Authorized representatives of the Secretary currently have authority to detain products for 20 days that are found outside an official establishment and not in compliance with the FMIA (see section 402 of the FMIA). Under present authority, FSIS must institute an action in the appropriate U.S. District Court in order to get a judicial seizure and condemnation order. The present authority is resource intensive and lengthy. FSIS frequently relies on voluntary recalls by official establishments. This new authority to require recall of certain adulterated or misbranded articles would allow FSIS to protect consumers more effectively and efficiently. Section 412, Refusal or Withdrawal of Inspection, would provide the Secretary with additional grounds upon which to refuse or withdraw inspection. Section 401 of the FMIA currently authorizes the Secretary, after opportunity for a hearing, to refuse to provide or to withdraw inspection based upon a determination that the applicant or recipient of inspection is unfit to engage in any business requiring inspection under the FMIA because the applicant, recipient, or anyone responsibly connected with the applicant or recipient, has been convicted in Federal or State court of certain violations of law. Section 412(a) would provide that the Secretary may refuse to provide or withdraw inspection from an applicant or recipient when it has been determined, after an opportunity for hearing, that the applicant or recipient or any person responsibly connected with the applicant or recipient (as defined in section 401) has committed any willful violation of the requirements of the Act or the regulations promulgated under the Act (one willful violation may result in this section being applied) or repeated violations of the requirements of the Act or the regulations promulgated under the Act. This provision does not require a determination of unfitness, nor is a prior criminal conviction or civil or administrative order or determination required. Section 412(b) would authorize the Secretary to deny or suspend inspection, pending an opportunity for an expedited hearing, with respect to an action under section 412(a) to refuse to provide or withdraw inspection, if the Secretary deems such denial or suspension in the public interest in order to protect the health or welfare of consumers or to assure the safe and effective performance of official duties under the Act. The Secretary would have the authority to take immediate action against a violator if such action is deemed in the public health or to assure the safe and effective performance of official duties under the Act. The denial or suspension would be effective upon service of the complaint or other such notice. Section 412(c) would provide that the determination and order of the Secretary is final and conclusive unless the affected person, firm, or corporation files for judicial review within thirty days after the effective date of the order. Unless the Secretary directs otherwise, inspection would be refused or withdrawn as of the effective date of the order, pending judicial review of the order. The United States Court of Appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business and the United States Court of Appeals for the District of Columbia Circuit would have jurisdiction. Judicial review would be on the record upon which the determination and order are based. Section 412(d) would provide that the remedies provided in section 412 are in addition to all other available remedies. Section 413, Civil Penalties, would authorize the Secretary to assess civil monetary penalties for violations of any provision of the Act, the regulations promulgated under the Act, or any order issued under new section 411 of the Act. Section 413(a) would authorize the Secretary to impose civil penalties of not more than $100,000 for each violation against any person, firm or corporation which violates any provision of the Act, the regulations under the Act, or any order issued under the Act. Each violation and each day would be a separate offense subject to civil penalties. These penalties would be assessed after the person, firm, or corporation has received notice and an opportunity for a hearing on the record in accordance with 5 U.S.C. 554 and 556. The sanction would be based upon the gravity of the violation, degree of culpability, size and type of business, and any history of prior offenses. Criminal sanctions are vital in ensuring the enforcement of the FMIA, but are not enough. Criminal prosecution can be a lengthy and cumbersome process in an overburdened judicial system. Civil monetary penalties, on the other hand, can be imposed administratively, ensuring a timely and effective resolution. Moreover, a monetary penalty is more tangible than a distant and lengthy legal process that may or may not be instituted and may or may not lead to a conviction. The proposed civil penalty amount is reasonable and will deter potential violators. Civil penalties would therefore be an effective enforcement tool. Section 413(b) would provide that orders of the Secretary assessing a civil penalty may be reviewed in the U.S. Court of Appeals for the circuit in which the party resides or has its principal place of business or in the U.S. Court of Appeals for the District of Columbia Circuit by filing a notice of appeal within thirty days from the date of such order and by simultaneously sending a copy of such notice by certified mail to the Secretary. The findings of the Secretary would be set aside only if found to be unsupported by substantial evidence on the record as a whole. Section 413(c) would provide that failure to pay the civil penalty after the order assessing the penalty has become final and unappealable or after the appropriate Court of Appeals has entered final judgement in favor of the Secretary shall result in the Secretary referring the matter to the Attorney General who shall institute a civil action to recover the assessed penalty. The validity of the Secretary's order would not be reviewable in such a collection action. Section 413(d) would require that the civil penalties collected under section 413 be paid into the U.S. Treasury. Section 413(e) would provide that the Secretary may refuse to provide inspection to, or suspend inspection from any person, firm, or corporation that fails to pay an assessment of a civil penalty after it has become a final and unappealable order, or after the appropriate Court of Appeals has entered final judgment in favor of the Secretary. Section 413(f) would provide that nothing in the Act shall require the Secretary to report for criminal prosecution or for the institution of libel or injunction proceedings violations of the Act when the Secretary believes that the public interest will be adequately served by the assessment of civil penalties. Section 413(g) would provide that the remedies provided in section 413 are in addition to all other available remedies. Section 3. Section 3 would amend section 5(c) the Poultry Products Inspection Act (PPIA) by substituting sections 12-22, and 31-33 of this Act for the reference to sections 12-22. Section 5(c) of the PPIA requires that the Secretary designate any State whose poultry products inspection requirements with respect to transactions wholly within such State are not at least equal to those of sections 1-4, 6-10, and 12-22 of the PPIA. This section would provide that sections 1-4, 6-10, 12-22, and 31-33 would apply to such intrastate transactions and no poultry or poultry products could be sold unless inspected for wholesomeness and passed by inspectors of the Food Safety and Inspection Service (FSIS). Section 3 of the bill would add at the end of the PPIA three new enforcement provisions related to notification and recall of products, the refusal and withdrawal of inspection, and the assessment of civil penalties. Section 31, Notification and Recall, would require persons (as defined in Section 4(j)) to notify the Secretary of the identity and location of adulterated and misbranded products. Further, section 31 would provide the Secretary with authority to issue orders to cease distribution of and orders to recall adulterated and misbranded products if there is a reasonable probability of a threat to public health. Section 31 would provide a mechanism to prevent such articles from reaching consumers. Section 31(a) would require any person which has a reasonable basis for believing that any adulterated or misbranded, immediately to notify the Secretary of the identity and location of such articles. The immediate notification of the identity and location of articles believed to be adulterated or misbranded is necessary to provide the Secretary with the opportunity to limit the distribution of such articles, and possibly avoid human illness. The Secretary would prescribe by regulation the means and manner that notification is to be provided. Section 31(b) would provide that if the Secretary finds, through notification or otherwise, that (1) any poultry or poultry products are adulterated or misbranded, and (2) there is a reasonable probability that human consumption of such poultry or poultry products presents a threat to public health, the Secretary would provide the appropriate person with an opportunity to (1) voluntarily cease distribution of such poultry or poultry products; (2) notify all persons transporting, storing, or distributing such poultry or poultry products or to which such poultry or poultry products were transported or sold to immediately cease distribution of such articles; (3) to recall the poultry or poultry products; and (4) to provide, in consultation with the Secretary notice, to consumers to whom such articles were, or may have been, distributed. If the person refuses to or does not voluntarily cease distribution, make notification, recall the articles, and notify the public, within the time and in the manner prescribed by the Secretary, the Secretary would have the authority to issue an order requiring the person immediately (1) to cease distribution of the poultry or poultry products and (2) to notify all persons transporting or distributing the poultry or poultry products, or to which the poultry or poultry products were transported or sold, to immediately cease distribution. The Secretary shall, as he deems necessary, provide for notice to consumers to whom such articles were, or may have been, distributed. Section 31(c) would provide for opportunity for an informal hearing, to be held as soon as possible but not later than two days after the issuance of the order, to allow the affected person the opportunity to contest the order. Further, the informal hearing would allow the affected person an opportunity to present evidence as to why the articles should not be recalled. Section 31(d) would give the Secretary authority to require recall of the articles if, after opportunity for a hearing under subsection (c), the Secretary continues to find that there is a reasonable probability of a threat to public health. Upon this determination, the Secretary would, as he deems necessary, amend the order to require a recall. The order would specify a timetable for the recall, require periodic reports describing the progress of the recall, and provide for notice to consumers, to whom such articles were or may have been distributed. If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary would be required to vacate the order. Section 31(e) would provide that the remedies provided in section 31 are in addition to all other available remedies. Section 31 would enable the Secretary to better protect the public from receiving products that present a reasonable probability that human consumption of the products presents a threat to public health. Authorized representatives of the Secretary currently have authority to detain products for 20 days that are found outside an official establishment and not in compliance with the PPIA (see section 19 of the PPIA). Under present authority, FSIS must institute an action in the appropriate U.S. District Court in order to get a judicial seizure and condemnation order. The present authority is resource intensive and lengthy. FSIS frequently relies on voluntary recalls by official establishments. This new authority to require recall of certain adulterated or misbranded articles would allow FSIS to protect consumers more effectively and efficiently. Section 32, Refusal or Withdrawal of Inspection, would provide the Secretary with additional grounds upon which to refuse or withdraw inspection. Section 18 of the PPIA currently authorizes the Secretary, among other things, to refuse to provide or to withdraw inspection, after opportunity for a hearing, based upon a determination that the applicant or recipient of inspection is unfit to engage in any business requiring inspection under the PPIA because the applicant or recipient (or anyone responsibly connected with the applicant or recipient) has been convicted in a Federal or State court of certain violations of law. Section 32(a) would provide that the Secretary may refuse to provide or withdraw inspection from an applicant or recipient when it has been determined, after an opportunity for hearing, that the applicant or recipient or any person responsibly connected with the applicant or recipient (as defined in section 18(a)) has had committed any willful violation of the requirements of Act or the regulations promulgated under the Act (one willful violation may result in this section being applied) or repeated violations of the requirements the Act or the regulations promulgated under the Act. This provision does not require a determination of unfitness, nor is a prior criminal conviction or civil or administrative order or determination required. Section 32(b) would authorize the Secretary to deny or suspend inspection, pending an opportunity for an expedited hearing, with respect to an action under section 32(a) to refuse to provide or withdraw inspection, if the Secretary deems such denial or suspension in the public interest in order to protect the health or welfare of consumers or to assure the safe and effective performance of official duties under the Act. The Secretary would have the authority to take immediate action against a violator if such action is deemed necessary to protect the public health or to assure the safe and effective performance of official duties under the Act. The denial or suspension would be effective upon service of the complaint or other such notice. Section 32(c) would provide that the determination and order of the Secretary is final and conclusive unless the affected person files for judicial review within thirty days after the effective date of the order. Unless the Secretary directs otherwise, inspection would be refused or withdrawn as of the effective date of the order, pending judicial review of the order. The United States Court of Appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business and the United States Court of Appeals for the District of Columbia Circuit would have jurisdiction. Judicial review would be on the record upon which the determination and order are based. Section 32(d) would provide that the remedies provided in section 31 are in addition to all other available remedies. Section 33 Civil Penalties, would authorize the Secretary to assess civil monetary penalties for violations of any provision of the Act, the regulations promulgated under the Act, or any order issued under new section 31 of the Act. Section 33(a) would authorize the Secretary to impose civil penalties of not more than $100,000 for each violation against any person who violates any provision of the Act, regulations under the Act, or any order issued under the Act. Each violation and each day would be a separate offense subject to civil penalties. These penalties shall be assessed after the person has received notice and an opportunity for a hearing on the record in accordance with 5 U.S.C. 554 and 556. The sanction would be based upon the gravity of the violation, degree of culpability, size and type of business of the person, and any history of prior offenses. Criminal sanctions are vital in ensuring the enforcement of the PPIA, but are not enough. Criminal prosecution can be a lengthy and cumbersome process in an overburdened judicial system. Civil monetary penalties, on the other hand, can be imposed administratively, ensuring a timely and effective resolution. Moreover, a monetary penalty is more tangible than a distant and lengthy legal process that may or may not be instituted and may or may not lead to a conviction. The proposed civil penalty amount is reasonable and will deter potential violators. Civil penalties could therefore be an effective enforcement tool. Section 33(b) would provide that orders of the Secretary assessing a civil penalty may be reviewed in the U.S. Court of Appeals for the circuit in which the person resides or has its principal place of business or in the U.S. Court of Appeals for the District of Columbia Circuit by filing a notice of appeal within thirty days from the date of such order and by simultaneously sending a copy of such notice by certified mail to the Secretary. The findings of the Secretary would be set aside only if found to be unsupported by substantial evidence on the record as a whole. Section 33(c) would provide that failure to pay the civil penalty after the order assessing the penalty has become final and unappealable or after the appropriate Court of Appeals has entered final judgement in favor of the Secretary shall result in the Secretary referring the matter to the Attorney General who shall institute a civil action to recover the assessed penalty. The validity of the Secretary's order would not be reviewable in such a collection action. Section 33(d) would require that the civil penalties collected under section 33 shall be paid into the U.S. Treasury. Section 33(e) would provide that the Secretary may refuse to provide inspection to, or suspend inspection from any person that fails to pay an assessment of a civil penalty after it has become a final and unappealable order, or after the appropriate Court of Appeals has entered final judgment in favor of the Secretary. Section 33(f) would provide that nothing in the Act shall require the Secretary to report for criminal prosecution or for the institution of libel or injunction proceedings violations of the Act when the Secretary believes that the public interest will be adequately served by the assessment of civil penalties. Section 33(g) would provide that the remedies provided in section 33 are in addition to all other available remedies.