2 (a) USDA-REGULATED PRODUCTS

16

Suggested Legislative Language Refinements to S. 510

(Updated Feb. 4, 2010)

[New language underscored; deleted language stricken through.]

Issue 1: Amend Existing Section 403 to Clarify USDA Food-Safety Statutory Authority Under Existing Statutes

Add the following language to the existing Sec. 403 in S. 510:

SEC. 403. JURISDICTION.

(a) Chapter IX (21 U.S.C. § 392 et seq.), Section 902(a) is amended as follows:

a. Insert “(1)” after “(a)” and strike “.” and insert in lieu thereof “;”

b. At the end, add –

“(2) Poultry and Poultry food products shall be exempt from the provisions of this Act to the extent of the application or the extension thereto of the Poultry Products Inspection Act, as amended (21 U.S.C. § 451 et seq.);

“(3) Egg Products shall be exempt from the provisions of this Act to the extent of the application or the extension thereto of the Egg Products Inspection Act, as amended (21 U.S.C. § 1031 et seq.); and

“(4) Facilities and operations thereof to the extent of the application or the extension thereto of the Federal Meat Inspection Act, as amended (21 U.S.C. § 601 et seq.), the Poultry Products Inspection Act, as amended (21 U.S.C. § 451 et seq.), the Egg Products Inspection Act, as amended (21 U.S.C. § 1031 et seq.), the U.S. Grain Standards Act, as amended (7 U.S.C. § 71 et seq.) and the U.S. Warehouse Act, as amended (7 U.S.C. § 241 et seq.) shall be exempt from the provisions of this Act.

(5) Facilities and operations thereof to the extent of the application or the extension thereto of a State or other program recognized by the Secretary of Agriculture as being at least equal to Federal regulation under the Federal Meat Inspection Act, as amended (21 U.S.C. § 601 et seq.); the Poultry Products Inspection Act, as amended (21 U.S.C. § 451 et seq.); the Egg Products Inspection Act, as amended (21 U.S.C. § 1031 et seq.); the U.S. Grain Standards Act, as amended (7 U.S.C. § 71 et seq.); and the U.S. Warehouse Act, as amended (7 U.S.C. § 241 et seq.) shall be exempt from the provisions of this Act.

Explanation/Rationale: This language clarifies the jurisdictional role of the Food and Drug Administration and the U.S. Department of Agriculture with respect to several food safety laws. Regarding products regulated under the Poultry products Inspection Act and the Egg Products Inspection Act, it adopts language identical to a current provision of the Food, Drug and Cosmetic Act regarding the Federal Meat Inspection Act. Thereby, it recognizes current practice of FDA deference to regulation by USDA of products “to the extent” they are regulated under a USDA statute. Similarly, facilities and operations subject to regulation by USDA would not be subject to redundant regulation under the Federal Food, Drug, and Cosmetic Act.

This additional language is necessary because:

· Existing S. 510 paragraph (1) applies only to regulation issued by USDA under the Agricultural Marketing Act, not the federal statutes that pertain to its oversight of meat, poultry and egg product safety.

· Existing S. 510 paragraphs (2) and (3) address other statutes and also do not reference the laws under which USDA has inspection/regulatory authority under existing statutes.

· Existing S. 510 paragraph (4) does reference USDA inspection/regulatory statutes, but only to the extent they pertain to animal health emergencies or foodborne illness outbreaks. Routine inspection and regulation are not covered.

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Issue 2: Modify Section 104 to Clarify Application of Performance Standards

SEC. 104. PERFORMANCE STANDARDS.

‘‘(1) IN GENERAL.—The Secretary shall not less frequently than every two years may, as appropriate, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses among others, to determine the most significant food-borne contaminants. Based on such review and evaluation, andWhen appropriate to reduce the risk of serious illness or death to humans or animals or to prevent the adulteration of the food under section 402 of the Federal Food, Drug, and Cosmetic Act, (21 U.S.C. 342) or to prevent the spread of communicable disease under section 361 of the Public Health Service Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and science-based guidance documents, action levels, or regulations. may promulgate regulations through the notice and comment rulemaking process under the Administrative Procedure Act (5 U.S.C. 553) that establish performance standards. No such rulemaking may be initiated by the Secretary without consulting with and seeking guidance from the National Advisory Committee on Microbiological Criteria for Foods, the Food Safety Advisory Committee, or the Veterinary Medicine Advisory Committee, or their successors, as appropriate for the subject matter. In addition, as part of any such rulemaking and with respect to existing regulations, the Secretary shall conduct a scientific risk assessment to determine whether the substance likely will cause serious illness or death to humans or animals and should be deemed to be an adulterant in food.  Such guidance, action levels, or regulations shall may apply to products or product classes and but shall not be written to be facility-specific.

‘‘(2) PUBLIC INPUT.—During the comment period on any notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.

“(3) ATTRIBUTION – When adopting any standard, the Secretary shall review the information generated under Section 205 of this Act as to the product or product class attributable to the food-borne contaminants . No less frequently than every two years after adoption of any standard, the Secretary shall use the data generated under Section 205 and other information to evaluate the effectiveness of the standard in reducing foodborne illnesses and make any modification to, including elimination of, the standard.

Explanation/Rationale: Clarifies that standards facilities are required to implement shall be promulgated through notice-and-comment rulemaking that provides for consideration of public comment and cost-benefit analysis. FDA under existing authorities may issue guidance, as well as action levels and advisory levels, on contaminants, which makes these references in S. 510 superfluous. But by their very nature, guidance and action/advisory levels may not represent official FDA policy and may be issued based upon incomplete scientific information. Given FDA’s expanded authorities under S. 510 (e.g., administrative detention and mandatory recall/cease-distribution), it is prudent that such authorities be limited to FDA policy actions promulgated through rulemaking. This section also stipulates that FDA use scientific risk-assessment to determine whether a contaminant or hazard is an adulterant; in some current circumstances, FDA’s regulations do not adequately consider whether specific types or subtypes of contaminants pose a risk to human or animal health.

This new language also: 1) makes the establishment of performance standards discretionary with the Secretary, and bases that determination on product risk; 2) cites expert scientific advisory bodies with which we believe FDA should consult in developing any performance standards; and 3) provides for at least three public meetings to provide input to the Secretary.

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Issue 3: Modify Section 207 (Mandatory Recall Authority) and Add New Section Authorizing Indemnification for Producers and Facilities Economically Damaged by Wrongfully Issued FDA Recall or Administrative-Detention Orders

The following language is offered to replace existing Sec. 207 in S. 510:

SEC. 207. MANDATORY RECALL AUTHORITY

(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), as amended by section 202, is amended by adding at the end the following:

SEC. 423. MANDATORY RECALL AUTHORITY.

(a) VOLUNTARY PROCEDURES.—If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with all information relevant to such determination and an opportunity to cease distribution and recall such article.

(b) MANDATORY PROCEDURES.—If the responsible party refuses to or does not voluntarily cease distribution and recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such party to immediately cease distribution and recall such article.

(c) CONTENTS OF RECALL ORDER. – A Mandatory Recall Order shall specify as precisely as possible the –

(1) responsible party;

(2) identity of the article;

(3) threat to human or animal health posed by the article;

(4) area of distribution or other information likely to identify potential distributors and consumers of the article; and

(5) reasonable actions required of the responsible party to –

(A) halt distribution of the article;

(B) provide appropriate notification to distributors and potential consumers of the article; and

(C) recall the article from commercial distribution.

(d) COOPERATION AND COORDINATION.— For purposes of any recall undertaken pursuant to this section, the Secretary shall designate a Government Recall Coordinator, who shall—

(1) cooperate with federal, state and local government authorities with responsibilities related to the recall;

(2) have overall responsibility for federal government actions and public statements regarding the recall; and

(3) coordinate all communications of federal, state and local government agencies with the responsible party regarding the recall.

(e) PUBLIC NOTIFICATION.—

(1)The Secretary shall promptly announce initiation of the recall under this section. Such public notification shall identify the –

(A) responsible party;

(B) identity of the article;

(C) threat to human or animal health posed by the article;

(D) area of distribution or other information likely to identify potential distributors and consumers of the article; and

(E) other information the Secretary determines may aid in the protection of human or animal health.

(2) The Secretary shall consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving articles involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary.

(f) DELEGATION.—The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

(g) EFFECT.—Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall under circumstances other than those set forth in subsection (a).

(h) INDEMNIFICATION. –

“(1) A wrongfully issued order to recall under this section or detain food under Section 304(h) shall be a tort for purposes of Chapter 171 of the Act of June 25, 1948 (28 U.S.C. 2671 et seq.).

“(2) For purposes of this subsection, a recall order or administrative-detention order shall be deemed to have been wrongfully issued with regard to an article of food unless the Secretary is able to establish by a preponderance of the evidence that:

(A) the article of food subject to such order was in fact adulterated under section 402 or misbranded under section 403(w), and

(B) the use of or exposure to the article of food subject to such order would have caused serious adverse health consequences or death to humans or animals.

“(3) No defense authorized under Chapter 171 of the Act of June 25, 1948 (28 U.S.C. 2680(a), (c) or (f)) shall be available with respect to any claim arising from the exercise of authority granted by this section.”

(b) CIVIL PENALTY.—Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is amended by inserting ‘‘or any person who does not comply with a recall order under section 423’’ after ‘‘section 402(a)(2)(B)’’.

(c) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 et seq.), as amended by section 106, is amended by adding at the end the following:

‘‘(rr) The refusal or failure to follow an order under section 423.’’.

Explanation/Rationale: This language provides for expedited mandatory recall authority (including cessation of distribution, which is to be implemented only as part of a recall order) in the event the Secretary determines that voluntary recall procedures are insufficient. It is a more streamlined approach than currently provided in S. 510. Upon a determination by the Secretary that a recall is required, the Secretary is required to provide the responsible party all information relevant to the determination. The mandatory recall authority of this amendment would take effect without opportunity for a pre-recall hearing. Thus, the mandatory recall would take effect at least two days sooner than the mandatory recall authority in S. 510. This amendment also provides for federal coordination of governmental communications regarding recalls undertaken at the direction of FDA.

Finally, to provide for due-process protections, indemnification for a wrongfully ordered recall would be available to a recalling firm under the Federal Tort Claims Act. In addition, the amendment would provide such indemnification for wrongfully ordered administrative detention of food, which is appropriate given that S. 510 would reduce significantly the legal threshold FDA currently is required to meet under the Bioterrorism Act of 2002 prior to issuing such an order.

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Issue 4: Modify Section 102 (Suspension of Facility Registration) – SEC. 102. REGISTRATION OF FOOD FACILITIES

…….

(b) SUSPENSION OF REGISTRATION.—

(1) IN GENERAL.—Section 415 (21 U.S.C. 350d) is amended—

(A) in subsection (a)(2), by inserting after the first sentence the following: ‘‘The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.’’;

(B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and

(C) by inserting after subsection (a) the following:

(b) SUSPENSION OF REGISTRATION.—

(1) IN GENERAL.— The Secretary may, by order, suspend the registration of the facility under this section in accordance with this subsection if

“(i) the Secretary determines that food manufactured, processed, packed or held by a facility registered under this section the facility manufactured and distributed produced and shipped food that is adulterated and that such food has a reasonable high probability of causing serious adverse health consequences or death to humans or animals. the Secretary may by order suspend the registration of the facility under this section in accordance with this subsection.

(2) HEARING ON SUSPENSION.—The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.

(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF ORDER.—

(A) CORRECTIVE ACTION PLAN.—If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review approve or deny such plan in a timely manner within fifteen (15) days of submission. If denied, the Secretary shall specify deficiencies of the plan in the denial. Approval or denial of the plan shall be final agency action unless otherwise mutually agreed upon by the Secretary and the registrant.

(B) VACATING OF ORDER.—Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.

(4) EFFECT OF SUSPENSION.—If the registration of a facility is suspended under this subsection, such facility shall not import food or offer to import food into the United States, or otherwise introduce food into interstate or intrastate commerce in the United States.

(5) REGULATIONS.—The Secretary shall promulgate regulations that describe the standards the Commissioner will use in making a determination to suspend a registration, and the format the Commissioner will use to explain to the registrant the conditions found at the facility. The Secretary may promulgate such regulations on an interim final basis.

(6) APPLICATION DATE. – Facilities shall be subject to the requirements of this subsection beginning on the earlier of –

(A) the date on which the Secretary issues regulations under paragraph (5); or

(B) 180 days after the date of enactment of the FDA Food Safety Modernization Act.

(7) NO DELEGATION.—The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.’’

(2) IMPORTED FOOD. – Section 801(l)(21 U.S.C. 381(l)) is amended by inserting “(or for which a registration has been suspended under such section)” after “section 415”.,

(b) Conforming Amendments. –

(1) Section 301(d) (21 U.S.C. 331(d) is amended by inserting “415,” after “404,”.

(2) Section 415(d), as redesignated by subsection (b), is amended by adding at the end before the period “for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)”.

Explanation/Rationale: This language recognizes that a higher threshold than “reasonable probability” of harm should be the evidentiary bar before FDA should be authorized to shut down a facility’s operations, particularly given that the agency also would be empowered under S. 510 to issue administrative-detention and mandatory recall/cease distribution orders requiring facilities to hold and recall products. This revision also would provide a reasonable, 15-day timetable by which the Secretary would be required to approve or deny a facility’s corrective action plan so that a facility is not unnecessarily shut down for an unreasonable period of time if it is prepared to institute measures satisfactory to resolve the food or feed safety problem that resulted in the suspension.

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Issue 5: Modify Section 103 (Sec. 418 – Hazard Analysis and Risk-Based Preventive Controls) to Relocate References to Intentional Contamination to Section 106 (Sec. 420 – Protection Against Intentional Adulteration)

SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

(b) HAZARD ANALYSIS. – The owner, operator or agent in charge of a facility shall –

(1) Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including…. –

(B) hazards that occur naturally, or may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; and

SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.

(a) IN GENERAL – Not later than 24 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture shall promulgate regulations to protect against the intentional adulteration of food subject to this Act.

(a) IN GENERAL – The owner, operator or agent in charge of a facility shall evaluate known or reasonably foreseeable hazards that could be intentionally introduced, including by acts of terrorism, that could cause food manufactured, processed, packed or held by the facility to become adulterated or pose serious adverse health consequences or death to humans or animals, and identify and implement food-defense measures to mitigate such hazards.

(b) GUIDANCE DOCUMENTS. – Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug and Cosmetic Act, as added by subsection (a).

(1) CONTENT. – The guidance documents issued under paragraph (b) shall –

(A) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food;

(A) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate;

(B) include a model vulnerability assessment for a person to use;

(C) include examples of mitigation strategies or measures described in subparagraph (1); and

(D) specify situations in which the examples of mitigation strategies or measures described in subparagraph (3) are appropriate.; and

(E) take into consideration existing food defense programs and practices implemented by various industry sectors.

(2) LIMITED DISTRIBUTION. – In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time and manner in which the guidance documents issued under paragraph (b) are made public, including by releasing such documents to targeted audiences.

(3) PERIODIC REVIEW. – The Secretary shall periodically review and, as appropriate, update the regulation under subsection (c) and the guidance documents under subsection (b).

(c) REGULATIONS. -- Not later than 24 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture shall may promulgate regulations to protect against the intentional adulteration of food subject to this Act.

(i) CONTENT OF REGULATIONS. – Regulations under subsection (a) shall only apply to food – If promulgated, regulations under subsection (c) shall only apply to food –

(A) for which the Secretary has identified clear vulnerabilities (such as short shelf-life or susceptibility to intentional contamination at critical control points);

(B) in bulk or batch form, prior to being packaged for the final consumer; and

(C) for which there is a high risk of intentional contamination, as determined by the Secretary that could cause serious adverse health consequences or death to humans or animals.

(ii) DETERMINATIONS. – In making the determinations under subsection

(b)(3) (c), the Secretary shall –

(A) conduct vulnerability assessments of the food system;

(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration at vulnerable points; and

(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.

(iii) EXCEPTION. – This section shall not apply to food produced on farms, except for milk.

(iv) DEFINITION. – For purposes of this section, the term ‘farm’ has the meaning given that term in section 1.227 of Title 21, Code of Federal Regulations (or any successor regulation).

(d) PROHIBITED ACTS. – Section 301 (21 U.S.C. 331 et seq.), as amended by section 105, is amended by adding at the end the following:

(qq) The failure to comply with section 420.

Explanation/Rationale: These changes recognize that the process used to identify unintentionally introduced hazards and develop preventive controls to address such hazards to acceptable levels as part of a written food safety plan are dramatically different and distinct from facility security and food defense plans used to address intentional contamination. It also requires the Secretary to consider existing food-defense programs implemented by various industry sectors. Further, it resolves the confusion in current Section 106 that appears to require facilities to implement food-defense measures specified by FDA in guidance documents prior to the promulgation of regulations for high-risk foods the agency determines to have clear vulnerabilities for intentional contamination.

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Issue 6: Add New Section to Provide Confidentiality Protection –

Sec. 101.

Add the following new subsection (c):

(c) RECORDS PROTECTION. –

(1) IN GENERAL. – Section 414(c) (21 U.S.C. 350c(c)) is amended by –

(A) striking “the Secretary” and inserting the following:

(1) IN GENERAL. – The Secretary”; and

(B) by adding at the end the following:

(2) APPROPRIATE MEASURES. – Appropriate measures under paragraph (1) shall include periodic risk assessment and planning to prevent unauthorized release and controls to –

(A) limit authorized reproduction of trade secret or confidential information;

(B) limit authorized access to trade secret or confidential information; and

(C) maintain records of access to trade secret or confidential information.”.

(2) REGULATIONS. – Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate regulations to prevent the unauthorized disclosure of trade secret or confidential information under section 414(c) of the Federal Food, Drug and Cosmetic Act (as amended by paragraph (1)), including, but not limited to information developed in conformance with regulations promulgated under Section 418 of this Act or amendments thereto.

Explanation/Rationale: This suggested addition is intended to prevent the inappropriate disclosure of confidential or proprietary business information or sensitive security-related information in the possession of FDA, including information obtained through expanded records access authority conferred by S. 510. The amendment would provide for FDA to undertake periodic risk assessment and planning to prevent unauthorized disclosure of sensitive information, while authorizing the sharing of food product safety incidents with State and Foreign Governments to protect public health. In addition, FDA would be required to establish procedures for limiting authorized reproduction and access to sensitive records, as well as maintaining records of personnel with access to sensitive records. This confidential and proprietary business information may include, but is not limited to, written food safety plans, preventive controls, quality-assurance plans, formulas and processing methods, food defense plans and other similar information.

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Issue 7: Modify Section 201 (Sec. 421(a)(2)(C)] to Provide Flexibility to FDA to Alter Inspection Frequency of Non-High-Risk Facilities –

Amend existing Sec. 421(a)(2)(C) as follows:

SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.

SEC. 421(a)(2)(C): NON-HIGH-RISK FACILITIES. – The Secretary shall ensure that each facility that is not identified under paragraph (1) as a high-risk facility is inspected not less than once every 4 5 years.

(i) The Secretary may alter the inspection frequency for non-high-risk facilities based on relative risk, the need to allocate inspection resources in a risk-based manner, and the need to respond to food-borne illness outbreaks and food recalls.

(ii) When modifying the inspection frequency for non-high-risk facilities, the

Secretary shall evaluate the type of food manufactured, processed, packed or held at the facility; location of the facility; compliance history of the facility; and such other factors as the Secretary determines by guidance to be relevant to assessing the relative risk posed by the facility.

Explanation/Rationale: In an effort not to set FDA up to fail, this change provides flexibility to FDA to alter the inspection frequency solely for non-high-risk facilities that pose negligible, if any, risk to food/feed safety. It mirrors some of the language contained in H.R. 2749, including changing the inspection frequency for non-high-risk facilities to five years from four.

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Suggested Perfecting Amendments

The following non-substantive revisions are suggested to further enhance S. 510 (New language underscored; deleted language stricken through):

1. SEC. 101. INSPECTION OF RECORDS.

(2) USE OF OR EXPOSURE TO FOOD OF CONCERN. – If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records directly relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.

Explanation/Rationale: This change clarifies that FDA’s access to records should be confined to those that relate to food or feed safety incidents, not to proprietary business information or other records not pertaining to such matters.

2. SEC. 103: HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

Modify SEC. 418 as follows:

(a) IN GENERAL. – The owner, operator or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed or held by such facility, identify and implement preventive controls to significantly minimize or prevent, eliminate or reduce the occurrence of such hazards to acceptable levels, and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice….

(c) PREVENTIVE CONTROLS. – The owner, operator or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that –

(1) Hazards identified in the hazard analysis conducted under subsection (b) will be significantly minimized or prevented, eliminated or reduced to acceptable levels; and.…

(f) VERIFICATION. – The owner, operator or agent in charge of a facility shall verify that…. –

(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing, eliminating or reducing to acceptable levels the occurrence of identified hazards, including through the use of environmental and product-testing programs and other appropriate means; and

(5) there is a documented, periodic reanalysis of the plan under subsection (i) to ensure provide assurance that the plan is still relevant to the raw materials, conditions and processes in the facility, and to new and emerging threats.

Explanation/Rationale: The changes to subsections (a) and (c) reflect language used in H.R. 2749 that more precisely specifies the degree to which hazards should be reduced, and removes the subjective determination that may result from the phrase “significantly minimize.” The change to subsection (f)(5) is consistent with the use of the phrase “provide assurance” in other sections of S. 510 and eliminates the inference of ironclad guarantees implied by the use of the term “ensure.”

3. SEC. 201 – TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT

Modify Sec. 421(a)(1)(C) as follows

SEC (421)(a)(1)(C): “The rigor effectiveness of the facility’s hazard analysis and risk-based preventive controls.

Explanation/Rationale: Given the tremendous diversity of agricultural products and facilities subjected to this requirement, this change reflects that what is important is whether a facility’s plans are effective in identifying and addressing hazards. A facility may have a very simple, but effective, process for addressing hazards that does not require a “rigorous” hazard analysis or “rigorous” preventive controls.] [Note: Chairman’s Mark added recommended term “effectiveness,” but retained term “rigor.”]