The Tester Amendments Part 2: Exemptions for Small Facilities

by: Jill Richardson

Sun Apr 18, 2010 at 23:10:15 PM PDT

The second part says that small facilities (those grossing under $500,000 per year) do not have to follow the new traceability laws other than keeping records of one step forward and one step back (i.e. "I bought these tomatoes from Green Valley Farm and I sold them to ABC Grocery").

On page 133, between lines 17 and 18, insert the following:

(l) DEFERRAL TO STATE REGULATION OF CERTAIN FACILITIES. This section shall not apply to a facility for a year if the average annual adjusted gross income of such facility for the previous 3-year period is less than $500,000.

On page 200, between lines 19 and 20, insert the following:

(C) LIMITATION FOR CERTAIN FACILITIES. In the case of a facility, in a year in which the average annual adjusted gross income of such facility for the previous 3-year period is less than $500,000, the recordkeeping requirements under this section shall be limited to records regarding the immediate suppliers and immediate subsequent recipients of such facility.

SEC. 103 HAZARD ANALYSIS AND RISK-BASED PREVENTATIVE CONTROLS.
(a) IN GENERAL. Chapter IV (21 U.S.C. 341 et seq.) is amended by adding at the end the following:

SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
(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 a facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards 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.

(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
(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and
(B) hazards that occur naturally, may be unintentionally introduced, or may be intentinally introduced, including by acts of terrorism; and
(2) develop a written analysis of the hazards.

(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; and
(2) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or misbranded under section 403(w).

(d) MONITORING OF EFFECTIVENESS. The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide insurances that the outcomes described in subsection (c) shall be achieved.

(e) CORRECTIVE ACTIONS. The owner, operator, or agent in charge of a facility shall establish procedures that a facility will implement if preventive controls implemented under subsection (c) are found to be ineffective through monitoring under subsection (d).

(f) VERIFICATION. The owner, operator, or agent in charge of a facility shall verify that
(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);
(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d);
(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (3);
(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and
(5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions, and processes in the facility, and new and emerging threats.

(g) RECORD KEEPING. The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of non-conformance material to food safety, the results of testing and other appropriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

(h) WRITTEN PLAN AND DOCUMENTATION. The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Such written plan, together with the documentation described in subsection (g), shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.

(i) REQUIREMENT TO REANALYZE. The owner, operator, or agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before such change in activities at the facility is operative. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards or developments in scientific understanding.

(j) DEEMED COMPLIANCE OF SEAFOOD, JUICE, AND LOW-ACID CANNED FOOD FACILITIES SUBJECT TO HACCP. The owner, operator, or agent in charge of a facility required to comply with 1 of the following standards and regulations with respect to such facility shall be deemed to be in compliance with this section, with respect to such facility:

(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration

(2) The Juice Hazard Analysis Critical Control Points Progarm of the Food and Drug Administration

(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).

(k) EXCEPTION FOR FACILITIES SUBJECT TO SECTION 419. This section shall not apply to a facility that is subject to section 419.

Here's the second part, the section that ends on page 200. My cat ended my attempt to type the whole thing out. Forgive me.

SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING.
(a) IN GENERAL. The Secretary, in consultation with the Secretary of Agriculture and representatives of State departments of health and agriculture, shall improve the capacity of the Secretary to effectively and rapidly track and trace, in the event of an outbreak, fruits and vegetables that are raw agricultural commodities.