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Request for Public Comment: Food Safety - 2018 Shellfish Rule Review

The Ohio Department of Agriculture is accepting comments regarding Ohio Administrative Code chapter 901:3-8. The rule in this package has been reviewed pursuant to Chapter 119 of the Revised Code and are being proposed as follows. The comment period will remain open through October 19, 2018. Comments may be emailed to eComments@agri.ohio.gov or mailed to Legal Section, Ohio Department of Agriculture, 8995 E. Main St., Reynoldsburg, Ohio 43068.

The rules in this package regulate the handling, processing, and transportation of shellfish products in the state of Ohio. As indicated in paragraph (A) of OAC 901:3-8-01, all food processing establishments that handled shellstock for interstate distribution shall meet the requirements of this Chapter to assure the sale or distribution of shellfish from safe sources and to assure shellfish has not been adulterated during cultivating, harvesting, processing, shipping, or handling. 

Without proper safeguards, errors in the food production process can result in the growth of highly dangerous pathogens such as Clostridium botulinum, E. coli 0157:H7, Salmonella, and Listeria monocytogenes. These bacteria can result in human illnesses including respiratory problems, pneumonia, diarrhea, vomiting, and in some cases can result in the death of the infected individual. Due to this high level of risk there is significant regulation to monitor the food production industry which is designed to prevent illness and protect consumers. 

These rules contained in this package mirror nationally approved standards in order to allow Ohio’s producers of shellfish and shellstock products to be able to ship all across the country. The rules below have been reviewed in accordance with Chapter 119 of the Ohio Revised Code and are being proposed as with the following changes:

901:3-8-01 sets forth the food processing establishments that are subject to the rules of this chapter. Additionally, this rule sets out the terms that have been defined in the chapter. The rule has been amended to update a code reference from 901:3-1 to 901:3-17.

901:3-8-02 outlines the transportation and shipping requirements for moving shellfish. Specifically, the rule outlines when shipments must be rejected and other equipment specifications. The rule has been amended to update a code reference from 901:3-1 to 901:3-17.

901:3-8-03 sets forth the requirement that each processor shall have a written hazard analysis to determine at what steps in their food production are food hazards likely to occur and ways that processors can apply controls to these hazards to limit their likelihood. All shellfish and shellstock product processors subject to the rules of this chapter shall develop a written Hazard Analysis and Critical Control Point plan, otherwise known as a HACCP plan. This is required whenever the hazard analysis reveals one or more food hazards are likely to occur during production. Additionally, the HACCP plan outlines how processors will monitor these critical control points and requires the development and implementation of corrective action plans should a deviation from the critical limits occur. 

The rule also requires processors to verify and validate that their HACCP plan is being implemented according to its design. A processor verifies and validates their HACCP plan by reviewing any consumer complaints, calibrating instruments, and recording any deviation that may occur. This validation must take place at least once every twelve months. 

Finally, the rule requires that all processors maintain records which document the processor’s HACCP plan. The processor must maintain records documenting that the processor continues to monitor the critical control points and their critical limits. 

The rule has been amended to update a code reference from 901:3-1 to 901:3-17.

901:3-8-04 outlines the requirements for shucking and packing of shellstock. The rule outlines critical control points that must be accounted for in addition to sanitation requirements for the facility and personnel. No changes have been made to this rule.

901:3-8-05 outlines the requirements for the repacking of shucked shellfish. The rule outlines critical control points that must be accounted for in addition to sanitation requirements for the facility and personnel. No changes have been made to this rule.

901:3-8-06 outlines the requirements for the shipping of shellfish. The rule outlines critical control points that must be accounted for in addition to sanitation requirements for the facility and personnel. No changes have been made to this rule.

901:3-8-07 outlines the requirements for the re-shipping of shellfish. The rule outlines critical control points that must be accounted for in addition to sanitation requirements for the facility and personnel. No changes have been made to this rule.

901:3-8-07 states that all processors shall have and implement a sanitation standard operating procedure. This procedure addresses sanitation controls at all points in the production line including, water sanitation, cross contamination of other insanitary objects (ie. utensils, food packaging material, gloves, and clothing), and control of employee health conditions. The rule is being amended to add the word “sanitary” to clarify the rule. Additionally, a sentence was removed from paragraph (A)(3) and moved to new paragraph (A)(4) to better highlight the requirement of preventing cross contamination of raw and cooked products.

901:3-8-08 outlines the requirement that processors of smoked and smoke-flavored fishery products must include in their HACCP plans how they are controlling the formulation of the Clostridium botulinum toxin in their product. The rule is being amended to comply with the style guidelines of the Legislative Services Commission. There are no substantive changes to the rule.

901:3-8-09 states that processors shall include in their HACCP plans how they are controlling the origin of molluscan shellfish. The rule is being amended to make stylistic changes which simplify the rule.

901:3-8-10 states that all shellstock shall bear a tag that discloses information about the harvest. The rule is being amended to make paragraph changes which help comprehension of the rule.

901:3-8-11 states that the failure of a processor to have and/or implement their HACCP plan shall render the fish or fishery product that the processor produces adulterated under section 3715.59 of the ORC. The rule is being amended to make a stylistic change.