DAR File No. 38262

Agriculture and Food, Regulatory Services

Rule R70-530

Food Protection

Notice of Proposed Rule

(Repeal and Reenact)

DAR File No.: 38262
Filed: 01/28/2014 01:49:48 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this filing is to adopt the 2009 FDA Model Retail Food Code and incorporate the current Code of Federal Regulations (CFR) for Food Manufacturing.

Summary of the rule or change:

Chapter 1: 1-201.10(B): added "Core item"; added "Cut leafy greens"; amended definition of "Injected" to remove the public health statement and process where no liquid is introduced; added "Mechanically Tenderized"; added "Non-continuous cooking"; revised "Potentially Hazardous Food (Time/Temperature Control for Safety Food)" subparagraph (2)(a) by adding "cut leafy greens"; added "Priority item"; added "Priority foundation item"; revised "Ready-to-Eat Food" subparagraph (1)(b) to correctly cross reference 3-401.11 (D)(1) and (3); revised subparagraph (1)(c) to update reference to subparagraph 3-401.11(D)(4); and revised "Reduced oxygen packaging" subparagraph (2)(d) and (2)(e) to correct spelling of "psychrotrophic". Chapter 2: 2-102.11(A): amended to replace "Critical items" with "Priority items"; and 2-103.11 (L): added "food allergy awareness" as a part of the food safety training of employees by the Person in Charge. Chapter 3: 3-201.11 (D): amended to correctly cross reference subparagraph 3-401.11 (D); 3-302.11(A)(1): amended language to exempt frozen, commercially processed and packaged raw animal foods from separate storage or display from RTE foods; added new subparagraph (c) that allows this exemption; 3-401.11(A)(2): added "mechanically tenderized" meats to the list of foods that shall be cooked to heat all parts of the food to 68 deg C (155 deg F) for 15 seconds; 3-401.11(D): amended to add new subparagraph (D)(2) to not allow the sale of undercooked, comminuted meat from a children's menu; 3-401.11(D)(2): amended to become the new (D)(3); 3-401.11(D)(3): amended to become the new (D)(4); 3-401.14: added a new section on non-continuous cooking of raw animal foods that specifies the criteria for using a non-continuous cooking process; 3-402.11(B): added new subparagraph (4) to exempt fish eggs that have been removed from the skein and rinsed from freezing for parasite destruction; 3-403.11(E): added new paragraph (E) which was missing in 2007 Supplement; 3-404.11(A): amended to correct the reference paragraph 8-201.12 (B) - (E) to paragraph 8-201.14(B) - (E); 3-501.17(D)(2): amended to correct a typographical error; 3-502.11(D): amended to include Listeria monocytogenes controls which are specified under Section 3-502.12; 3-502.11(E): amended paragraph (E) to replace the word "and" with "or" to clarify that a variance would be required when operating a molluscan shellfish life-support system display tank, regardless of whether the tank was used for storing (back-of-the-house) or displaying (front-of-the-house) shellfish; 3-502.12: amended tag line to clarify that no variance is required for Reduced Oxygen Packaging methods listed in this section; 3-502.12(A): amended to clarify that all Reduced Oxygen Packaging methods in this section require controls for growth and/or toxin formation by Clostridium botulinum and Listeria monocytogenes, not just methods with two barriers; 3-502.12(B)(2)(d): amended to clarify that raw vegetables have high levels of competing organisms; 3-502.12(B)(5)(a): amended to clarify that prohibition only applies to ready-to-eat food to prevent conflict with Section 3-301.11; 3-502.12(D): amended to show this paragraph is not optional and remove italics; 3-502.12(D)(1): amended to clarify that implementing a HACCP plan is required; 3-502.12(D)(2)(c): amended to add cross reference to Part 3-3; 3-502.12(D)(2)(d): amended to clarify when bags should be sealed for cook-chill and sous vide; 3-502.12(E): amended to show this paragraph is not optional with no variance and remove italics; 3-502.12(E)(2)and (E)(3): amended to combine (E)(2) with (E)(3), 3-502.12(E)(4): amended to become the new (E)(3), 3-502.12(E)(5): amended to become the new (E)(4); and 3-603.11(A): amended cross reference from 3-401.11(D)(3) to 3-401.11(D)(4). Chapter 4: 4-204.110(A) and (B): amended to clarify that subparagraphs 4-204.110(A) and (B) applies to molluscan shellfish life support system tanks that are used for either storing or displaying molluscan shellfish; 4-501.114: amended lead-in paragraph to change "exposure times" to "contact times" and "manufacturer's label use instruction or directions" to "EPA-registered label use instructions" to harmonize with EPA terminology (CFP 2008-III-010); 4-501.114(A): added chlorine concentration ranges and changed "Minimum Concentration" to "Concentration Range" in the chart (CFP 2008-III-010); 4-501.114(B)(1): amended to change the minimum temperature requirement for an iodine solution from "24 deg C (75 deg F)" to "20 deg C (68 deg F) to be consistent with EPA iodophor registration protocols (CFP 2008-III-010); 4-501.114(C)(3): amended to change "manufacturer's label" to "EPA-registered label use instructions" to harmonize with EPA terminology (CFP 2008-III-010); 4-501.114(E): amended to change "manufacturer's directions including the labeling" to "EPA-registered label use instructions" to harmonize with EPA terminology (CFP 2008-III-010); 4-703.11(C): amended to change "exposure time" to "contact time" to harmonize with EPA terminology in (C)(1)(2)(3) and (4) (CFP 2008-III-010); added sentence to clarify that contact times shall be consistent with EPA-registered labels and to harmonize with EPA terminology; 4-904.13: revised the text regarding preset tableware to clarify under what circumstances preset tableware may be exposed and not protected from contamination by wrapping, covering, or inverting; and 4-904.14: added a new Section 4-904.14 to allow the application of a post-sanitizing rinse restricted to commercial warewashing machines and the circumstances under which it may be allowed (2008-III-016). Chapter 5: 5-102.12(B): amended to remove "and irrigation"; 5-203.13: added a new paragraph (B) to address use limitations for toilets and urinals and amended existing paragraph to be new paragraph (A); and 5-203.15: amended to change "double" check valve to "dual" check valve. Chapter 6: 6-301.12: added new paragraph (D) to allow the use of a high velocity blade of non-heated, pressurized air for hand drying; 6-306.10: amended to change the cross reference in the paragraph from Section 5-203.13 to paragraph 5-203.13(A); Section 5-203.13 has (A) and (B) paragraphs. The cross reference now only refers to paragraph (A); 6-501.18: amended to delete cross reference to Section 5-205.11 as it pertains to handwashing sinks only and not toilets and urinals; and 6-501.111: amended the lead-in paragraph to clarify that establishments are expected to be free of pests. Chapter 7: 7-204.12: added a new paragraph (B) that allows the use of ozone on fruits and vegetables according to 21 CFR 173.368. Chapter 8: 8-201.13(A)(2): amended cross reference from subparagraph 3-401.11(D)(3) to subparagraph 3-401.11(D)(4); 8-304.11(G): amended to remove reference to deleted paragraph 8-304.11(H); 8-304.11(H): deleted paragraph (H) as it references subparagraph 3-501.16(A)(2) that was deleted from the Code in the Supplement to the 2005 Food Code; renumbered remaining paragraphs; 8-304.11(I): amended to become new paragraph (H); 8-304.11(J): amended to become new paragraph (I); 8-304.11(K): amended to become new paragraph (J); 8-401.20(A): amended to change "critical" to "priority items or priority foundation items"; 8-401.20(B): amended to change "noncritical" to "core items"; 8-403.10(B)(3): amended to change "critical items" to "priority items or priority foundation items"; 8-405.11(A) and (B): amended to change "critical item" to "priority item or priority foundation item"; 8-405.20(A) and (B): amended to change "critical item" to "priority item or priority foundation item"; and 8-406.11(A): amended to change "noncritical violations" to "core items".

State statutory or constitutional authorization for this rule:

• Section 4-5-17

This rule or change incorporates by reference the following material:

• Updates 21 CFR Parts 100-199, published by Office of the Federal Register, 04/01/2013
• Updates Food Code 2009, published by U.S. Department of Health and Human Services, 01/01/2010

Anticipated cost or savings to:

the state budget:

The state budget is not affected because the adoption of these current versions of the Food Code and the CFR does not affect the Division's budget. These are minor changes which do no affect the workload.

local governments:

Local governments have no responsibilities in Rule R70-530. There will be no impact to local government.

small businesses:

No costs or savings have been identified. The adoption of the current food code and the CFR includes very minor changes which will not affect small businesses.

persons other than small businesses, businesses, or local governmental entities:

The adoption of the current food code and the CFR includes very minor changes which will not affect persons other than small businesses, businesses, or local government entities.

Compliance costs for affected persons:

The Division has reviewed this proposed rule extensively with industry. No increased or decreased compliance costs have been identified.

Comments by the department head on the fiscal impact the rule may have on businesses:

This rule adopts the current retail and manufacturing food safety standards. The Division has worked extensively with the industry for two years. This proposed rule was approved by the Utah Food Code Committee on 05/09/2013 and by the Agriculture Advisory Board on 07/16/2013.

LuAnn Adams, Commissioner

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Agriculture and Food
Regulatory Services
350 N REDWOOD RD
SALT LAKE CITY, UT 84116-3034

Direct questions regarding this rule to:

• Kyle Stephens at the above address, by phone at 801-538-7102, by FAX at 801-538-7126, or by Internet E-mail at kylestephens@utah.gov
• Kathleen Mathews at the above address, by phone at 801-538-7103, by FAX at 801-538-7126, or by Internet E-mail at kmathews@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

03/17/2014

This rule may become effective on:

06/01/2014

Authorized by:

LuAnn Adams, Commissioner

R70. Agriculture and Food, Regulatory Services.

[R70-530. Food Protection.

R70-530-1. Authority and Purpose.

(1) Authority.

Promulgated under the authority of the Section 4-5-17.

(2) Purpose.

This rule shall be liberally construed and applied to promote its underlying purpose of safeguarding public health and providing to consumers food that is safe, unadulterated, and honestly presented.

 

R70-530-2. Scope.

This rule establishes definitions; sets standards for management and personnel, food operations, equipment, and facilities; and provides for food establishment plan review, inspection, and employee restriction. It shall be used to regulate bakeries, grocery and convenience stores, meat markets, food and grain processors, warehouses and any other establishment meeting the definition of a food establishment.

 

R70-530-3 Incorporation by Reference.

(1) The food standards, labeling requirements and procedures as specified in 21 CFR, 1 through 200, April 1, 2008 edition, 40 CFR 185, July 1, 2007 edition, and 9 CFR 200 to End, January 1, 2008 edition, are incorporated by reference.

(2) The requirements as found in the U.S. Public Health Service, Food and Drug Administration, Food Code 2005, Chapters 1 through 8, Annex 1, and Annex 2, Federal Food, Drug, and Cosmetic Act, 21, U.S.S. 342, Sec. 402 are adopted and incorporated by reference, with the exclusion of Sections 8-302.14(C)(2),(D) and (E), 8-805.40, and 8-809.20; and

(3) with the following additions or amendments:

(a) Amend section 8-103.10 to read:

8-103.10 Modifications and Waivers.

(A) The regulatory authority may grant a variance by modifying or waiving the requirements of this Code if in the opinion of the regulatory authority a health hazard or nuisance will not result from the variance. If a variance is granted, the regulatory authority shall retain the information specified under section 8-103.11 in its records for the food establishment.

(b) Amend section 8-103.11 to add:

(D) In addition, a variance from section 3-301.11 may be issued only when:

(1) the variance is limited to a specific task or work station;

(2) the applicant has demonstrated good cause why section 3-301.11 cannot be met;

(3) suitable utensils are used to the fullest extent possible with ready-to-eat foods in the rest of the establishment; and

(4) the applicant can demonstrate active management control of this risk factor at all times.

(c) Amend Section 8-302.14 (C) to read:

A statement specifying whether the food establishment is mobile or stationary and temporary or permanent.

(d) Amend section 8-302.14 to renumber (F) to (D), (G) to (E), and (H) to (F).

(e) Amend section 8-304.10(A) to read:

(A) Upon request, the regulatory authority shall provide a copy of the food service sanitation rule according to the policy of the local regulatory agency.

(f) Amend section 8-304.11(J) to read:

Accept notices issued and served by the REGULATORY AUTHORITY according to LAW:

(g) Amend section 8-304.11(K) to read:

Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with this Code or a directive of the regulatory authority, including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives.

(h) Amend section 8-401.10(A) to read:

(A) Except as specified in paragraphs (B) and (C) of this section, the regulatory authority shall inspect a food establishment at least once every 6 months and twice in a season for seasonal operations.

(i) Amend section 8-501.10(B) to read:

(B) Requiring appropriate medical examinations, including collection of specimens for laboratory analysis, of a suspected food employee or conditional employee;

(j) Add section 8-501.10(C) to read:

(C) Meeting reporting requirements under Communicable Disease Rule R386-702 and Injury Reporting Rule R386-703.

(k) Amend section 8-601.10 to read:

Due process and equal protection shall be afforded as required by law in all enforcement and regulatory actions.

(l) Amend section 8-701.30 to read:

Service is effective at the time the notice is served or when service is made as specified in section 8-701.20(B).

(m) Amend section 8-803.10 to read:

8-803.10 Embargo, Detainment and Destruction of Adulterated Food Products Authorized.

(A) The embargo and detainment of adulterated food products is authorized under Section 4-5-5, UCA.

(B) The regulatory authority may place an embargo or detainment tag on food found to be adulterated and unfit for human consumption.

(C) The regulatory authority may issue a hold order to the person in charge or to a person who owns or controls the food, without prior warning, notice of a hearing, or a hearing on the hold order, where food or drink is handled, sold, or served to the public, but is found or is suspected of being adulterated and unfit for human consumption.

(D) Upon five days notice and a reasonable opportunity for a hearing to the interested parties, the regulatory authority may condemn, destroy or render unsalable for human food the adulterated food if deemed necessary for the protection of the public health.

(E) If the regulatory authority has reasonable cause to believe that the hold order will be violated, or finds that the order is violated, the regulatory authority may remove the food that is subject to the hold order to a place of safekeeping.

(F) If a hold order is sustained upon appeal or if a timely request for an appeal hearing is not filed, the regulatory authority may order the person in charge or the owner or other person who owns or has custody of the food to bring the food into compliance with this rule or to destroy or denature the food under the regulatory authority's supervision.

(n) Amend section 8-803.60 to read:

The regulatory authority may examine, sample, and test food in order to determine its compliance with this Code in section 8-402.11.

(o) Amend section 8-803.90 to read:

The regulatory authority shall issue a notice of release from a hold order and shall physically remove the hold tags, labels, or other identification from the food if the hold order is vacated.

(p) Amend section 8-804.30 number/catchline to read:

8-804.30 Contents of the Summary Suspension Notice.

(q) Amend section 8-805.10(A) to read:

(A) A person who receives a notice of hearing shall file a response within 10 calendar days from the date of service. Failure to respond may result in license suspension, license revocation, or other administrative penalties.

(r) Amend section 8-805.20 to read:

A response to a hearing notice or a request for a hearing as specified in section 8-805.10 shall be in written form and contain the following:

(A) Response to a notice of hearing must include:

(1) An admission or denial of each allegation of fact;

(2) A statement as to whether the respondent waives the right to a hearing;

(3) A statement of defense, mitigation, or explanation concerning all claims; and

(4) A statement as to whether the respondent wishes to settle some or all of the claims made by the regulatory authority.

(B) A request for hearing must include:

(1) A statement of the issues of fact specified in section 8-805.30(B) for which a hearing is requested; and

(2) A statement of defense, mitigation, denial, or explanation concerning each allegation of fact.

(C) Witnesses - In addition to the above requirements, if witnesses are requested, the response to a notice of hearing and a request for hearing must include the name, address, telephone number, and a brief statement of the expected testimony for each witness.

(D) Legal Representation - Legal counsel is allowed, but not required. All documents filed by the respondent must include the name, address, and telephone number of the respondent's legal counsel, if any.

(s) Amend section 8-805.50(A)(1) to read:

(1) Except as provided in paragraph (B) of this section, within 5 calendar days after receiving a written request for an appeal hearing from:

(t) Adopt subsections 8-805.50(A)(1)(a) through (c) without changes.

(v) Amend subsection 8-805.50(A)(2) to read:

(2) Within 30 calendar days after the service of a hearing notice to consider administrative remedies for other matters as specified in section 8-805.10(C) or for matters as determined necessary by the regulatory authority.

(v) Amend section 8-805.60 number/catchline to read:

8-805.60 Notice of Hearing Contents.

(w) Amend section 8-805.80 number/catchline to read:

8-805.80 Expeditious and Impartial Hearing.

(x) Amend section 8-805.90 number/catchline to read:

8-805.90 Confidentially of Hearing and Proceedings.

(y) Amend section 8-805.90(A) to read:

(A) Hearings will be open to the public unless compelling circumstances, such as the need to discuss a person's medical or mental health condition, a food establishment's trade secrets, or any other matter private or protected under federal or state law.

(z) Amend section 8-806.30(B) to read:

(B) Unless a party appeals to the head of the regulatory authority within 10 calendar days of the hearing or a lesser number of days specified by the hearing officer.

(aa) Adopt subsections 8-806.30(B)(1) through (2) without changes.

(ab) Amend section 8-807.60 to read:

Documentary evidence may be received in the form of a copy or excerpt if provided to the hearing officer and opposing party prior to the hearing as ordered by the hearing officer.

(ac) Amend section 8-808.20 to read:

Respondents accepting a consent agreement waive their rights to a hearing on the matter, including judicial review.

(ad) Amend section 8-811.10(B) to read:

(B) Any person who violates any provision of this rule may be assessed a civil penalty not to exceed the sum of $5,000.00 or be punished for violation of a class B misdemeanor for the first violation. Each day the violation exits may constitute a separate violation. For any subsequent similar violation within two years, the person may be punished for violation of a class A misdemeanor as provided in section 26-23-6.

(ae) Amend section 8-813.10 number/catchline to read:

8-813.10 Petitions, Penalties, Contempt, and Continuing Violations.

(af) Amend section 8-813.10(B) to replace the phrase "designate amount" with the phrase "$5,000".

(ag) Add paragraph 8-813.10(D) to read:

(D) The adjudicative body, upon proper findings, shall assess violators a fee for each day the violation remains in contempt of its order.

(4) The requirements of the Utah Uniform Building Standards Act Rules as found in Sections R156-701(1)(c), and R156-56-803 are adopted and incorporated by reference.

]R70-530. Food Protection.

R70-530-1. Authority and Purpose.

(1) Authority.

This rule is promulgated under the authority of Section 4-5-17 UCA.

(2) Purpose.

This rule shall be liberally construed and applied to promote its underlying purpose of safeguarding public health and providing to consumers food that is safe, unadulterated, and honestly presented.

 

R70-530-2. Scope.

This rule establishes definitions; sets standards for management and personnel, food operations, equipment, and facilities; and provides for food establishment plan review, inspection, and employee restriction. It shall be used to regulate bakeries, grocery and convenience stores, meat markets, food and grain processors, warehouses and any other establishment meeting the definition of a food establishment.

 

R70-530-3 Incorporation by Reference.

(1) The food standards, labeling requirements and procedures as specified in 21 CFR, 1 through 200, 2013 edition, 40 CFR 185, April 17, 2012 edition, and 9 CFR 200 to End, January 1, 2012 edition, are incorporated by reference.

(2) The requirements as found in the U.S. Public Health Service, Food and Drug Administration, Food Code 2009, Chapters 1 through 8, Annex 1, and Annex 2, Federal Food, Drug, and Cosmetic Act, 21, U.S.S. 342, Sec. 402 are adopted and incorporated by reference, with the exclusion of Sections 8-302.14(C)(2),(D) and (E); and with the following additions or amendments:

(a) Amend section 8-103.11 to add:

(D) In addition, a variance from section 3-301.11 may be issued only when:

(1) the variance is limited to a specific task or work station;

(2) the applicant has demonstrated good cause why section 3-301.11 cannot be met;

(3) suitable utensils are used to the fullest extent possible with ready-to-eat foods in the rest of the establishment; and

(4) the applicant can demonstrate active management control of this risk factor at all times.

(b) Amend section 8-304.10(A) to read:

(A) Upon request, the regulatory authority shall provide a copy of the food service sanitation rule according to the policy of the local regulatory agency.

(c) In section 1-201.10 under Priority Item, replace the semicolon and the word "and" at the end of paragraph (2) with a period; replace the period at the end of paragraph (3) with "; and"; and insert a new paragraph after paragraph (3) to read: "(4) 'Priority Item' will also be referred to as 'critical 1' in the state rule."

(d) Amend section 8-302.14 to renumber (F) to (D), (G) to (E), and (H) to (F).

(e) Amend section 8-401.10(B)(2) to delete the phrase "and at least once every 6 months the establishment is contacted by telephone or other means by the regulatory authority to ensure that the establishment manager and the nature of food operation are not changed."

(f) Add section 8-501.10(C) to read:

(C) Meeting reporting requirements under Communicable Disease Rule R386-702 and Injury Reporting Rule R386-703.

(g) Amend section 8-601.10 to read:

Due process and equal protection shall be afforded as required by law in all enforcement and regulatory actions. Enforcement of this Rule shall be in accordance with title 4-2-2(J), Title 4-2-12, and R70-201.

(h) In section 1-201.10 under Priority Foundation Item, replace the semicolon and the word "and" at the end of paragraph (2) with a period; replace the period at the end of paragraph (3) with,"; and"; and add a new paragraph after paragraph (3) to read: "(4) 'Priority foundation item' will also be referred to as 'critical 2' in the state rule."

(i) After section 2-102.11 paragraph (17), add a new section to read: "2-102-12 Food Employee Training.

Food employees shall be trained in food safety as required under 26-15-5 and shall hold a valid food handler's permit issued by a local health department."

(j) At the end of section 5-101.12, add: "The process shall be in accordance with the American Water Works Association (AWWA) C651-2005 for disinfection and testing."

(k) At the end of section 5-202.13, add: "Where the distance to the adjacent wall is closer than three pipe diameters, the air gap shall not be less than 1-1/2 inch."

(l) After the reference to the section number "5-202.13" in section 5-203.15 paragraph (A), delete the article "a" and insert: "an American Society of Safety Engineers (ASSE) 1022".

(m) After the reference to paragraph (B) in section 5-402.11 paragraph (A), delete the coma; insert the word "and"; and delete the text, ", and (D)" that follows the reference to paragraph (C).

(n) Delete paragraph (D) from section 5-402.11

(o) Add "8-7 Penalties; 8-701.10 State Construction Code

All parts of the food establishment shall be designed, constructed, maintained, and operated to meet the standards of the state construction code adopted by the Utah Legislature under Title 15A UCA. A copy of the construction code is available at the office of the local building inspector."

 

KEY: food[ safety], inspections

Date of Enactment or Last Substantive Amendment: [September 25, 2008]2014

Notice of Continuation: March 7, 2012

Authorizing, and Implemented or Interpreted Law: 4-5-17