DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Division of Public Health

Statutory Authority: 16 Delaware Code, Section 122 (1) & (3) a, f & j

(16 Del.C. §§122 (1) & (3) a, f & j)

ORDER

Nature of the Proceedings:

Delaware Health and Social Services (“DHSS”) initiated proceedings to adopt the State of Delaware Regulations Governing the Production and Sale of Milk and Milk Products. The DHSS proceedings to adopt regulations were initiated pursuant to 29 Delaware Code Chapter 101 and authority as prescribed by 16 Delaware Code, Section 122 (1) & (3) a, f & j.

On March 1, 2005 (Volume 8, Issue 9), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by March 31, 2005, or be presented at a public hearing on March 23, 2005, after which time DHSS would review information, factual evidence and public comment to the said proposed regulations.

One written comment in favor of the proposed regulations was received. No other comments (verbal or written) were received at the public hearing or during the official public comment period (March 1-31, 2005).

Findings of Fact:

The Department finds that the proposed regulations, as set forth in the attached copy should be adopted in the best interest of the general public of the State of Delaware.

THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations Governing Production and Sale of Milk and Milk Products are adopted and shall become effective May 10, 2005, after publication of the final regulation in the Delaware Register of Regulations.

Vincent P. Meconi, Secretary, 4/15/05

461 Regulations Governing the Production and Sale of Milk and Milk Products

1.0 General Provisions

1.2 Purpose

It is hereby declared that the purpose of this Regulation is to protect, preserve and promote the public health and wellbeing of the people, to minimize the incidence of communicable diseases and to regulate the inspection of dairy farms, milk and milk product plants and provide for the examination, labeling, pasteurization, distribution and sale of milk and milk products. It is hereby further declared that the purpose of this Regulation is to establish minimum chemical, bacteriological and temperature standards for milk and milk products and an adequate level of operation and maintenance and provision for the administrative and enforcement thereof.

1.3 Definitions

Regulatory Agency: as defined in the PMO, Section 1, Definition II, shall mean the Secretary, Delaware Health and Social Services or his official designee.

1.4 Application and Scope

The requirements of this section shall apply to the construction, alteration, addition, establishment maintenance and or the operation of all dairy farms, milk and milk product plants in the State of Delaware, and also to any milk and milk products from outside the boundaries of the state that are sold in Delaware.

The Regulatory Agency may grant a variance by modifying or waiving the requirements of these Regulations if in the opinion of the Regulatory Agency a health hazard or nuisance will not result from the variance or waiver.

Enforcement: It shall be the duty of the Regulatory Agency to enforce the provisions of these Regulations

Repeal and Date of Effect: All current or previous regulations or parts of regulations in conflict with these Regulations are hereby repealed; and these Regulations shall be in full force and effective on _______[May 10, 2005].

Severability: Should any section, paragraph, sentence, clause or phrase of these Regulations be declared unconstitutional or invalid for any reason, the remainder of the Regulation shall not be affected in any way.

1.5 Imminent Danger to Public Health: Suspension of Permit

If some condition(s) is/are determined to exist which present(s) an imminent health hazard to the public, the Regulatory Agency may suspend the operating permit of the facility, without hearing, for a period not to exceed ten (10) government business days. The suspension shall be effective upon receipt of written notice by the permit holder or another reasonably responsible employee. A suspension statement recorded on an inspection report by the inspecting Regulatory Agency representative constitutes written notice. The permit shall not be suspended for a period longer than ten (10) government business days without a hearing. Failure to hold a hearing within ten (10) government business days shall automatically terminate the suspension.

The permit holder of the Facility may request, in writing, a hearing before the Regulatory Agency at any time during the period of suspension, for the purpose of demonstrating the imminent health hazard(s) no longer exist. The request for hearing shall not stay the suspension.

1.6 Unsanitary Conditions: Suspension, Revocation or Refusal to Reissue Permit

The Regulatory Agency, may after providing an opportunity for a hearing, suspend, for a period not to exceed ninety (90) days, revoke, or recommend non-reissuance of a permit to operate a Facility for serious or repeated violations of any requirements of these Regulations or refusing access to representatives of the Regulatory Agency.

This section is not intended to preclude enforcement of this Regulation through the institution of court action by the Regulatory Agency.

1.7 Global Footnote Clarification

Whereas indicated in the PMO as footnote 2, page v, of the introduction and footnote 1, pages 1, 8, 9 and 113 of the body, insert “the State of Delaware”.

2.0 Grade “A” Pasteurized Milk Ordinance 2003 Revision

This section incorporates by reference the U.S. Public Health Service/Food and Drug Administration’s Grade “A” Pasteurized Milk Ordinance, 2003 Revision. For copies contact the Division of Public Health or the Registrar of Regulations.

8 DE Reg. 1615 (5/1/05)