Proposed Rules Title 25

TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 31. NUTRITION SERVICES

SUBCHAPTER C. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC)

25 TAC §31.25, §31.37

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes amendments to §31.25 and §31.37, concerning the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

BACKGROUND AND PURPOSE

Under federal and state enabling legislation, the WIC Program is funded entirely by a combination of federal grant funds and by rebates from manufacturers of infant formula and infant cereal that can only be expended to defray WIC food costs. The United States Department of Agriculture (USDA) awards federal grant funds to the department to administer the program, provided the department does so in accordance with federal law and regulations and in accordance with the department's annual submission of a state plan approved by USDA. USDA deems the following types of changes to be substantive amendments to the state plan that require federal approval: rule or policy changes initiated by legislation, USDA, or the state agency; changes affecting client or vendor services and benefits; changes in the monitoring/oversight of vendors and local agencies; any other operational changes aimed at improving or enhancing program delivery or accountability; and changes in related state procedures.

Revisions to these rules are proposed primarily to comply with new federal regulations governing the WIC program in 7 Code of Federal Regulations (CFR) Part 246.

SECTION-BY-SECTION SUMMARY

The amendment to §31.25, concerning certification time periods for WIC eligibility, is authorized by federal regulations governing the WIC Program at 7 CFR §246.7(g), which give state WIC programs the option to set the certification of eligibility time period for breastfeeding women at intervals of approximately six months or a period of up to one year (to the last day of the month in which her infant turns one year old or she ceases breastfeeding, whichever occurs first). The department proposes to amend the certification time from a six-month period to up to one year to eliminate the necessity for a second in-person certification interview that is no longer required by federal regulations for many breastfeeding clients.

The amendment to §31.37, concerning the selection of allowable foods for the WIC program, will align the department with new federal WIC regulations at 7 CFR §246.10, that add new foods to the foods currently issued to WIC recipients. The current list of foods must be updated to add the new foods. Detailed descriptions concerning individual food types, such as whether or not milk must be low fat, are being eliminated as unnecessary. In addition, the process for informing food manufacturers about food changes is being amended to eliminate information that could become out of date. The proposed language continues to mandate notification to food manufacturers without specifying the process, thus making it subject to department and state policies, rules, and laws affecting such business transactions.

FISCAL NOTE

Mike Montgomery, Director, Nutrition Services Section, has determined that for each year of the first five years the sections are in effect, there will be no fiscal implications to state or local governments as a result of enforcing or administering the sections as proposed. All activities required by §31.25 and §31.37 will be performed by existing department staff and with existing funding.

SMALL AND MICRO-BUSINESS ECONOMIC IMPACT ANALYSIS

Mr. Montgomery has also determined that there will be no adverse economic impact on small businesses or micro-businesses. This was determined by interpretation of the rules that small businesses and micro-businesses will not be required to alter their business practices as a result of the changes. The change to §31.25 applies only to breastfeeding women who are enrolled in WIC and has no implications or effect on businesses. The change to §31.37 is to add new foods to those offered to recipients by the WIC program to comply with federal regulations. No food manufacturers classified as small or micro-businesses are required to provide WIC foods to contracted food vendors for purchase by the WIC Program, and none that do so will be deprived of a business opportunity to provide WIC foods since the amendment only adds new foods to the current selection of allowable foods. An economic impact statement and regulatory flexibility analysis are not required. There are no anticipated economic costs to persons, including WIC applicants and WIC recipients, as proposed. There is no anticipated negative impact on local employment.

PUBLIC BENEFIT

Mr. Montgomery has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections is improved access to nutrition services by streamlining the certification process for WIC eligibility for breastfeeding women and an assurance that the department is in compliance with federal regulations governing the WIC Program.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposed amendments do not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, do not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Valerie Wolfe, Nutrition Services Section, Mail Code 1933, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, (512) 341-4533 or by email to Valerie.Wolfe@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

STATUTORY AUTHORITY

The amendments are authorized under Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

The amendments affect Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.

§31.25.Participant Certification Periods.

(a) - (c) (No change.)

(d) A breastfeeding woman shall be certified to receive one set of food instruments each month for up to one year [ ~~a six-month period~~]. The certification expiration date shall be set to the last day of the month in which her infant turns one year old or she ceases breastfeeding, whichever occurs first [ ~~for the last day of the sixth month. Any subsequent certification shall expire on the day of the infant's first birthday~~].

(e) - (g) (No change.)

§31.37.Selection of Allowable WIC Program Supplemental Foods.

(a) - (c) (No change.)

(d) The state agency shall review the WIC Program list of allowable foods annually to determine the need for adding or deleting food products. If the state agency determines that the list of allowable foods should be changed, the state agency shall notify the appropriate manufacturers of that intent.

[(1) If the state agency determines that the list of allowable cereals or juices should be changed, the state agency shall notify both juice and cereal manufacturers of that intent through a request for information (RFI).]

~~[(2) Juice and cereal manufacturers may contact the WIC Program at any time during the year to request that their names and addresses be added to the mailing list for an RFI.]~~

[(3) Manufacturers of juice and cereal shall certify through their RFI response that their products meet the requirements for nutritional content as specified in federal regulations governing the program.]

(e) - (k) (No change.)

(l) Allowable foods may include: milk; cheese; tofu; soy-based beverages; breakfast cereal; juice; beans; peas; lentils; peanut butter; tuna; salmon; mackerel; sardines; fruits; vegetables; whole wheat bread; whole grain bread; brown rice; bulgur; oatmeal; whole grain barley; corn or whole wheat tortillas; infant cereal; infant fruits; infant vegetables; infant meats; infant formula; exempt infant formula; and WIC-eligible medical foods.

~~[(l) Additional criteria for each food type are as follows:]~~

~~[(1) Milk. Milk shall be:]~~

~~[(A) unflavored, fresh, whole, reduced fat, low-fat or fat-free (nonfat or skim) milk including cultured buttermilk fortified with vitamins A and D to meet the federal standards;]~~

~~[(B) whole, low-fat, or fat-free (nonfat) evaporated milk fortified with vitamins A and D to meet the federal standards; and/or]~~

~~[(C) nonfat, dry, powdered milk fortified with vitamins A and D to meet the federal standards.]~~

~~[(2) Cheese. Cheese shall be unflavored and pasteurized.]~~

~~[(3) Cereals.]~~

~~[(A) Cereal shall contain a minimum of 28 milligrams of iron per 100 grams of dry cereal, and not more than 21.2 grams of sucrose and other sugars per 100 grams of dry cereal (6 grams per ounce).]~~

~~[(B) The state agency reserves the right to determine the number and brands of cereals, which shall include at least one hot cereal and at least one corn, wheat, oat, rice, and multi-grain cereal.]~~

~~[(4) Juice.]~~

[(A) Juices shall be single-strength fluid fruit or vegetable juices containing a minimum of 30 milligrams of vitamin C per 100 milliliters and/or concentrated fruit or vegetable juices containing a minimum of 30 milligrams of vitamin C per 100 milliliters of reconstituted juice.]

~~[(B) Juices shall be 100% juice and shall contain no added sugar, or other natural or artificial sweeteners.]~~

~~[(C) Juices packaged in a variety of containers, even though made by the same manufacturer, shall be evaluated separately.]~~

~~[(5) Eggs. Eggs shall be fresh grade A or grade AA large, medium, or small.]~~

~~[(6) Beans/Peas/Lentils. Beans, peas, and lentils shall be dry with the exception of canned beans/peas/lentils which may be authorized only for the homeless food package.]~~

~~[(7) Peanut Butter. Peanut butter shall contain no other ingredients such as jelly or candy pieces.]~~

~~[(8) Tuna. Tuna shall be packed in water.]~~

~~[(9) Carrots. Carrots shall be bagged, fresh, large carrots without tops and/or canned, sliced carrots.]~~

~~[(10) Infant formula. Infant formulas shall be registered with the United States Food and Drug Administration as complying with the legal definition of infant formula.]~~

~~[(11) Infant cereal. Infant cereal shall contain a minimum of 45 milligrams of iron per 100 grams of dry cereal in dehydrated flake form.]~~

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on May 13, 2009.

TRD-200901910

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 28, 2009

For further information, please call: (512) 458-7111 x6972

CHAPTER 97. COMMUNICABLE DISEASES

SUBCHAPTER A. CONTROL OF COMMUNICABLE DISEASES

25 TAC §97.7

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes an amendment to §97.7, concerning the control of communicable diseases requiring exclusion from schools.

BACKGROUND AND PURPOSE

The Communicable Disease Act requires the department to designate communicable diseases that require exclusion from schools not child-care facilities (Health and Safety Code, §81.042). Child-care facilities are governed by minimum standards, designed to promote the health and safety of children attending licensed facilities, promulgated by the Department of Family and Protective Services (Human Resources Code, §42.042(e)). The Department of Family and Protective Services rule (40 TAC §746.3603) adopts by reference the department's current rule, §97.7 (being amended here) on school exclusion. The references to child-care facilities in §97.7 are being deleted because the department has no authority to exclude children from child-care facilities.

The overall purpose of the rule is to provide school personnel as well as parents with guidance regarding appropriate control measures for the prevention and containment of wound, skin, and soft tissue infections. The amendments are necessary to provide a more comprehensive rule related to the prevention of transmission of skin and soft tissue infections in school settings.

Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 97.7 has been reviewed and the department has determined that reasons for adopting the section continue to exist because a rule on this subject is needed.

SECTION-BY-SECTION SUMMARY

The amendments to §97.7 create an additional condition for which children may be excluded from schools to prevent the transmission of bacterial infections, especially antibiotic resistant staphylococcal infections. The amendment addresses all wound and skin and soft tissue infections instead of only one specific skin and soft tissue infection concerning impetigo. The caption and text of the rule has also been amended to delete references to exclusion from child-care facilities because the department has no authority to exclude children from child-care facilities. Exclusion from these facilities is addressed in 40 TAC §746.3603, of the Department of Family and Protective Services, which adopts by reference the exclusion list in the department's current rule, §97.7 (being amended here).

FISCAL NOTE

Adolfo Valadez, M.D., MPH, Division Director, Prevention and Preparedness Services, has determined that for each calendar year of the first five years the section is in effect, there will be no fiscal implications to state government because the state does not operate schools. For each calendar year of the first five years the section is in effect, there may be minor fiscal implications to local school districts as a result of enforcing or administering the section as proposed. The rule will have a neutral or net positive effect on local school districts. Public school systems must provide home or hospital bedside instruction when a student is unable to attend school for chronic or temporary illnesses that are anticipated to amount to four weeks or more of confinement. Schools send a teacher to serve the student at home or hospital bedside and receive weighted funding to cover the expenses. They may lose funds from the state when a student cannot attend because of this rule. But because this rule will prevent the spread of disease, overall absenteeism will be reduced along with these attendant costs. It is anticipated that this will be a rare occurrence.

SMALL AND MICRO-BUSINESS ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS

Dr. Valadez has also determined that there will be no adverse economic impact on small businesses or micro-businesses required to comply with the section as proposed. This was determined by interpretation of the rule that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the section. There are no anticipated economic costs to persons who are required to comply with the section as proposed. There is no anticipated negative impact on local employment. Therefore, an economic impact statement and regulatory flexibility analysis for micro-businesses and small businesses are not required.

PUBLIC BENEFIT

In addition, Dr. Valadez has also determined that for each year of the first five years the section is in effect, the public will benefit from adoption of the section. The public benefit anticipated as a result of enforcing or administering the section is to prevent transmission of infectious diseases, specifically skin and soft tissue infections.

REGULATORY ANALYSIS

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposed amendment does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Marilyn Felkner, Infectious Disease Control Unit, Department of State Health Services, MC 1960, P.O. Box 149347, Austin, Texas 78714-9347, (512) 458-7676, or by email to marilyn.felkner@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rule has been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

STATUTORY AUTHORITY

The amendment is authorized by Health and Safety Code, §81.004, which gives the commissioner of the department (commissioner) general statewide responsibility for the administration of the Communicable Disease Act and authorizes the adoption of rules necessary for its effective administration and implementation; §81.042(c), which requires rules to establish procedures to determine if a child should be reported and excluded from school; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of the Health and Safety Code, Chapter 1001. The review of the rule implements Government Code, §2001.039.

The amendment affects Health and Safety Code, Chapters 81 and 1001; and Government Code, Chapters 531 and 2001.

§97.7.Diseases Requiring Exclusion from [~~Child-care Facilities and~~] Schools.

(a) The [~~owner or operator of a child-care facility, or the~~] school administrator[,] shall exclude from attendance any child having or suspected of having a communicable condition. Exclusion shall continue until the readmission criteria for the conditions are met. The conditions and readmission criteria are as follows:

(1) amebiasis--exclude until treatment is initiated;

(2) campylobacteriosis--exclude until after diarrhea and fever subside;

(3) chickenpox--exclude until the lesions become dry;

(4) common cold--exclude until fever subsides;

(5) conjunctivitis, bacterial and/or viral--exclude until written permission and/or permit is issued by a physician or local health authority;

(6) fever--exclude until fever subsides without use of fever suppressing medications;

(7) fifth disease (erythema infectiosum)--exclude until fever subsides;

(8) gastroenteritis--exclude until diarrhea subsides without the use of diarrhea suppressing medications;

(9) giardiasis--exclude until diarrhea subsides;

(10) head lice (pediculosis)--exclude until one medicated shampoo or lotion treatment has been given;

(11) hepatitis A--exclude until one week after onset of illness;

(12) infections (wounds, skin, and soft tissue)--exclude until drainage from wounds or skin and soft tissue infections is contained and maintained in a clean dry bandage; restrict from situations that could result in the infected area becoming exposed, wet, soiled, or otherwise compromised;

~~[(12) impetigo--exclude until treatment has begun;]~~

(13) infectious mononucleosis--exclude until physician decides or fever subsides;

(14) influenza--exclude until fever subsides;

(15) measles (rubeola)--exclude until four days after rash onset or in the case of an outbreak, unimmunized children should also be excluded for at least two weeks after last rash onset occurs;

(16) meningitis, bacterial--exclude until written permission and/or permit is issued by a physician or local health authority;

(17) meningitis, viral--exclude until fever subsides;

(18) mumps--exclude until nine days after the onset of swelling;

(19) pertussis (whooping cough)--exclude until completion of five days of antibiotic therapy;

(20) ringworm--exclude until treatment has begun;

(21) rubella (German measles)--exclude until seven days after rash onset or in the case of an outbreak, unimmunized children should be excluded for at least three weeks after last rash onset occurs;

(22) salmonellosis--exclude until diarrhea and fever subside;

(23) scabies--exclude until treatment has begun;

(24) shigellosis--exclude until diarrhea and fever subside;

(25) streptococcal sore throat and scarlet fever--exclude until 24 hours from time antibiotic treatment was begun and fever subsided; and

(26) tuberculosis, pulmonary--exclude until antibiotic treatment has begun and a physician's certificate or health permit obtained.

(b) The [~~owner or operator of a child-care facility, or the~~] school administrator[,] shall exclude from attendance any child having or suspected of having a communicable disease designated by the Commissioner of Health (commissioner) as cause for exclusion until one of the criteria listed in subsection (c) of this section is fulfilled.

(1) submitting a certificate of the attending physician, advanced practice nurse, or physician assistant attesting that the child does not currently have signs or symptoms of a communicable disease or to the disease's non-communicability in a [ ~~child-care or~~] school setting;

(2) submitting a permit for readmission issued by a local health authority; or

(3) meeting readmission criteria as established by the commissioner.