PROPOSED ACTION ON REGULATIONS

TITLE 3. DEPARTMENT OF FOOD AND AGRICULTURE

NOTICE IS HEREBY GIVEN that the Department of Food and Agriculture (hereinafter referred to as "Department") is proposing to take the action described in the Informative Digest. A public hearing is not scheduled for this proposal. A public hearing will be held if any interested person, or his or her duly authorized representative, submits a written request for a public hearing to the Department no later than 15 days prior to the close of the written comment period. Any person interested may present statements or arguments in writing relevant to the action proposed to the person designated in this Notice as the contact person beginning January 24, 2014 and ending at 5:00 p.m., March 10, 2014. Following the public hearing, if one is requested, or following the written comment period if no public hearing is requested, the Department, upon its own motion or at the instance of any interested party, may thereafter adopt the proposals substantially as described below or may modify such proposals if such modifications are sufficiently related to the original text. With the exception of technical or grammatical changes, the full text of any modified proposal will be available for 15 days prior to its adoption from the person designated in this Notice as contact person and will be mailed to those persons who submit written or oral testimony related to this proposal or who have requested notification of any changes to the proposal.

Authority and Reference: Pursuant to the authority vested by sections 407, 24013, and 24011.6, Food and Agricultural Code, and to implement, interpret or make specific sections 24001, 24002, 24003, 24004, 24005, 24006, 24007, 24008, 24009, 24010, 24011, 24011.6, 24012, and 24015 of the Food and Agricultural Code, the Department is proposing to make various changes to Chapter 6, Division 2, of Title 3 of the California Code of Regulations, to read as follows:

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW

Existing law, section 407 of the Food and Agricultural Code, provides that the Secretary may adopt such regulations as are reasonably necessary to carry out the provisions of this code which she is directed or authorized to administer or enforce.

Existing law, Chapter 8 (commencing with section 24000) of Division 11 of the Food and Agricultural Code authorizes the Department to implement the Equine Medication Monitoring Program (EMMP) to prevent the misuse of drugs and medications in equines. The EMMP monitors horses in public shows and sales through random sample collection for chemical analysis.

Existing law section 24001(e) defines a prohibited substance, which includes non-steroidal anti-inflammatory drugs (NSAIDs), within existing section 24011.5, permitting the use of some NSAIDs as specified.

Existing law, section 24006 of the Food and Agricultural Code states that administration of a prohibited substance is a violation of the chapter.

Existing law, section 24011.5 of the Food and Agricultural Code prohibits use of certain drugs or drug combinations, yet accommodates specific legitimate therapeutic use of medications within specified parameters. Prohibited substances are drugs or medications that affect the performance or disposition of the horse, mask or interfere with laboratory testing for chemicals, or are metabolites or derivatives of a prohibited substance.

Pursuant to AB 1388 (Stats. 2013, Ch. 116) Food and Agricultural Code section 24011.5 sunsets July 1, 2014, and will be replaced with section 24011.6, at which time the Department must have an approved therapeutic medications and drug list in regulation. The regulation will update the current list in Food and Agricultural Code section 24011.5, as is specified in this proposal under new regulation section 1280.8. The rulemaking changes are needed for the purpose of regulating the administration of therapeutic drugs and medicines and to describe the circumstances in which the administration of these substances shall be prohibited. The permissible list in Food and Agricultural Code section 24011.5 included NSAIDs only. This revision to the list of therapeutic drugs and medicines, as proposed, includes two drugs which are not NSAIDs yet may be prescribed by a veterinarian for therapeutic reasons to treat a veterinarian-diagnosed illness or injury.

Existing law, section 24013 of the Food and Agricultural Code authorizes the Department to adopt regulations necessary to carry out the provisions of the chapter. It also specifies that in making and adopting regulations, the Department is to first consult with the advisory committee appointed pursuant to section 24013.5.

On October 31, 2013, the EMMP advisory committee approved the initiation of an emergency rulemaking action to implement regulations for random testing and a list of approved therapeutic medications and maximum detectable plasma and urine levels for equines in public horse shows and sales. The Department was also seeking to implement the new national regulations set by the United States Equestrian Federation (USEF), General Rule (GR) 414 "Prohibited Practices." The USEF is the National Governing Body for Equestrian Sports. The new ruling specifies that no injectable substances may be administered to any horse or pony within 12 hours prior to competing, with exceptions, as specified. The EMMP emergency rulemaking action was approved by the Office of Administrative Law on December 5, 2013 and effective January 1, 2014.

In order to make the emergency regulations permanent in Title 3 of the California Code of Regulations, the Department is proceeding with a regular rulemaking action to adopt sections 1280, 1280.1, 1280.8 and 1280.10, and amend section 1280.7 of Article 1, Chapter 6, Division 2 of Title 3 of the California Code of Regulations to: (1) implement the provisions of AB 1388 (Stats. 2013, Ch. 116); (2) align the EMMP drug testing protocols with the national standards of the USEF; (3) codify existing requirements for the administration of the EMMP including adopting forms and incorporating them by reference pursuant to Government Code sections 11340.5(a) and 11340.9(c), and section 20 of Title 1 of the California Code of Regulations; and (4) adopt a section specifying fines and penalties for a violation of specified sections of the EMMP statutes or regulations.

Anticipated Benefits of the Proposal: The California horse industry produces goods and services valued at approximately $4.1 billion and approximately 698,000 horses in California, over 70 percent of which are involved in showing, sales, and recreation. This proposal benefits the equine industry by promoting the safety of the horse and rider in competition and horses at public sales to prevent any potential misuse of drugs or medications that could fraudulently mask a disease, condition, or injury of the horse which could place its rider in jeopardy.

The EMMP monitors horses in public equine events and public sales through random blood or urine sample collection for chemical analysis. The intent is to ensure the integrity of public horse shows and sales through the control of performance and disposition enhancing drugs and permitting limited therapeutic use of drugs at horse shows and competitions. "Therapeutic drugs or medicines" means drugs or medicines prescribed by a licensed veterinarian for the treatment of a diagnosed illness or injury. Prohibited substances are therapeutic drugs or medicines used without a prescription by a licensed veterinarian for treatment of illness or injury; or any stimulant, depressant, tranquilizer, anesthetic, including local anesthetic, sedative, analgesic, cortco-steroid excluding dexamethasone, anabolic steroid, or masking agent administered within 24 hours before public competition or 72 hours before public sale. The misuse of drugs and medicines in a performance horse can mask a serious injury, or respiratory problem, or other serious health issue which could place the rider of the horse in jeopardy.

This proposal serves to ensure the Department fulfills its mandate of the protection of both the horse and rider in public horse shows and sales in accordance with Food and Agricultural Code sections 24005, 24006, 24007, 24008, 24009, 24010, 24011, 24012, 24013, and 24015.

Consistency and Compatibility with Existing State Regulations: The Department has evaluated this proposal and believes that it is not inconsistent or incompatible with existing State regulations. The Department is the sole State authority over specified public equine events and sales pursuant to Chapter 8 (commencing with section 24000) of Division 11 of the Food and Agricultural Code.

Documents Incorporated by Reference:

• Form 76-024A (Rev. 12/13) Application to Register Equine Event/Assessment Report for Registered Event/Event Copy for Managers

• Form 76-025 (Rev. 11/2013) Law Prohibiting Drugging of Horses/Saleyard Assessment Report

• Form 76-027 (Rev. 11/13) Official Form for Declaration of Drugs Administered

Technical, Theoretical, and Empirical Study, Report, or Similar Documents

• Minutes from the October 31, 2013 Equine Medication Monitoring Program Advisory Committee meeting.

• United States Equestrian Federation (USEF), general rule, "GR 414 Prohibited Practices" effective December 1, 2013.

• Clinical Guidelines for Veterinarians Treating the Non-Racing Performance Horse, dated July 2011.

• EMMP Brochure dated January 2013, "Equine Medication Monitoring Program-Drugs and Medication Guidelines".

• EMMP spreadsheet showing some of the violations issued as evidence of the drugging of horses in the non-USEF competitions in California.

• Economic Impact Assessment

• Article regarding a petition, Force Change, "Commending Crackdown on Horse Drugging at Competitions".

• Article from Politicol News, June 24, 2012, "Ann Romney's Horse Lawsuit-Over Drugging a Lame Horse to Sell It".

• Article published in the New York Times, December 27, 2012 "Sudden Death of Show Pony Clouds Elite Pursuit".

• Article published by the New Jersey, Star-Ledger, January 20, 2013 "USEF moving to control over-use of medications in show horses".

• Article from the Arabian News World, online library, March 2013, "Putting the Horse First".

• Article published by The Horse, October 15, 2013, "Badminton, Burghley Winner Produces Positive Drug Test".

• http://www.sfgate.com/bayarea/article/Parents-can-sue-over-equestrian-daughter-s-death-2478604.php: Article concerning a 17-year-old that was killed while riding the cross country course at Galway Downs in Temecula, California, in 2006.

• http://tracks.endurance.net/2013/07/distance-rider-dies-in-horse-accident.html http://www.legacy.com/obituaries/omaha/obituary.aspx?pid=166063927: Articles concerning an incident at an Endurance Ride through the Sierra-Nevada Mountains near Lake Tahoe, when a horse tripped causing the death of the rider.

• http://horsetalk.co.nz/news/2009/08/022.shtml http://www.auburnjournal.com/article/waitte-lead-tevis-cup-penyrn-womans-horse-euthanized: Articles concerning two horse deaths associated with the 100-mile Tevis Cup Endurance Ride in California.

FISCAL IMPACT ESTIMATES

Fiscal Impact on Public Agencies Including Costs or Savings to State Agencies or Costs/Savings in Federal Funding to the State: None.

Nondiscretionary Costs/Savings to Local Agencies: None.

Local Mandate: None.

Cost to Any Local Agency or School District for Which Government Code Sections 17500 et seq. Require Reimbursement: None.

Business Impact: The Department has made an initial determination that the proposed regulatory action will have no significant statewide adverse economic impact directly affecting California businesses, including the ability of California businesses to compete with businesses in other states. This initial determination is based on the fact that the proposed regulation imposes no new fees or costs to the equine industry. The proposal benefits the industry and the public by codifying the requirements of the EMMP, including the establishment of a list of permissible drugs and medications for horses in public events and public horse sales in accordance with Chapter 8 (commencing with section 24000) of Division 11 of the Food and Agricultural Code.

Cost Impacts on Representative Private Persons or Businesses: The Department is not aware of any cost impacts that representative private persons or businesses would necessarily incur in reasonable compliance with the proposed action. California hosts approximately 1,800 registered horse events annually, ranging from small backyard schooling shows to internationally recognized endurance events, shows and other types of competition, as well as public horse sales. The proposed regulation does not impose any new fees or costs to persons or businesses. It codifies the requirements of the EMMP, including the establishment of a list of permissible drugs and medications for horses in public events and public horse sales in accordance with Chapter 8 (commencing with section 24000) of Division 11 of the Food and Agricultural Code. The anticipated compliance requirements as a result of this proposal are as follows:

• Paperwork/Reporting requirement: There are no new fees or costs associated with the paperwork requirement. It codifies the forms used by the EMMP. The proposal affects any person participating in a public equine show or competition, or public horse sale. It affects any person designated as an event manager, who is responsible for registering the event with the Department. The event manager is required to register the event with the Department using Form 76-024A (Rev. 12/13) Application to Register Equine Event/Assessment Report for Registered Event/Event Copy for Managers. If a horse is consigned for sale Form 76-025 (Rev. 11/2013) Law Prohibiting Drugging of Horses/Saleyard Assessment Report must be completed and submitted to the Department. If any drugs are administered, Form 76-027 (Rev. 11/13) Official Form for Declaration of Drugs Administered, must be completed and sent to the Department.

Effect on Housing Costs: None.

Effect on Small Business: The Department's proposal may affect small businesses.

RESULTS OF ECONOMIC IMPACT ASSESSMENT

Impact on Jobs/New Businesses: The Department has determined that this regulatory proposal will not have any impact on the creation of jobs or businesses or the elimination of jobs or existing businesses or the expansion of businesses in California.

The Department has made a determination that this regulatory proposal:

• Will have no significant, statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states by making it more costly to produce goods or services, and that it will not create or eliminate jobs or occupations.

• Will not affect the creation of new businesses or the elimination of existing businesses within the State of California, and does not affect the expansion of businesses currently doing business within the State of California.

• Does not impact multiple industries.

• Benefits the industry and the public by codifying the requirements of the EMMP, including the establishment of a list of permissible drugs and medications for horses in public events and public horse sales in accordance with Chapter 8 (commencing with section 24000) of Division 11 of the Food and Agricultural Code.

Benefits of the regulation to the health and welfare of California residents, worker safety, and the State's environment: The Department is not aware of any specific benefits this proposal will have on the health and welfare of California residents, worker safety, or the State's environment. The Department believes this proposal benefits the welfare of California residents by protecting the economic health of the affected equine industry. The California horse industry produces goods and services valued at approximately $4.1 billion and approximately 698,000 horses in California, over 70 percent of which are involved in showing, sales, and recreation. This proposal further benefits the equine industry by promoting the safety of the horse and rider in competition and horses at public sales to prevent any potential misuse of drugs or medications that could fraudulently mask a disease, condition, or injury of the horse which could place its rider in jeopardy. This proposal serves to ensure the Department fulfills its mandate of the protection of both the horse and rider in public horse shows and sales in accordance with Food and Agricultural Code sections 24005, 24006, 24007, 24008, 24009, 24010, 24011, 24012, 24013, and 24015.

Occupations/Businesses Impacted: The Department has made an initial determination that this regulatory proposal will impact persons required to register with the Department any public horse shows and sales held in California, and affect persons participating in public horse shows and sales in accordance with Food and Agricultural Code sections 24001, 24012 and 24015.

Business Reporting Requirement: The regulation does require a report, which shall apply to businesses. The forms are provided by the Department, and incorporated by reference in this proposal. They are as follows:

• Form 76-024A (Rev. 12/13) Application to Register Equine Event/Assessment Report for Registered Event/Event Copy for Managers

• Form 76-025 (Rev. 11/2013) Law Prohibiting Drugging of Horses/Saleyard Assessment Report

• Form 76-027 (Rev. 11/13) Official Form for Declaration of Drugs Administered

Comparable Federal Regulations: This proposal does not duplicate or conflict with federal regulations because there are no federal regulations governing public equine events or sales. The Department of Food and Agriculture is the sole State authority over specified public equine events and sales pursuant to Chapter 8 (commencing with section 24000) of Division 11 of the Food and Agricultural Code.

CONSIDERATION OF ALTERNATIVES

The Department must determine that no reasonable alternative considered or that has otherwise been identified and brought to the attention of the Department would be more effective in carrying out the purpose for which the action is proposed or would be as effective and less burdensome to affected private persons than the proposed action, or would be more cost effective to affected private persons and equally effective in implementing the statutory policy or other provision of law. This proposal serves to ensure the Department fulfills its mandate of the protection of both the horse and rider in public horse shows and sales in accordance with Food and Agricultural Code sections 24005, 24006, 24007, 24008, 24009, 24010, 24011, 24012, 24013, and 24015.

Any interested person may present statements or arguments orally or in writing relevant to the above determinations at the hearing (if a hearing is requested) or during the written public comment period.

INITIAL STATEMENT OF REASONS AND INFORMATION

The Department has prepared an initial statement of reasons for the proposed action and has available all the information upon which the proposal is based.

TEXT OF PROPOSAL

Copies of the exact language of the proposed regulations and of the initial statement of reasons, and all the information upon which the proposal is based, may be obtained by contacting the persons named below or by accessing the Department's website as indicated below in this Notice.

AVAILABILITY AND LOCATION OF THE FINAL STATEMENT OF REASONS AND RULEMAKING FILE

All the information upon which the proposed regulations are based is contained in the rulemaking file, which is available for public inspection by contacting the persons named below.

Any person may obtain a copy of the final statement of reasons once it has been prepared, by making a written request to the contact persons named below or by accessing the website listed below.

CONTACT PERSONS

Inquiries concerning the substance of the proposed regulations, or any written comments concerning this proposal are to be addressed to the following:

Katie Flynn, BVMS, MRCVS
Equine Staff Veterinarian
Department of Food and Agriculture Animal Health Branch/EMMP
1220 N Street,
Sacramento, CA 95814
Telephone: 916-900-5039
E-mail: katherine.flynn@cdfa.ca.gov

The backup contact person is:

Nancy Grillo, Associate Analyst
Department of Food and Agriculture
Animal Health & Food Safety Services
1220 N Street,
Sacramento, CA 95814
Telephone (916) 900-5033
E-mail: nancy.grillo@cdfa.ca.gov

Website Access: Materials regarding this proposal can be found by accessing the following Internet address: http://www.cdfa.ca.gov/ahfss/regulations.html