THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY M. O'BRIEN, KULA, SWANGER, DALEY, CALTAGIRONE, CARROLL, COHEN, DeLUCA, GOODMAN, HARKINS, KOTIK, MURT, READSHAW, TAYLOR, WAGNER AND YOUNGBLOOD, JULY 18, 2011

REFERRED TO COMMITTEE ON AGRICULTURE AND RURAL AFFAIRS, JULY 18, 2011  

AN ACT

Prohibiting the administration of certain antimicrobial agents

in agriculture; providing for inspection and testing of

agricultural operations, for enforcement, for reporting by

agricultural operations and for alternatives to

administration of antimicrobial agents to animals; and making

related repeals.

Section 1.  Short title.

This act shall be known and may be cited as the Safe Food and

Safe Families Act.

Section 2.  Findings and purpose.

The General Assembly finds and declares as follows:

(1)  Several antimicrobial agents, including, but not

limited to, penicillin, tetracycline, erythromycin,

lincomycin, bacitracin and virginiamycin are used in, or are

related to, antimicrobial agents used for the treatment of

infectious diseases in humans and are also used in animal

feed or otherwise administered to animals for nontherapeutic

purposes, such as the promotion of animal growth.

(2)  Mounting expert opinion and government actions show

that using antimicrobial agents in animal feed contributes to

the increasing prevalence of antimicrobial-resistant

pathogenic bacteria, such as campylobacter, enterococci,

staphylococci and salmonella, that can cause hard-to-treat

infections in humans. Populations that are especially

vulnerable to antimicrobial resistance include children,

senior citizens, persons with cancer, persons with HIV/AIDS,

persons with diabetes and persons who are otherwise receiving

immunosuppressive therapy, including therapy after organ

transplants. Moreover, farmers and their families have been

shown to be at increased risk of developing an antimicrobial

resistant bacterial infection.

(3)  The Swann Committee, formed in the United Kingdom in

1969 to examine the public health effects of the use of

antimicrobial agents in food-producing animals, recommended

that antimicrobial agents be divided into "feed" and

"therapeutic" classes of drugs and that drugs used

therapeutically in humans or animals not be included in the

"feed" class.

(4)  The United States Food and Drug Administration

proposed in 1977 to ban the subtherapeutic use of penicillin

and tetracycline, but the ban was never put into effect.

(5)  The World Health Organization recommended in 1997

that antimicrobial agents that are used to treat humans

should not be used to promote animal growth.

(6)  The National Academy of Sciences, in a July 1998

report prepared at the request of the United States

Department of Agriculture and the Food and Drug

Administration, concluded that "there is a link between the

use of antibiotics in food animals, the development of

bacterial resistance to these drugs and human disease."

(7)  Individual European countries, including the United

Kingdom, Denmark, Finland and Sweden, banned the use of

certain antimicrobial agents in animal feed. Subsequently, in

December 1998, health ministers for the European Union

countries voted to ban the four remaining human-use

antimicrobial agents that were still being administered in

the European Union to promote animal growth. The ban by the

European Union on using virginiamycin, tylosin, spiramycin

and bacitracin in animal feed became effective for the 15

member states on July 1, 1999.

(8)  An April 1999 study by the United States General

Accounting Office concluded that resistant strains of

salmonella, campylobacter and E. coli cause illness or

disease in humans and are linked to the use of antimicrobial

agents in animals.

(9)  The American Medical Association passed a resolution

in June 2001 opposing the use of antimicrobial agents in

livestock except when needed to treat an animal's illness.

(10)  Recent scientific medical studies from the

Netherlands and Canada suggest that animal agriculture,

specifically swine facilities, may be a source of

methicillin-resistant staphylococcus aureus (MRSA) strains

that are entering the human population via workers at those

facilities.

(11)  More than 350 other medical, public health,

environmental and sustainable agriculture organizations have

publicly opposed the subtherapeutic use of antimicrobial

agents in livestock, including the American College of

Preventive Medicine, the American Nurses Association, the

Pennsylvania State Nurses Association, the American Public

Health Association, the American Academy of Pediatrics, the

Ambulatory Pediatric Association, the National Association of

County and City Health Officials, the American Academy of

Family Physicians, the American Geriatrics Society, the

Breast Cancer Fund, the Catholic Health Association of the

United States, the Infectious Diseases Society of America,

the Leukemia and Lymphoma Society, the National Alliance of

State and Territorial AIDS Directors, the Physicians for

Social Responsibility, the Center for Science in the Public

Interest, The Center for Food Safety, the National Campaign

for Sustainable Agriculture, American Rivers, the Chesapeake

Bay Foundation, Citizens for Pennsylvania's Future, Clean

Water Action, the Environmental Defense Fund, the National

Environmental Trust, the Natural Resources Defense Council

and the Sierra Club.

(12)  The Food and Drug Administration in July 2005

withdrew its approval for the use of fluoroquinoline

antimicrobial agents for therapeutic administration to

poultry because of concerns over the development of

antibiotic-resistant bacteria.

(13)  On June 28, 2010, the United States Food and Drug

Administration issued a draft guidance paper stating the

agency's position that feeding critically important

antibiotics to livestock for growth promotion and feed

efficiency are not considered judicious use.

(14)  States have the right to enact laws more

restrictive than Federal laws concerning antimicrobial

agents.

(15)  A Federal court of appeals in 1978 held that a

municipality could inspect meat delivery vehicles for

violation of its public health ordinances even though the

United States Department of Agriculture has the sole

responsibility for the inspection of meat plants.

(16)  The United States Supreme Court in 1985 unanimously

upheld local regulations of blood plasma centers that were

stricter than the Food and Drug Administration's regulations

governing the safety of blood plasma.

(17)  Because a Federal district court in 1986 held that

regulations issued by the Food and Drug Administration and

the United States Department of Agriculture prevented the

court from requiring that a veal producer label that its

calves had been fed subtherapeutic levels of antibiotic

drugs, consumers in this Commonwealth do not now have a

reliable way of knowing whether the food they buy contains

bacteria that is resistant to antimicrobial agents.

(b)  Purpose.--The purpose of this act is to protect the

health and safety of the citizens of this Commonwealth by

prohibiting the use of certain antimicrobial agents in

agriculture in a nontherapeutic manner or as growth promoters.

Section 3.  Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Administer."  To give an antimicrobial agent to an animal by

implantation, ingestion or injection or by addition to feed or

water.

"Agricultural operation."  The management and use of farming

resources for the production of livestock, poultry or fish.

"Animal."  Any livestock, poultry or fish.

"Antimicrobial agent."  Any drug, chemical or other substance

that either kills or slows the growth of a microbe. The term

includes, but is not limited to, antimicrobial drugs that kill

bacteria, antiviral agents that kill viruses, antifungal agents

that kill fungi and antiparasitic drugs that kill parasites. The

term includes both naturally occurring substances, such as

penicillins, and synthetic agents designed for the same purpose.

"Antimicrobial resistance."  The ability of a microbe to

survive treatment by antimicrobial agents resulting from changes

that reduce or eliminate the effectiveness of drugs, chemicals

or other agents to cure or prevent infections in animals or

humans.

"Department."  The Department of Health of the Commonwealth.

"Land grant institution."  An educational institution located

within this Commonwealth that has received a grant of public

land made by the Congress of the United States for the support

of education under the Morrill Act (12 Stat. 503, 7 U.S.C. § 301 

et seq.).

"Microbe."  A unicellular organism or virus that is so small

that it can be seen only by use of a microscope.

"Nontherapeutic manner."  Any application of an antimicrobial

agent not intended to combat an established infection or

exposure to a bacterial disease, or in the absence of any

clinical sign of disease, any application of an antimicrobial

agent not provided in curative doses or any application of an

antimicrobial agent provided in any manner to healthy animals

not known to be exposed to a bacterial disease.

"Organism."  Any living thing. The term includes humans,

animals, plants, bacteria, protozoa, fungi and viruses.

Section 4.  Prohibition of the administration of certain

antimicrobial agents in a nontherapeutic manner.

(a)  General rule.--Beginning one year from the effective

date of this section, a person shall not:

(1)  Administer to an animal in a nontherapeutic manner

any kind of penicillin, tetracycline, macrolide, lincosamide,

streptogramin, aminoglycoside or sulfonamide.

(2)  Administer to an animal in a nontherapeutic manner

any other antimicrobial agent designated by the department.

(3)  Administer to an animal any antimicrobial agent for

growth promotion.

(b)  Affidavit required.--

(1)  A person or legal entity owning or operating an

agricultural operation shall file annually with the

department an affidavit stating that the animals produced by

that agricultural operation have not been administered an

antimicrobial agent in violation of subsection (a).

(2)  A person or legal entity who contracts for the

production of animals with a person or legal entity owning or

operating an agricultural operation shall file annually with

the department an affidavit stating that the animals produced

by that agricultural operation have not been administered an

antimicrobial agent in violation of subsection (a), and that

no directions, guidance or requirements have been issued to

the owner of an agricultural entity for the administration of

an antimicrobial agent in violation of subsection (a).

(c)  Designation of antimicrobial agents.--The department may

designate additional antimicrobial agents that shall not be

administered to an animal in a nontherapeutic manner. Before

making a designation, the department shall request the views of

the Department of Agriculture, the Physician General and the

Animal Health and Diagnostic Commission. The department shall

annually publish in the Pennsylvania Bulletin a report of the

designated antimicrobial agents, if any, and the rationale for

the designations. A designation of an antimicrobial agent shall

be deemed an adjudication under 2 Pa.C.S. § 101 (relating to

definitions) and shall be made and be subject to review in

accordance with 2 Pa.C.S. (relating to administrative law and

procedure).

Section 5.  Inspection and testing of agricultural operations.

(a)  Regular inspection and testing.--The department shall

regularly perform such investigations, inspections and tests and

take such other actions as are necessary to enforce the

provisions of this act or any order, rule or regulation

promulgated under this act and may enter, at reasonable times,

any agricultural operation for those purposes. A person owning

or operating an agricultural operation shall grant access to the

department and shall not hinder, obstruct, prevent or interfere

with the department in the performance of its duties.

(b)  Cooperation with other agencies.--In performing the

inspections and testing under subsection (a), the department may

request the assistance of the Department of Agriculture, the

Department of Environmental Protection, the Pennsylvania Fish

and Boat Commission, the Physician General, the Animal Health

and Diagnostic Commission, the State Board of Veterinary

Medicine, the State Board of Medicine and the State Board of

Osteopathic Medicine, which assistance shall reasonably be

provided.

Section 6.  Enforcement.

(a)  Equitable relief.--

(1)  A mandatory preliminary injunction, special

injunction or temporary restraining order may be issued upon

the terms prescribed by the court of common pleas of the

county that is the site of an agricultural operation, if the

court finds:

(i)  that a person is administering an antimicrobial

agent in violation of section 4; or

(ii)  that a person is denying access or otherwise

hindering, obstructing, preventing or interfering with

the department in the performance of its duties under

this act.

(2)  Notice of the application for a mandatory

preliminary injunction, special injunction or temporary

restraining order shall be given in accordance with the rules

of equity practice. In any such proceeding, the department

shall not be required to post a bond.

(b)  Civil penalties.--In addition to any other relief

ordered by a court in accordance with subsection (a), the court

may impose civil penalties on any person who knowingly

administers an antimicrobial agent in violation of section 4 or

who denies access or otherwise hinders, obstructs, prevents or

interferes with the department in the performance of its duties

in violation of section 5. The civil penalties shall be in the

amount of not more than $1,000 for each day of each violation.

(c)  Other relief.--Any microbial agent administered in

violation of section 4 shall be deemed a "hazardous substance"

under 3 Pa.C.S. § 2303 (relating to definitions) and shall be

subject to regulation as a "hazardous substance" under 3 Pa.C.S.

Ch. 23 (relating to domestic animals) notwithstanding any

provision of that title to the contrary.

Section 7.  Reporting.

The department, in consultation with the Department of

Agriculture, shall promulgate regulations requiring annual

reporting by agricultural operations on the use of antimicrobial

agents in animals, including a list of the antimicrobial agents

used and the approximate weight administered. The department

shall compile the information into an annual report that

includes statistics on antimicrobial agent use Statewide and in

each of the counties. The information shall be published and

maintained on the department's Internet website.

Section 8.  Alternatives to administration of antimicrobial

agents to animals.

In the allocation of any funds appropriated by the General

Assembly to the Department of Agriculture, the Animal Health and

Diagnostic Commission or a land grant institution for

agricultural research, priority shall be given to research and

development of alternatives to the administration of

antimicrobial agents to animals, including improved animal

husbandry and hygiene.

Section 9.  Rules and regulations.

The department may promulgate rules and regulations to

administer and enforce this act.

Section 10.  Repeals.

All acts and parts of acts are repealed insofar as they are

inconsistent with this act.

Section 11.  Effective date.

This act shall take effect in 120 days.