AN ACT

 

1Prohibiting the administration of certain antimicrobial agents
2in agriculture; providing for inspection and testing of
3agricultural operations, for enforcement, for reporting by
4agricultural operations and for alternatives to
5administration of antimicrobial agents to animals; and making
6related repeals.

7The General Assembly of the Commonwealth of Pennsylvania
8hereby enacts as follows:

9Section 1. Short title.

10This act shall be known and may be cited as the Safe Food and
11Safe Families Act.

12Section 2. Findings and purpose.

13The General Assembly finds and declares as follows:

14(1) Several antimicrobial agents, including, but not
15limited to, penicillin, tetracycline, erythromycin,
16lincomycin, bacitracin and virginiamycin are used in, or are
17related to, antimicrobial agents used for the treatment of
18infectious diseases in humans and are also used in animal
19feed or otherwise administered to animals for nontherapeutic
20purposes, such as the promotion of animal growth.

1(2) Mounting expert opinion and government actions show
2that using antimicrobial agents in animal feed contributes to
3the increasing prevalence of antimicrobial-resistant
4pathogenic bacteria, such as campylobacter, enterococci,
5staphylococci and salmonella, that can cause hard-to-treat
6infections in humans. Populations that are especially
7vulnerable to antimicrobial resistance include children,
8senior citizens, persons with cancer, persons with HIV/AIDS,
9persons with diabetes and persons who are otherwise receiving
10immunosuppressive therapy, including therapy after organ
11transplants. Moreover, farmers and their families have been
12shown to be at very high risk of exposure to antimicrobial-
13resistant pathogens through the use of these drugs in animal
14feeds.

15(3) The Swann Committee, formed in the United Kingdom in
161969 to examine the public health effects of the use of
17antimicrobial agents in food-producing animals, recommended
18that antimicrobial agents be divided into "feed" and
19"therapeutic" classes of drugs and that drugs used
20therapeutically in humans or animals not be included in the
21"feed" class.

22(4) The United States Food and Drug Administration
23proposed in 1977 to ban the subtherapeutic use of penicillin
24and tetracycline, but the ban was never put into effect.

25(5) The World Health Organization recommended in 1997
26that antimicrobial agents that are used to treat humans
27should not be used to promote animal growth.

28(6) The National Academy of Sciences, in a July 1998
29report prepared at the request of the United States
30Department of Agriculture and the Food and Drug

1Administration, concluded that "there is a link between the
2use of antibiotics in food animals, the development of
3bacterial resistance to these drugs and human disease."

4(7) Individual European countries, including the United
5Kingdom, Denmark, Finland and Sweden, banned the use of
6certain antimicrobial agents in animal feed. Subsequently, in
7December 1998, health ministers for the European Union
8countries voted to ban the four remaining human-use
9antimicrobial agents that were still being administered in
10the European Union to promote animal growth. The ban by the
11European Union on using virginiamycin, tylosin, spiramycin
12and bacitracin in animal feed became effective for the 15
13member states on July 1, 1999.

14(8) An April 1999 study by the United States General
15Accounting Office concluded that resistant strains of
16salmonella, campylobacter and E. coli cause illness or
17disease in humans and are linked to the use of antimicrobial
18agents in animals.

19(9) The American Medical Association passed a resolution
20in June 2001 opposing the use of antimicrobial agents in
21livestock except when needed to treat an animal's illness.

22(10) Recent scientific medical studies from the
23Netherlands and Canada suggest that animal agriculture,
24specifically swine facilities, may be a source of
25methicillin-resistant staphylococcus aureus (MRSA) strains
26that are entering the human population via workers at those
27facilities.

28(11) More than 350 other medical, public health,
29environmental and sustainable agriculture organizations have
30publicly opposed the subtherapeutic use of antimicrobial

1agents in livestock, including the American College of
2Preventive Medicine, the American Nurses Association, the
3Pennsylvania State Nurses Association, the American Public
4Health Association, the American Academy of Pediatrics, the
5Ambulatory Pediatric Association, the National Association of
6County and City Health Officials, the American Academy of
7Family Physicians, the American Geriatrics Society, the
8Breast Cancer Fund, the Catholic Health Association of the
9United States, the Infectious Diseases Society of America,
10the Leukemia and Lymphoma Society, the National Alliance of
11State and Territorial AIDS Directors, the Physicians for
12Social Responsibility, the Center for Science in the Public
13Interest, The Center for Food Safety, the National Campaign
14for Sustainable Agriculture, American Rivers, the Chesapeake
15Bay Foundation, Citizens for Pennsylvania's Future, Clean
16Water Action, the Environmental Defense Fund, the National
17Environmental Trust, the Natural Resources Defense Council
18and the Sierra Club.

19(12) The Food and Drug Administration in July 2005
20withdrew its approval for the use of fluoroquinoline
21antimicrobial agents for nontherapeutic administration to
22poultry because of concerns over the development of
23antibiotic-resistant bacteria.

24(13) States have the right to enact laws more
25restrictive than Federal laws concerning antimicrobial
26agents.

27(14) A Federal court of appeals in 1978 held that a
28municipality could inspect meat delivery vehicles for
29violation of its public health ordinances even though the
30United States Department of Agriculture has the sole

1responsibility for the inspection of meat plants.

2(15) The United States Supreme Court in 1985 unanimously
3upheld local regulations of blood plasma centers that were
4stricter than the Food and Drug Administration's regulations
5governing the safety of blood plasma.

6(16) Because a Federal district court in 1986 held that
7regulations issued by the Food and Drug Administration and
8the United States Department of Agriculture prevented the
9court from requiring that a veal producer label that its
10calves had been fed subtherapeutic levels of antibiotic
11drugs, consumers in this Commonwealth do not now have a
12reliable way of knowing whether the food they buy contains
13bacteria that is resistant to antimicrobial agents.

14(b) Purpose.--The purpose of this act is to protect the
15health and safety of the citizens of this Commonwealth by
16prohibiting the use of certain antimicrobial agents in
17agriculture in nontherapeutic amounts or as growth promoters.

18Section 3. Definitions.

19The following words and phrases when used in this act shall
20have the meanings given to them in this section unless the
21context clearly indicates otherwise:

22"Administer." To give an antimicrobial agent to an animal by
23implantation, ingestion or injection or by addition to feed.

24"Agricultural operation." The management and use of farming
25resources for the production of livestock, poultry or fish.

26"Animal." Any livestock, poultry or fish.

27"Antimicrobial agent." A drug, chemical or other substance
28that either kills or slows the growth of a microbe. The term
29includes, but is not limited to, antimicrobial drugs that kill
30bacteria, antiviral agents that kill viruses, antifungal agents

1that kill fungi and antiparasitic drugs that kill parasites. The
2term includes both naturally occurring substances, such as
3penicillins, and synthetic agents designed for the same purpose.

4"Antimicrobial resistance." The ability of a microbe to
5survive treatment by antimicrobial agents resulting from changes
6that reduce or eliminate the effectiveness of drugs, chemicals
7or other agents to cure or prevent infections in animals or
8humans.

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

10"Land grant institution." An educational institution located
11within this Commonwealth that has received a grant of public
12land made by the Congress of the United States for the support
13of education under the Morrill Act (12 Stat. 503, 7 U.S.C. § 301
14et seq.).

15"Microbe." A unicellular organism or virus that is so small
16that it can be seen only by use of a microscope.

17"Nontherapeutic amount." An amount of an antimicrobial agent
18that constitutes a dose below that necessary to kill a pathogen.

19"Organism." Any living thing. The term includes humans,
20animals, plants, bacteria, protozoa, fungi and viruses.

21Section 4. Administration of certain antimicrobial agents
22prohibited.

23(a) General rule.--Beginning one year from the effective
24date of this section, a person may not:

25(1) Administer to an animal a nontherapeutic amount of
26penicillin, tetracycline, erythromycin, lincomycin,
27bacitracin or virginiamycin.

28(2) Administer to an animal a nontherapeutic amount of
29any other antimicrobial agent designated by the department.

30(3) Administer to an animal an antimicrobial agent for

1growth promotion.

2(b) Affidavit required.--A person or legal entity owning or
3operating an agricultural operation shall file annually with the
4department an affidavit stating that the animals produced by
5that agricultural operation have not been administered an
6antimicrobial agent, in violation of subsection (a).

7(c) Designation of antimicrobial agents.--The department may
8designate antimicrobial agents that may not be administered to
9an animal in a nontherapeutic amount. Before making a
10designation, the department shall request the views of the
11Department of Agriculture, the Physician General and the Animal
12Health and Diagnostic Commission. The department shall annually
13publish in the Pennsylvania Bulletin a report of the designated
14antimicrobial agents, if any, and the rationale for the
15designations. A designation of an antimicrobial agent shall be
16deemed an adjudication under 2 Pa.C.S. § 101 (relating to
17definitions) and shall be made and be subject to review in
18accordance with 2 Pa.C.S. (relating to administrative law and
19procedure).

20Section 5. Inspection and testing of agricultural operations.

21(a) Regular inspection and testing.--The department shall
22regularly perform such investigations, inspections and tests and
23take such other actions as are necessary to enforce the
24provisions of this act or any order, rule or regulation
25promulgated under this act and may enter, at reasonable times,
26an agricultural operation for those purposes. A person owning or
27operating an agricultural operation shall grant access to the
28department and shall not hinder, obstruct, prevent or interfere
29with the department in the performance of its duties.

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

1inspections and testing under subsection (a), the department may
2request the assistance of the Department of Agriculture, the
3Department of Environmental Protection, the Pennsylvania Fish
4and Boat Commission, the Physician General, the Animal Health
5and Diagnostic Commission, the State Board of Veterinary
6Medicine, the State Board of Medicine and the State Board of
7Osteopathic Medicine, which assistance shall reasonably be
8provided.

9Section 6. Enforcement.

10(a) Equitable relief.--

11(1) A mandatory preliminary injunction, special
12injunction or temporary restraining order may be issued upon
13the terms prescribed by the court of common pleas of the
14county that is the site of an agricultural operation, if the
15court finds:

16(i) that a person is administering an antimicrobial
17agent in violation of section 4; or

18(ii) that a person is denying access or otherwise
19hindering, obstructing, preventing or interfering with
20the department in the performance of its duties under
21this act.

22(2) Notice of the application for a mandatory
23preliminary injunction, special injunction or temporary
24restraining order shall be given in accordance with the rules
25of equity practice. In any such proceeding, the department
26shall not be required to post a bond.

27(b) Civil penalties.--In addition to any other relief
28ordered by a court in accordance with subsection (a), the court
29may impose civil penalties on a person who knowingly administers
30an antimicrobial agent in violation of section 4 or who denies

1access or otherwise hinders, obstructs, prevents or interferes
2with the department in the performance of its duties in
3violation of section 5. The civil penalties shall be in the
4amount of not more than $1,000 for each day of each violation.

5(c) Other relief.--A microbial agent administered in
6violation of section 4 shall be deemed a "hazardous substance"
7under 3 Pa.C.S. § 2303 (relating to definitions) and shall be
8subject to regulation as a "hazardous substance" under 3 Pa.C.S. 
9Ch. 23 (relating to domestic animals) notwithstanding any
10provision of that title to the contrary.

11Section 7. Reporting.

12The department, in consultation with the Department of
13Agriculture, shall promulgate regulations requiring annual
14reporting by agricultural operations on the use of antimicrobial
15agents in animals, including a list of the antimicrobial agents
16used and the approximate volume administered. The department
17shall compile the information into an annual report that
18includes statistics on antimicrobial agent use Statewide and in
19each of the counties. The information shall be published and
20maintained on the department's Internet website.

21Section 8. Alternatives to administration of antimicrobial
22agents to animals.

23In the allocation of any funds appropriated by the General
24Assembly to the Department of Agriculture, the Animal Health and
25Diagnostic Commission or a land grant institution for
26agricultural research, priority shall be given to research and
27development of alternatives to the administration of
28antimicrobial agents to animals, including improved animal
29husbandry and hygiene.

30Section 9. Rules and regulations.

1The department may promulgate rules and regulations to
2administer and enforce this act.

3Section 10. Repeals.

4All acts and parts of acts are repealed insofar as they are
5inconsistent with this act.

6Section 11. Effective date.

7This act shall take effect in 60 days.