AN ACT

 

1Prohibiting the administration of certain antimicrobial agents
2in agriculture; and 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.

6The General Assembly of the Commonwealth of Pennsylvania
7hereby enacts as follows:

8Section 1. Short title.

9This act shall be known and may be cited as the Safe Food and
10Safe Families Act.

11Section 2. Findings and purpose.

12(a) Declarations.--The General Assembly finds and declares
13as 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

1feed or otherwise administered to animals for nontherapeutic
2purposes, such as the promotion of animal growth.

3(2) Mounting expert opinion and government actions show
4that using antimicrobial agents in animal feed contributes to
5the increasing prevalence of antimicrobial-resistant
6pathogenic bacteria, such as campylobacter, enterococci,
7staphylococci and salmonella, that can cause hard-to-treat
8infections in humans. Populations that are especially
9vulnerable to antimicrobial resistance include children,
10senior citizens, persons with cancer, persons with HIV/AIDS,
11persons with diabetes and persons who are otherwise receiving
12immunosuppressive therapy, including therapy after organ
13transplants. Moreover, farmers and their families have been
14shown to be at increased risk of developing an antimicrobial
15resistant bacterial infection.

16(3) The United States Food and Drug Administration
17proposed in 1977 to ban the subtherapeutic use of penicillin
18and tetracycline, but the ban was never put into effect.

19(4) The World Health Organization recommended in 1997
20that antimicrobial agents that are used to treat humans
21should not be used to promote animal growth.

22(5) The National Academy of Sciences, in a July 1998
23report prepared at the request of the United States
24Department of Agriculture and the Food and Drug
25Administration, concluded that "there is a link between the
26use of antibiotics in food animals, the development of
27bacterial resistance to these drugs and human disease."

28(6) Individual European countries, including the United
29Kingdom, Denmark, Finland and Sweden, banned the use of
30certain antimicrobial agents in animal feed. Subsequently, in

1December 1998, health ministers for the European Union
2countries voted to ban the four remaining human-use
3antimicrobial agents that were still being administered in
4the European Union to promote animal growth. The ban by the
5European Union on using virginiamycin, tylosin, spiramycin
6and bacitracin in animal feed became effective for the 15
7member states on July 1, 1999.

8(7) An April 1999 study by the United States General
9Accounting Office concluded that resistant strains of
10salmonella, campylobacter and E. coli cause illness or
11disease in humans and are linked to the use of antimicrobial
12agents in animals.

13(8) The American Medical Association passed a resolution
14in June 2001 opposing the use of antimicrobial agents in
15livestock except when needed to treat an animal's illness.

16(9) A study conducted at the Penn State Milton S.
17Hershey Medical Center by researchers from The Pennsylvania
18State University and the Johns Hopkins University Bloomberg
19School of Public Health found that the medical center was no
20longer the main source of methicillin-resistant
21staphylococcus aureus (MRSA) infections at the hospital, and
22that livestock-associated strains of MRSA were among the
23strains of MRSA being brought into the hospital.

24(10) Recent scientific medical studies from the United
25States, Netherlands and Canada suggest that animal
26agriculture, specifically swine facilities, are a source of
27MRSA strains that are entering the human population via
28workers at those facilities.

29(11) More than 375 medical, public health, environmental
30and sustainable agriculture organizations have publicly

1opposed the subtherapeutic use of antimicrobial agents in
2livestock, including the American Medical Association, the
3American College of Preventive Medicine, the American Nurses
4Association, the Pennsylvania State Nurses Association, the
5American Public Health Association, the American Academy of
6Pediatrics, the Ambulatory Pediatric Association, the
7National Association of County and City Health Officials, the
8American Academy of Family Physicians, the American
9Geriatrics Society, the Breast Cancer Fund, the Catholic
10Health Association of the United States, the Infectious
11Diseases Society of America, the Leukemia and Lymphoma
12Society, the National Alliance of State and Territorial AIDS
13Directors, the Physicians for Social Responsibility, the
14Center for Science in the Public Interest, The Center for
15Food Safety, the National Campaign for Sustainable
16Agriculture, American Rivers, the Chesapeake Bay Foundation,
17Citizens for Pennsylvania's Future, Clean Water Action, the
18Environmental Defense Fund, the National Environmental Trust,
19the Natural Resources Defense Council and the Sierra Club.

20(12) The Food and Drug Administration in July 2005
21withdrew its approval for the use of fluoroquinoline
22antimicrobial agents for therapeutic administration to
23poultry because of concerns over the development of
24antibiotic-resistant bacteria.

25(13) On June 28, 2010, the United States Food and Drug
26Administration issued a draft guidance paper stating the
27agency's position that feeding critically important
28antibiotics to livestock for growth promotion and feed
29efficiency are not considered judicious use.

30(14) On March 23, 2012, Federal Judge Theodore Katz

1ordered the Food and Drug Administration to withdraw
2approvals for the use of penicillins and tetracyclines in
3animal feeds unless drug makers are able to show that they
4are safe.

5(15) States have the right to enact laws more
6restrictive than Federal laws concerning antimicrobial
7agents.

8(16) A Federal court of appeals in 1978 held that a
9municipality could inspect meat delivery vehicles for
10violation of its public health ordinances even though the
11United States Department of Agriculture has the sole
12responsibility for the inspection of meat plants.

13(17) The United States Supreme Court in 1985 unanimously
14upheld local regulations of blood plasma centers that were
15stricter than the Food and Drug Administration's regulations
16governing the safety of blood plasma.

17(18) Because a Federal district court in 1986 held that
18regulations issued by the Food and Drug Administration and
19the United States Department of Agriculture prevented the
20court from requiring that a veal producer label that its
21calves had been fed subtherapeutic levels of antibiotic
22drugs, consumers in this Commonwealth do not now have a
23reliable way of knowing whether the food they buy contains
24bacteria that is resistant to antimicrobial agents.

25(b) Purpose.--The purpose of this act is to protect the
26health and safety of the citizens of this Commonwealth by
27prohibiting the use of certain antimicrobial agents in
28agriculture in a nontherapeutic manner or as growth promoters.

29Section 3. Definitions.

30The following words and phrases when used in this act shall

1have the meanings given to them in this section unless the
2context clearly indicates otherwise:

3"Administer." To give an antimicrobial agent to an animal by
4implantation, ingestion or injection or by addition to feed or
5water.

6"Agricultural operation." The management and use of farming
7resources for the production of livestock, poultry or fish.

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

9"Antimicrobial agent." Any drug, chemical or other substance
10that either kills or slows the growth of a microbe. The term
11includes, but is not limited to, antimicrobial drugs that kill
12bacteria, antiviral agents that kill viruses, antifungal agents
13that kill fungi and antiparasitic drugs that kill parasites. The
14term includes both naturally occurring substances, such as
15penicillins, and synthetic agents designed for the same purpose.

16"Antimicrobial resistance." The ability of a microbe to
17survive treatment by antimicrobial agents resulting from changes
18that reduce or eliminate the effectiveness of drugs, chemicals
19or other agents to cure or prevent infections in animals or
20humans.

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

22"Land grant institution." An educational institution located
23within this Commonwealth that has received a grant of public
24land made by the Congress of the United States for the support
25of education under the Morrill Act (12 Stat. 503, 7 U.S.C. § 301
26et seq.).

27"Microbe." A unicellular organism or virus that is so small
28that it can be seen only by use of a microscope.

29"Nontherapeutic manner." Any application of an antimicrobial
30agent not intended to combat an established infection or

1exposure to a bacterial disease, or in the absence of any
2clinical sign of disease, any application of an antimicrobial
3agent not provided in curative doses or any application of an
4antimicrobial agent provided in any manner to healthy animals
5not known to be exposed to a bacterial disease.

6"Organism." Any living thing. The term includes humans,
7animals, plants, bacteria, protozoa, fungi and viruses.

8Section 4. Prohibition of the administration of certain
9antimicrobial agents in a nontherapeutic manner.

10(a) General rule.--Beginning one year from the effective
11date of this section, a person shall not:

12(1) Administer to an animal in a nontherapeutic manner
13any kind of penicillin, tetracycline, macrolide, lincosamide,
14streptogramin, aminoglycoside or sulfonamide.

15(2) Administer to an animal in a nontherapeutic manner
16any other antimicrobial agent designated by the department.

17(3) Administer to an animal any antimicrobial agent for
18growth promotion.

19(b) Affidavit required.--

20(1) A person or legal entity owning or operating an
21agricultural operation shall file annually with the
22department an affidavit stating that the animals produced by
23that agricultural operation have not been administered an
24antimicrobial agent in violation of subsection (a).

25(2) A person or legal entity who contracts for the
26production of animals with a person or legal entity owning or
27operating an agricultural operation shall file annually with
28the department an affidavit stating that the animals produced
29by that agricultural operation have not been administered an
30antimicrobial agent in violation of subsection (a), and that

1no directions, guidance or requirements have been issued to
2the owner of an agricultural entity for the administration of
3an antimicrobial agent in violation of subsection (a).

4(c) Designation of antimicrobial agents.--The department may
5designate additional antimicrobial agents that shall not be
6administered to an animal in a nontherapeutic manner. Before
7making a designation, the department shall request the views of
8the Department of Agriculture, the Physician General and the
9Animal Health and Diagnostic Commission. The department shall
10annually publish in the Pennsylvania Bulletin a report of the
11designated antimicrobial agents, if any, and the rationale for
12the designations. A designation of an antimicrobial agent shall
13be deemed an adjudication under 2 Pa.C.S. § 101 (relating to
14definitions) and shall be made and be subject to review in
15accordance with 2 Pa.C.S. (relating to administrative law and
16procedure).

17Section 5. Inspection and testing of agricultural operations.

18(a) Regular inspection and testing.--The department shall
19regularly perform such investigations, inspections and tests and
20take such other actions as are necessary to enforce the
21provisions of this act or any order, rule or regulation
22promulgated under this act and may enter, at reasonable times,
23any agricultural operation for those purposes. A person owning
24or operating an agricultural operation shall grant access to the
25department and shall not hinder, obstruct, prevent or interfere
26with the department in the performance of its duties.

27(b) Cooperation with other agencies.--In performing the
28inspections and testing under subsection (a), the department may
29request the assistance of the Department of Agriculture, the
30Department of Environmental Protection, the Pennsylvania Fish

1and Boat Commission, the Physician General, the Animal Health
2and Diagnostic Commission, the State Board of Veterinary
3Medicine, the State Board of Medicine and the State Board of
4Osteopathic Medicine, which assistance shall reasonably be
5provided.

6Section 6. Enforcement.

7(a) Equitable relief.--

8(1) A mandatory preliminary injunction, special
9injunction or temporary restraining order may be issued upon
10the terms prescribed by the court of common pleas of the
11county that is the site of an agricultural operation, if the
12court finds:

13(i) that a person is administering an antimicrobial
14agent in violation of section 4; or

15(ii) that a person is denying access or otherwise
16hindering, obstructing, preventing or interfering with
17the department in the performance of its duties under
18this act.

19(2) Notice of the application for a mandatory
20preliminary injunction, special injunction or temporary
21restraining order shall be given in accordance with the rules
22of equity practice. In any such proceeding, the department
23shall not be required to post a bond.

24(b) Civil penalties.--In addition to any other relief
25ordered by a court in accordance with subsection (a), the court
26may impose civil penalties on any person who knowingly
27administers an antimicrobial agent in violation of section 4 or
28who denies access or otherwise hinders, obstructs, prevents or
29interferes with the department in the performance of its duties
30in violation of section 5. The civil penalties shall be in the

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

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

8Section 7. Reporting.

9The department, in consultation with the Department of
10Agriculture, shall promulgate regulations requiring annual
11reporting by agricultural operations on the use of antimicrobial
12agents in animals, including a list of the antimicrobial agents
13used and the approximate weight administered. The department
14shall compile the information into an annual report that
15includes statistics on antimicrobial agent use Statewide and in
16each of the counties. The information shall be published and
17maintained on the department's Internet website.

18Section 8. Alternatives to administration of antimicrobial
19agents to animals.

20In the allocation of any funds appropriated by the General
21Assembly to the Department of Agriculture, the Animal Health and
22Diagnostic Commission or a land grant institution for
23agricultural research, priority shall be given to research and
24development of alternatives to the administration of
25antimicrobial agents to animals, including improved animal
26husbandry and hygiene.

27Section 9. Rules and regulations.

28The department may promulgate rules and regulations to
29administer and enforce this act.

30Section 10. Repeals.

1All acts and parts of acts are repealed insofar as they are
2inconsistent with this act.

3Section 11. Effective date.

4This act shall take effect in 120 days.