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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| HOUSE BILL |
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| INTRODUCED BY M. O'BRIEN, KULA, SWANGER, DALEY, CALTAGIRONE, CARROLL, COHEN, DeLUCA, GOODMAN, HARKINS, KOTIK, MURT, READSHAW, TAYLOR, WAGNER AND YOUNGBLOOD, JULY 18, 2011 |
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| REFERRED TO COMMITTEE ON AGRICULTURE AND RURAL AFFAIRS, JULY 18, 2011 |
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| AN ACT |
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1 | Prohibiting the administration of certain antimicrobial agents |
2 | in agriculture; providing for inspection and testing of |
3 | agricultural operations, for enforcement, for reporting by |
4 | agricultural operations and for alternatives to |
5 | administration of antimicrobial agents to animals; and making |
6 | related repeals. |
7 | Section 1. Short title. |
8 | This act shall be known and may be cited as the Safe Food and |
9 | Safe Families Act. |
10 | Section 2. Findings and purpose. |
11 | The General Assembly finds and declares as follows: |
12 | (1) Several antimicrobial agents, including, but not |
13 | limited to, penicillin, tetracycline, erythromycin, |
14 | lincomycin, bacitracin and virginiamycin are used in, or are |
15 | related to, antimicrobial agents used for the treatment of |
16 | infectious diseases in humans and are also used in animal |
17 | feed or otherwise administered to animals for nontherapeutic |
18 | purposes, such as the promotion of animal growth. |
19 | (2) Mounting expert opinion and government actions show |
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1 | that using antimicrobial agents in animal feed contributes to |
2 | the increasing prevalence of antimicrobial-resistant |
3 | pathogenic bacteria, such as campylobacter, enterococci, |
4 | staphylococci and salmonella, that can cause hard-to-treat |
5 | infections in humans. Populations that are especially |
6 | vulnerable to antimicrobial resistance include children, |
7 | senior citizens, persons with cancer, persons with HIV/AIDS, |
8 | persons with diabetes and persons who are otherwise receiving |
9 | immunosuppressive therapy, including therapy after organ |
10 | transplants. Moreover, farmers and their families have been |
11 | shown to be at increased risk of developing an antimicrobial |
12 | resistant bacterial infection. |
13 | (3) The Swann Committee, formed in the United Kingdom in |
14 | 1969 to examine the public health effects of the use of |
15 | antimicrobial agents in food-producing animals, recommended |
16 | that antimicrobial agents be divided into "feed" and |
17 | "therapeutic" classes of drugs and that drugs used |
18 | therapeutically in humans or animals not be included in the |
19 | "feed" class. |
20 | (4) The United States Food and Drug Administration |
21 | proposed in 1977 to ban the subtherapeutic use of penicillin |
22 | and tetracycline, but the ban was never put into effect. |
23 | (5) The World Health Organization recommended in 1997 |
24 | that antimicrobial agents that are used to treat humans |
25 | should not be used to promote animal growth. |
26 | (6) The National Academy of Sciences, in a July 1998 |
27 | report prepared at the request of the United States |
28 | Department of Agriculture and the Food and Drug |
29 | Administration, concluded that "there is a link between the |
30 | use of antibiotics in food animals, the development of |
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1 | bacterial resistance to these drugs and human disease." |
2 | (7) Individual European countries, including the United |
3 | Kingdom, Denmark, Finland and Sweden, banned the use of |
4 | certain antimicrobial agents in animal feed. Subsequently, in |
5 | December 1998, health ministers for the European Union |
6 | countries voted to ban the four remaining human-use |
7 | antimicrobial agents that were still being administered in |
8 | the European Union to promote animal growth. The ban by the |
9 | European Union on using virginiamycin, tylosin, spiramycin |
10 | and bacitracin in animal feed became effective for the 15 |
11 | member states on July 1, 1999. |
12 | (8) An April 1999 study by the United States General |
13 | Accounting Office concluded that resistant strains of |
14 | salmonella, campylobacter and E. coli cause illness or |
15 | disease in humans and are linked to the use of antimicrobial |
16 | agents in animals. |
17 | (9) The American Medical Association passed a resolution |
18 | in June 2001 opposing the use of antimicrobial agents in |
19 | livestock except when needed to treat an animal's illness. |
20 | (10) Recent scientific medical studies from the |
21 | Netherlands and Canada suggest that animal agriculture, |
22 | specifically swine facilities, may be a source of |
23 | methicillin-resistant staphylococcus aureus (MRSA) strains |
24 | that are entering the human population via workers at those |
25 | facilities. |
26 | (11) More than 350 other medical, public health, |
27 | environmental and sustainable agriculture organizations have |
28 | publicly opposed the subtherapeutic use of antimicrobial |
29 | agents in livestock, including the American College of |
30 | Preventive Medicine, the American Nurses Association, the |
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1 | Pennsylvania State Nurses Association, the American Public |
2 | Health Association, the American Academy of Pediatrics, the |
3 | Ambulatory Pediatric Association, the National Association of |
4 | County and City Health Officials, the American Academy of |
5 | Family Physicians, the American Geriatrics Society, the |
6 | Breast Cancer Fund, the Catholic Health Association of the |
7 | United States, the Infectious Diseases Society of America, |
8 | the Leukemia and Lymphoma Society, the National Alliance of |
9 | State and Territorial AIDS Directors, the Physicians for |
10 | Social Responsibility, the Center for Science in the Public |
11 | Interest, The Center for Food Safety, the National Campaign |
12 | for Sustainable Agriculture, American Rivers, the Chesapeake |
13 | Bay Foundation, Citizens for Pennsylvania's Future, Clean |
14 | Water Action, the Environmental Defense Fund, the National |
15 | Environmental Trust, the Natural Resources Defense Council |
16 | and the Sierra Club. |
17 | (12) The Food and Drug Administration in July 2005 |
18 | withdrew its approval for the use of fluoroquinoline |
19 | antimicrobial agents for therapeutic administration to |
20 | poultry because of concerns over the development of |
21 | antibiotic-resistant bacteria. |
22 | (13) On June 28, 2010, the United States Food and Drug |
23 | Administration issued a draft guidance paper stating the |
24 | agency's position that feeding critically important |
25 | antibiotics to livestock for growth promotion and feed |
26 | efficiency are not considered judicious use. |
27 | (14) States have the right to enact laws more |
28 | restrictive than Federal laws concerning antimicrobial |
29 | agents. |
30 | (15) A Federal court of appeals in 1978 held that a |
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1 | municipality could inspect meat delivery vehicles for |
2 | violation of its public health ordinances even though the |
3 | United States Department of Agriculture has the sole |
4 | responsibility for the inspection of meat plants. |
5 | (16) The United States Supreme Court in 1985 unanimously |
6 | upheld local regulations of blood plasma centers that were |
7 | stricter than the Food and Drug Administration's regulations |
8 | governing the safety of blood plasma. |
9 | (17) Because a Federal district court in 1986 held that |
10 | regulations issued by the Food and Drug Administration and |
11 | the United States Department of Agriculture prevented the |
12 | court from requiring that a veal producer label that its |
13 | calves had been fed subtherapeutic levels of antibiotic |
14 | drugs, consumers in this Commonwealth do not now have a |
15 | reliable way of knowing whether the food they buy contains |
16 | bacteria that is resistant to antimicrobial agents. |
17 | (b) Purpose.--The purpose of this act is to protect the |
18 | health and safety of the citizens of this Commonwealth by |
19 | prohibiting the use of certain antimicrobial agents in |
20 | agriculture in a nontherapeutic manner or as growth promoters. |
21 | Section 3. Definitions. |
22 | The following words and phrases when used in this act shall |
23 | have the meanings given to them in this section unless the |
24 | context clearly indicates otherwise: |
25 | "Administer." To give an antimicrobial agent to an animal by |
26 | implantation, ingestion or injection or by addition to feed or |
27 | water. |
28 | "Agricultural operation." The management and use of farming |
29 | resources for the production of livestock, poultry or fish. |
30 | "Animal." Any livestock, poultry or fish. |
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1 | "Antimicrobial agent." Any drug, chemical or other substance |
2 | that either kills or slows the growth of a microbe. The term |
3 | includes, but is not limited to, antimicrobial drugs that kill |
4 | bacteria, antiviral agents that kill viruses, antifungal agents |
5 | that kill fungi and antiparasitic drugs that kill parasites. The |
6 | term includes both naturally occurring substances, such as |
7 | penicillins, and synthetic agents designed for the same purpose. |
8 | "Antimicrobial resistance." The ability of a microbe to |
9 | survive treatment by antimicrobial agents resulting from changes |
10 | that reduce or eliminate the effectiveness of drugs, chemicals |
11 | or other agents to cure or prevent infections in animals or |
12 | humans. |
13 | "Department." The Department of Health of the Commonwealth. |
14 | "Land grant institution." An educational institution located |
15 | within this Commonwealth that has received a grant of public |
16 | land made by the Congress of the United States for the support |
17 | of education under the Morrill Act (12 Stat. 503, 7 U.S.C. § 301 |
18 | et seq.). |
19 | "Microbe." A unicellular organism or virus that is so small |
20 | that it can be seen only by use of a microscope. |
21 | "Nontherapeutic manner." Any application of an antimicrobial |
22 | agent not intended to combat an established infection or |
23 | exposure to a bacterial disease, or in the absence of any |
24 | clinical sign of disease, any application of an antimicrobial |
25 | agent not provided in curative doses or any application of an |
26 | antimicrobial agent provided in any manner to healthy animals |
27 | not known to be exposed to a bacterial disease. |
28 | "Organism." Any living thing. The term includes humans, |
29 | animals, plants, bacteria, protozoa, fungi and viruses. |
30 | Section 4. Prohibition of the administration of certain |
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1 | antimicrobial agents in a nontherapeutic manner. |
2 | (a) General rule.--Beginning one year from the effective |
3 | date of this section, a person shall not: |
4 | (1) Administer to an animal in a nontherapeutic manner |
5 | any kind of penicillin, tetracycline, macrolide, lincosamide, |
6 | streptogramin, aminoglycoside or sulfonamide. |
7 | (2) Administer to an animal in a nontherapeutic manner |
8 | any other antimicrobial agent designated by the department. |
9 | (3) Administer to an animal any antimicrobial agent for |
10 | growth promotion. |
11 | (b) Affidavit required.-- |
12 | (1) A person or legal entity owning or operating an |
13 | agricultural operation shall file annually with the |
14 | department an affidavit stating that the animals produced by |
15 | that agricultural operation have not been administered an |
16 | antimicrobial agent in violation of subsection (a). |
17 | (2) A person or legal entity who contracts for the |
18 | production of animals with a person or legal entity owning or |
19 | operating an agricultural operation shall file annually with |
20 | the department an affidavit stating that the animals produced |
21 | by that agricultural operation have not been administered an |
22 | antimicrobial agent in violation of subsection (a), and that |
23 | no directions, guidance or requirements have been issued to |
24 | the owner of an agricultural entity for the administration of |
25 | an antimicrobial agent in violation of subsection (a). |
26 | (c) Designation of antimicrobial agents.--The department may |
27 | designate additional antimicrobial agents that shall not be |
28 | administered to an animal in a nontherapeutic manner. Before |
29 | making a designation, the department shall request the views of |
30 | the Department of Agriculture, the Physician General and the |
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1 | Animal Health and Diagnostic Commission. The department shall |
2 | annually publish in the Pennsylvania Bulletin a report of the |
3 | designated antimicrobial agents, if any, and the rationale for |
4 | the designations. A designation of an antimicrobial agent shall |
5 | be deemed an adjudication under 2 Pa.C.S. § 101 (relating to |
6 | definitions) and shall be made and be subject to review in |
7 | accordance with 2 Pa.C.S. (relating to administrative law and |
8 | procedure). |
9 | Section 5. Inspection and testing of agricultural operations. |
10 | (a) Regular inspection and testing.--The department shall |
11 | regularly perform such investigations, inspections and tests and |
12 | take such other actions as are necessary to enforce the |
13 | provisions of this act or any order, rule or regulation |
14 | promulgated under this act and may enter, at reasonable times, |
15 | any agricultural operation for those purposes. A person owning |
16 | or operating an agricultural operation shall grant access to the |
17 | department and shall not hinder, obstruct, prevent or interfere |
18 | with the department in the performance of its duties. |
19 | (b) Cooperation with other agencies.--In performing the |
20 | inspections and testing under subsection (a), the department may |
21 | request the assistance of the Department of Agriculture, the |
22 | Department of Environmental Protection, the Pennsylvania Fish |
23 | and Boat Commission, the Physician General, the Animal Health |
24 | and Diagnostic Commission, the State Board of Veterinary |
25 | Medicine, the State Board of Medicine and the State Board of |
26 | Osteopathic Medicine, which assistance shall reasonably be |
27 | provided. |
28 | Section 6. Enforcement. |
29 | (a) Equitable relief.-- |
30 | (1) A mandatory preliminary injunction, special |
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1 | injunction or temporary restraining order may be issued upon |
2 | the terms prescribed by the court of common pleas of the |
3 | county that is the site of an agricultural operation, if the |
4 | court finds: |
5 | (i) that a person is administering an antimicrobial |
6 | agent in violation of section 4; or |
7 | (ii) that a person is denying access or otherwise |
8 | hindering, obstructing, preventing or interfering with |
9 | the department in the performance of its duties under |
10 | this act. |
11 | (2) Notice of the application for a mandatory |
12 | preliminary injunction, special injunction or temporary |
13 | restraining order shall be given in accordance with the rules |
14 | of equity practice. In any such proceeding, the department |
15 | shall not be required to post a bond. |
16 | (b) Civil penalties.--In addition to any other relief |
17 | ordered by a court in accordance with subsection (a), the court |
18 | may impose civil penalties on any person who knowingly |
19 | administers an antimicrobial agent in violation of section 4 or |
20 | who denies access or otherwise hinders, obstructs, prevents or |
21 | interferes with the department in the performance of its duties |
22 | in violation of section 5. The civil penalties shall be in the |
23 | amount of not more than $1,000 for each day of each violation. |
24 | (c) Other relief.--Any microbial agent administered in |
25 | violation of section 4 shall be deemed a "hazardous substance" |
26 | under 3 Pa.C.S. § 2303 (relating to definitions) and shall be |
27 | subject to regulation as a "hazardous substance" under 3 Pa.C.S. |
28 | Ch. 23 (relating to domestic animals) notwithstanding any |
29 | provision of that title to the contrary. |
30 | Section 7. Reporting. |
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1 | The department, in consultation with the Department of |
2 | Agriculture, shall promulgate regulations requiring annual |
3 | reporting by agricultural operations on the use of antimicrobial |
4 | agents in animals, including a list of the antimicrobial agents |
5 | used and the approximate weight administered. The department |
6 | shall compile the information into an annual report that |
7 | includes statistics on antimicrobial agent use Statewide and in |
8 | each of the counties. The information shall be published and |
9 | maintained on the department's Internet website. |
10 | Section 8. Alternatives to administration of antimicrobial |
11 | agents to animals. |
12 | In the allocation of any funds appropriated by the General |
13 | Assembly to the Department of Agriculture, the Animal Health and |
14 | Diagnostic Commission or a land grant institution for |
15 | agricultural research, priority shall be given to research and |
16 | development of alternatives to the administration of |
17 | antimicrobial agents to animals, including improved animal |
18 | husbandry and hygiene. |
19 | Section 9. Rules and regulations. |
20 | The department may promulgate rules and regulations to |
21 | administer and enforce this act. |
22 | Section 10. Repeals. |
23 | All acts and parts of acts are repealed insofar as they are |
24 | inconsistent with this act. |
25 | Section 11. Effective date. |
26 | This act shall take effect in 120 days. |
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