CITY AND COUNTY OF SAN FRANCISCO DEPARTMENT OF THE ENVIRONMENT

Transcription

1 Mark Farrell Mayor asgdfasdfmark Mark Deborah O. Raphael Director CITY AND COUNTY OF SAN FRANCISCO DEPARTMENT OF THE ENVIRONMENT NOTICE OF PUBLIC HEARING AND PUBLIC COMMENT PERIOD REGARDING ADOPTION OF REGULATIONS FOR THE ANTIBIOTIC USE IN FOOD ANIMALS ORDINANCE (Ordinance No , San Francisco Environment Code Chapter 27) WHAT: WHEN: Public Hearing regarding the adoption of regulations for the Antibiotic Use In Food Animals Ordinance Monday, March 19, 2018 at 11:00 a.m. LOCATION: San Francisco City Hall, 1 Dr. Carlton B. Goodlett Place, Room 421, San Francisco, CA Members of the public are invited to provide written comments regarding the proposed regulations. Written comments should be ed to ABXordinance@sfgov.org or mailed to Attn: Antibiotics Use Ordinance, San Francisco Department of the Environment, 1455 Market Street, Suite 1200, San Francisco, CA The Department must receive all written comments concerning the proposed regulations no later than 5:00 p.m. on April 5, AUTHORIZATION San Francisco Environment Code Chapter 27 The Antibiotic Use in Food Animals Ordinance (Ordinance) was signed by the Mayor on October 24, 2017 and became effective on November 23, The Ordinance requires certain retailers of raw meat and poultry to report the use of antibiotics in such products to the Department of the Environment, and requires City departments to report the use of antibiotics in raw meat and poultry purchased by the City to the Department of the Environment, as codified in Municipal Code: Environment Code, Chapter 27. The Director of the Department of the Environment promulgates these regulations pursuant to her authority to adopt rules necessary to implement this Ordinance pursuant to Environment Code, Chapter 27, Section San Francisco Department of the Environment 1455 Market Street, Suite 1200, San Francisco, CA Telephone: (415) Fax: (415) environment@sfgov.org SFEnvironment.org Printed on100% post-consumer recycled paper.

2 Important Information Copies of draft regulations and all explanatory documents are available at (1) the Department of the Environment (Department), 1455 Market Street, Suite 1200, San Francisco, California, between the hours of 9 a.m. and 5 p.m., Photo identification is required for entry to the building. (2) on the Department s website (3) upon request at telephone number , or via at ABXordinance@sfgov.org within three business days of the hearing. If any materials related to an item on this agenda have been distributed after distribution of the agenda packet, those materials are available for public inspection at the Department of the Environment, 1455 Market Street, Suite 1200, San Francisco, CA during normal office hours or will be made available on the website During the hearing, members of the public will have the opportunity to comment about individual agenda items or speak generally about the Antibiotic Use in Food Animals Ordinance. Persons unable to attend the hearing may submit to the Department of the Environment, by 5:00 p.m. on April 5, 2018, written comments. These comments will be made a part of the official public record and shall be brought to the attention of the Department. Announcement The ringing of and use of cell phones, pagers and similar sound-producing electronic devices are prohibited at this hearing. Please be advised that the hearing officer may order the removal from the meeting room of any person(s) responsible for the ringing or use of a cell phone, pager, or other similar sound-producing electronic devices. Public Comment At this time, members of the public may speak on items of interest that are relevant to the Antibiotic Use in Food Animals Ordinance but are not on today s agenda. Public comment will be taken following each agendized item. Each member of the public may address the hearing for up to three minutes, unless otherwise announced by the hearing officer. Disability Access The hearing will be held at the San Francisco City Hall, 1 Dr. Carlton B. Goodlett Place, Room 421, San Francisco, CA The San Francisco City Hall is wheelchair accessible. The closest accessible BART station is the Civic Center Station at United Nations Plaza and Market Street. Accessible MUNI lines serving this location are: Van Ness and the Metro Stations at Van Ness and Market and at Civic Center. For information about MUNI accessible services call (415) There is accessible curbside parking adjacent to City Hall on Grove Street and Van Ness Avenue and in the vicinity of the Veterans Building at 401 Van Ness Avenue adjacent to Davies Hall and the War Memorial Complex.

3 In order to assist the City's efforts to accommodate persons with severe allergies, environmental illnesses, multiple chemical sensitivity or related disabilities, attendees at public meetings are reminded that other attendees may be sensitive to various chemical based products. Please help the City accommodate these individuals. Individuals with chemical sensitivity or related disabilities should call the Mayor s Office on Disability at (415) or (415) (TTY) for additional information. The following services are available on request 72 hours prior to the meeting; except for Monday meetings, for which the deadline shall be 4:00 p.m. of the last business day of the preceding week: For American sign language interpreters or the use of a reader during a meeting, a sound enhancement system, and/or alternative formats of the agenda and minutes, please contact SF Environment at (415) to make arrangements for the accommodation. Late requests will be honored, if possible. Language Access Per the Language Access Ordinance (Chapter 91 of the San Francisco Administrative Code), Chinese, Spanish and or Filipino (Tagalog) interpreters will be available upon requests. Meeting Minutes may be translated, if requested, after they have been adopted by the Commission. Assistance in additional languages may be honored whenever possible. To request assistance with these services please contact the Commission Affairs Manager at , or anthony.e.valdez@sfgov.org at least 48 hours in advance of the hearing. Late requests will be honored if possible. 語言服務 根據語言服務條例 ( 三藩市行政法典第 91 章 ), 中文 西班牙語和 / 或菲律賓語 ( 泰加洛語 ) 傳譯人員在 收到要求後將會提供傳譯服務 翻譯版本的會議記錄可在委員會通過後透過要求而提供 其他語言協助 在可能的情況下也將可提供 上述的要求, 請於會議前最少 48 小時致電 或電郵至 anthony.e.valdez@sfgov.org 向委員會秘書提出 逾期提出的請求, 若可能的話, 亦會被考慮接納 Acceso A Idioma De acuerdo con la Ordenanza de Acceso a Idiomas Language Access Ordinance (Capítulo 91 del Código Administrativo de San Francisco Chapter 91 of the San Francisco Administrative Code ) intérpretes de chino, español y/o filipino (tagalo) estarán disponibles de ser requeridos. Las minutas podrán ser traducidas, de ser requeridas, luego de ser aprobadas por la Comisión. La asistencia en idiomas adicionales se tomará en cuenta siempre que sea posible. Para solicitar asistencia con estos servicios favor comunicarse con el Secretario de la Comisión al , o anthony.e.valdez@sfgov.org por lo menos 48 horas antes de la reunión. Las solicitudes tardías serán consideradas de ser posible. Access Sa Wika Ayon sa Language Access Ordinance (Chapter 91 ng San Francisco Administrative Code), maaaring mag-request ng mga tagapagsalin sa wikang Tsino, Espanyol, at/o Filipino (Tagalog). Kapag hiniling, ang mga kaganapan ng miting ay maaring isalin sa ibang wika matapos ito ay aprobahan ng komisyon. Maari din magkaroon ng tulong sa ibang wika. Sa mga ganitong uri ng kahilingan, mangyaring tumawag sa Clerk ng Commission sa

4 3709, o anthony.e.valdez@sfgov.org sa hindi bababa sa 48 oras bago mag miting. Kung maari, ang mga late na hiling ay posibleng pagbibigyan. Know your Rights under the Sunshine Ordinance (Chapter 67 of the San Francisco Administrative Code) Government s duty is to serve the public, reaching its decisions in full view of the public. Commissions, boards, councils, and other agencies of the City and County exist to conduct the people s business. This ordinance assures that deliberations are conducted before the people and that City operations are open to the people s review. For more information on your rights under the Sunshine Ordinance or to report a violation of the ordinance, contact the Sunshine Ordinance Task Force, City Hall, Room 244, One Dr. Carlton B. Goodlett Place, San Francisco, CA at Phone No.: (415) ; Fax No.: (415) ; sotf@sfgov.org. Copies of the Sunshine Ordinance can be obtained from the Clerk of the Sunshine Task Force, the San Francisco Public Library and on the City s website at Lobbyist Registration and Reporting Requirements Individuals and entities that influence or attempt to influence local legislative or administrative action may be required by the San Francisco Lobbyist Ordinance [SF Campaign & Governmental Conduct Code 2.100, et. seq] to register and report lobbying activity. For more information about the Lobbyist Ordinance, please contact the Ethics Commission at: 25 Van Ness Avenue, 2nd Floor, San Francisco, CA 94102; telephone (415) , fax (415) , web site at General Department of the Environment Contact Information: TEL: (415) ; FAX: (415) Posted: March 5, 2018 ATTACHED: San Francisco Department of the Environment Draft Regulation SFE AUIFA Proposed Regulations Implementing the Antibiotic Use in Food Animals Ordinance.

5 A. Authorization. San Francisco Department of the Environment Regulation SFE AUIFA Proposed Regulations Implementing the Antibiotic Use in Food Animals Ordinance (Ordinance No ) Regulation Effective Date: Upon Director s Signature The Antibiotic Use in Food Animals Ordinance (Ordinance) was signed by the Mayor on October 24, 2017 and became effective on November 23, The Ordinance requires certain retailers of raw meat and poultry to report the use of antibiotics in such products to the Department of the Environment (Department), and requires City departments to report the use of antibiotics in raw meat and poultry purchased by the City to the Department of the Environment, as codified in Municipal Code: Environment Code, Chapter 27 (Chapter 27). The Director of the Department of the Environment (Director) promulgates these regulations pursuant to her authority to adopt rules necessary to implement this Ordinance pursuant to Environment Code, Chapter 27, Section B. Scope. The Antibiotic Use in Food Animals Ordinance requires that Grocers report to the Department, on a form prescribed by the Director, the Antibiotics Use Policy for each Product Group sold in the City of San Francisco (City) during the previous year. A Grocer, as defined in Chapter 27, Section 2702, means an entity that owns and/or operates a grocery store in the City and also owns or operates 25 or more grocery stores anywhere. Antibiotics Use Policy means a description of the antibiotic use practices of a Producer of each Product Group sold in a Grocer s stores. Violation of the Ordinance may result in administrative penalties, suspension or revocation of any permits held, fines and/or imprisonment. These regulations specify the contents of the form required by Chapter 27, Section 2703(a), and provide guidance on petitioning for a waiver of any reporting requirement under Chapter 27, Section 2703(b). The final format for the reporting form will be available on the Department of the Environment s website, and will incorporate the contents described in Appendix A below. To receive notification of important meetings and updates, ABXordinance@sfgov.org to be added to the mailing list. These regulations do not duplicate the Ordinance and must be read together with the Ordinance. C. Definitions: Antibiotic Use in Food Animals Reporting Form or Form the form for reporting the Antibiotics Use Policy for each Product Group to the San Francisco Department of the Environment. The format of the form may change over time. The most current version of the Form is available on the Department s website, Substantial Evidence means evidence that a reasonable person would deem adequate to support a conclusion. Substantial evidence shall include facts, reasonable assumptions predicated upon facts, and expert opinion supported by facts. D. Interpretive Regulations and Guidelines

6 1.0 Contents of the Form. Each Grocer shall provide information to the City on an annual basis regarding the use of antibiotics for each of its raw meat and poultry Product Groups, as required in Section 2703(a) of the Ordinance. Such information shall be provided on the Form, the content of which is specified in Appendix A. The Form will be available on the Department of the Environment s website, Refer to this website for the latest instructions on submitting the Form as its format may change over time (e.g., from to online survey software). 1.1 Compliance. Compliance with the Antibiotic Use in Food Animals Ordinance requires that a Grocer report antibiotic use policies and practices for all of its raw meat and poultry product groups on a form prescribed by the Department of the Environment. As required in Section 2703(a) of the Ordinance, a Grocer shall fill out a separate form for each distinct retail banner operated and/or owned by the Grocer. Each form shall be submitted to the Department of the Environment according to the instructions for submission provided on the Department s website, A Grocer may seek a waiver for any element of the Form, pursuant to Section D.2, infra. 1.2 Reporting Period. The reporting period for this Ordinance is the calendar year, from January through December, prior to the year in which the Form is due. For example, the reporting period for Forms due by April 1, 2019 is January 1, 2018 through December 31, Maintaining Documentation. Grocers must maintain documentation regarding each meat and poultry Producer s antibiotics use for five (5) years from filing the report. 1.4 More Than One Producer for a Product Group. Where a Product Group includes meat from more than one Producer, the Grocer should report information for each of these Producers. For example, if three Producers supply pork chops for a Grocer s Simply Natural Product Group, data from each of the three Producers should be reported on the Form for Simply Natural. That is, if Producer A supplies 20%, Producer B supplies 45% and Producer C supplies 35% of the pork chops used for the Simply Natural Product Group, these percentages should be reported. 1.5 Exception for Grocers with Storewide Policy. Where a Grocer has a storewide policy prohibiting medically-important antibiotics use, instead of submitting one Form per Product Gorup, the Grocer may submit one Form per retail banner included under the policy, as outlined in Appendix A. The Grocer must provide documentation that evidences the policy and the method used to enforce the policy. The Director will review the Grocer s documentation. If a determination that the Grocer s storewide policy prohibits medically-important antibiotics use cannot be made, the Grocer will have up to 30 days beyond the filing deadline to provide additional evidence of the policy or to submit completed Forms for every Product Group sold by Grocer. 2.0 Waiver. A Grocer may request a waiver of specific elements of the Form by submitting a petition to the Department of the Environment by at abxordinance@sfgov.org. Without an approved waiver, failure to provide information constitutes a delay in submitting the required report. In the petition, for which more guidance is provided below (see infra 2.1 and 2.2), the Grocer must demonstrate, based on substantial evidence, that reporting the specific information for which a waiver is sought for a Product Group is not feasible without significant hardship. The Grocer may submit one petition requesting multiple waivers for multiple elements of the Form for one or more Product Groups. Where a Grocer consolidates multiple waiver requests into one petition, the Grocer must nonetheless present substantial evidence pertaining to each individual element of the Form for which the waiver is sought, and for each Product Group or other grouping of products, for which the waiver is sought.

7 2.1 Waiver Petition Contents. To be eligible for a waiver from reporting any of the information required on the Antibiotic Use in Food Animals Reporting Form, an applicant must demonstrate substantial evidence as to why it is not feasible to provide the required information without significant hardship. To be considered, a waiver petition must, at minimum, include the following: Name of Grocer filing the petition; Name(s) of additional Grocer(s) on whose behalf the petition is being filed, if any; Product Group(s) for which a waiver is being sought; Specific element(s) of the Form for which waiver is sought; Demonstration as to why it is not feasible to currently provide the required information without significant hardship; Steps required to obtain the information and Grocer s plan for obtaining the information in the future; Estimate of time required by Grocer(s) to obtain and report the required information, and the basis for this estimate; and Any supporting documentation that Grocer relies upon, unless it is publicly-reported information that is cited. 2.2 Considerations For Petition. The Director of the Department of the Environment or his/her designee (Director) will consider petitions on a case-by-case basis. When granting or denying a petition for waiver, the Department of the Environment will take into consideration information including, but not limited to, the following: - What hardship is the petitioner claiming? - What steps, if any, has the petitioner taken to report the information for which the petitioner is seeking a waiver? What additional steps could have been taken to report the information, and how much time and effort would have been required to take these steps? - What documentation has the petitioner provided to show its efforts to report the information for which the petitioner is seeking a waiver? - Did terms of a contract prevent or prohibit Grocer from obtaining or reporting information from a Producer? Could these terms be modified to allow Grocer to obtain the required information from Producer, and if so, when? 2.3 Petitioner Filing On Behalf of Multiple Grocers. One Grocer or organization of Grocers may file a petition on behalf of multiple Grocers seeking a waiver for the same elements of the Form for a Product Group or other grouping of products. The petition must list every Grocer, as well as each distinct retail banner operated and/or owned by the Grocer, to be included in the petition. The petition must also provide the information listed in Section 2.1, supra. 2.4 Duration of Waiver. The Director has discretion to approve a waiver for a reasonable duration based on the evidence. 3.0 Deadline for Antibiotic Use in Food Animals Reporting. The deadline for reporting the antibiotic use in food animals will be April 7 of each year (or the next business day if April 7 falls on a weekend). Grocers are encouraged to file early.

8 3.1 Deadline for Waiver Petition. The deadline for filing a petition to waive reporting requirements is January 15 of the same year as the reporting deadline. For example, for reporting due April 7, 2019, the deadline for filing a waiver petition shall be January 15, The Director may, at his or her discretion, accept petitions filed for good cause after this filing deadline. Grocers are encouraged to file early. The Director of the Department of the Environment hereby adopts these regulations as of the date specified below. Deborah O. Raphael Director Department of the Environment Approved: Date:

9 Appendix A: Content of the Antibiotic Use in Food Animals Reporting Form The Antibiotic Use in Food Animals Ordinance (No ) requires certain retailers of raw meat and poultry to report the use of antibiotics in such products to the San Francisco Department of the Environment. Instructions: A Grocer shall provide the following information for each of its existing Product Groups. A Product Group means Raw Meat or Poultry of the same species of animal(s), brand, and sub-brand. A Product Group is also known in the meat industry as a product line. For example, each of Foster Farms three turkey product lines Fresh & Natural, Simply Raised, and Organic qualifies as its own Product Group for the purposes of Chapter 27. A Grocer shall provide the following information separately for each of its distinct retail banners operated and/or owned by the Grocer, even where a Grocer sells the same Product Groups across multiple retail banners. If a waiver of a reporting requirement has been approved for the relevant Product Group, include the waiver s approval number in the answer section(s) for the relevant questions (e.g., Waiver #321). Part 1 Information About Grocer Filing This Report 1. Grocer name (e.g., Albertsons Companies LLC): 2. Banner store name (if different from Grocer Name) (e.g., Safeway, Inc.): 3. Banner store addresses (e.g., list addresses of all Safeway stores in San Francisco being included in this Form): 4. Contact name: 5. Contact 6. Contact phone number: 7. Does Grocer have a storewide policy prohibiting medically-important antibiotics use? a. If yes, provide documentation of the policy (e.g., public statement, website, etc.) and process by which the Grocer enforces the policy (e.g., purchasing specifications, third-party certifications, etc.). Then skip to Part 7. b. If no, continue to Part 2. Part 2 Information About Product Group for Which Grocer is Filing 1. Product Group name (e.g., Tyson s Hillshire Farms): 2. Associated UPCs for Product Group (e.g., , , ): 3. Meat or poultry type (chicken, beef, pork, lamb, etc.): 4. Does Grocer have a storewide policy prohibiting medically-important antibiotics use for this particular meat or poultry type? a. If yes, provide documentation of the policy (e.g., public statement, website, etc.) and the process by which the Grocer enforces the policy (e.g., purchasing specifications, third-party certifications, etc.). Then skip to Part 7 for that meat or poultry type. b. If no, continue to next question. 5. Indicate the total number of Producers that provided meat or poultry for this Product Group in the reporting year: 6. Is this Product Group organic or has this Product Group not been administered antibiotics? Yes/No a. If yes, upload a certification, affidavit, or Producer s public website showing its antibiotics use policy. In addition, if the antibiotic use was third-party certified, provide the name of the certifier and certification type. Then skip to Part 7. b. If no, continue to Part 3.

10 Note: If multiple Producers provide meat or poultry to the Product Group, but at least one of the Producers is not organic or uses antibiotics, the Answer to Part 2, Question 5 should be No. Part 3 Antibiotics Policy for the Product Group 1. Do the policies for the Product Group prohibit the use of medically important antibiotics for growth promotion? 2. Do the policies for the Product Group prohibit medically important antibiotics for use to prevent disease in the absence of contact with animals or birds with bacterial disease as diagnosed by a licensed veterinarian? 3. Do the policies for the Product Group allow the use of medically important antibiotics for disease control, i.e., to stop the spread of a bacterial disease present in the flock or herd? a. If yes, is a diagnosis of disease in the flock or herd required before antibiotics are administered? b. If yes, are medically important antibiotics allowed to be given to animals beyond the housing unit in which sick animals are present? 4. Do the policies for this Product Group require veterinarian oversight (e.g., a veterinary feed directive or other prescription) for all medically-important antibiotics administered (including for injections and topical applications)? 5. Describe any other antibiotic use restrictions that are not listed above. Part 4 Information About the Producer(s) of the Product Group 1. Please provide the following information about the Product Group. If there is more than one Producer for the Product Group, please provide the information for each Producer. Note: Please ensure that the total percentage of meat supplied to the Product Group by all the Producers adds up to 100%. a. Producer name(s): b. Percentage of the Product Group that Producer represents: c. Number of animals raised by Producer. Please provide this information according to the schedule below. For pork: For sheep: For beef: # of slaughtered pigs # of slaughtered sheep # of slaughtered cows/bullocks/bulls # of living sows in inventory # of living sheep # of slaughtered heifers # of slaughtered calves/young cattle For chicken or turkey: # of chickens or turkeys slaughtered When a Product Group has multiple Producers, Grocers may provide for each Producer the specific number of animals raised and volume of medically important antibiotics used for the particular Product Group if that information is known. Alternatively, the Grocer may provide for each Producer the total number of animals raised and total volume of medically important antibiotics used by that Producer. This latter information will be used to generate a weighted average of antibiotic use. Part 5 Information About Antibiotics Use in Product Group 1. Medically important antibiotics used. Consult Appendix A of FDA s Guidance for Industry #152 and subsequent revisions for a list of medically important antibiotics. a. Was this Product Group raised with any medically important antibiotics? [Yes/No] If yes, answer the following questions. If no, skip to Part 5, Question 2.

11 b. How many kilograms of each medically important antibiotic were used in the reporting year for this Product Group? c. What percentage of animals was treated with medically important antibiotics for each Producer of this Product Group? 2. Non-medically important antibiotics used. a. Was this Product Group raised with any non-medically important antibiotics? Yes/No. If yes, answer the following questions. If no, skip to Part 7. b. How many kilograms of each non-medically important antibiotic were used in the reporting year for this Product Group? c. Indicate what percentage of animals was treated with non-medically important antibiotics for each Producer of this Product Group. Part 6 Partial reporting The ordinance requires reporting the total antibiotics use over animals lifetimes. Refer to regulation guidelines for filing a waiver petition. If a waiver is granted for part of the animals lifetimes, then provide the approval number of the relevant waiver and the percentage of (or the number of days of) the animals lives to which the waiver applies. Part 7 Signature of Person Preparing This Form 1. Preparer s Information. Provide the following information concerning the preparer: a. Last name: b. First name: c. Business or Organization Name: d. Daytime Phone number: e. Address: f. Mailing Address: 2. Declaration to be completed by all preparers when submitting the Form, including attorneys and authorized representatives: I declare that I prepared this Antibiotic Use in Food Animals Reporting Form on behalf of the Grocer, that it is based on all the information of which the Grocer has knowledge, and that the information is true to the best of my knowledge and that of the Grocer. Signature of Preparer: Date of Signature: