Title
Introduction of Ordinance Amending the Alameda Municipal Code by Adding Section 7-9.9 (Animal Testing Ban) to Article 7-9 (General Provisions) of Chapter VII (Animal Control) to Prohibit Animal Testing and Experimentation on Property Owned or Controlled by the City of Alameda in its Proprietary Capacity. (City Attorney’s Office 10023040)
Body
To: Honorable Mayor and Members of the City Council
From: Jennifer Ott, City Manager
Yibin Shen, City Attorney
EXECUTIVE SUMMARY
On January 16, 2024, by way of referral, the Alameda City Council directed staff to draft an ordinance prohibiting animal testing and experimentation on property owned or controlled by the City of Alameda (City). The proposed amendment to Chapter VII (Animal Control) of the Alameda Municipal Code is presented for City Council’s further consideration of that issue. To support the City Council in its decision-making, this staff report includes information on the regulatory framework that governs animal testing and emerging alternatives in the biomedical field; a summary of community and stakeholder feedback on the proposed animal testing ban; and an explanation of steps that would be taken to implement the ordinance if approved.
BACKGROUND
Currently, the Alameda Municipal Code is silent on the topic of animal testing and experimentation on property owned or controlled by the City. Therefore, such uses may occur if otherwise allowed. For example, with City Council approval the City may enter a lease agreement for City owned property with a tenant that includes use language authorizing the tenant to engage in animal testing on the property. Or, the City may be a tenant on a third-party landlord’s property and, if allowed by the master lease, sublease the property to a subtenant that intends to engage in animal testing on the property.
The City does not currently have leasing, licensing, or other real property agreements with tenants conducting animal testing activities on City owned or controlled property. Nonetheless, this ordinance would prohibit the City from entering into a new contractual arrangement of this nature or otherwise authorizing any persons to engage in animal testing and experimentation on property owned or controlled by the City.
On January 16, 2024, by way of referral, City Council directed staff to draft an ordinance prohibiting animal testing and experimentation on property owned or controlled by the City. During the discussion, Councilmembers expressed interest in knowing more about animal testing alternatives in the life sciences sector, the opinions of local Alameda residents on animal testing, and the potential effect that such an ordinance could have on Alameda’s reputation, including the ability to attract or retain businesses.
DISCUSSION
To support the City Council in addressing some of their questions and concerns expressed on January 16, City staff conducted research on the regulatory framework for animal testing, hosted meetings with stakeholders from the life sciences industry, hosted a community workshop, and provided an online survey for community members. The results of this research and engagement are summarized here.
Staff have utilized the following definition of animal testing in stakeholder engagement:
Experimentation on living animals for the purpose of studying diseases and biology, the effectiveness of newly developed pharmaceuticals and medications, and the safety of consumer products like cosmetics, cleaners, and food additives.
(Humane Society International. About Animal Testing, <https://www.hsi.org/news-media/about/> (Accessed February 14, 2024)).
Regulatory Context
In the context of biomedical research, animal testing has been mandated by federal law as an initial step in the U.S. Food and Drug Administration’s (FDA) approval process for new drugs, and the results of such testing are often determinative of whether a drug will proceed to clinical trials. Some of the relevant federal and state laws include:
The Food, Drug, and Cosmetic Act (FD&C Act) of 1938-which was passed to enhance consumer protection against dangerous and ineffective drugs and deceptive product packaging. This law mandated the use of animal testing within the FDA approval process for new drugs by directing manufacturers to initially assess the toxicology and effectiveness of new products on animal subjects before advancing to human subjects. It does not allow for alternative testing methods.
The Animal Welfare Act (AWA) of 1966-established the regulation of and standards of care for the transportation, sale, and handling of certain animals within research facilities. It includes detailed requirements for research protocol, veterinary care, housing, feeding, lighting, handling, sanitation, ventilation, and the enrichment of all animals involved in research. The AWA mandates that research facilities register with the U.S. Department of Agriculture (USDA), which is responsible for administering and enforcing the AWA primarily by conducting pre-licensing inspections and at least one, unannounced, inspection to each facility every year.
FDA Modernization Act 2.0 of 2022-lifts the requirement that pharmaceutical companies use animals to test new drugs before human trials. The Act gives companies the option to use scientifically rigorous, proven non-clinical test methods when they are suitable to demonstrate the safety and effectiveness of investigational drugs prior to or during human trials.
The legislation represents a shift away from animal use, but researchers caution that alternative methods may not be ready to replace the animal model to test drugs in development. It is staff’s understanding that, in practice, in certain research contexts, alternative methods are not yet developed enough and/or approved by the FDA. Also, the FDA has not yet published its final rules to implement the Modernization Act 2.0 and establish clear guidelines for non-animal test methods. Researchers and advocates are pushing the FDA to develop protocols for these alternative research methods. For example, Biocom California, a California life science advocacy business organization with over 1,700 members, recently submitted a letter to the FDA, encouraging it to develop comprehensive guidelines and criteria for the use of alternative testing methods.
California Cruelty-Free Cosmetics Act (SB 1249)-In 2018, California became the first state to prohibit the sale of cosmetic products that use animal testing.
California Prohibiting Extraneous Testing (PET) Act (SB 879)-Passed in 2022, the PET prohibits toxicity testing on dogs and cats for pesticides, chemical substances and other products. The bill includes exemptions for tests related to products intended for use in dogs or cats, including medical treatments. It does not impact federally required testing.
Alameda’s Life Sciences Sector
Life Science is one of the City’s six priority economic sectors as identified in the City’s 2018 Economic Development Strategic Plan. The Life Science sector includes pharmaceuticals, biotechnology, medical devices, biomedical technologies, food processing, and other industry subsectors. Some Life Science subsectors may be subject to the regulatory framework and therefore may conduct animal testing activities. There are currently no Life Science companies operating on City owned or controlled property.
Since 2018, the Life Science sector has more than tripled in size, adding more than 3,300 jobs to the local economy. Currently in Alameda there are approximately 35 life science companies employing approximately 4,600 people, ranging from small startup companies in local incubators to some of the City’s largest companies, such as Penumbra, Abbott Diabetes Care, and Exelixis. Also, some of the City’s recent major commercial construction projects have been Life Science related, including Senti Bioscience’s manufacturing facility and Azzur’s clean rooms.
Staff does not know how many companies in Alameda currently do animal testing. Animal testing and vivariums are not a use that is actively tracked or reported on by the City.
Public Engagement
City staff has solicited feedback from Alameda-based Life Sciences companies, residents, and the general public regarding the proposed ban on animal testing and experimentation on City owned or controlled property. Engagement activities included a roundtable discussion with local Life Science sector executives, a publicly noticed community workshop at Mastick Senior Center and a community survey.
Business Engagement
On February 26, 2024, the Alameda Chamber & Economic Alliance and City staff hosted a roundtable discussion with local Life Sciences business executives to get their thoughts on the proposed animal testing ban ordinance and any potential consequences that it may have on the City if adopted. The group engaged in a robust discussion regarding the animal testing regulations that govern the Life Sciences sector; third-party animal testing facilities; and current and emerging alternatives to animal testing in the industry. Some of the most common feedback provided regarding the proposed animal testing ban on Cityowned and controlled property was:
• A ban on animal testing would significantly risk the City’s reputation as an innovation hub for the Life Sciences sector and impact Alameda’s ability to attract and retain Life Sciences companies in the future, including companies considering locating and/or expanding on privately owned properties.
• A ban in Alameda could convey a lack of support for the Life Sciences industry, giving businesses in the sector the impression that they are unwelcome.
• Alameda would suffer as the first city in the area to pass a ban (staff has not found another municipality in California that has enacted a similar ban).
• Alameda Point lends itself to certain Life Sciences sector uses due to the large buildings/floorplates.
• Banning animal testing on City-owned and controlled property could establish a precedent for expanding the ordinance to include private property in the City.
• Banning animal testing on City-owned and controlled property will result in contracting the animal testing to companies located outside of the region. Furthermore, outsourcing would result in less oversight on the testing and animal welfare and in lower levels of quality work.
• The Life Sciences industry is a proponent of developing alternative testing methods, but the science and technology, as well as FDA requirements, are not currently available to simultaneously analyze the impacts on multiple organ systems. Alternative models do not replicate living systems.
Overall, the group of executives expressed concern about the proposed animal testing policy. Furthermore, they implied that enacting a ban on City-owned or controlled property could set a precedent, resulting in similar bans in other Bay Area cities. They expressed a desire to slow down the process to allow more time to consider the full implications of the ordinance. A summary of comments from the roundtable discussion is attached as Exhibit 1 to this report.
City staff have also heard informally from other Life Science companies in Alameda expressing concern about the proposed ordinance and a reluctance to publicly speak in opposition on this controversial issue.
Community Workshop and Survey
In mid-February 2024, staff announced that the City would host a community workshop on March 6, 2024, to provide information about the proposed ban to residents and to seek their feedback. The workshop was publicly noticed by the City Clerk, advertised on the City’s social media accounts, and sent to subscribers to the City’s email distribution lists. The meeting notice included instructions for requesting special accommodations such as language interpretation and American Sign Language translation. It was also mentioned that refreshments would be available at the workshop.
On March 6, 2024, the community workshop was held at the Mastick Senior Center, attended by roughly three self-identified Alameda residents and roughly 12 interested individuals who lived outside of the City. The meeting participants were divided into breakout groups facilitated by City staff. Each group’s facilitator provided a brief presentation on the regulatory framework that governs animal testing activities, data regarding the life sciences industry in the City, the draft ordinance and an explanation of which City properties would be subject to it if adopted. After the facilitators concluded the presentation, meeting participants were asked questions to garner feedback on the proposed ordinance. The same questions were asked in an online survey made available to the meeting participants at that event. The survey was then opened to the broader public and 22 responses have been received to date from 20 self-identified Alameda residents and two self-identified non-residents. The survey will remain open until April 15 after which the responses will be shared with City Council and posted to the agenda. The notes from the community workshop are attached as Exhibit 2 of this report. Below are some of the comments that represents the range of sentiments expressed by the participants in the meeting and survey:
• Supports Ban. Most participants strongly opposed animal testing and support an ordinance banning such activities on city-controlled land. If a ban is not enacted, there will be too many businesses at Alameda Point conducting animal testing.
• Supports Ban with Modifications. Some participants support a local ban on animal testing but also wanted to expand the ordinance to encourage companies to use alternative testing methods. Other participants proposed modifying the ordinance language to ban testing on certain animals (i.e., primates) and specific types of animal testing (i.e., behavioral testing). Some participants expressed interest in a ban that was more expansive than on City controlled property
• Opposes Ban. There were a few participants that support animal testing, indicating that Life Sciences businesses will be impacted by the ban. A ban may imply the City’s lack of support for the Life Sciences industry which could cause companies to locate their operations in other cities with fewer restrictions.
• Supports Alternatives to a Ban. Some participants were in favor of the implementation of the FDA Modernization Act 2.0 despite its current lack of detail. Other participants would like the City to support Life Sciences companies that focus on breakthrough research using alternative, non-animal testing methods.
• Positive Impacts on the City’s Reputation. The ban would enhance the City’s reputation among residents who support living in a City that does not allow companies that conduct animal testing to operate on its property which demonstrates a support for modernization in the industry. They stated introducing a ban could positively reflect on Alameda for taking a stance that leads to advancement in animal testing alternatives, shift public perception, and garner increased support.
• Negative Impacts on the City’s Reputation. Some participants stated the ban could impact the City’s ability to retain current business and attract new ones.
While the majority of individuals who participated in the community engagement processes supported the ban, it is unclear whether the 37 responses reflect the sentiments of the broader Alameda community.
Proposed Ordinance
The proposed ordinance prepared by staff, Option A, reflects the referral from City Council on January 16. Minor modifications have been made to the initial language provided in the community meeting, solely to provide greater clarity and not to change intent.
A City Council member has also proposed alternative ordinance language, Option B. The alternative proposal would prohibit animal testing on City owned or controlled land, with specific exceptions made for City-owned land in the Enterprise District zoning areas in Alameda Point, solely when required as part of a regulatory filing process and for limited purposes.
Exhibit 3 to this report is a red-line comparison of the two options.
If City Council elects to approve either proposal, the ordinance would become an amendment to Chapter VII (Animal Control) of the Alameda Municipal Code.
Impacts of the Ordinance
The City owns or controls property throughout Alameda, which includes civic facilities, commercial buildings, remnant parcels, marinas and other areas in the State Tideland Trust. Many of these properties are used for specific purposes (i.e., libraries, community centers) or have use restrictions (i.e., State Tidelands) that prohibit animal testing activities. The City properties that would be subject to the ordinance are located at Alameda Point.
Next Steps to Implement an Ordinance
If City Council approves an ordinance, staff will work with the City Attorney’s Office to modify the City’s real estate agreement templates to include a provision regarding the animal testing ban.
ALTERNATIVES
After opening the public hearing and considering all of the documents and testimony, City Council may consider four alternative courses of action, including:
§ Approve the first reading of Option A, amending the Alameda Municipal Code to prohibit Animal Testing and Experimentation on Property Owned or Controlled by the City of Alameda in Its Proprietary Capacity.
§ Approve the first reading of Option B, proposed by a member of the City Council, which would prohibit animal testing on City-owned or controlled land, with specific exceptions made for Enterprise District zoning areas.
§ Choose to not approve the first reading of either the ordinance prepared by staff or the ordinance proposed by the City Councilmember and recommend an alternative ordinance.
§ Choose to not approve the first reading of the ordinance and not move forward with amending the Alameda Municipal Code to include an animal testing ban.
FINANCIAL IMPACT
There may be financial impacts resulting from this item which cannot be determined conclusively at this time.
MUNICIPAL CODE/POLICY DOCUMENT CROSS REFERENCE
This action amends the Alameda Municipal Code.
ENVIRONMENTAL REVIEW
This action does not constitute a “project” as defined in California Environmental Quality Act (CEQA) Guidelines Section 15378 and therefore no further CEQA analysis is required.
CLIMATE IMPACT
There are no identifiable climate impacts or climate action opportunities associated with the subject of this report.
RECOMMENDATION
Introduce an ordinance amending the Alameda Municipal Code by adding Section 7-9.9 (Animal Testing Ban) to Article 7-9 (General Provisions) of Chapter VII (Animal Control) to prohibit animal testing and experimentation on property owned or controlled by the City of Alameda in its proprietary capacity.
Respectfully submitted,
Len Aslanian, Assistant City Attorney
Abigail Thorne-Lyman, Base Reuse and Economic Development Director
By,
Eric Fonstein, Development Manager
Nicole Franklin, Base Reuse Manager
Financial Impact section reviewed,
Margaret O’Brien, Finance Director
Exhibits:
1. Summary of Comments from Feb. 26, 2024 Stakeholder Meeting
2. Summary of Comments from March 6, 2024 Community Workshop
3. Redline Comparison of Ordinance Options