CICNTA Presentation – Paul Wynne
中文：国际辐照行业发展及趋势
Paul Wynne，国际辐照协会，2025年10月
介绍
我不会以传统的方式谈论辐照行业，而是会重点介绍那些对其产生重大影响的外部“事件”。有些事件是积极的，有些则是消极的。我将列举我认为值得关注的10个事件。其中4个事件影响了食品和植物检疫辐照，3个事件影响了医疗保健，3个事件影响了科技。这段旅程始于1980年。
活动
- 1980年专家委员会报告。粮农组织、国际原子能机构和世卫组织合作，委托撰写了一份关于辐照食品健康性的专家委员会报告。该报告于1980年10月发布。
食品辐照的概念并非新鲜事物，自20世纪30年代以来就已在某些情况下使用。到了20世纪60年代，一些公司应运而生，利用这一机遇。
专家委员会的成立旨在解决人们的担忧，并评估电离辐射加工对食品营养成分、化学成分和微生物安全性的影响程度。
委员会提出了一系列前所未有的建议，确定任何食品在总平均剂量不超过10 kGy的辐照下都不会产生毒理学危害，而且，不再需要对经过此类处理的食品进行毒理学检测。该报告被认为是一个里程碑，因为它确定了辐照食品健康性的最大吸收剂量。
1984年，三大发起国（粮农组织、国际原子能机构和世卫组织）更进一步，成立了国际食品辐照磋商小组 (ICGFI)，以协助发掘食品辐照的潜力。到20世纪90年代末，ICGFI成员已达48个国家。遗憾的是，这些积极的进展并未取得成果，该倡议最终解散。
- 1987年《蒙特利尔议定书》。《关于消耗臭氧层物质的蒙特利尔议定书》是一项具有里程碑意义的多边环境协定，旨在规范近100种被称为消耗臭氧层物质 (ODS) 的人造化学品的生产和消费。该议定书于1987年9月通过，并获得了全球批准，因此实属罕见。
ODS包括广泛用于环氧乙烷 (EO) 灭菌的氯氟烃 (CFC)。 20世纪80年代，大多数环氧乙烷（EO）工厂使用12/88混合比例——12%的环氧乙烷（EO）和88%的氯氟烃（CFC）。使用氯氟烃是出于
安全考虑。这一变化有可能显著减少环氧乙烷（EO）的加工，从而导致辐照（γ射线）的增加。环氧乙烷（EO）技术仍在使用纯环氧乙烷（Eto），但工艺现在更加复杂，成本也更高。最大的受益者是专业的合同灭菌公司，因为现在很少有医疗器械制造商进行环氧乙烷（EO）加工。
- Rhodotron 1989年。Rhodotron诞生于法国原子能管理局（CEA）提出的概念。第一台原型机由法国原子能管理局（CEA）于1990年制造，并于1991年与IBA签订了独家工业化协议。这代表了对当时直流和射频（RF）系统的重大改进，并为X射线的使用开辟了一条可行的途径。
- 1994年和1995年《无菌保证法规》。1994年和1995年出台了两项重要标准。
第一项是1994年发布的欧洲标准EN556-1。该标准规定，最终灭菌医疗器械的无菌保证水平（SAL）为10⁻⁶。第二项是1995年首次发布的ISO 11137《医疗保健产品灭菌——辐射》。
这些标准要求制造商提供证据，证明先前接受的25 kGy剂量已达到所需的保证水平。这些标准仍在不断更新和扩展。
如今，医疗器械管理局（MDA）要求制造商确保无菌保证专业人员的能力。我将在总结发言中再次讨论这一点。
- 1999年《欧盟食品法规》。这些法规协调了各成员国的食品辐照规则。他们制定了一个共同框架，要求对辐照食品进行明确标识，并批准加工设施。虽然这些规则创造了一个公平的竞争环境，但也造成了巨大的障碍，因为辐照只允许用于有限的食品，主要是干香草和香料。这项禁令极大地复杂化了与依赖辐照作为食品安全措施的非欧盟国家的贸易。
- 2002年和2005年的压力/游说团体。2002年，美国公民组织（Public Citizen）反对食品辐照，强调了对该技术的担忧。该组织通过倡导和鼓励消费者反对食品辐照，积极反对食品辐照。他们声称辐照食品可能被视为受污染，并鼓励人们将其与对核技术的更广泛担忧联系起来。食品与水观察组织（Food and Water Watch）也于2005年成立，该组织也积极反对食品辐照。这些行动非常有效。
- 甲基溴 2005 年和 2015 年。根据《蒙特利尔议定书》，甲基溴因其臭氧消耗潜能值而被国际禁用。发达国家已于 2005 年逐步淘汰其使用，而发展中国家则于 2015 年淘汰。新鲜农产品生物安全要求为植物检疫辐照的大幅增长创造了机会。虽然这一进程尚未如预期般迅速，但亚太地区和美洲地区正在取得进展。
- 2013年美国法规。美国拨款法案草案提议对美国的伽马射线设施进行彻底的限制，这是一项更广泛的倡议，旨在转向替代技术（EB和X）。业界联手反对这些提案，最终法规以《联邦法规》第10卷第37部分的形式制定。重点关注第一类和第二类放射性物质的安全和运输。
- 2014年俄罗斯制裁。2014年，美国对俄罗斯占领的克里米亚实施制裁。近年来，制裁已成为限制或无疑使货物运输复杂化的日益重要的特征。地缘政治事件现在对辐照行业产生了影响。
- 2015年环境协定。2015年通过的《联合国巴黎协定》设定了首个全球气候相关目标和集体应对框架。现有的环境立法体系意义重大，并且每年都在扩展。这些规则对商业和投资产生了深远的影响。
结论和趋势
我提到的每一个要点都对辐照行业的发展产生了影响，有些甚至持续影响着我们的行业。最后，我将重点介绍我认为值得关注的六个问题。
- 食品和植物检疫辐照。了解食品和植物检疫辐照之间的区别至关重要。食品辐照是为了确保食品安全（粮食保障），而植物检疫辐照是为了确保生物安全。食品辐照仍然具有挑战性，而植物检疫辐照正逐渐被广泛接受。当消费者有选择时，他们会购买辐照食品。我们需要支持国际植物检疫标准和规程的制定——国际植物检疫协会 (iia) 正在通过我们的植物检疫辐照平台 (PsIP) 计划支持这项工作。
- 人工智能和数学建模正在创造提高效率的机会，并可能在未来几年产生更大的影响。这将通过国际植物检疫协会的辐射加工科学与工程 (SERP) 计划得到解决。
- 技术，包括安全、拒绝装运和网络安全。 iia 的 Gamma 和 EB/X 工作组积极致力于解决技术问题。
- 环境法规持续产生深远影响，但辐照技术相比环氧乙烷等替代技术更具优势。
- 无菌保证。无菌保证专业人员能力证明的需求正在通过无菌保证专业人员协会 (SfSAP) 得到解决，这是一个合作倡议，iia 在其中发挥着主导作用。
- 地缘政治事件给许多行业带来挑战——辐照技术也未能幸免。关键问题包括制裁、关税和恐怖主义。iia 与世界各地的组织合作，共同应对这些挑战。
参考
- 国际辐照协会 (iia)：iiaglobal.com
- 无菌保证专业人员协会 (SfSAP)：sfsap.org
- 植物检疫辐照平台 (PsIP)：psipglobal.org
- 辐照食品卫生专家委员会：iris.who.int/items/d5df0110-aa69-4121-8047-88a3dffbfd85
- 蒙特利尔议定书：www.unep.org/ozonaction/who-we-are/about-montreal-protocol
- Rhodotron：www.iba-industrial.com/beyond/
- EN 556： knowledge.bsigroup.com/products/sterilization-of-medical-devices-requirements-for-medical-devices-to-be-designated-sterile-requirements-for-terminally-sterilized-medical-devices
- ISO 11137：www.iso.org/standard/81721.html
- 欧盟食品法规：eur-lex.europa.eu/EN/legal-content/summary/foodstuffs-treatment-with-ionising-radiation.html
- 公民公共利益：www.citizen.org/wp-content/uploads/top10.pdf
- 食品与水观察组织：www.foodandwaterwatch.org/wp-content/uploads/2021/06/Food-Irradiation-Gross-Failure-March-2006.pdf
- 甲基溴： www.gov.uk/government/publications/methyl-bromide-properties-and-incident-management/methyl-bromide-general-information
- 10 CFR 第 37 部分：www.federalregister.gov/documents/2016/03/14/2016-05260/physical-protection-of-category-1-and-category-2-quantities-of-radioactive-material
结尾
English: The Development and Trends of the International Irradiation Industry
Paul Wynne, International Irradiation Association, October 2025
Introduction
Rather than talk about the irradiation industry in a traditional way I am going to highlight external ‘events’ that have had a significant impact. Some events are positive others negative. I will reference 10 events that I believe are worthy of note. 4 events impact food and Phytosanitary irradiation, 3 Healthcare and 3 Technology. This journey starts 1980.
Events
1. Expert Committee Report 1980. The FAO/IAEA/WHO collaborated to commission an Expert Committee Report on the Wholesomeness of Irradiated Food. The Report was published in Oct 1980.
The concept of food irradiation was not new having been used in certain situations since the the 1930. By the 1960’s companies were being established to take advantage of the opportunity.
The Expert Committee was commissioned to address concerns and to evaluate the extent to which processing by ionizing radiation may affect the nutritional content, chemical composition, and microbiological safety of food.
In a set of unprecedented recommendations, the committee determined that the irradiation of any food commodity up to an overall average dose of 10 kGy presents no toxicological hazard and, moreover, that toxicological testing of foods so treated was no longer required. The report is recognized as a landmark in that it established a maximum absorbed dose for the wholesomeness of irradiated food.
In 1984 the 3 sponsors (FAO/IAEA/WHO) went further and created the International Consultative Group on Food Irradiation (ICGFI) to assist in unlocking the potential for food irradiation. By the late 1990’s 48 countries were members of ICGFI. Unfortunately, these positive developments did not yield results and the initiative has been disbanded.
2. Montreal Protocol 1987. The Montreal Protocol on Substances that Deplete the Ozone Layer was a landmark multilateral environmental agreement that regulates the production and consumption of nearly 100 man-made chemicals referred to as ozone depleting substances (ODS). The Protocol was adopted in September 1987 and was rare as it achieved universal ratification.
ODS included CFC’s widely used in Ethylene Oxide (EO) sterilisation. In the 1980’s most EO plants used 12/88 mixtures – 12% EO, 88 CFC. The CFC’s were used for
safety reasons. This change had the potential to significantly reduce EO processing hence creating an irradiation (gamma) to grow. EO technology continues using pure Eto but the process is now much more complex and expensive. The biggest beneficiaries were specialist contract sterilisation companies as EO processing is now rarely undertaken by medical device manufacturers.
3. Rhodotron 1989. The Rhodotron was born from a concept developed by the French Atomic Energy Authority. The first prototype was built by the CEA in 1990 which led to an exclusive industrialization agreement with IBA in 1991. This represented a significant improvement on the DC and RF systems that were currently available and introduced a viable route to using X-ray.
4. Sterility Assurance Regulations 1994 & 1995. Two important standards were introduced in 1994 and 1995.
The first was the European standard EN556-1 published in 1994. This specified a Sterility Assurance Level (SAL) of 10⁻⁶ for terminally sterilized medical devices. The second was ISO 11137 – Sterilisation of Healthcare Products – Radiation which was first published in 1995.
These standards required manufacturers to provide evidence that the previously accepted dose of 25 kGy achieved the desired assurance level. The standards continue to be updated and expanded.
Today the MDA requires manufacturers to ensure the competency of Sterility Assurance Professionals. I will come back to this in my concluding remarks.
5. EU Food Regulations 1999. These Regulations harmonized the rules on food irradiation across Member States. They created a common framework that required explicit labelling of irradiated foods and approval of processing facilities. Whilst creating a level playing field the rules have created significant barriers, as irradiation was only permitted for a limited list of foods, primarily dried herbs and spices. This prohibition has significantly complicated trade with non-EU countries who rely on irradiation as a food safety measure.
6. Pressure/Lobby Groups 2002 & 2005. In 2002, Public Citizen (U.S. pressure group) opposed food irradiation emphasizing concerns about the technology. The group aggressively opposed food irradiation through advocacy and by encouraging consumer opposition to food irradiation. They claimed that irradiated food could be viewed as contaminated and encouraged a perceived linkage with a broader concern about nuclear technology. Food and Water Watch, which also actively opposed food irradiation, was established in 2005. These were very effective.
7. Methyl Bromide 2005 & 2015. Methyl bromide was banned internationally due to its ozone-depleting potential, as mandated by the Montreal Protocol. Developed countries phased out their use by 2005, while developing countries by 2015. Fresh produce biosecurity requirements have created an opportunity for a significant growth in phytosanitary irradiation. This hasn’t materialised as quickly as expected but progress is being made Asia Pacific and the Americas.
8. US Regulations 2013. A Draft U.S. Appropriations Bill proposed radical and restrictive on gamma facilities in the US and was part of a wider initiative to switch to alternative technologies (EB and X). Industry collaborated to oppose the proposals and the eventual regulations were set out 10 CFR Part 37. There was a focus on security and transport of Category 1 and Category 2 quantities of radiological material.
9. Russian Sanctions 2014. In 2014 the U.S. imposed sanctions on Russian-occupied Crimea. Sanctions have become an increasing feature life restricting or certainly complicating the movement of goods over recent years. Geopolitical events now have consequences for the irradiation industry.
10. Environmental Agreements 2015. The UN Paris Agreement, adopted in 2015, set the first global climate-related targets and a framework for a collective response. The body or environmental legislation that exist today is significant and expanding each year. These rules are having far-reaching impacts on business and investment.
Conclusions and Trends
Each of the points that I have referenced have had an impact on the development of irradiation industry and some continue to have an impact on our industry. I will end by highlighting 6 issues that I believe are worthy of note.
1. Food and Phytosanitary Irradiation. It is important to understand the difference between food and phytosanitary irradiation. Food irradiation is undertaken to ensure food safety (food security) whilst phytosanitary irradiation is undertaken to ensure biosecurity. Food irradiation remains challenging whilst phytosanitary irradiation is becoming reasonably well accepted. When consumers are given a choice, they buy irradiated food. We need to support the development of international phytosanitary Standards and Protocols – iia is supporting this work via our Phytosanitary Irradiation Platform (PsIP) initiative.
2. AI and Mathematical Modelling is creating efficiency opportunities and is likely more impactful over the coming years. This will be addressed via the iia the Science & Engineering of Radiation Processing (SERP) initiative.
3. Technology this includes the security, denial shipments and cyber security. The iia Gamma and EB/X Working Groups are active in addressing technology issues.
4. Environmental Regulations continue to have far-reaching impacts, but irradiation stands up well against alternative technologies such as Ethylene Oxide.
5. Sterility Assurance. The need to demonstrate the competency of sterility assurance professional is being addressed via the Society for Sterility Assurance Professionals SfSAP which is a collaborative initiative in which iia is playing a leading role.
6. Geopolitical Events create challenges for many industries – irradiation is not immune to these pressures. Key issues include Sanctions, Tariffs and Terrorism. Iia collaborates with groups around the world in helping to address these challenges.
References
- International Irradiation Association (iia): iiaglobal.com
- Society for Sterility Assurance Professionals (SfSAP): sfsap.org
- Phytosanitary Irradiation Platform (PsIP) psipglobal.org
- Expert Committee on Wholesomeness or Irradiated Food: iris.who.int/items/d5df0110-aa69-4121-8047-88a3dffbfd85
- Montreal Protocol: www.unep.org/ozonaction/who-we-are/about-montreal-protocol
- Rhodotron: www.iba-industrial.com/beyond/
- EN 556: knowledge.bsigroup.com/products/sterilization-of-medical-devices-requirements-for-medical-devices-to-be-designated-sterile-requirements-for-terminally-sterilized-medical-devices
- ISO 11137: www.iso.org/standard/81721.html
- EU Food Regulations: eur-lex.europa.eu/EN/legal-content/summary/foodstuffs-treated-with-ionising-radiation.html
- Public Citizen: www.citizen.org/wp-content/uploads/top10.pdf
- Food and Water Watch: www.foodandwaterwatch.org/wp-content/uploads/2021/06/Food-Irradiation-Gross-Failure-March-2006.pdf
- Methyl Bromide: www.gov.uk/government/publications/methyl-bromide-properties-and-incident-management/methyl-bromide-general-information
- 10 CFR Part 37: www.federalregister.gov/documents/2016/03/14/2016-05260/physical-protection-of-category-1-and-category-2-quantities-of-radioactive-material
End