全屏显示专题章节

With the help of dedicated food safety funding, FDA—particularly, its Office of Regulatory Affairs—has been able to step up its efforts to ensure that FDA-regulated products comply with the consumer protection laws and regulations enforced by the agency.For example, in FY2000, FDA conducted about 5,700 food inspections for products at “high risk” of microbiological contamination, a 90 percent increase from its 3,000 such inspections for FY 1999.With respect to on-site inspections of foreign food establishments to complement inspections of incoming food at the U.S.border, FDA undertook 165 in FY 2000, nearly double the number in the previous fiscal year.

Sprouts and eggs saw considerable progress in safety measures in FY 2000, as did juice and dairy products and other foods, whether produced in the United States or in other countries.Samples of standout accomplishments follow:

● Steps for Safer Eggs

Recognizing egg safety as a public health issue warranting immediate federal interagency action, FDA, in partnership with USDA and CDC, developed an “Egg Safety Action Plan”, which was announced in December 1999.The joint FDA/USDA action plan identified practices to be implemented to achieve a reduction and ultimately an elimination of eggs as a source of human Salmonella enteritidis (SE)illness.An interim goal of the egg safety action plan is a 50 percent reduction in egg-associated SE illnesses by 2005.

“It’s an important foodborne illness to address,” says John Sheehan, Director of CFSAN’s Division of Dairy and Egg Safety.“Reducing the frequency of these illnesses will have a tremendously positive impact on society.That many more people will be at work, productive and healthy.”

After holding two public meetings and considering stockholder input, in July 2000, FDA and the USDA’s Food Safety Inspection Service (FSIS)made available the agencies’ “Current Thinking Papers” on national standards for egg safety and met with representatives from industry, academia and consumer groups to discuss whether the documents represented the most effective approach to carrying out the Egg Safety Action Plan.

The first rule to come out of these FY 2000 steps, a rule that requires shell eggs to carry safe handling statements and to be refrigerated under specific conditions at retail establishments such as grocery stores, nursing homes and restaurants, was published in December 2000.Specifically, the safe handling instructions state, “To prevent illness from bacteria:keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” The refrigeration portion of the rule requires that eggs be placed promptly under refrigeration at 45 degrees Fahrenheit or lower upon delivery at retail establishments.

“You can get a pretty bad case of illness from a relatively low dose of the organism, so refrigeration is needed to preclude the rapid growth of Salmonella,” Sheehan explains.“It’s a worthwhile effort that is supported by the egg industry and marks another important step toward eliminating egg-associated Salmonella enteritidis.”

1.Farm-to-Table Initiatives for Safer Domestic, Imported Food

标题可译为：为了获得更加安全的国产和进口食品而采取的由农场到餐桌的（保障）行动

2.With the help of dedicated food safety funding, FDA—particularly, its Office of Regulatory Affairs—has been able to step up its efforts to ensure that FDA-regulated products comply with the consumer protection laws and regulations enforced by the agency.

本句比较长，主要句子成分是FDA has been able to step up its efforts，译为：FDA有能力加强其（执法）力度。

主语 FDA 和谓语 has been able to step up之间用破折号分隔开的名词性短语particularly， its Office of Regulatory Affairs （特别是它下属的法规事务处）是FDA的同位语。

to ensure that FDA-regulated products comply with the consumer protection laws and regulations enforced by the agency中，to ensure 是一个不定式短语表示目的：以确保。that FDA-regulated products comply with the consumer protection laws and regulations enforced by the agency中的that 引导的是一个宾语从句，表示确保的内容，可译为： FDA管理的产品符合消费者保护法及FDA已生效法规。

With the help of dedicated food safety funding是一个介词短语，表示伴随状态，可译为：在食品安全专用基金的支持下。

全句可译为：在食品安全专用基金的支持下，FDA，特别是其下属的法规事务处，得以加强其执法力度，确保该机构管理的产品符合消费者保护法及该机构已生效的法规。

3.For example, in FY2000, FDA conducted about 5,700 food inspections for products at “high risk” of microbiological contamination, a 90 percent increase from its 3,000 such inspections for FY 1999.

全句可译为：例如：在2000财政年度，FDA对有“高风险性”受微生物污染的食品进行了5 700次检查，与1999财政年度的3 000次检查相比较，有了90%的增长。

4.on-site inspections 现场检查

5.FDA undertook 165 in FY 2000, nearly double the number in the previous fiscal year.

全句可译为：FDA在2000财政年度进行了165次检查，其次数比上一财政年度翻了一翻。

6.Sprouts and eggs saw considerable progress in safety measures in FY 2000, as did juice and dairy products and other foods,

本句是一个倒装句，正常的语序应该为：We saw considerable progress in sprouts and eggs safety measures in FY2000， just as we saw in juice and dairy products and other foods.

由于两个句子的谓语动词都是see，为了避免重复，用did 代替 see，使得句子变得简练。

全句可译为：正像在果汁、奶制品和其他食品安全方面取得的进步一样，在2000财政年度，甘蓝类蔬菜和蛋类的安全方面取得了显著的进步。

7.Recognizing egg safety as a public health issue warranting immediate federal interagency action, FDA, in partnership with USDA and CDC, developed an “Egg Safety Action Plan”, which was announced in December 1999.

Recognizing egg safety as a public health issue warranting immediate federal interagency action 是一个分词短语做状语，分词 recognizing 的逻辑主语和句子的主语相同，都是FDA，代替了状语从句When FDA recognized egg safety as a public health issue warranting immediate federal interagency action。warranting immediate federal interagency action 是一个分词短语，在句子中代替了一个定语从句，修饰issue。a public health issue warranting immediate federal interagency action可译为：一个需要联邦政府有关机构立即共同采取措施的公共卫生问题。

整个句子的主要结构是：FDA developed an “Egg Safety Action Plan” （FDA制定了一个“蛋品安全行动计划”）。in partnership with USDA and CDC 是一个介词短语，做状语，表示FDA开展活动的方式，即FDA，在美国农业部和疾病控制中心的参与下，制定了一个“蛋品安全行动计划。which was announced in December 1999是一个非限制性定于从句，对整个句子进行补充说明。

全句可译为：当认识到蛋品安全是一个需要联邦政府多个部门立即共同采取措施的公共卫生问题，FDA，在美国农业部和疾病控制中心的参与下，制定了一个“蛋品安全行动计划”，该计划于1999年12月公布。

8.to achieve a reduction and ultimately an elimination of eggs as a source of human Salmonella enteritidis (SE)illness.

to achieve 不定式引导的一个目的状语，可译为：以期达到减少并最终消灭蛋源（因素）引起的人类肠道沙门（氏杆）菌疾病。

9.It’s an important food-borne illness to address.

句中address 是动词，意为“处理，对付，解决”。

10.After holding two public meetings and considering stockholder input, in July 2000, FDA and the USDA’s Food Safety Inspection Service (FSIS)made available the agencies’“Current Thinking Papers” on national standards for egg safety and met with representatives from industry, academia and consumer groups to discuss whether the documents represented the most effective approach to carrying out the Egg Safety Action Plan.

本段就是由一个长句组成，理解起来比较吃力，其主、谓语分别是：FDA and the USDA’s Food Safety Inspection Service （FSIS）made available ...and met with （FDA与美国农业部食品安全检查局使得……成为可能，并会见了……）。After holding two public meetings and considering stakeholder input 是一个动名词短语，代替了状语从句After FDA and FSIS held two public meetings and considered stockholder input（在FDA和FSIS 举行两次公开会议和考虑了股东们已投资金之后……）。

该状语从句表示的动作发生在谓语之前，因此常用分词的完成时来表示：Having held two public meetings and considered stockholder input。

made available the agencies’“Current Thinking Papers” on national standards for egg safety agencies指的是FDA和FSIS的做法。papers意为“论文，文章”；thinking原意为“想法”，此处可引伸为“意见”；Current Thinking Papers指“目前意见文件”。拟定了关于蛋品安全全国标准的“目前意见文件”。met with representatives from industry， academia and consumer groups，可译为：会见了来自（生产）企业、学术界和消费者代表。the most effective approach to carrying out the Egg Safety Action Plan句中，approach是名词，意思是“方法”。其后的 to 是介词，后跟的 carrying out 是动名词。

全句可译为：在举行两次公开会议和考虑了股东们的投资之后，FDA与美国农业部食品安全检查局拟定了关于蛋品安全全国标准的“目前意见文件”并会见了来自（生产）企业、学术界和消费者代表群体，讨论这些文件制定的办法是否能最有效地实行“蛋品安全行动计划”。

11.The first rule to come out of these FY 2000 steps, a rule that requires shell eggs to carry safe handling statements and to be refrigerated under specific conditions at retail establishments such as grocery stores, nursing homes and restaurants, was published in December 2000.

本句较长，主语是The first rule，谓语是was published：第一项法规是在2000年12月颁布的。a rule that requires shell eggs to carry safe handling statements and to be refrigerated under specific conditions at retail establishments such as grocery stores， nursing homes and restaurants是对2000年12月颁布的法规进行进一步的说明：是一项要求带壳蛋带有安全处理的说明，并要求杂货店、护理院及餐馆等零售企业按规定的条件对蛋品进行冷藏。

12.The refrigeration portion of the rule requires that eggs be placed promptly under refrigeration at 45 degrees Fahrenheit or lower upon delivery at retail establishments.

the rule requires that eggs be placed是一个虚拟的宾语从句，句中省略了情态动词 should。完整的表达应为：the rule requires that eggs should be placed ...

全句可译为：法规中有关冷藏部分要求蛋品在从零售企业购买来后（进货后），应及时放置于华氏45度以下的环境中。

1.In FY2000, FDA conducted about 5,700 food inspections for products at “high risk” of microbiological contamination, __________ increase from its 3,000 such inspections for FY1999.

A.that was a 90%　B.which was a 90%　C.a 90%

2.Sprouts and eggs saw considerable progress in safety measures in FY 2000, __________ juice and dairy products and other foods.

A.so as　B.so did　C.such as

3.“It’s an important foodborne illness to __________,” says John Sheehan, Director of CFSAN’s Division of Dairy and Egg Safety.

A.emphasize　B.tell　C.be addressed

4.The first rule to come out of these FY 2000 steps was a rule that requires shell eggs to carry safe handling statements and __________ under specific conditions.

A.to be refrigerated　B.being refrigerated　C.to be refrigeration

5.You can get a pretty bad case of illness from a relatively low dose of the organism, so refrigeration is needed to __________ the rapid growth of Salmonella.

A.stop　B.speed up　C.slowing down

The significance of this advance:“Without a system of testing sprouts prior to1selling them on the market, there was no guarantee2that there weren’t pathogens in the sprouts,” says Charles Sizer, Ph.D.3, Director of the National Center for Food Safety and Technology (NCFST).An FDA guidance document based on the scientific development, titled “Guidance for Industry:Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production,” became available in FY 2000, as did a more general guidance document on “Reducing Microbial Food Safety Hazards for Sprouted Seeds”.

Notes：1.prior to 在……之前　2.guarantee 保证、担保

3.Ph.D.[拉] Philosophiae Doctor = Doctor of Philosophy 哲学博士

一、美国FDA的历史背景

19世纪，药品在美国只有在州一级监管，联邦政府不监管。1813年美国通过了免疫法案，1862年美国FDA从属农业部，是农业部中的一个化学部门，当时只有一名化学家，所有研究都在这部门进行。1887—1902年农业部出版了关于农产品污染监管法例，鼓励一些志愿者参加对污染产品试验。1901年美国农业部属下的化学部门改名为化学局。1906年，针对当时药品管理较松，假劣药较多的情况，美国国会通过了《食品药品法》立法。1937年发生磺胺酏剂事件，致死105人。为此，1938年美国重新修订《食品药品法》，强调药品应安全无毒。50年代末至60年代初的“反应停事件”被称为20世纪最大的药物灾难，迫使许多国家重新修订药品法规。美国于1962年第三次修订了《食品药品化妆品法》。也就是说美国的药品管理立法已有近百年历史。美国药品立法与修改都是适应了市场经济发展的需要。

二、美国FDA组织机构与职能简介

美国食品药品管理局（Food and Drug Administration）是美国历史最悠久的保护消费者组织之一。FDA有员工9 000余人，分布在美国167个城市。FDA与美国公众的生活紧密相关，其每年监督管理的产品价值超过1万亿美元。每个美国纳税人每年大约花费3美元用于FDA的正常运行。

FDA的职责简单明确：帮助安全有效的产品（供人和动物使用的药品、生化产品、医疗器械、化妆品和有放射性的消费品）尽快上市并继续监测产品上市后的安全性，以促进和保护公众健康，并帮助公众获得能改善他们健康的药物和食物的精确、科学信息。

1.FDA职责可划分为5个方面

（1）新产品上市前的审评

（3）制订标准及法规

FDA是一个相当庞大的机构，划分的8个办公室和中心之间的工作既相互独立又紧密配合，共同履行FDA的各项职责。

（1）局长办公室

（2）生物制品评估与研究中心

（3）药品审评与研究中心

（4）食品安全与营养中心

（5）医疗器械与放射性产品健康中心

（6）国家毒理学研究中心

（7）监督管理办公室

3.FDA各派出机构主要职责

为确保FDA相关法规的正确执行，FDA在全国各地建立了许多派出机构。各派出机构的人员数量约占FDA总人数的三分之一，是FDA履行职责和掌握情况的重要部门。目前FDA分别在美国中部、东北部、东南部、西南部及太平洋区设立5个地区办事处（regional office）及13个药品检验所。每个地区办事处管理若干个辖区办事处（district office），共有19个辖区办事处。每个辖区办事处可下设几个监督检查站，共有135个监督检查站。

（1）日常事务管理处

（2）法规监督处

（3）进口事务管理处

（4）国内检查稽查处

FDA绝大部分员工在其总部工作，仅有三分之一员工在各派出机构。这种强调大中央、小地方的组织机构与其职能分配是紧密相关的。

当前世界各国存在着各种各样的药品、食品、化妆品监督管理模式。应该说，各种监督管理模式都有自已的优点与缺点，有产生这种管理模式的时代背景与历史背景。但从分析可以看出，美国FDA的这种监督管理模式确有其一定的优点，因此，这种管理模式正在越来越多的国家中得以推行。如何更好地对美国FDA管理模式进行综合分析，更好地洋为中用，更好地保证我国药品监督管理工作的高效运转，应该引起我们的高度重视。