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I. Purpose
目的
To establish guidelines for the administrative control of 1) new process chemicals, 2) on site products, 3) product intermediates, 4) on site waste .
对1）新的化学品、2）产品、3）中间体、4）废物的管理控制而建立的指导性纲领。
II. General
总则
A. Material Safety Data Sheets must be obtained, reviewed and approval obtained before new chemicals can be brought on the site.
在购买新的化学品前，必须获得并审核该化学品的MSDS，同时需得到购买许可。
B. The originator of the requisition is responsible for insuring that an MSDS is available on site or will accompany the shipment before ordering a chemical.
申请购买者在购买前需确保厂内已有该化学品的MSDS或MSDS会随该化学品一起运来。
III. New Chemicals From Vendors
从厂家购买新的化学试剂
A. Prior to ordering any new chemical, the completed new chemical authorization form attached to the MSDS are to be signed by the following:
在购买任何新的化学品之前，一张附带MSDS的新化学试剂购买授权表必须经下列人员签字：
1. Originator
购买者
2. SHE manager/ supervisor
SHE 经理/ 主管
B. The new chemical's vendor MSDS is to be sent to S&OH department who will then add it to the electronic MSDS database and master hard copy file.
新的化学试剂的MSDS须送交给安卫部，其将把该MSDS加入到MSDS电子资料库中并主管硬拷贝。
IV. New On Site Product, Intermediate or Waste Chemicals
新的产品、中间体或废弃化学品
A. Before a new on site product, product intermediate chemical, or new on site waste chemical is manufactured, an on site MSDS must be drafted except for the Health Hazard Information Section. The Corporate Hazard Determination Procedure is to be used to evaluate the hazards of the chemical。
在一种新的产品、中间体或废弃化学品产生之前，必须起草相应的MSDS（健康危害信息这部分除外）。危险程度辨别程序将用来估计该化学品的危害。
B. A new on site product, intermediate or waste MSDS approval form (See Attachment 2) is to be attached to the MSDS and circulated for approval.
附带MSDS的新的产品、中间体或废弃化学品的MSDS授权表（见附表2）需得到诸多部门的批准。
C. The site SHE office will then forward the MSDS to the SBU MSDS Coordinator for the health hazard information section.
然后工厂SHE部门将该MSDS提交给SBU MSDS协调员以获得健康危害信息部分的内容。
V. On Plant Chemicals
厂内化学品
The user of the chemical is responsible either for obtaining the new vendor MSDS or drafting a new or modified MSDS for a DuPont material and sending it to the SHE office when an on site chemical is:
当厂内化学品有如下变动时，化学品的使用者负责从供应商处获得MSDS或拟定一新的或更新的MSDS作为DuPont文件并发给安全部。
o Received or shipped in different concentrations or
接收到不同浓度的或
o Had its OSHA limit, AEL or TLV changed or
化学品的OSHA范围、AEL或TLV发生改变或
o Received or shipped in a different container or
接收到使用不同容器储存的或
o Supplied by a new manufacturer or distributor or
由一新的生产商或经销商供货或
o When any vendor/intermediate health or safety
information has changed or
当任何供应商/中间体的健康或安全信息发生变化或
o When any container/vessel composition has changed.
当容器中组成发生变化。
The SHE office will add the revised vendor/intermediate MSDS to the site's electronic MSDS database and master hard copy file.
安全部将会把修改后的MSDS加入到工厂的电子MSDS信息库中并持有硬拷贝。
VII. Guidelines For Filling Out New Chemical Authorization Form
填写新化学试剂许可表格要领
A. The new chemical authorization form (See Attachment 1) must be filled out and approved before a new chemical can be purchased and used. Use these definitions for filling out the Chronic Hazard Section of the authorization form. The AEL and combined carcinogen lists in the SHE office files are the sources for obtaining this information.
在购买和使用一新化学品前必须填写新化学品许可表格（见附表1）。使用如下定义来填写授权许可表格的慢性危害部分。安全部文件中的AEL和致癌列表是这类信息的来源。
1. The capital letters "C H", "R", "D", and "M" identify chemicals that have undergone a hazard determination and a decision has been made that a special annual employee communication is REQUIRED and must be documented concerning the chemical's carcinogenic, reproductive, developmental, or germ cell mutagenic hazard.
大写字母 “C-H”, “R”, “D” 及 “M” 代表化学品已经过危害评定，有必要进行特殊的年度员工危害沟通，及记录有关化学品的致癌的、生殖的、发育的或生殖细胞突变的危害。
2. The small letters "c", "r", and "m" identify chemicals that have undergone a hazard determination and a decision has been made that a special annual employee communication is NOT REQUIRED, provided that (1) the results of the hazard determination are included with the normal toxicity information available to employees about chemicals in their workplace, and (2) upon completion of the hazard determination, employees shall be notified of the results of that hazard determination.
小写字母“c”、“r”及“m”代表化学品已经过危害评定，没有必要进行特殊的年度员工危害沟通，如果1）危害评定的结果包含在工作场化学品常见毒性信息内；2）危害评定一结束，员工必须被告知危害评定结果。
3. Parentheses (NC), (c), (R), (D), and (M) identify chemicals that have undergone a hazard determination and a decision has been made that no hazard exists.
加括号的（NC）、（c）、（R）、（D）及（M）表示化学品已经过危害评定并表明无危害存在。
4. Haskell's Classification System for Hazard Determinations.
Haskell危害评定分类系统如下：
a. Carcinogen
致癌物
C H KNOWN HUMAN CARCINOGEN
C-H 已知的使人致癌物
Substances which are known to be carcinogenic in humans. There is sufficient evidence, based on epidemiology data, to establish a causal association between exposure to the substance and the development of cancer.
已被认为对人类有致癌作用的物质。必须有充分的证据，以流传病学数据为基础，在在该物质中的暴露和癌的发展之间建立起因果关系。
C A PROBABLE HUMAN CARCINOGEN (POTENT ANIMAL CARCINOGEN)
C-A 很有可能的使人致癌物（动物致癌物）
There is sufficient evidence in one or more adequately conducted studies that the substance is clearly carcinogenic in experimental animals.
在一个或多个的研究中有足够的证据证实该物质对实验动物有致癌作用。
There are no epidemiology data available or the existing epidemiology data are conflicting or limited/insufficient to establish a causal association between human exposure and the development of cancer.
没有流行病学资料或现存的流行病资料与在人类暴露和癌的发展之间建立因果关系不一致的或有限制的。
c POSSIBLE HUMAN CARCINOGEN (WEAK ANIMAL CARCINOGEN OR LIMITED EVIDENCE IN ANIMALS)
可能的使人致癌物（微弱的动物致癌物或在动物身上存在极有限的证据）
There is some or limited evidence that the substance is carcinogenic in experimental animals.
存在一些或极其有限的证据来证实该物质对实验中的动物有致癌作用。
There are no epidemiology data available or the existing epidemiology data are conflicting or limited/insufficient to establish a causal association between human exposure and the development of cancer.
没有足够的流行病资料来证实人类暴露与癌变有关联。
(c) NOT LIKELY TO BE A HUMAN CARCINOGEN (ANIMAL CARCINOGEN UNLIKELY TO HAVE HUMAN RELEVANCE)
不太可能成为使人致癌物质。（ 动物致癌物不一定与人 类有太大
关联）
There is sufficient or limited evidence in experimental animal studies that the substance is carcinogenic at high dose levels (may have exceeded the MTD), by routes of administration, in tissues, or by mechanisms that are not considered relevant to potential human exposure.
在动物实验研究中有足够的或有限的证据证明：物质在高剂量时
（可能超过MTD）有致癌作用，通过服药途径、在组织中不被认为与潜在人体暴露有关联。
(NC) NOT CONSIDERED TO BE A CARCINOGENIC HAZARD TO HUMANS (LACK OF EVIDENCE OF CARCINOGENICITY)
不认为对人类有致癌危害（缺乏类癌瘤证据）
There is evidence from an adequately conducted experimental animal study showing a lack of carcinogenicity.
从一单独进行的动物实验的研究中表明缺乏致癌性。
If any epidemiology evidence exists, it supports the conclusion that there is no known association between exposure and an increase in cancer risk to humans.
如存在任何传染病学证据，其将支持在人类暴露与患癌的机率
增加之间没有明显关联的结论。
b. Development Toxin An agent with the potential to interfere with the development of an individual while in utero or after birth.
发育毒素－干扰个体在母体子宫内或出生后的发育的物质。
Potency is determined by the Developmental Hazard Index (DHI) which is the ratio of the minimum dose toxic to the mother and the minimum dose toxic to the conceptus. Substances or agents with DHIs of greater than 5 are considered potent and are identified on the AEL List by a capital letter D; DHIs of 3 to 5 indicate a less potent substance or agent and are identified on the AEL List by a small letter d; substances or agents with a DHI of less than 3 are not considered developmental toxins and are identified on the AEL List by a D in parentheses, e.g., (D).
其影响能力由发育危险指数来决定（DHI），DHI等于母亲体内的最小毒物剂量与孕体内的最小毒物剂量的比值。DHI大于5的物质被认为有发育能力，
在AEL列表中用大写字母D表示；DHI在3～5之间的物质被认为有较小的
发育能力，在AEL列表中用小写字母d表示；DHI小于3的物质不认为是
发育毒素，在AEL列表中用带括号的大写字母D表示，如（D）。
c. Reproductive Toxin An agent with the potential to affect adversely the reproductive process of adult males and/or females.
生殖毒素－一对成人男性和/和女性的生殖功能有负面影响的物质。
Potency is determined as follows:
其影响能力有以下方面决定：
o Reproductive toxicity occurred at a dose level considerably below that resulting in other signs of toxicity. These substances or agents are considered potent and are indicated on the AEL List by a capital letter R. Male or female will also be indicated if reproductive toxicity occurred only in one sex.
生殖毒素以低于引起其它症状毒素的剂量水平存在。这些物质被认
为具备生殖能力，在AEL列表中用大写字母R表示。
o Reproductive toxicity occurred at a dose level at or just below that resulting in other signs of toxicity. These substances or agents are considered less potent and are identified on the AEL List by a small letter r. Male or female will also be indicated if reproductive toxicity occurred only in one sex.
生殖毒素以等于或正好低于引起其它症状毒素的剂量水平时。这些物质被
为人具有较低的生殖能力，在AEL列表中用小写字母r表示。如生殖毒素仅以一种性别存在，则同时需用雌雄性表征。
o If reproductive toxicity occurred, but only at a dose level considerably greater than that resulting in other signs of toxicity, these substances or agents are not considered reproductive toxins and are identified on the AEL List by an R in parenthese, e.g., (R).
如果存在生殖毒素，但仅当其剂量水平大于引起其它毒素时，这些物质不
认为是生殖毒素，在AEL列表中用（R）表示。
a. Germ Cell Mutagen A genotoxic agent with the potential to cause permanent heritable damage in germ (reproductive) cells of exposed individuals. A substance is identified as a mutagen if it is:
生殖细胞诱变剂－一潜在的生殖毒害剂会导致暴露个体的生殖细胞发生永久性遗传伤害。有如下症状即被认为时诱变剂：
o A proven human germ cell mutagen,
一已被证实的生殖细胞诱变剂，
o Positive in a mammalian in vivo germ cell assay for gene mutations or chromosome aberrations, or
在哺乳动物体内生殖细胞的基因突变或染色体畸变试验中呈阳性的，或
o Positive in a mammalian in vivo somatic (non reproductive) cell assay for gene mutations or chromosome aberrations, and, in addition, the substance is either positive in a mammalian in vivo germ cell assay for DNA damage and repair, or is identified on the AEL List as a reproductive toxin.
在哺乳动物体内非生殖细胞的基因突变或染色体畸变试验中呈阳性的，或
该物质在哺乳动物体内生殖细胞的DNA损坏和修复试验中呈阳性，或在
AEL列表列为生殖毒素。
In evaluating experimental studies in mammals, the following factors are considered.
在评估哺乳动物试验研究中，应考虑如下因素：
o The experimental design and route of administration.
试验设计和给药路线。
o The dose required to produce genotoxicity.
导致生殖毒害所需的剂量。
o The magnitude of the genotoxic response and the presence of a dose response relationship.
生殖毒害反应程度与所需反应剂量间的关系。
o The general concordance of positive findings among different germ cell genotoxicity assays (if known).
在不同的生殖细胞毒害试验中呈阳性的物质的一些共性（如知道）。
o The genetic endpoint assessed (gene mutations, chromosome aberrations, DNA repair).
评估生殖终点（基因突变、染色体畸变、DNA修复）。
Potent mutagens are identified on the AEL List by a capital letter M whereas less potent mutagens receive a small letter m. Agents not considered to be mutagens are identified by a capital letter M in parentheses, e.g., (M).
在AEL列表中生殖诱变剂用大写字母M表示，而程度小的生殖诱变剂用小写字母表示。没有被证实为诱变剂的物质用（M）表示。
Potent germ cell mutagen categorization M is primarily applied to:
生殖细胞诱变剂的M类应用于如下：
o Proven human germ cell mutagens, or
证实人类生殖细胞诱变剂，或
o Experimental mammalian germ cell mutagens with a strong evidence of causing genotoxic damage in humans.
存在强有力的证据证实对哺乳动物生殖细胞的毒害。
In general, validated germ cell mutagens in experimental mammals receive a small letter m.
概括的讲，被证实的试验哺乳动物生殖细胞诱变剂用小写字母m表示。
Contact the SHE office if questions arise.
如有问题，请与安全部联系。
ATTACHMENT 1
附表1
AUTHORIZATION FOR PURCHASE
AND/OR USE OF A NEW CHEMICAL
购买或使用新化学品的授权
Division部门: Area区域:_________________________
The hazards of this chemical have been evaluated and the precautions
outlined below provide adequate control.
该化学品的危害已被评估，以下罗列的预防措施将提供充分的控制。
Name and Composition of Chemical: __________________________________
化学品名称和组成：
Quantity to be Purchased: Quantity to be Used:__________
购买的数量： 使用的数量：
Proposed Use:_______________________________________________________
计划使用情况：
Estimated Personnel Exposure (hrs/week):____________________________
估计的个人暴露量（小时/星期）：
Exposure Limit (ppm, mg/M3, other) as AEL, TLV, OSHA:_______________
暴露极限（ppm、mg/M3、其它），如AEL、TLV、OSHA：
Chronic Hazards:
慢性危害：
A. Carcinogenic Health Effects致癌信息
1. AEL Designation (circle one) 2. Comments
AEL命名（选择其中之一） 备注
"C H" c "C A" N/A
B. Reproductive Toxin 生殖毒害
1. AEL Designation (circle one) 2. Comments
R r N/A
C. Developmental Toxin (circle one)发育毒害
D d N/A
D. Germ cell Mutagen Toxic生殖细胞诱变剂毒害
M m N/A
MSDS Attached: (circle one) 1. Yes 2. No
是否附带MSDS：
Environmental: Biodegradability: WWTP Inhibition ___________
环保：生物降解：_____ WWTP抑制作用：________
Aquatic Toxicity LC50:________________________________
水生物毒性LC50：
Waste Disposal Means:_________________________________
废料处置方法：
Approval and Authorization:
批准及授权：
1. Originator __________________ 2. SHE_________________
提出人 安全部
Date Approved
授权日期 __________________
ATTACHMENT 2
附表2
NEW ON SITE INTERMEDIATE / PRODUCT / WASTE
MSDS APPROVAL FORM
新的中间体/产品/废料的MSDS授权表
Division: _________________________________________________________________
部门
Area: _________________________________________________________________
区域
Chemical: _________________________________________________________________
化学品
Approval and Authorization
批准及授权
1. Originator ___________________________________________
提出人
2. SHE ___________________________________________
安全部
Date Approved __________________________________________
批准日期 |
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发表于 2010-5-12 12:46
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发表于 2010-5-12 16:18